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2019 Vol. 1
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Skeleton key
How glass opens the door for new implantable devices
Light touch
Creating new possibilities
with flexible photonics
Go digital
The FDA regulation changing
the future of the industry
From the editor
On reflection
T
here is a famous scene in the 1967 film The Graduate, where a family
friend takes aside Benjamin Braddock, played by Dustin Hoffman, and
On the web... whispers to him, “Plastics… There’s a great future in plastics.” This seems
Find the latest features, market odd today, particularly in light of increasing concerns about sustainability, but
analysis and supplier information at at the time this material was new and exciting.
www.medicaldevice-developments.com If film-makers had been able to see into the future, they would have
Medical Device Developments inevitably made a reference to the digital age in which we find ourselves today.
Vol. 1 2019 An age where new technologies are transforming a number of industries, not
Editorial least medical devices, where there is an ever-increasing number of possibilities
Editor Emma Green to improve efficiencies in manufacturing, create more advanced devices and
emmag@compelo.com
Chief sub-editor Thom Atkinson address unmet health needs, all of which we explore in this issue.
Sub-editor Todd Palmer
Senior feature writer Greg Noone
We investigate the use of new materials, such as using glass for implantables,
Feature writers Tim Gunn, Will Moffitt which we dive into with Professor Julian Jones from Imperial College London
Production manager Dave Stanford
Group art director Henrik Williams on page 102. We also find out about potential medical devices made through
Designer Martin Faulkner
the use of flexible photonics that are capable of bending and stretching in a
Commercial discussion with MIT associate professor Juejun Hu on page 57.
Client services executive Derek Deschamps
Division sales manager Martin John
In addition to widening opportunities for devices, the definition of what
Publication manager Steve Norris constitutes a device is also expanding. This has resulted in more companies
steve.norris@compelo.com
Subscriptions marketing manager Dorothy Musariri entering the market, with unique offerings and new ways of working. The
Publisher William Crocker
means with which consumers are interacting with devices is also shifting, where
they can now be active agents, rather than passive patients, with regard to their
care. We discuss these issues with Sundeep Karnik and Matt Singer from ZS in
Medical Device Developments is published by Compelo,
light of the new FDA regulation on ‘software as a medical device’ on page 12.
Registered in England No. 09901510.
These advances all demand greater engagement between humans and
John Carpenter House,
John Carpenter Street London, EC4Y 0AN, UK
technology, both inside and outside the body. It’s an exciting time for the
Tel: +44 207 936 6400 industry and I am thrilled to be able to provide a platform for stimulating
www.compelo.com
www.medicaldevice-developments.com discussions and debates on these topics.
ISSN 1747-9610 © 2019 Compelo.
All rights reserved. No part of this publication may be Emma Green, editor
reproduced, stored in a retrieval system or transmitted in any
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Contents
In this issue
Cover story
102
20
10 News & numbers
The headlines and vital statistics
19 A test of character
Wickham Laboratories
27
disadvantages of insourcing versus
outsourcing in manufacturing.
impacting the market. However, recently, companies
20 Change on the horizon have become more interested in
Regulatory With uncertainty around Brexit new ways of working. Within the
12 Your own devices and what it means for the NHS, it is UK this has taken the form of
The FDA plans to develop a new easy to have missed some important partnerships with Academic Health
regulatory framework for reviewing signals that support the greater use Science Networks in order to
‘software as a medical device’. of structured data within the health capitalise on the expertise of
Aiming for a more ‘streamlined’ service. Global Medical Device academia and industry.
review, it has updated the software Nomenclature Agency’s Mark Wasmuth
pre-certification pilot programme outlines how medical devices can be 31 Using stock components can
and a working model of this will more accurately identified. reduce time to market
soon be released. Emma Green Qosina
speaks to Sundeep Karnik and 25 Strategic medical writing
Matt Singer from ZS about the for device submissions 33 Advanced photochemical
implications of this new regulation Trilogy Writing & Consulting etching solutions
for the industry. Micrometal
Contract manufacturing
16 Navigate the regulations 27 Act together 35 The art of science
for in vitro devices There has been ongoing debate Developing a metal medical
NSF about the relative merits and device requires balancing a budget,
deadlines, design considerations and from industry and academia. Ben industry 4.0, manufacturers have
more. In light of rapid technological Wicks from Team Consulting speaks begun to explore a wide range of new
advances, deciding upon the best to Emma Green about the status technologies. Karen Taylor, director
process to maximise manufacturing of sustainability within medical of the Centre for Health Solutions
efficiencies can be challenging. device manufacturing. at Deloitte, speaks to Emma Green
about how to best implement these
38 Myopic medicine 42 Your perfect technologies into manufacturing
In order to achieve sustainability in moulding partner processes to maximise efficiency
manufacturing operations, it needs Accumold while minimising cost.
to be incorporated in all stages of
the supply chain. One key aspect is Manufacturing technology 48 Connect the bots
obtaining sustainable components 43 Break the fourth wall Collaborative robots, or cobots, are a
from eligible suppliers. Recently, this Since we entered the fourth age of new class of robots that are bridging
topic has gained greater attention the industrial revolution, known as the gap between fully manual
assemblies and fully automated
manufacturing lines. Lightweight,
¨¡®£¤¤န
flexible, easily programmable and safe
to implement, collaborative robots
can meet some of the challenges
associated with these processes in
an efficient and effective way. Astrid
Weiss of the Vienna University of
Technology speaks to Emma Green
about how best to integrate these
cobots into manufacturing processes.
64 Produce customised silicon, which, though the cheapest speaks to Lan Yue, assistant professor
medical devices material available, is not the most of research at USC, about the
TRUMPF efficient. Now, a team of engineers potential of this technology for
at the Massachusetts Institute of medical device manufacturers.
Electronics Technology has developed a new way
66 Smash the ultrasound barrier to fabricate ultra-thin semiconducting 81 B is for bonding
Scientists at the University of British films made from a host of exotic DATA MODUL
Columbia, Canada, have developed a materials. Michael Shaw talks to
portable ultrasound device that can Jeehwan Kim, the class of 1947 Microelectronics
connect to a smartphone and costs career development assistant 82 The power to succeed
only $100. The new transducer can professor in the departments of In vivo networking (IVN) is a
be used to look at any part of the mechanical engineering and materials novel approach to powering – and
body producing instant and clear science and engineering, about the communicating with – implanted
images. Research lead Carlos Gerardo potential applications of this research. medical devices. Jim Banks talks to
talks to David Callaghan about the assistant professor Fadel Adib, one
potential for this new device, which 75 Negotiate the MDR checklist of the researchers involved in an
includes patients wearing it for RECOM Power IVN project at MIT, about how
monitoring purposes. the research could bring about a
76 Next evolutionary step paradigm shift.
71 Decrease work pressure, Thanks to bioelectronics, devices are
improve patient well-being starting to replace drugs for a wide Materials
and gain insight range of conditions. Bioelectronic 85 The shape of things to come
Fujitsu medicine explores how targeted Tim Gunn talks to Dr Andrew Weems
electrical signals can harness the of the University of Birmingham,
72 The heart of the problem body’s natural mechanisms to diagnose Professor Lorenzo Moroni of
The vast majority of semiconductors and treat a range of diseases, helping Maastricht University, and Dr
in medical devices are made from the body heal itself. Emma Green Christophe Marquette of Lyon’s 3D
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Contents
112
of sustainable electronic materials, Although the use of plasma treatments
which may lead to a greener future in for medical device coatings has
biomedical and environmental sensing. been around for some time, in recent
Alexander Smith, a biomedical years it is enjoying something of a
engineering PhD student and the renaissance. Andrew Tunnicliffe talks
founder of the start-up e-Biologics, with Professor Denis Dowling about
speaks to Abi Millar about the value its potential and its limitations.
of these materials for medical devices. Packaging
115 Coat with confidence 130 Many hands make light work
97 The right design choices Formacoat The global market for sustainable
have lasting implications packaging is rapidly developing.
Lapp Tannehill 117 A point well made However, medical device companies
Argon Medical are still lagging behind their
99 Medical devices – it all comes counterparts. Peylina Chu, executive
down to the wire Microfluidics director of Healthcare Plastics
Sandvik 118 Cancer detector Recycling Council, discusses key
Cancer DNA changes in response to principles to consider in bringing the
101 Catheter safety and its environment, favouring alterations medical device industry up to speed.
performance with tie layer that help it survive long term. These
Zeus include large and small changes, and 135 Seal the deal
the latter can be almost invisible. Atlas Vac Machine
Biomaterials Chrissy O’Keefe and a team at Johns
102 Glass healing Hopkins University have created a 137 Design outside of the box
Bouncing, bending and bonding to digital microfluidics platform to help Brentwood
bone, glass is looking more and more detect these changes. She talks to
like a miracle material. The liquid-like Kerry Taylor-Smith about how this Logistics
solid is showing its worth in everything technology could revolutionise 138 Chains of command
from healing wounds to replacing cancer detection. Heavy regulation from design to
intervertebral discs. Tim Gunn talks delivery can make optimising the
to Professor Julian Jones of Imperial Filtration & fluid control logistics process highly challenging.
College London and Professor Aldo 123 Liquid flow Kim Thomas talks to Bruce J Stanley,
Boccaccini from the University of A number of disposable sensors are president-principal at the Stanley
Erlangen-Nuremberg about the now available to monitor fluid control East Consulting Group, about key
properties of bioactive glass that make in medical devices and these tend strategies designed to maximise the
it so valuable for medical devices. to be low-cost because there are efficiency of logistics procedures.
no electronics located in the sensor.
107 Patented textile- IVAM CEO Dr Thomas R Dietrich 141 Considerable care from
forming technologies discusses the potential of these origin to destination
Secant Group sensors for mobile and point- Turkish Cargo
of-care diagnostics.
Motors & motion control 142 Your cargo is special
108 Make it stick 127 Cutting-edge AirBridgeCargo
When choosing a motor, the need porous solutions
to balance multiple factors such as Porex 144 Product showcase
80,396
Number of citizens from 27 European countries that contributed
to the 2012—17 Eurobarometer data on robots.
Gnambs and Appel
$52 billion
support these decisions. It is estimated that by payers. The second barrier is the
these mistakes account for almost 60% of all requirement of more data about the risk
medical errors and result in an estimated to patients of such technologies. The degree
40,000–80,000 deaths each year. AI offers to which a software product comes with Projected amount saved by AI by 2021.
huge potential to reduce this error rate by information that explains how it works and Becker’s Healthcare
51%
The number of
med-tech companies
implementing new
business models.
71%
Those who
believe that
healthcare
providers and clinicians are not
ready to use data generated
The estimated increase in value of the internet of medical things
from connected medical devices.
market, by region between 2017-22
50 -
45 ■ 22017:
017:
7: total
t $40
$4
40
4 0 billion 51
67%
44
40 - ■ 22022:
02
02 total $158
$158 billion
billion
IIncrease
In
nc of $118 billion
lio
ion
30 -
Billions ($)
Those who
20 -
believe that 13
12
11
the regulatory 10 - 9 9
Med-tech companies are transforming from innovative product suppliers to insightful partners
A
s technology continues to advance all Use of SaMD is continuing to increase. It can be
facets of healthcare, software has become used across a broad range of platforms, including
an important part of products and is medical device platforms, commercial off-the-shelf
now integrated widely into digital platforms serving platforms and virtual networks, to name a few. Such
a range of purposes. Software as a medical device software was previously referred to by the industry,
(SaMD) is one of three types of software related international regulators and healthcare providers as
to medical devices. The other two types include ‘stand-alone software’, ‘medical device software’ or
software that is integral to a device, and software ‘health software’, causing considerable confusion.
used in the manufacture or maintenance of a Due to the rapid evolution of devices based on
medical device. It is the former that is associated this technology, the FDA has recently taken action
with the most uncertainty, as it’s a relatively new to modernise its approach to regulation. It released a
technology and has less clearly defined boundaries ‘digital health innovation action plan’, involving piloting
than the other types. a new digital health recertification programme to
ensure that patients are able to have access to safe this,’” says Karnick. “If you have thought about it
and effective devices as quickly as possible. carefully, done all that homework and brought the
These changes by the FDA have been a long time right information to the FDA, the process should,
coming, with the former 510(k) process having been technically, go faster.”
in place since 1976. This was heavily based upon
the concept of substantive equivalence, the idea of “Companies will be forced to think more deeply
a new device being sufficiently similar to an existing
about how either a physician or a patient lives
one – a predicate device. If this could be supported
by data, this provided manufacturers with a fast-track with a particular device.”
to market. “While that worked for a lot of medical Sundeep Karnik
devices, over the past few years, as innovations have
been coming to market, especially around software These new regulations mean that manufacturers
and digital services, this has pushed the limits of need to think differently about the products that
what the original intent was,” explains Sundeep they want to bring to market. “I think something the
Karnik, a consultant at ZS.
A new approach
The FDA’s Total Product Life-cycle (TPLC) approach enables the evaluation and
monitoring of a software product from its pre-market development to post-market
performance, along with continued demonstration of the organisation’s excellence.
Excellence appraisal
Identifying the objective criteria and methodology that the FDA will use to pre-certify
a company and decide whether a company can keep its pre-certification status.
The FDA is currently basing the pilot programme’s criteria on five excellence
principles: patient safety, product quality, clinical responsibility, cybersecurity
responsibility and proactive culture. The FDA is currently considering two levels of pre-
certification based on how a company meets the excellence principles and whether it
has demonstrated a track record in delivering safe and effective software products.
Review determination
Developing a risk-based framework so that a pre-certified company can determine
the pre-market review pathway for their products. Potentially pre-certified companies
could market their lower-risk devices without FDA pre-market review, or only a
streamlined pre-market review, based on the company’s pre-certification level and
international medical device regulators forum (IMDRF) risk categorisation.
The FDA is planning to leverage the IMDRF framework to help determine the risk
past. “Companies will be forced to think more categorisation of an SaMD product, incorporating information about the medical
deeply about how either a physician or a patient purpose of the SaMD and the seriousness of the medical condition that the SaMD is
intended to treat.
lives with a particular device,” says Karnick. “Digital
The FDA is also considering appropriate means to educate patients and providers
and software-based solutions imply a fundamentally about the pre-market review and post-market monitoring obligations for each SaMD
different engagement model, one which is integral risk category.
to the effectiveness of the device.”
Streamlined review
This involves identifying the type of information that a pre-certified company would
Time to get engaged include in its pre-market submission for the FDA to review software products for safety
Historically, most devices have been relatively and effectiveness before patients access them.
passive, and those that have been interactive The FDA is exploring using an interactive streamlined review of a SaMD with
have been limited in their scope. In contrast, information the agency has already gained from the process to pre-certify a
company, and additional information the company would share about the SaMD’s
newer technologies facilitate a much higher product performance, clinical association between the SaMD output and a clinical
level of engagement with the patient. “If we condition, and safety measures.
take a more interactive device, let’s say you
have a high-glucose problem, or diabetes, and Real-world performance
Identifying the type of information that a pre-certified company may have access to
you have a device that tells you when your blood
about how its software product is performing with patients to support the regulatory
glucose is high – you would pop a drop of blood status of the product, and new and evolving product functions.
on there, it would say your blood glucose was The FDA is considering how best to work with a company to collect and
high and then it was up to you what you did interpret real-world information about an SaMD, and evolve the product’s safety and
effectiveness to address any emerging risks. The sources of real-world performance
with that information,” says Karnick. “But when
data may include information about a user’s experience, software performance data
you start to add software services, now that and clinical outcomes.
device is going to provide you with suggestions Source: FDA
What is a PRRC?
A PRRC is a ‘person responsible for
regulatory compliance’. This is a new role
that must be fulfilled for all manufacturers
and is similar to that of a qualified person
Contrary to popular belief, equivalence of IVDs is hard to demonstrate.
in pharma. Each manufacturer shall
have at least one person responsible have to be prepared. As most IVDs do extent of the impact and support the
for regulatory compliance who possess not have certificates of conformity issued transition. Companies may need to
the requisite expertise in the field of IVD by a notified body, these products will rationalise their product range as well
and medical devices. need to meet the new requirements by as decide whether they are going to
Small and micro enterprises do not have May 2022. hire additional resources to keep
to have this person within their organisation Preparations among manufacturers manufacturing in-house or if they will use
but must have one permanently at their should typically start with a gap analysis, third parties for some of these functions.
disposal. This person, as the name infers, which compares the current processes
is responsible for regulatory compliance, and procedures with what the new How does NSF International
including ensuring reporting obligations are regulation requires. From there, they help companies implement
fulfilled. Authorised representatives are also need to march though a very methodical, these procedures?
required to have a PRRC permanently and project-managed time line to start An impressive offering at NSF
continuously at their disposal. handling some of those gaps. International is its regulatory and quality
training. We are continually producing
“The main deadline for the EU IVDR is May 2022. e-learning resources and face-to-face
training because regulations are
Manufacturers are allowed to maintain their constantly changing. If people haven’t
current certifications until they expire but there thought of some of these things, there
are a number of new post-market activities they is a fantastic e-learning module on
the new regulation. Our staff includes
are obliged to incorporate after May 2022.” ex-regulators from the EU, ex-notified
body staff and internationally recognised
What are the time frames Many IVD manufacturers think IVD experts. NSF International goes
for the EU IVDR and how that because they have an FDA 510(k) beyond traditional consulting. There are
can manufacturers prepare? for their IVD that they will not have people involved in clinical evaluation
The main deadline for the EU IVDR is many gaps to fill. Worryingly, this is not reports, technical file remediation and
May 2022. Manufacturers are allowed the case. Equivalence of IVDs is much performance evaluation reports. They are
to maintain their current certifications harder to demonstrate, especially now helping companies remediate those
until they expire but there are a number with the emphasis in European law on files and keep them updated. A call to
of new post-market activities they are demonstrating state-of-the-art capabilities action is the biggest message. Companies
obliged to incorporate after May 2022 in the product. cannot wait for more guidance – they
and the end of the certificate. Indeed, the IVDR impacts on almost need to act now. ●
However, if a manufacturer makes a all functions of a manufacturing company,
‘significant change’ after May 2022, they not just the regulatory affairs and quality
have to switch to the new regulation. It assurance departments. It is imperative For further information
goes without saying, therefore, that they that senior management are aware of the www.nsf.org
A test of character
Wickham Laboratories carries out biological assessment reports (ISO 10993-1) on a range of
medical devices, working with clients to determine the appropriate regulatory pathway, saving
them money and reducing unnecessary testing.
M
edical device testing is one of the
more complex services offered
in the life sciences sector, both
in terms of the diversity of the products
tested and the different levels of safety or
biocompatibility required prior to approval
for use in patients.
There is a high demand for reliable
testing services for medical devices as
it is one of the fastest-growing industries
in healthcare. The European medical
device industry, constituting a third of
the global market, is thought to be worth
approximately €100 billion.
Within the US, the FDA’s Center for
Wickham Laboratories is committed to determining the appropriate regulatory pathway for clients.
Devices and Radiological Health (CDRH)
is responsible for ensuring the safety manufacturer to identify any hazards or USP Plastic Class I-VI series;
and effectiveness of medical devices. associated with the device. These they include:
The FDA was given authority to begin specifications should always be adhered ■ 10993-3: Genotoxicity
regulating all medical devices in 1976, to and the standard is applicable to all ■ 10993-4: Haemocompatibility
when President Ford signed the Medical stages of the medical device life cycle. ■ 10993-5/USP 87: Cytotoxicity
Device Amendments Act. In addition, pharmaceutical and medical ■ 10993-6/USP 88: Implantation
The EU’s rules relating to performance device manufacturers should always ■ 10993-10/USP 88: Sensitisation
and safety of medical devices were consider environmental monitoring before and skin irritation
harmonised during the 1990s and recently manufacturing, as this can lower the ■ 10993-11/USP 88: Acute, sub-
updated in 2017 with two applicable risk of contamination and help them to acute, chronic systemic toxicity
regulations: the medical device understand the levels of microorganisms and pyrogenicity
regulations (MDR) and the in vitro within their environments. ■ 10993-13: Identification and
diagnostic device regulations (IVDR). quantification of degradation
In the lab products from polymers
Medical device testing overview Before considering testing, Wickham ■ 10993-14: Identification and
The classification of a medical device covers Laboratories works with clients to quantification of degradation
a wide range of device types, each requiring determine the appropriate regulatory products from ceramics
various levels of safety or biocompatibility pathway for their situation, keeping ■ 10993-15: Identification and
testing before market release. its ethical obligations at the forefront. quantification of degradation
All biocompatibility testing carried out It recommends biological assessment products from coated and
should adopt a tiered approach in order reports (ISO 10993-1) instead of testing, uncoated metals and alloys
to minimise the amount of in vivo testing ultimately saving the client money and ■ 10993-18: Chemical characterisation
required. This means that before any reducing unnecessary testing. of materials.
testing takes place, it is essential to have Biocompatibility testing, or ‘Biological
both the device and materials used for Evaluation of Medical Devices’ (as There are a variety of other tests that
manufacturing assessed to ensure the set out in ISO standard series 10993), may also be required, including 11135-1
correct route of testing or evaluation is a set of guidelines and testing and 11737-2: Sterility testing, and 11737-1:
is taken. parameters for assessment of medical Bioburden determination. ●
ISO 14971, the application of risk device safety before any medical device
management to medical devices, is a comes to market. The required tests For further information
standard that specifies a process for the are generally referred to as the ISO 10993 www.wickhamlabs.co.uk
Change on
the horizon
With uncertainty around Brexit and what it means for the NHS, along with news about the
government’s 10-year plan, it is easy to have missed some important signals that support
the greater use of structured data within the health service. The Global Medical Device
Nomenclature Agency’s chief executive, Mark Wasmuth, gives some insight into how medical
devices can be more accurately identified to optimise patient safety.
N
HS medical device suppliers have been told The NHS e-procurement strategy directs trusts
to prepare product data to comply with to ensure that the medical devices they purchase
procurement contract standards introduced are barcoded and their relevant product data is
by the 2014 NHS e-procurement strategy. collected in a central database.
Despite challenges around new IT systems Most people are familiar with barcodes in the
introduced to the health service, the policy is supermarket, and they also appear on medicine
still intact. In fact, the latest initiative from the packets, but, surprisingly to many, they are only
Department of Health and Social Care, NHSX, takes starting to appear on medical devices.
the digital transformation to a new level, promising Barcode numbers are individual to each product
“a new joint organisation for digital, data and from each manufacturer and often also contain
technology” for the NHS. additional information, such as the batch number or
expiry date. They are especially useful for need to compare the use of similar medical devices
managing the stock level of individual items, from a range of providers. The GMDN groups
whether that is baked beans or syringes. medical devices that have the same use, which is
Putting aside the odd problem at the self-service also vital when it is discovered that the problem
checkout, they are a powerful aid to helping with a medical device is not limited to one
retailers know exactly what they have in stock, manufacturer but may also be shared by other
planning future demand and knowing when extra products that use the same technology or materials.
supplies need to be ordered or when to cut back. A good example of this is metal-on-metal hip
The use of barcodes on products is particularly joints, which were found to cause problems and
helpful when you need to locate a batch that needs were produced by several different manufacturers.
to be returned to the manufacturer or has exceeded The GMDN would enable this systematic problem
its expiry date. For instance, supermarkets use to be identified early, whereas the barcode is only
barcodes to instantly identify and remove specific useful for identifying an issue with a specific device
packs of food that have been identified by the from one manufacturer.
manufacturer as having a safety issue.
Hospitals are also starting to make use of “The GMDN groups medical devices that have
this technology to help them better manage the same use, which is also vital when it is
their supplies and capital equipment.
Examples of how barcodes can bring dramatic
discovered that the problem with a medical
healthcare benefits include the use of barcoded device is not limited to one manufacturer but
wristbands to improve the identification of patients, may also be shared by other products that use
enabling the reduction of errors in their care. the same technology or materials.”
For instance, the medical implants used to treat
a patient can be scanned before an operation and The GMDN can be used to identify all the
linked to a specific patient, making them easier to different products in the market that might have
monitor after the operation. the same problem, so hospitals can quickly be
But barcodes are not so useful when you alerted to remove the faulty products, thereby
need to compare similar devices made by several reducing risks to patients.
manufacturers; invariably, the codes they use will The key to the success of using the barcode
be different, because the barcode relates just to the and the related product information, including the
specific product from one specific manufacturer. GMDN, is that the database lists all the products to
form a catalogue. This is used to retrieve data when
Device categorisations the barcode is scanned.
The need for a standardised system for naming and
grouping medical devices has led to the creation of Data mining
the Global Medical Device Nomenclature (GMDN) A central catalogue of products is being created for
international categorisation of medical devices the NHS, primarily using the existing GS1 data pool
by those responsible for medical device safety. network, which borrows its specifications from the
This categorisation system is important for requirements used by the US FDA in its UDI Rule.
several reasons, ranging from improving hospital The US FDA has been collecting product data from
efficiency and patient protection, to helping long- manufacturers as part of a continuous programme
term medical studies find out what devices are to ensure it has a complete list of medical devices
most effective. on the US market.
For instance, at a basic level, a hospital may The programme started in 2014 with higher-risk
well want to know how many 50ml syringes or devices, and is being phased in to include all devices
bedside scanners it has. The GMDN enables them by 2022. It has been a considerable challenge for
to quickly answer this as it helps hospitals measure manufacturers to consolidate the large amounts of
and control inventories where they have similar data necessary to identify all the devices on the US
devices by different manufacturers. FDA database system, called GUDID.
The GMDN can also be used to improve The NHS catalogue is being built as part of
efficiency. It allows easy comparison when an new contractual arrangements between trusts and
improved or more cost-effective device comes on suppliers. The new NHS pre-acquisition questionnaire
the market while older versions are still in use – (PAQ Form) is already being seen, which may also
whether it’s beds, operating tables, syringe pumps form part of a new contract. The PAQ Form uses the
or respirators. Another example of how the GMDN GMDN code to identify the general description of the
is used is in long-term medical studies, which often medical device.
When trying to come up with new and innovative solutions to support patients and healthcare Our specialists and experts
providers in the medical device industry, medical device manufacturers often end up with solutions will provide modular
that include software. In fact, there are many opportunities to enhance existing products with support along the entire
software: for example, by complementing existing products with a mobile phone app that patients value chain of your
can use from home. products. Visit our website
at www.knoell.com for
Nevertheless, medical device manufacturers often need a better understanding of the requirements
detailed information.
for placing medical device software on the market and providing post-market support.
knoell Germany GmbH
Our medical device experts can support you in all aspects when it comes to medical Business Development
device software: Medical Devices
Regulatory requirements for your kind of software and relating to your intended market Tel +49 621 718858-0
Best practices when it comes to working with external software development companies meddev@knoell.com
Software development strategies when you decide to develop software inhouse
Implications for your quality management system (pre- and post-market) www.knoell.com
Visit us at TrilogyWriting.com
writers@trilogywriting.com
Company insight
U
ntil recently, the documents needed these documents do what they need to. Furthermore, although scientists
for device evaluations were not well More than ever, the medical writer is there understand the principles and ideas behind
defined and were generally written as an advisor to provide knowledge gleaned the science of what they are working on,
by one person (often a medical writer), from writing many regulatory documents many are not skilled at communicating
essentially on their own. Now, with the in the arena of drug development and those ideas in the written form. For device
increased regulatory requirements brought understanding the needs of regulatory documentation, the science behind the
on by the EU medical device regulations guidelines. With larger teams, the role of product is an important part of the story to
from 2017, more people are getting involved the medical writer becomes more strategic, be told. There is a lot of non-medical data
in preparing the clinical evaluation reports as they serve to ensure all functions on a to be described in addition to the clinical
(CERs) and the writing game is changing. CER team (medical affairs, clinical, safety data. The scope of scientific knowledge that
Input is needed from a team of CER surveillance and research and development) medical writers bring to these documents
contributors and reviewers, including a provide necessary input while helping is very relevant in order to effectively tell
clinical specialist who understands the mediate cross-functional differences of the whole story of the device. Experienced
environment the device is to be applied opinion on what messages there are to tell. medical writers have the skills to interpret
in; a regulatory expert who has knowledge Writing scientific documents as a scientific data and present it in a way that
of the regulatory background for the class collaborative process, instead of as a meets the regulatory goals, ensuring that
of device and who can inform the medical single author, does not come naturally to agency reviewers will clearly understand
writer about the assessor’s expectations many contributors. Experienced medical the messages to be told.
based on prior discussions with the writers often serve as a kind of glue for the
CER regulatory assessor; the safety different functions on the CER team. They Well-honed tricks for new sectors
surveillance group to provide details pull team members together by focusing In the world of drug development, this
of post-marketing surveillance; and them on telling a cohesive narrative – this role of strategic medical writing to assist
someone who can provide depth of is achieved by effective interpersonal skills. dossier writing teams in pulling ideas
knowledge on the technical development Strong argumentation and leadership skills together has been applied for decades.
and characteristics of the product. are needed to challenge and guide a team Now that the world of devices has become
Many of these newly formed teams do to find the best way of presenting complex more regulated, this role of the medical
not have experience in preparing regulatory data sets, and telling the story consistently writer has become important to efficiently
documents and are unsure of how to make and clearly. produce CERs that aid the clinical
evaluation of devices. Medical writers
experienced in writing submission
dossiers for drug applications are well
versed in applying the evidence-based
principles required by the new EU
medical device regulations.
By tapping into this experience,
device manufacturers have access to a
well-developed skill set that will make
producing and updating CERs less of a
burden, and ensure these documents are
truly fit for purpose. ●
21-23.5.2019
Two strong
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join forces
NUREMBERG, GERMANY
medteclive.com/
become-visitor
Contract manufacturing
Act together
There has been ongoing debate about the relative merits and disadvantages of insourcing
versus outsourcing in manufacturing. However, recently, companies have become more
interested in new ways of working. Within the UK, this has taken the form of partnerships
with Academic Health Science Networks (AHSNs) in order to capitalise on the expertise
of academia and industry. Louise Thomas takes a look at these developments.
I
t is an exciting time for the industry. Fresh A model that has begun to be more heavily
opportunities are increasing each day, driven used in the UK is the partnering of industry
by the needs of healthcare systems to improve with Academic Health Science Networks (AHSNs).
patient diagnosis, treatment and experience. This These are UK organisations, first licensed in 2013,
has not only led to greater demand for innovative which are pioneering new ways of developing
devices, but also the potential to work in a new, and implementing innovations for use within the
more collaborative way, breaking down the traditional UK’s NHS in the disease areas defined as being the
silos between industry and academia, as well as highest priorities. AHSNs have established a med-
interacting with healthcare professionals throughout tech innovation national network to accelerate
the development process. this process for medical devices, which includes
physical devices and in vitro diagnostics. This manufacturers seeking to tap into this market,
remit therefore excludes software as a medical which aimed to ensure that the resulting products
device and large devices, such as MRI scanners. meet patients’ needs as well as being commercially
The Eastern Academic Science Network (Eastern successful. Throughout this process there are a
AHSN) has reported that the NHS currently spends number of areas for collaboration with academics
£6 billion a year on medical devices, highlighting and healthcare professionals.
the huge potential for manufacturers. “The health and science infrastructure in
The medical device landscape is shifting and the UK is uniquely positioned to take advantage
faces challenges in the form of new regulatory of the opportunities for economic growth and
requirements, as well as the strong market forces improved patient outcomes created by med-tech,”
demanding competitively priced products for says Piers Ricketts, vice-chairman of the AHSN
a complex and diverse healthcare procurement and CEO of the Eastern AHSN. “However, there
environment. In their 2019 report, the Eastern is a risk of companies getting lost as they navigate
AHSN proposed an innovation pathway aimed at the innovation maze.”
Relationships of convenience
Case study: CMR Surgical
Working more collaboratively with academia can
CMR Surgical, from Cambridge, has developed a next-generation surgical robotic
also take the form of ‘clustering’, when companies
system that aims to transform minimal access surgery (MAS) over the next few years.
The system, named Versius, is designed to be more portable, versatile and cost- concentrate efforts in a particular geographical
effective than existing systems. The CMR vision is to make MAS universally accessible, location. The NIHR has designated 11 MICs to
thereby improving healthcare outcomes at lower cost. The Versius system is specifically build expertise and capacity in the NHS to develop
designed to meet this vision. The medical robotic market is highly competitive, with
new medical technologies and provide evidence
an established global leader and emerging competition from several companies the
backing of which includes the likes of Google and Johnson & Johnson. Global annual on commercially supplied diagnostics. These
revenues for robot-assisted MAS are presently approximately $4 billion and anticipated bring together patients, clinicians, researchers
to reach $20 billion by 2025. The Versius system takes up a smaller footprint, is commissioners and industry.
portable and flexible, and is intended to come to market at a significantly lower cost.
There is growing interest in these clusters, with
CMR recently attracted $100 million in the largest ever series B investment deal raised
by a European medical device company. a current network of more than 100 science and
“Typically, medical device development, from idea or design through to technology parks in England. Although there is no
commercialisation, is normally a 10-year journey, and we will have done that in single formula for a cluster, the Eastern AHSN has
around five,” says ECO Martin Frost. “You can only do that by having clear focus on identified a number of key success factors.
what you want to deliver and why, recruiting excellent people and creating a culture
that facilitates creative, responsive thinking.
The first of these is academic strengths, as
“We identified an unmet need – 95% of minimal access procedures are not yet done facilities can provide world-leading expertise from
robotically,” he continues. “We then looked at why this was the case and what we researchers in physical sciences and engineering.
could do to address that need. From the beginning, we had a plan of how we would The interdisciplinary way of working also allows areas
get our product to market and our commercial advantage.”
Source: ‘The MedTech Landscape Review’ by the AHSN Office for Life Sciences and the NHS
of convergence to be capitalised upon. In addition,
clusters facilitate access to leading research
Commissioning and adoption is the next stage. clinicians, patient populations and real-world data.
The NHS supply chain has a new operating model Effective business networking can also take place
that aims to deliver improved procurement and within these clusters, as they bring together small
logistics support to the NHS. This will be achieved and large companies in a structured way. Regional
in three ways: increasing uptake of products sponsorship is another potential advantage. These
published via the national route to market, environments are attractive in terms of schools,
increasing the use of a standard range of products housing and transport. There are also opportunities for
by the NHS, and using enhanced buying power to funding of relocation and supportive business rates.
influence purchasing behaviours and ensure that Furthermore, the ecosystem also includes legal advice,
the best products are provided in a cost-effective specialist design consultancy and manufacturing,
way to the NHS. and access to investors. The infrastructure not only
provides specialist facilitates and equipment but also
local capabilities such as advanced manufacturing.
“The potential of cutting-edge technologies “The potential of cutting-edge technologies to
to support preventative, predictive and support preventative, predictive and personalised
personalised care is huge, and the UK has care is huge, and the UK has the chance to lead
the chance to lead the world.” the world,” says Richard Phillips, director of
healthcare policy at the Association of British
Richard Phillips, Association of British HealthTech Industries HealthTech Industries, who co-authored the report.
“We have the opportunity to build an ecosystem that
There are six main routes to market for continually creates the best technology that can be
companies interested in supplying their products exported, alongside new methods and insights that
to the NHS. These are direct to trusts or primary can contribute to health outcomes globally.”
care organisations, through the NHS supply chain, The AHSN’s work remains in an early stage but
through collaborative purchasing arrangements, offers huge potential for OEMs to work in a more
national framework contracts, government tenders collaborative way – in manufacturing and the other
and contracts, as well as selling to companies aspects of the product development process. The
that use the product to deliver their service in AHSNs have outlined the next steps of their work.
the NHS. AHSNs play a key role in supporting This includes rigorously assessing and prioritising
adoption of new devices into the NHS, which technologies for national support in the UK,
has been supported by a recent study by the facilitating access to cutting-edge research and
King’s Fund. Findings highlighted the need for development, connecting companies to high-tech
new technologies to be incorporated into a wider manufacturing advice, partnering with NHS providers
service redesign in order to positively impact seeking to adopt novel technologies and supporting
health outcomes. OEMs in market access activities. ●
G
etting your product to market
is rarely an easy task. In fact,
it can be quite daunting. As
engineers, you may feel that you spend
much more time searching for and
developing parts than actually creating
products. Qosina hopes to alleviate
this stress by providing medical OEM
components and innovative solutions
to make your device concept a reality.
Here’s how Qosina helps to eliminate
your go-to-market challenges.
0,1 mm 0,1 mm
Advanced photochemical
etching solutions
Karl Martinson, Micrometal’s North American sales director, looks at the challenges involved in the
design and manufacture of photochemically etched metal components for the medical industry, and
the advancements in technology and increased levels of precision achieved to address them.
M
any medical devices and
applications require small metal
components that demand very
specific characteristics. These can include:
■ ultra-high precision
■ very thin material
■ unique physical features
■ unique surface textures
■ identification features
■ extreme consistency part-to-part
■ ease of integration into the final device Etched parts can be manufactured in thicknesses as low as 0.025mm (0.001in), up to 0.500mm (0.020in).
■ competitive cost. Parts can be manufactured in thicknesses Because the process is non-mechanical,
as low as 0.025mm (0.001in), up to there are no residual artefacts such as
Also, different medical applications 0.500mm (0.020in) with hole/feature sizes burrs or material stresses that must be
require components made from a variety smaller than the material thickness. removed. A non-mechanical process
of different metals including stainless steel, Advancements in etching technology also ensures that there is no wear or
copper, alloys and clad materials. It is allow levels of precision, both in physical degradation of tooling over time,
a significant challenge to balance the feature size and in dimensional tolerances, providing the ultimate consistency from
combination of the above characteristics that were previously considered part to part. Production capacity from
with the desired material, while maintaining unachievable for volume production a single set of photomask tooling is
cost and production requirements. components. Micron-level precision is essentially limitless; the first component
While numerous manufacturing common for many applications. will be identical to the 10 millionth
technologies exist to create precision metal component. Also, because the process
components, one technology in particular A focus on precision generates very little heat, there are
offers the capability to incorporate all of The precision in physical feature size no thermal stresses and no localised
these characteristics in one seamless comes from a combination of technology hardening of the material (as would result
manufacturing process. Photochemical developments. Thinner photoresist layers from a process like laser machining).
etching – also referred to as photochemical and high-resolution photomask tools, such In summary, photochemical etching
machining or chemical milling – possesses as those used by Micrometal, provide provides a compelling solution to many
the unique ability to meet all of the above exceptionally tight tolerances. of the medical industry’s demands for
demands when compared with technologies These, combined with extremely precise high-precision metal components. The
such as stamping or laser machining. monitoring and control of the chemical technology has evolved and improved
Photochemical etching also eliminates etching rate, allow features and precision dramatically in recent years. By offering a
the need for certain post-processing, such that cannot be achieved in production with distinct combination of precision, unique
as removal of burrs and thermal stresses, other manufacturing technologies such as physical features and competitive cost,
sharpening of blades, for example. The stamping or laser cutting. etching may be the ideal manufacturing
development of continuous ‘reel-to-reel’ Most importantly, etching offers technology for many applications.
etching production has dramatically exceptional design freedom; features are Component designers have new
improved production capacity while reducing not limited to two dimensions. Blade edges, options for designs that they may have
cost and improving consistency in quality. capillary grooves, conical holes and textures considered to be impossible in the past. ●
Common examples of etched components can be included in the design. Etching
are surgical blades, surgical needles and allows medical component designers to
lancets, micro-separation filters, screens, ‘think outside the box’ with regard to For further information
implants, springs and electrical contacts. component size, shape and features. www.micrometal.de/en
www.ionisos.com
Gamma Plant
Gamma Plant Gamma Plant
Gamma Plant Gamma
Gamma Plant
Plant Gamma
E-Beam PlantPlant
Parc
ParcDombes
Dombes ZIZI de
deMontifaut
Montifaut ZIZIde
del’Aubrée
L’Aubrée Ionisos Baltics
Chaumesnil
Cotière Activités 31, rue René Truhaut 72300 Sablé-sur-Sarthe 10500 Brienne-le-Chateau
Côtière activités
01120 Dagneux
31 rue René Truhaut
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F-72300 Sablé-sur-Sarthe
France
Kurvi tee 406a, Alliku Küla
France
F-01120
France Dagneux, France F-85700
France Pouzauges, France France
Tél. : +33 (0)2.43.92.57.01 76401
Tél. Saue Vald, Harjumaa,
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Stermed
Chaumesnil
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5 GmbH Stérylène
ZI les Montoires Stérylène
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(Guenca) 1640002625 Bautzen
Taracon, 45500 Gien
Nikolaus-Otto-Strasse 5 ZI les Montoires, 69380 Civrieux d’Azergues
13, ZI du Pontet,
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Espagne
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France
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CuencaAllemagne
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+ Your leading swiss
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DEUTSCHLAND BALTICS
for implantable components.
IBERICA
Modular offer.
Single modules or complete packages.
M
anufacturing all the components for tools When millions of components are needed on
and devices in the industry is an ongoing a weekly basis, this can be easily achieved with
effort involving balancing precision and stamping. Machining these quantities could require
quality. With the growing needs of life sciences, over 100 machining centres, making it unfeasible
metal components have become an integral part for this purpose.
of building medical devices for the treatment of Tooling costs are another important
a range of diseases. consideration. As machining is more versatile
Biocompatibility is a constant challenge as and precise, it is preferable for devices requiring
devices need to be used internally and externally tight tolerances that need to be produced in high
within a range of medical applications. For this volumes. As long as a suitable machining centre
reason, designs are continually changing and is available, it can be relatively easily programmed
require rapid prototyping to ensure that they are to accommodate the part geometry. In contrast,
fit for purpose. The ability to meet these demands a progressive stamping die takes much longer
in an efficient and effective way is the result to design and build, and is much more costly.
of rapid advancements in metals and alloys for Part geometry is also an important variable to
components that are small or complex. bear in mind as there are some components that
When manufacturing a device that involves are not able to be stamped. Certain diameters
metal, a key decision lies between machining and cannot be pierced using stamping. In such cases,
stamping. These choices are determined by the fit, machining is a better option, which can be
form and function of a particular component, along combined with laser technology.
with the geometry of the part and material used. Material selection factors are also significant
If a medical device is designed for a large number in making a decision between stamping and
of uses, then machining works best, as it produces machining, particularly thickness and hardness.
complex parts that support durability. For products For example, stamping can be limiting because
that are meant to be used just once, stamping is thickness must be uniform throughout the part and
more suitable as it produces precision parts that hardness needs to be carefully considered because
tend to be less durable. Volume is another key of the potential for cracking during forming. In
driver in the decision-making process. contrast, almost any hardness can be machined.
Most red metals, stainless steels, titanium and with pressure sensors in each cavity, as well as
cold-rolled steel can be stamped. Titanium and in runner systems.
stainless steel are the most commonly used MIM is essentially a four-step process, consisting
materials for stamping. Both are popular for of compounding, moulding, debind and sintering.
implantable medical devices due to their The biggest disadvantage with MIM is the lead time.
biocompatibility. However, titanium is often only However, the choice of materials makes it a popular
available in wire, rod and sheet forms, rather than choice for OEMs. It is best suited to shaping complex
in continuous strips, the latter of which tends to components in high volumes and when higher material
be needed for the majority of stamping operations. properties, or implantable materials, are needed.
The heavier the gauge and higher the hardness, Many OEMs have considered bringing MIM
the more difficult it is to use stamping. manufacturing in-house, but this has been met with
There is also less room for error with stamping mixed success. Start-up costs can be several million
than with machining; it is thus hugely important dollars for the equipment alone, which includes
that the designs are reviewed and approved by compounding, moulding, debind, sintering and
the manufacturer early in the design process. secondary apparatus.
With machining, it is difficult to re-engineer MIM has been proposed to be 85% science and
the part using stamping to reduce costs without 15% art. Understanding the dynamics of sintering,
making fundamental design changes. and how to minimise the effect of gravity and friction,
is essential, and developing a consistent process often
takes years of experience.
“Metal injection moulding can be a
This can be minimised with the hiring of experienced
useful middle ground to minimise costs personnel, but they are in high demand and thus can
while gaining the benefits of machining. be hard to find. A further issue is how to design for
MIM has been increasingly used in recent the MIM process. Most specialists will help with
redesigning components, but this can take time,
years by manufacturers to expand their as most also serve as programme managers.
design capabilities.” In recent years, some companies have started
to help OEMs design components to optimise the
Meet in the middle advantages of MIM. This can save time and money,
Metal injection moulding (MIM), or metal injection as they can go directly into production without any
moulding plus machining, can be a useful middle expensive redesigns during the production process.
ground to minimise costs while gaining the benefits Such organisations are also able to manage the entire
of machining. MIM has been increasingly used in journey from design, through production, and can
recent years by manufacturers to expand their teach the OEM about the process throughout.
design capabilities.
Increasingly complex applications mean that A big decision
sometimes MIM is the only suitable process. With the Finding the right supplier can be difficult, with
inclusion of biocompatible and implantable materials, hundreds of qualified contractors worldwide. Often
components that were routinely machined can now be newer suppliers will underestimate the amount of work
‘MIMed’ for a fraction of the cost. Some OEMs have needed to get a medical component into production.
brought this process in-house, but as it demands An established facility with substantial experience is
specialised skills and equipment, contract thus likely to better meet required timelines and have
manufacturing can be an attractive alternative. a comprehensive understanding of the procedures
Orthoscopics was one of the first fields to adopt required to meet medical specifications. However,
MIM. Graspers, blades, staplers and cauterising the additional work created by increased quality
cutters are small, geometrically complex and must requirements, along with the required documentation,
be manufactured in a biocompatible material. Early means that established MIM facilities will be more
designs were machined, which meant each component expensive than newer suppliers.
was expensive. However, as MIM become more Companies unfamiliar with requirements may
established, suppliers became more consistent, initially be cheaper, but will soon discover they need
and more companies began using the process. additional resources or training to meet the needs of a
Today, MIM applications are broad, including particular device, so may not be cheaper over the long
bone drills, robotic arms for surgery, bone rasps, term. It is therefore essential for OEMs to do their
cutting jaws, biopsy jaws, needle guides, saw guides homework and prequalify any potential supplier well in
and hundreds of endoscopic instruments. Over time, advance of making a decision. This can be assisted by a
moulding has become much more sophisticated, visit to a potential supplier’s manufacturing facility to
Since 1960
www.daprorubber.com | 918-258-9386
Myopic medicine
In order to achieve sustainability in manufacturing operations, it needs to be incorporated
in all stages of the supply chain. One key aspect is obtaining sustainable components from
eligible suppliers. Recently, this topic has gained greater attention from industry and academia.
Ben Wicks from Team Consulting speaks to Emma Green about the status of sustainability
within medical device manufacturing.
D
iscussion of sustainability is increasing immunology and virology, as well as a PhD in
in all sectors. Loosely defined as the ability clinical biochemistry, he certainly isn’t short of
to meet the present needs of an industry credentials. He also isn’t afraid of holding back
without compromising those of future generations, in a discussion about sustainability within medical
its principles have not been readily adopted by device manufacturing.
most OEMs. This is largely because in relation “For much of the industry, I don’t think
to the wealth and gravity of other factors to sustainability is very important,” he says. “We’ve
consider within medical device manufacturing, got a ton of other regulation to worry about,
it pales into insignificance. everyone is concerned with FDA and the European
This is certainly the view of Ben Wicks, a med- notifying bodies because they hold the key to you
tech consultant with over 20 years’ experience in having a product on sale or not. Sustainability
the industry. With a background in microbiology, is not in their world or in their remit.”
Although legislation on sustainability is currently benefit, I’ll save some money and the user
lacking, this may change in the near future. will be happier.”
Wicks remains unconcerned about this
possibility, however. “I suspect it will Fix the flaws of perception
start becoming something you’re It’s not just the perception of sustainability that
asked to think about, and we are hinders its implementation; there are also a number
seeing and hearing patient groups of practical considerations when attempting to
and industry start to get it on the integrate its principles into the manufacturing Ben Wicks
table for discussion,” he admits. process. “For many people in the industry, we’re
“But it’s still often an almost sweating bringing the product to market, and once
inconsequential issue.” we have brought it to market, it’s difficult to make
In light of this context, it is changes to the product without doing a ton of
thus unsurprising that, unlike reverification,” Wicks explains. “If it’s just the
other sectors, the industry has secondary packaging, I might be able to cope with
been reluctant to embrace that. But if I’ve got a complex medical device and
sustainability. The responsibility to want to change its primary packaging, I might have
ensure patient safety has also been a to reverify my sterilisation or my stability trials, and
large contributor. “We are focused on that might cost several million pounds.” This means
trying to save people’s lives –right here, that any benefit to sustainability is likely outweighed
right now,” Wicks says. “Rightly by the hassle of successfully achieving it.
or wrongly as an
industry, we think
that we have a “For much of the industry, I don’t think
higher calling. sustainability is very important. We’ve got
a ton of other regulation to worry about,
everyone is concerned with FDA and the
European notifying bodies because they hold
the key to you having a product on sale or not.”
can ensure that the end device means that but now you have to because that’s standard
patients get better and don’t get worse,” says practice.” One rare case where sustainability did
Wicks. “Sustainability hardly makes it onto that become more important was the use of propellant
checklist for supplier selection.” in metered-dose inhalers (MDIs). “They originally
used chlorofluorocarbons as propellants, which
The status sphere have a serious ozone-depleting effect,” explains
The low status of sustainability within the industry Wicks. These were discontinued in January 1996,
is also driven by the relative lack of consequences except in a few rare cases.
if its principles are not adhered to. “You screwing it A new class of propellant, called
up, if that product fails and people die, lawsuits fly hydrofluoroalkanes took over, which was much
around, products come off the market, companies more environmentally friendly. However, they
go bust,” says Wicks. “Nobody loses their job or are certainly not carbon-neutral. “These are way
dies if I use a printed circuit board that wasn’t as better but they are still a serious greenhouse gas
recyclable as another one.” contributor,” says Wicks. For large companies, the
use of these propellants contributes a significant
amount to their overall carbon footprint.
“If a product fails and people die, lawsuits There are currently discussions about moving
fly around, products come off the market, to an alternative propellant, but manufactures are
companies go bust. Nobody loses their job or reluctant to make any changes unless it becomes
dies if I use a printed circuit board that wasn’t mandatory. “The industry doesn’t want to make
the switch if it can help it because it will be a pain
as recyclable as another one.” to do all the reverification and revalidation,” says
Wicks. “Nobody wants to spend the time or money,
It’s clear that from a purely business perspective, or cause potential risk to their patients.”
sustainability just does not come into the Although clearly unlikely to immediately jump
equation. “It’s not like someone running off with a to the top of the priority list for OEMs, public
commercial advantage saying ‘look at our devices, perception looks set to be a future driver of
they’re all biodegradable,’” says Wicks. “That just sustainability within the industry. “We are
isn’t a thing.” seeing patients and users, such as healthcare
Nevertheless, there are small indicators of change professionals, starting to recognise these issues,”
The search is on in the industry, such as batteries in disposable admits Wicks. “But even though they say that,
for a propellant
with minimal goods. “Nowadays you would expect a disposable as a device developer, it’s a secondary or tertiary
environmental effects. medical device that has a battery in it for you to issue. Ultimately, if this device doesn’t work safely,
be able to take the battery out it might not be commercially viable or, worse still,
in accordance with the Waste it might harm someone. Of course, that is not okay.”
Electrical and Electronic Despite the reluctance from industry to embrace
Equipment Directive,” says sustainability, it is likely that small steps will
Wicks. “There are examples continue to happen, largely driven by legislation.
where, in the past, you’d have “I would expect that within the coming years,
not cared about getting the we’ll see a nod towards sustainability from the
batteries out before you regulator,” says Wicks. “But it’s never going to
chucked the device away, be high on their priority list.” ●
Your perfect
moulding partner
Maintaining an efficient micromoulding project is a delicate balancing act. Having a clear plan,
understanding the risks and, not least, choosing the correct partner are all crucial to success. Aaron
Johnson, vice-president of marketing and customer strategy at Accumold, talks about the challenges
involved in the moulding process.
A
s minimally invasive procedures
have become more prevalent,
demand for smaller, more complex
medical devices has increased. This has
put more pressure on original equipment
manufacturers (OEMs) to design specialised
components with thinner walls and more
intricate features.
One of the technologies used to support
this ever-shrinking world is micromoulding,
a highly specialised manufacturing
process that produces small, high-precision
thermoplastic components that are used
in a variety of medical tools.
With over 30 years of industry Accumold is one of the leaders in the field of micromoulding and has over 30 years of experience.
experience, Accumold is one of the leaders
in this field, producing plastic components Given that these tolerances can be down the ISO 14001 environmental standard.
for microelectronics, micro-optics and to a few microns – a fifth the size of a human It is also championing a zero waste
sensors in a range of medical devices. hair – there is precious room for error here. manufacturing initiative, collaborating
These include surgical tools, hearing aids, “There has to be a clear and efficient with Mega Recycling to ensure that all
handheld devices and micro-connectors. infrastructure dedicated to micromoulding,” of its components are reused.
As a vice-president for marketing Johnson says. “We feel like we have made a great
at Accumold, Aaron Johnson is acutely Because of the nature of the business, accomplishment by being as productive with
aware of the steps required in overseeing partners also need to make extremely small our resources as we possibly can,” Johnson
a successful micromoulding project. and sophisticated parts a million times over. says. “Of course, it doesn’t hurt that our
For Johnson, ensuring design for “If you are making a disposable, you need products that we make are very tiny.”
manufacturability (DFM) is the single to know the system can provide, not only Asked about the future, Johnson is
most important part of the process. from the prototype, but all the way through adamant that things are going to get smaller.
“We always say, start with your ideal to production,” says Johnson. “We are amazed at the innovation and
design in mind,” he says. “And then let’s And the final requirement is concerned ingenuity in the industry, whether we are
have a conversation about where you with sustainability. making wearable devices for diagnostics
can push the limits, or what is capable “Once they get approved, medical or delivery, or a transcatheter that is
with microplastics.” devices don’t tend to like change, so you delivering a new way to treat patients
need to find a partner that can be with inside the body,” he says. “The more creative
Pick a partner you for the life of that product,” says the industry becomes, the more it pushes
For Johnson, a good moulding partner needs Johnson. “Sometimes that can be for a limits and the more we can provide. We will
to provide three things: capability, scalability very long time.” continue to help customers do more in the
and sustainability. Over the course of its 30-year history, same space or do more in less space – and
When it comes to the former, precisely Accumold has consistently focused on that trend isn’t going to stop.” ●
the right equipment is required to ensure sustainability, endeavouring to make
that specific micro-level features or smaller components more efficiently,
tolerances can be made in a detailed and with less waste. The company continues For further information
efficient manner. to endorse that mantra by committing to www.accu-mold.com
Break the
fourth wall
Since we entered the fourth age of the industrial revolution, known as industry 4.0, manufacturers
have begun to explore a wide range of new technologies. Karen Taylor, director of the Centre
for Health Solutions at Deloitte, speaks to Stephanie Webster about how to best implement these
technologies into manufacturing processes to maximise efficiency while minimising cost.
W
e are all aware of the rapid pace of change approach to implementation is taken. However, there
across multiple industries due to significant remain huge opportunities for industry 4.0 to enhance
technological developments and the manufacturing processes.
reduced costs of using them. These trends are distinct One such technology is factory automation,
from the greater level of process automation, driven which makes production lines more efficient,
by advances in electronics and information technology, enhances resource effectiveness and improves
since the 1970s. The greater adoption of industry 4.0 is productivity. Although seemingly simple to integrate,
paving the way for disruptive approaches in a number they can be complex to manage on a daily basis.
of areas, including medical device manufacturing. “Factory automation is probably the simplest
It’s important to note that these technologies are not application of robotic process automation,” says
new. “What’s changed is the cost, and the fact that the Taylor. “But these technologies, especially if they’re
connectivity, miniaturisation, computer speeds and going to have connected sensors embedded in
infrastructure has all changed to make it a reality to them, are very sensitive to change and need to
apply it at scale,” says Karen Taylor, director of the be highly monitored.”
Centre for Health Solutions at Deloitte. This is in line Cobots, or collaborative robots, are expected to
with Moore’s Law, which predicts that the capacity of be used increasingly within manufacturing. Recent
microchips, bandwidth and computers doubles every research has predicted this market will grow from
18 months, representing exponential growth. $710 million in 2018 to $12.3 billion by 2025. This
is largely due to the technology being safer, more
Humans and robots adaptable and compact than ever before. However,
In light of the highly regulated nature of the medical such technologies are not yet able to replace humans.
device industry, it is imperative that a strategic “There is a need for human-in-the-loop, but you
R
obots have long fascinated authors, scientists robots, as well as of service robots, to grow with
and the general public. Despite the high double-digit margins over the next few years.
levels of interest, not all predictions about Researchers have suggested that many societies
robot capabilities have materialised. It is notable are currently on the verge of a robotic era, which
that Blade Runner, a world of humans and human- will result in robots soon being commonplace in
like robotic replicates, was set in the year 2019. people’s daily lives worldwide.
Nevertheless, the momentum of these technologies The perception of robotics is not uniformly
is stronger than ever. The International Federation positive, however. A 2019 study by scientists
of Robotics has predicted the sale of industrial at the University of Würzburg reported increasing
©VTT Studio/Shutterstock.com
work is how humans interact with new technology.
As developments in this area are progressing at a
rapid pace, it is essential to not only explore the
capabilities of the technologies themselves but
also the way in which to best integrate these with
current working practices.
Cobots offer a number of benefits compared with costs around $24,000. “They must be able to be Designed by Softbank
Robotics, Pepper
traditional robots, if used mindfully. “Collaborative implemented safely without expensive safety is a semi-humanoid
robots may reduce some of the environmental hardware, like dedicated workspace or fences,” robot that is able
to read emotions.
and spatial dangers traditional robots may cause, explains Weiss.
allowing them to work alongside humans,” explains The second relates to the amount and nature of
Weiss. “However, this is only true if the robots human input needed for a particular task. “Cobots
are very easily reprogrammed, ideally by naive offer most benefit to smaller production volumes
operators, and if safety is ensured.” and lot sizes that require frequent reprogramming
It’s important to bear in mind that, although – ideally without expensive software tools or robot
possessing a wide range of abilities, these cobots and computer vision specialists.”
are not suitable for all manufacturing activities.
“In cases where very precise manufacturing
“Collaborative robots may reduce some of the
tasks are done, such as polishing small metal parts,
collaborative robots could not achieve satisfying
environmental and spatial dangers traditional
results,” admits Weiss. “For other domains, such robots may cause, allowing them to work
as screwing or gluing parts together, they are much alongside humans.”
more effective.”
There are also a number of challenges that
Question to consider come with using cobots. “Traditional robot systems
When considering whether cobots offer are mostly programmed offline, with text-based
an advantage to a particular manufacturing programming languages or by complex CAD/CAM-
application, Weiss suggests considering three based simulation tools,” explains Weiss. “That is
key questions: can safe human-robot collaboration only suitable for specialised situations such as
without a fence be guaranteed? Do I have a use optimised and fenced working environments,
case in which the robot increases productivity? Do I which only exist within the context of high
have a use case in which the robot performs equally production volumes.”
well or better than the human in its specific task? In response to such concerns, robot
Cobots are best suited to small and mid-sized manufacturers have already begun to optimise
production applications, where they are much their safety and ease of use. Work in this area has
more likely to represent a good return on included “limiting system power and implementing
investment. When using this technology in such
situations, Weiss highlights two key success factors
safe control system structures and functionalities,
such as restricting speed or the workspace they can
$24,000
Average cost
that must be met. The first of these relates to cost, operate in”. This ensures that use meets the DIN of a cobot.
an important consideration when the average cobot ISO 10218, a piece of regulation specifically Barclays
A
pium, the innovative professional The best-in-class temperature
3D printing company from management system of the Apium M220
Germany, is the pioneer and 3D printer enables temperature regulation
one of the world leaders in processing in the processing of the 3D-printed medical
speciality polymers. devices for the best possible results, and
The company’s activities focus on together with the integrated filtration
the key industrial 3D printing trends, system, prevents contamination of the
high-performance polymers, metals printed part.
and medical 3D printing. The medical-grade PEEK filament
Apium is a technology leader in processed by Apium’s M220 3D printer
PEEK 3D printing and the first company is developed from the VESTAKEEP
worldwide to make 3D printing of long- i4 resin by the speciality chemical
The M220 3D printer from Apium features a
term implantable PEEK medical devices producer Evonik. best-in-class temperature management system.
commercially available. The company’s The 3D printing of this medical-grade
design and development activities have PEEK, using Apium M220 3D printers, The necessary certificates of
resulted in advanced products and meets the biocompatibility criteria biocompatibility for material and
improvement in time-to-market for required to produce medical implants and machine can be provided upon request
medical devices. devices in the areas of craniomaxillofacial and are included in the delivery of
and hand. the product.
Apium M220 Series 3D printers:
a game-changer technology
in healthcare “Apium is a technology leader in PEEK 3D
Apium’s engineers have developed printing and the first company worldwide to
a professional material extrusion 3D make 3D printing of long-term implantable
printing technology, which enables the
3D printing of medical-grade PEEK,
PEEK medical devices commercially available.”
without affecting its biocompatibility and
sterilisation properties. This new production technology Some of the statements and claims
is guaranteed to reduce lead times in this article may be forward-looking
and the cost of implant manufacturing. statements or statements of future
With medical-grade 3D printing, expectations based on currently
production can now be performed available information. Such statements
on-site in hospitals, and medical are naturally subject to risks and
devices can be supplied with shorter uncertainties. Actual results or
lead times, saving patients’ lives in developments may vary depending on
time-critical surgeries. changes in the operating environment.
Neither Apium Additive Technologies
Disclaimer for Apium M220 nor Evonik Resource Efficiency assume
and Apium PEEK an obligation to update the forecasts,
The additive manufacturing device expectations or statements contained
Apium M220 is not covered by the in this article. ●
guidelines on medical devices. However,
it is suitable for clean rooms and for For further information
The processed medical-grade PEEK filament meets
key biocompatibility criteria for implants and devices. the production of medical devices. www.apiumtec.com
Somos® from DSM Additive Manufacturing has been at the forefront of 3D Printing since its
inception over 30 years ago. During that time, many ground-breaking materials have been
launched which revolutionized various applications and industries.
As times are changing and the technology has evolved, the need for innovative materials with
higher performance keeps growing. As material experts, we have been and will continue to be your
trusted partner on this journey.
W
hen GE Healthcare began elastomeric resin families. Even so, AM test that mirrored a metal tool, MGS
developing a new imaging generated tooling rarely moulded greater used Somos PerFORM to produce printed
device component, it partnered than 50 parts before failure.” inserts to successfully mould more than
with MGS Mfg. Group and chose DSM GE Healthcare has partnered with MGS 100 parts. Several other 3D-printed
additive manufacturing materials for the to help refine and optimise its product materials performed admirably during
application. GE Healthcare and MGS have design and development process, similar testing, but none performed
transformed the product development specifically targeting shorter lead times, nearly as well as the DSM material.
process for this component, resulting lower costs and high-performance resins.
in faster prototype production and cost Benefits to be had
savings of nearly 70%. Enabling manufacturability DSM materials are playing a key role in
“GE Healthcare’s partnership with MGS, “Early involvement by MGS and DSM in helping businesses reduce cost and time
and use of DSM materials, has resulted in design considerations for manufacturability to manufacture, and bring new products
streamlining new product development,” for customers like GE Healthcare has to market. For the GE Healthcare medical
says Jesse Schrimpf, senior AME – significantly improved the prototyping instrument project, Somos PerFORM
additive, GE Healthcare. “The ability to stages of product development, which enabled MGS to produce tooling three
3D print moulding inserts and then test leads to a seamless transition from times faster than traditional steel tooling,
design iterations with real materials has prototype tooling to high-quality at a third of the cost. The tool produced
made product development much more production-grade tooling,” says Klotz. using Somos PerFORM inserts cost near
robust. It also has the added benefit of Development of an imaging $6,000, compared with a steel tool that
making the designs more ‘mouldable’ as device component for GE Healthcare would have cost upwards of $20,000.
we transition towards the creation of demonstrated how MGS partners with Furthermore, the quality of the moulded
expensive production tooling.” customer product design teams to parts using Somos PerFORM inserts was
identify the best 3D machine/material so good that GE Healthcare was able to
Challenges to overcome system to generate rapid tooling and use them for customer testing.
Reducing lead time and costs to make moulded prototypes. Another key benefit is being able to
prototypes that perform like the final A key part of this is how MGS helped quickly and cost-effectively produce a
product is a significant challenge faced GE Healthcare build its injection mould tool when changes are needed. This helps
by all product development teams. GE design skills early in the production make product design and development
Healthcare successfully produces ‘printed’ process. For the GE Healthcare imaging more effective. Using Somos PerFORM,
prototypes for its product development device, and many other projects, MGS designers are able to produce a realistic
groups in-house but needed to expand its had recommended DSM additive physical part, test it, and, if necessary,
capability to include printing tooling inserts manufacturing materials. make changes and quickly produce
that can make ‘moulded’ prototypes. GE another tool.
Healthcare knows that for truly effective Solution on offer In addition, producing tools out of
new-product testing, it is imperative that “DSM products, like Somos PerFORM, Somos PerFORM makes the moulding of
prototype parts closely match the finished make possible additive manufactured prototypes possible in materials such as
product in terms of colour, strength and tooling inserts that perform exceptionally glass-filled nylons, polyesters and even
chemical resistance. well during injection-mould processing filled polyetherimide materials.
Kevin Klotz, engineering manager at of various resins. Somos PerFORM MGS is now providing this service to
MGS – a DSM business partner and a US tool inserts withstand the pressures, several clients. Klotz says, “The ability
rapid prototyping specialist – says, “3D temperatures and abrasive characteristics to successfully provide prototype parts
printing additive materials have been of high-performance moulding resins moulded of engineering-grade materials
used to print tooling inserts for several that other additive manufacturing is the differentiating factor between
years. However, optional injection materials simply cannot withstand,” Somos PerFORM and inserts printed in
moulding resins that can be processed explains Klotz. alternative SL resins.” ●
using additive manufacturing (AM) The GE Healthcare imaging device
tooling was limited to resins that process component needed 100 or more parts
at low temperature and pressure. Typical moulded of a material that demanded For further information
examples include the polyolefin and challenging process conditions. In one www.dsm.com/additive-manufacturing
Mikron G05
Assembly Platform CUSTOMER PRODUCTS
ASSEMBLED AND TESTED ON
MIKRON SOLUTIONS
W
hether in the pharmaceutical,
medical technology,
automotive or electrical
industries, the demands from customers
have risen sharply in recent years. In an
extremely competitive market, pressure
on performance is rising and the lead time
for new products is getting ever shorter.
An assembly solution often has to be
ready before all the details of the new
product are even known. In many cases,
assembly solutions also need to be
frequently switched to another variant.
So it is no wonder that demand for
innovative, cost-optimised solutions has
risen dramatically over the past few years. Mikron Automation scalable solutions.
The future belongs to agile automation the validation process through to the greatly shortens delivery times. What
systems that can be expanded and pilot line, and to the highest-performance is more, using the company’s standard
enhanced easily and cost-effectively – production, our full range of G05 platforms, process stations are validated
from the development phase through automation and feeding platforms at an early stage and can be transferred
to fully automatic production. serves our customers in the long term.” from one automation level to the next.
Everything
is illuminated
Traditional photonic devices have been fabricated from rigid materials on rigid substrates, limiting their
applicability in the healthcare sector. Now, researchers at the Massachusetts Institute of Technology
(MIT) have developed a method for making photonic devices that can bend and stretch without
damage and without compromising optical performance. Patrick Kingsland speaks to MIT associate
professor Juejun Hu about the application of this technology for medical device manufacturing.
I
t is a word that is rarely used in common technologies, new possibilities are emerging in the
parlance, but over the past few decades, diagnosis, treatment and prevention of disease.
photonics – the science of generating, “Light is an extremely important probe that
controlling and detecting light – has become people can use to investigate biomedical
an integral part of our everyday lives. phenomena,” says Juejun Hu, associate professor
In the manufacturing sector, laser-based of materials science and engineering at the
technologies are enabling cleaner, higher-volume Massachusetts Institute of Technology (MIT).
and lower-cost methods of production. In the field At the cutting edge of the technology are new
of communications, photonic technology is driving designs and materials for flexible photonic sensors,
advances in optical fibres – the backbone of which can be bent, folded, rolled, twisted and
today’s internet. stretched to conform to human skin without
Perhaps the most life-changing – or saving – field compromising optical performance.
of photonics can be found in the medical device Hu, and other researchers at MIT, say such
sector. From oil candles to electricity, light sources devices could be used in a range of skin-mounted,
have been used in healthcare throughout human wearable health monitors, potentially revolutionising
history. But with modern optic and photonic the medical device manufacturing sector.
$56
“With optical coherence tomography, people use allocation between 2021 and 2027 is a mouth-
light to generate and reconstruct three-dimensional watering €100 billion.
images of tissue that would be difficult to obtain using “Medical photonics research and innovation is
other techniques,” Hu explains. “It does no damage to leading towards the development of easy-to-use,
billion
Projected value
human tissue and has been used very widely in eye
surgery as well in examining skin conditions.”
low-cost screening methods that can be carried out
at a general doctors premises, or even at home,”
The ability of light to carry information in said a European Commission Horizon 2020 press
of the photonics multiple dimensions means photonics is also used release. “These photonic point-of-care technologies
industry in 2020. for medical sensing. Different wavelengths interact can provide a risk assessment of age and lifestyle-
German Federal Ministry of
Education and Research with biological tissues in different ways – some are related diseases within a few minutes.”
€100
Unsurprisingly, photonics has been identified as on rigid substrates, such as semiconductors or glass,
one of the fastest-growing areas within healthcare. which are deemed inappropriate for soft, curvilinear
The global market is projected to increase from human bodies.
approximately $32 billion in 2011 to $56 billion in
2020 according to recent market research published
jointly by the German Federal Ministry of Education
“If you look at how people conventionally make
these miniaturised, integrated photonic devices, it is on
some kind of rigid substrate,” says Hu. “But if you look
billion
Proposed budget
and Research, the Mechanical Engineering Industry at biological tissues in human beings, we are made of allocation, between
Association, the German Electrical and Electronic this soft, squishy stuff. That means there is a very large 2021–27, of
Manufacturers’ Association and the German High elastic mismatch with traditional photonic devices.” the European
Tech Industry Association. The obvious candidates to overcome this elastic Commission’s
“Photonic devices are penetrating into many mismatch are organic polymers, from which most Horizon 2020.
European Commission
different fields and biomedical applications,” says Hu. flexible photonic devices have traditionally been
fabricated. But while these polymers have inherent
Photonics flexing its muscles mechanical flexibility, they also present their own
While many photonic devices have already been problem: a low refractive index and poor ability to
clinically validated and are widely used in the confine light beams.
medical sector, there is still a great deal of work “Most of the polymers have more or less the
to be done according to Hu. The researcher, who same refractive index,” Hu explains. “This could be
is a principal investigator at the Photonic Materials problematic because for a lot of cases you want to
Group, is particularly interested in developing be able to manipulate the light probe with freedom.
integrated photonic structures that are smaller Polymers do not allow you to do that.”
and more practical than traditional devices. Hu and other researchers have therefore been
“Current optical coherence tomography searching for a method to make photonic devices
instruments are pretty big, bulky machines and that can do two things simultaneously – bend, twist,
can really only be used in a dedicated laboratory stretch and seamlessly integrate with biological
or a doctors clinic,” he says. “We are looking into tissues such as human skin while also maintaining
essentially trying to miniaturise this and make strong optical performance.
it more accessible. This is the emerging area
within photonics.” “If you look at how people conventionally make
Hu’s group is also focused on making new
materials for integrated photonics that are flexible
these miniaturised, integrated photonic devices,
and can be mechanically deformed. Photonic it is on some kind of rigid substrate. But if you
devices that could stretch and bend like human skin look at biological tissues in human beings, we
could be used in a range of medical applications,
such as skin-mounted monitoring devices to detect
are made of this soft, squishy stuff. That means
heart rate, blood oxygen levels and blood pressure. there is a very large elastic mismatch with
“We anticipate that the identification of new traditional photonic devices.”
application fields, where mechanical flexibility
either constitutes the key feature enabling the target “My group has been working on that for the past
applications or contributes to significantly improved six to seven years, and we have developed a whole
device performance, will certainly accelerate array of different components along the line,” Hu
penetration of the technology into diverse market says. “Components must exhibit good mechanical
sectors in the future,” Hu’s team said in a recent ruggedness and flexibility that does not compromise
paper titled ‘Flexible integrated photonics: where the optical properties.”
materials, mechanics and optics meet’.
Flexible devices of this kind are not a novel idea. A hybrid platform
The concept of flexible electronics dates back to the Searching for a material that does this, Hu’s group
1960s and is now a $5.13 billion global industry. has turned to an unusual source – a specialised kind
Lighter and more durable than what came before, of glass called chalcogenide. Though regarded as a
flexible electronic devices have seen widespread fragile substrate, the glass material is widely used in
adoption in the consumer electronics and healthcare the microelectronics industry and possess a high
market, where they are used in lab-on-chip devices, refractive index with strong optical confinement.
X-ray detectors and health monitors. “The glass materials’ success in the
But bringing this technology to the biomedical microelectronics industry, coupled with their
field has proved challenging. This is because the vast superior optical performance, point to chalcogenide
majority of integrated photonic devices are fabricated glass micro-photonics as the natural next step of
H T
LI G E
H ER S
N G K ET CK ET
D I Y T IC /TI
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E A B U S.CO
E L OT
O NI
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T H -P H
- OF
O R LD
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world-of-photonics.com
M
ore than 1,300 exhibitors from cutting edge of progress in the A platform for young talent
around 45 countries will present semiconductor and electronics field, or Growth dynamics is a reason why photonics
their innovations at LASER contributing to quality assurance in the provides a very good environment for
World of PHOTONICS on 24–27 June 2019 food industry with new imaging techniques. founders. The market has more than
at the fairgrounds in Munich. Also awaiting doubled in ten years. The Start-Up Area at
visitors in parallel is a trend-setting Prizes for viable solutions LASER World of PHOTONICS offers young
conference boasting seven individual Two awards at once are being handed talents a platform in the middle of the trade
conferences and more than 5,000 experts out at this year’s LASER World of show. Additionally, the Makeathon again
from around the world. In a nutshell, PHOTONICS; the Innovation Award, provides young engineers and students with
Munich is awaiting an event of superlatives being conferred for the first time, honours a platform for demonstrating their expertise
that will provide deep insights into the the best product premieres by exhibitors, in the photonics arena.
future of photonics. while the Start-Up Award, being presented
The trade show offers a complete market for the third time, is directed at young World of Photonics Congress
overview – from optoelectronics to lasers entrepreneurs offering innovative with well-known speakers
in production and imaging. One of the solutions. The awards are worth €5,000. This time, Europe’s leading congress
topics will also be biophotonics and how “The Start-Up Award contestants are comprises seven conferences – the
it is enabling ever more accurate medical living proof just how many innovative ideas newcomer is the OSA conference ‘Imaging
diagnoses. LASER World of PHOTONICS are being generated by photonics,” says and Applied Optics’. In addition, the
2019 brings together key players from Katja Stolle, the trade fair’s exhibition ‘European Conference on Lasers and
the fields of analytics, diagnostics and director. “Which is why it isn’t just Electro-Optics and the European Quantum
bio-technological research. Many of the established Start-Up Award being Electronics Conference’ (CLEO/Europe –
the exhibitors are developing optical conferred at LASER World of PHOTONICS EQEC) will again be shining the spotlight
systems and components, but not for one 2019 but the Innovation Award as well. on basic research in the laser technology
application area alone; they may also be This enables us to give innovation an even and quantum optics fields.
active in the aerospace industry, or at the bigger platform.” Professor Anton Zeilinger will also
address quantum technologies in a keynote
speech, offering insights into the work
of his group at the Vienna Institute for
Quantum Optics and Quantum Information.
The opening keynote speech for the
congress on the first day of the trade show
will be by Prof Karsten Danzmann, director
of the Institute for Gravitational Physics at
the University of Hanover and director of
the Albert Einstein Institute.
Anyone wanting to gain a clearer idea
of the future in photonics should schedule
a visit to the trade fair in Munich on 24–27
June 2019. ●
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Company insight
Possible polariser
application requirements
German polariser specialist CODIXX knows the most common requirements for choosing the right
polariser for your application.
A
s discussed in the previous purer the transmitted light, the higher ■
Size: due to the manufacturing process,
volume of Medical Device the value, which ranges between 100:1 some polarisers are limited in size
Developments, polarisation for low-budget sheet polarisers and 106:1 and are not available in larger sizes.
is a singular property of light that for high-quality birefringent polarisers, or The most common sizes are up to
can significantly improve medical even 107:1 for dichroic glass polarisers. around 40–50mm.
applications, but only if the right polariser
is selected. Different polariser types
“The requirements of the application should be
are available with vastly different
specifications. To find the right one, the defined and matched with the polariser.”
requirements of the application should be
defined and matched with the polariser. A high contrast is not essential to ■
Thickness: some polarisers are thicker
There are several important remove glare, but analysing contents than others due to the optical path
application characteristics: or concentrations of a pharmaceutical length required for the polarisation. The
■ Wavelength range: which wavelength substance requires a very high contrast. thickness, and therefore the required
range is used to be the light source or space within the application, varies
monitored effect? Applications can use Secondary specifications between 0.2mm and 35mm.
the whole spectrum or just a smaller On top of these three main specifications, ■
Durability: possible environmental
range; for example, UV, visible or IR. secondary ones need to be considered: influences like temperature, chemical
Most polarisers are optimised for ■ Wavefront distortion: describes the or radiation exposure should be
a smaller wavelength range, so the wavefront distortion caused by passing considered as well to avoid damage
wavelength range plus-minus a few through a transmitting component. It or destruction of the polariser.
nanometres should be known. might cause focus shifts and spot size ■
Handling: some polarisers require
■ Transmission: this describes the ability increases, thus causing a blurred image. special handling to protect the
of the polariser to let light pass through ■ Laser damage threshold (LDT): polarisation properties during
as a percentage. An ideal polariser another key factor to consider when installation or regular usage.
would transmit 100% of the light dealing with a laser light source. ■
Cost: last but not least, the cost needs
parallel to the polarisation axis and 50% The LDT per square centimetre can to be considered as polarisers can range
of unpolarised light. As there are no range 1W to 500kW depending on from the price of a cup of coffee to that
ideal polarisers, usually between 40% the polariser. of a small car. In general, the lower or
and 98% of optimally polarised light ■ Acceptance angle: should be chosen fewer the requirements, the lower the
is transmitted. adequately if uncollimated light is price. Should one of the more expensive
■ Extinction ratio or contrast: the evident on the polariser. It usually polarisers be required, the cost can be
ratio between p-wave and s-wave. The ranges from ±2° to ±25°. reduced by choosing a smaller size.
Produce customised
medical devices
3D printing solutions from TRUMPF, including the TruPrint 1000 3D printer, produce intricate, made-to-
measure implants with excellent material properties that save medical device companies time and money.
A
dditive manufacturing is ideal
for producing medical devices.
When designing an implant, a
CAD engineer will first create a computer
model based on patient data and then
set the 3D printer to work. What’s more,
products made using this technology
have excellent material properties –
for example, polymer devices that are
robust but elastic and shock-absorbent, or
implants with a porous structure that fuse
well with healthy tissue but remain stable
and durable. Additive manufacturing is
also suitable for producing custom-fit
implants on a cost-effective basis. A
further benefit is that, unlike conventional Conmet uses TRUMPF’s TruPrint 1000 3D printer to produce customised craniomaxillofacial implants.
machining methods, 3D printing does not
produce any waste in the form of shavings clear that the ideal set-up was TRUMPF’s the surgeon; and the machine prints it
or swarf. And in the manufacture of own TruPrint 1000 3D printer with the out. “We currently produce 60 implants
medical implants, where the material of laser focused to a diameter of 30μm. a month with the TruPrint 1000, and
choice is generally an expensive titanium Equipped with a 200W fibre laser we’re planning to increase our output
alloy, this means genuine savings. developed by TRUMPF, the machine has by 10%,” says Nadeschda Morozova,
Furthermore, there are none of the no problems working with the titanium project manager at Conmet. The
retooling costs of conventional methods. alloys generally used to produce implants. implants not only have an especially
Conmet, a market leader in TRUMPF also proved its expertise to fine high quality level overall – they are
craniomaxillofacial surgery and tune the focal diameter at which the laser also substantially cheaper.
implantology, first looked at additive beam hits the powder bed. “Our tests “Compared with conventional
manufacturing 10 years ago. At the showed that reducing the focal diameter machining methods, such as turning
time, however, the technology was still to 30μm improves the surface smoothness and milling, the new process saves
insufficiently mature for such applications. of the implants by around 20%,” Margolf us 40% in production costs,” Morozova
In 2017, the company decided to explains. This makes the process slower reports. In the near future, Conmet
approach TRUMPF to find out how far and slightly more expensive but reduces intends to start producing custom-
the technology had evolved. “TRUMPF the cost of post-processing the surface.” fit spinal fixation devices using 3D
is the only supplier on the market for printing. The company also has plans to
3D printing that develops its own lasers 40% saved in production costs manufacture mass-produced prosthetics
and all the optical components,” explains Conmet has been operating with the with the TruPrint 1000. For this, Conmet
Andreas Margolf, project manager for TruPrint 1000 at its Moscow production will be investing in new machinery
additive manufacturing at TRUMPF. facilities since the beginning of 2018. and has once again opted for TRUMPF
“We also have a wealth of experience in The company uses the new machine technology. As Morozova explains, the
the areas of machine tools and services. to produce dental components and new machine will be a TruPrint 3000,
That means we’re able to assist Conmet craniomaxillofacial implants for, among with a larger construction chamber. ●
with any aspect of the process.” others, cancer patients. Hospitals
The first task was to determine the provide Conmet with CT data of
right machine for Conmet, along with the patients; engineers at Conmet then For further information
relevant process parameters. It was soon design the implant, in consultation with www.trumpf.com
TRUMPF is the market leader for machine tools and lasers for industrial manufacturing.
We are also your knowledgeable partner for additive technologies. Additive manufac-
turing enables precise and reliable series production of medical equipment or implants
in compliance with the usual quality requirements – layer by layer and component by
component.
www.trumpf.com/s/additivemanufacturing
Electronics
Smash the
ultrasound barrier
Scientists at the University of British Columbia, Canada, have developed a portable ultrasound
device that can connect to a smartphone and costs only $100. The new transducer can be used to
look at any part of the body, producing instant and clear images. Research lead Carlos Gerardo
talks to David Callaghan about the potential for this new device, which includes patients wearing it
for monitoring purposes.
T
he future of ultrasound devices could be bright can produce clearer images with more detail. Each
with the development by scientists in Canada of drum, which is the diameter of a human hair –
a portable scanner that embraces radical new 100μm, or 1/10th of a millimetre – vibrates according
technology and can be powered by a smartphone. to the level of high-frequency sound waves received
Using different materials to the traditional ultrasound by the device. The resin, which is cheap and quick
machines, researchers at the University of British to produce, is made from polymer capacitive micro-
Columbia (UBC) have produced a scanning device machined ultrasound transducers, or polyCMUTs.
the size of a plaster that costs just $100. In the scanners currently used around the world the
The new device has the potential to be woven piezoelectric crystals act as a transducer by changing
into clothes or wrapped around the body to monitor shape under an electrical current, and emitting sound
changes in performance of a person’s internal organs. waves that can then pass into the body. Once the
There are also plans for a patch-type scanner, or waves hit an obstacle they bounce back and the
even tiny versions of the device being used to look crystals convert them into electric currents, which
inside arteries and veins. are then processed into a sonogram image. The issues
University engineers have replaced piezoelectric with this ultrasound technology are that it is expensive
crystals, commonly found in ultrasound scanners, to produce, has limited bandwidth and the images are
with minute drums made from a polymer resin, which not always as clear as they could be.
CMUT technology is not new, but, despite its plastic transducer that can replace the existing Left: Portable scanner
for ultrasound
high efficiency rating, it was restricted in the way technology. It is simpler to fabricate, and the devices, developed
it could be used in ultrasound due to the material manufacturing costs are much lower.” by researchers at the
University of British
used to make the drums. Rigid silicone materials The question now is what happens next, and how
Columbia, Canada.
have been adapted, which are costly to produce, can this product be further developed?
are sometimes subject to acoustic crosstalk, and “We have ambitions for an ultrasound ‘patch’ that
$7.3
there has been a limit to how deep into tissue can be placed under the skin to monitor the heart
these scanners can penetrate. for a few days or weeks. An ultrasound ‘probe’
With the new polymer drum technology, the could be attached to the body and used to send
manufacturing process is much cheaper than with
silicone, meaning that CMUTs become a much more
attractive option to use in ultrasound scanners. The
information remotely,” Gerardo says.
The new device is not limited in its use to
a particular part of the body, and can be used
billion
Current global
polymer is also strong but sensitive, the impedance in exactly the same way as existing ultrasound value of the
factor is lessened and the voltage required to make scanners, including for cardiovascular examinations ultrasound market.
it work is low, at just 10V. and obstetrics, for example. GBI Research
Enlarged microscopic “We are creating prototypes and seeing which ones ultrasound device attached to a smartphone is a
image of CMUT cells.
to go with,” he says. The team are going to create vision the team has for their product.
a small start-up company in the next few months, “We have a dream, but we have to take it step
with a view to a partnership with a commercial by step,” Gerardo says. “Our dream is something
manufacturer and possibly a contract. portable that uses batteries and is affordable. A
Next year, if all goes well, the research team hope patch would require a low voltage – we need to
to see the polyCMUT ultrasound device on the market produce several prototypes.”
and available to buy. The establishment of a patent, to Certainly the cost of the device will be crucial if it
ensure the technology developed by the UBC team is is to be used in developing countries, where money
properly protected from being copied, is a priority. is scarce but the need is great. If the cost can
By dealing with all aspects of the development of a be brought down below $100 then it may become
new product it will eventually lead to a better device, a possibility for those countries. The ultrasound
Gerardo says. “We need to invest this time, as it market was forecast to grow from a global figure
means we will better design things in the lab. of $4.6 billion in 2012 to $7.3 billion this year,
“We can tell people how it is done, and with the according to figures from GBI Research, meaning
research community we have to do this. A basic lab there is enormous potential for these products.
can replicate the results – you don’t need expensive The UBC team’s polyCMUT device could be a
equipment. But the key parameters and the tiny breakthrough development that transforms the
details we keep to ourselves for commercial purposes,” ultrasound market and its use of technology.
$100Proposed cost of
he says. It is also important on the flip side to ensure
they don’t infringe on someone else’s design.
For example, there is a US company called
Butterfly Network, which has developed a handheld
If the product costs less than $100 yet produces
better images than existing scanners, there will
surely be many takers from all over the world.
Ultrasound could become available in parts of
UBC’s new scanner. ultrasound scanner that can produce images of the the world where it is currently only dreamt about.
In contrast, current whole body. Conditions such as liver disease or heart With the current price tag of between $10,000 for
portable scanners disease can be diagnosed relatively easily. It costs portable scanners and $250,000 for top of the range
cost a minimum $2,000 to purchase with a user licence fee on top. scanners, it’s not difficult to see why the cost is
of $10,000. This device doesn’t use the traditional piezocrystal currently prohibitive to some communities.
UBC
technology, replacing it with a single silicone Existing scanners using piezoelectric crystals
chip. It is battery-powered, and can be used with could be phased out, with all the implications a
www.fujitsu.com/IoT
Company insight
H
ospitals deal with a large number appointments, waiting times and routes,
of patients on a daily basis, which therefore contributing towards a positive
involves the movement of an even hospital experience. Indoor navigation
greater amount of supplies and equipment. also allows insight into visitor and patient
Today’s healthcare facilities are under traffic and enables detailed profiling of
serious pressure to have equipment visitor behaviour.
available at the right time and location. Fujitsu Smart Beacon is a Bluetooth
Combining nursery tasks with tracing smart transmitter that broadcasts specific
hospital equipment is an inefficient use of data in the form of a unique identification
resources when alternatives are available. number, information on transmission
Fujitsu Components has developed power or a URL. The unique identification
an IoT solution to cover hospital asset number enables smart devices – such as a
management; the solution can also monitor phone or tablet – to recognise the beacon
environmental conditions, such as room and relate it to a specific app. The number
temperature, acceleration and humidity. also identifies the group or groups to which
that specific beacon belongs. Information
Hospital asset management Fujitsu has developed a solution that can trace any about the transmission power can be used
hospital asset equipped with Fujitsu tags.
Fujitsu has developed a solution that for navigation and localisation purposes.
can trace any hospital asset equipped solution can also be applied to avoid Combining information provided on
with Fujitsu tags. It is based upon mesh picking errors in hospital warehousing transmission power and information
networking, which allows communication or in patient medication distribution. retrieved from the unique identification
between all assets. This way, anchor nodes number enables precise navigation and
build a network that allows the asset tags Monitoring environmental conditions localisation – right down to specific rooms
to communicate data to the gateway. By In hospitals, monitoring environmental and areas. Indoor navigation requires a
using the mesh network, an unlimited data can be of great importance for the predictable transmitting characteristic,
amount of assets can be added or removed patient and for a medical device’s life cycle. and the Fujitsu beacons are able to do
without the need for network maintenance; Fujitsu Sensor Beacons can be used to this consistently. Beacons are also able to
the assets tags simply reroute the data. monitor various environmental values, broadcast a URL that will be displayed on
The solution offers operators a live like temperature, humidity or acceleration, smart devices and can be activated by the
view of where assets are located and how providing a wealth of information that user. This provides web-based interaction
many are available – even maintenance can contribute to patient well-being with the user that can then involve any
information can be added. In real life, and provide insight on variables that can type of information.
this enables the maintenance department, influence device maintenance and stock The Fujitsu IoT Connectivity Solutions
nurses and any member of staff to locate control of medical devices. offer great advantages for nursing and
assets such as hospital beds, and monitor maintenance staff, as well for management.
their occupation and maintenance. But the Patient experience and The solution provides insight on usage,
solution is not limited to just hospital beds; traffic flow monitoring efficiency and maintenance, which offers
all types of hospital equipment can have Whether used to monitor visitor great potential for process optimisation. ●
Fujitsu tags, from various medical devices experience or patient-traffic flow, indoor
and wheelchairs, to life-saving equipment navigation provides multiple advantages.
like a defibrillator. Plus the possibilities are App-based indoor navigation can offer For further information
not restricted to only tracking assets; the the visitor tailored information about www.fujitsu.com/iot
The vast majority of semiconductors in medical devices are made from silicon, which, though the
cheapest material available, is not the most efficient. Now, a team of engineers at the Massachusetts
Institute of Technology (MIT) has developed a new way to fabricate ultra-thin semiconducting films
made from a host of exotic materials. Michael Shaw talks to Jeehwan Kim, the university’s class of
1947 career development assistant professor in the departments of mechanical engineering and
materials science and engineering, about the potential applications of this research.
T
he baby was delivered stillborn and Mark C and into the ventricle of his tiny heart. The spindle
Lidwill was running out of ideas. Artificial was connected to a generator, which – Lidwill
respiration and injections of adrenalin hoped – would deliver the 16V necessary to restart
had failed; now, the only option left open to the the patient’s pacemaker.
doctor and his assistant was a highly experimental Remarkably, the procedure worked. “The heart
technique of cardiac therapy. Together they responded to each impulse,” Lidwell wrote in an
plunged a needle straight into the baby’s chest article describing the procedure. “At the end of 10
Epic potentials
What difference, then, would remote epitaxy
make to the field of medical devices? According
to Kim, by laying each of these films produced
Above: Jeehwan Kim Kim and his team quickly discovered limits through remote epitaxy on to one another, it could
(front centre) and his
team at MIT.
to this new manufacturing method. While they be possible to design new and more flexible types
experienced success in their creation of gallium of devices.
Below: LEDs that arsenide and gallium nitride films, when they “Typically, the electrical and optical properties
have been grown on decided to conduct new experiments on the same of single crystalline films are much better than
graphene and then
peeled off. lines with germanium and silicon, they were not any other electronic functional materials,” he says.
able to peel off any new layers of either material The use of these films in medical device design
from the middle graphene section. could, Kim argues, lead to the first viable implants
embeddable inside skin. After all, the largest organ
in the body yields a variety of symptoms and signs
“There’s no way to put those semiconductors on to clinicians that might be more easily interpreted
the skin, because the semiconductor is rigid. By with such devices.
using our technology, you can make this and put “In order to sense that kind of information from
it on the skin. By putting [a device in] the skin the skin pore, you need to have high-quality silicon
conductors,” explains Kim. “But there’s no way
patch, you can then acquire instant information to put those semiconductors on the skin, because
from the body through the skin pore.” the semiconductor is rigid. By using our technology,
you can make this and put it on the skin. By
The reason why remote epitaxy failed to copy putting [a device in] the skin patch, you can then
anything similar was, according to the professor, acquire instant information from the body through
down to the ionic bonding properties of both the skin pore.”
materials. “Silicon does not have polarity,” explains Kim also envisions health-monitoring devices
Kim, referring to the interactions between the implanted in or near major organs, the better to
atoms in the substrate and those lain on top of the communicate with individual cells. He concedes,
though, that this is all speculation. The full practical
potential of remote epitaxy is yet to be realised.
“I think it will be five to 10 years,” says Kim, on
how long before medical OEMs will be able to use
this new manufacturing method. Even so, the work
of Kim and his team at MIT points towards new and
exciting developments in the form and potential
of medical devices. Just as it took the invention of
©Professor Jeehwan Kim et al
Negotiate the
MDR checklist
The European Commission’s new medical device regulations puts the onus on medical device
manufacturers to ensure they conform to increasingly stringent regulations. RECOM Power
knows the new legislation and advises companies on remaining compliant.
T
he European Commission (EC) chain management and production, but will need to be an ongoing and
has decided that the existing EU you will struggle to meet the regulatory regular re-assessment. You will need to
medical device directive (MDD) is requirements for traceability and contact each and every customer who
not rigorous enough and it has been recast post-market surveillance. has purchased the product on a regular
to the medical device regulation (MDR).
The difference between a directive “The MDR will apply to all medical device
and a regulation is that all member states manufacturers, meaning every manufacturer of a
in the EU are legally bound to abide by medical device or accessory will have new obligations.”
a regulation without any modifications
(it enters law immediately), and the EC 2. As a manufacturer of a component that basis over the lifetime of the product.
can take measures to punish countries, in itself is not a medical device (for It would be advisable to enter into
manufacturers, importers, distributors instance, a power supply), you will not a contractual arrangement with
or even individuals if it feels that any be required to carry out clinical trials or customers to formalise this procedure.
transgressions have been made and apply for a unique identification code. 4. There are not enough notified
the local authorities have not been However, you will still need to support bodies (NBs) accredited to meet the
zealous enough in ensuring compliance. and react to any adverse results arising requirements for the MDR. It can be
The wording used in a regulation is from the use of the product inside the that a new medical product may have a
necessarily dictatorial. medical device over its lifetime. It is delayed market entry because there is no
advisable to create a serial number NB available to take on the responsibility
Check it out for every product supplied, linked of monitoring it. Plan also for increased
The following checklist from RECOM may to full documentation (production costs as demand outstrips supply.
help manufacturers wanting to stay in the testing results, quality control, bill 5. Manufacturers will be required to
medical market after 2024: of materials). A simple date code have someone within the organisation
1. If you are an importer or distributor, identifier will probably be insufficient. responsible for regulatory compliance
you will have the same responsibilities 3. If the supplied part has a potential hazard who possesses expert knowledge in
and liabilities as if you were a (electrical, thermal, sharp-edges or the field of medical devices. If there
manufacturer. Unless you have direct radiation), you will be required to carry is no such specialist in-house, you will
contact with the original manufacturer out a risk assessment. This goes beyond need to make arrangements with an
with access to the design team, supply the simple safety or EMC certifications, external consultant.
B
y definition, bioelectronics is the convergence of applications of bioelectronics within common use,
of biology and electronics. We tend to think of including pacemakers and medical imaging technology.
it as a new term but the first reference was in Despite these developments, it was not until the mid-
1912. According to a 2009 report by the US National 1990s when the term became more commonly used
Institute of Standard and Technology, this was in within the scientific literature. Today, bioelectronics is
relation to the measurement of electrical signals used to describe a range of applications for electronics
generated by the body. We already have a number within biology and medicine.
A number of different types of devices have Reliability is a particular area of concern. The
been developed using bioelectronics. This includes majority of micro-fabricated bioelectronic devices
a large variety of diagnostic, monitoring and are either fabricated by small custom suppliers or
therapeutic electronic devices, from the organ level are manufactured within academic facilities. While
to the cellular or subcellular level. For example, semiconductor technologies can be used to fabricate
there are devices that use biosensors to detect small features, they are not yet able to fabricate
and characterise biological materials, such as DNA, complex bioelectronics. However, with the rapid
protein and cells. In addition, there are implantable development of these technologies, it is likely
devices that interface with biological systems to only a matter of time before this is possible.
repair, restore or enhance physiological functions. Another technological challenge is ensuring
Biolectronics also includes implantable devices, that a device is sustainable within the body.
such as pacemakers, deep-brain stimulators, “Proper encapsulation is essential to the longevity
cochlear implants, visual implants, electrical of a device in the physiological environment,”
bladder controllers, muscle implants, spinal cord explains Yue.
and peripheral nerve stimulators.
Lan Yue, assistant professor of
research ophthalmology at University ™
of Southern California (USC) is
committed to advancing bioelectronics
and is currently focused on retinal
applications of this technology. HIGH PERFORMANCE
Despite a great deal of progress made
within the field and exciting future
applications, there are also a number
of challenges. This is exacerbated
because of the inherent convergent
nature of bioelectronics. Barriers can
thus arise from a lack of technological
advancement, biological understanding SMT Enclosure Coin Cell Contacts
or a combination of the two. Although
there is a requirement for innovation
across a number of different fields,
this also allows cross-discipline
collaboration among researchers
and a productive platform for
creative thinking.
Small problems
In terms of technological difficulties,
the inherent challenge is making
devices small enough to be used
inside the body and producing these at
a high volume. “Device miniaturisation
demands advancement in
microelectronics and fabrication,”
explains Yue. s Accommodates coin cell diameters 12mm to 30mm s Accommodates all coin cell heights (1.2mm to 10mm) s Ideal for enclosures
with self contained battery compartments s Easy battery access, removal and installation s Ultra low profile s Features gold-plated
Fabrication methods for other fields,
stainless steel contacts s Spring tension contacts adjust to variations in battery diameter for a dependable connection
such as the semiconductor industry, are s Available on Tape & Reel s Positive and Negative contacts can be used as a design set or individually on a PCB
optimised for minimising trace widths
and feature sizes. A wide variety of IT’S WHAT’S ON THE INSIDE THAT COUNTS
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materials have been incorporated into
the fabrication processes to improve E L E C T R O N I C S C O R P.
performance while reducing costs. www.keyelco.com s (516) 328-7500 s (800) 221-5510
However, in biology and medicine,
methods for building microdevices REQUEST CATALOG!
are not well established.
B is for bonding
PCAP touchscreens have conquered the medical industry, but it is rare to see manufacturers
offering TFT displays bonded with a touchscreen unit. In Europe, only DATA MODUL currently
offers the in-house availability of all common bonding technologies.
T
hanks to developments in gloved Detailed structure of the single components
and bonding layers.
operation or operating through
liquids, as well as the optimisation
of touchscreens through optical bonding,
increasing numbers of PCAP touch
monitors are being used at PoC and in other
medical areas. However, it is rare to see
manufacturers offering TFT displays bonded
with a touchscreen unit. For this reason,
DATA MODUL established in-house
expertise in optical bonding in 2011 and
has been improving it ever since.
Bonding means the connection of device
components using an optical, transparent
adhesive – the refractive index of which
must match that of the media to be bonded.
A distinction is made here between the
bonding of cover glass and PCAP Touch,
cover glass, and TFT. Bonding minimises
distracting reflections, does not dampen to-soft). The top OCA of the touch sensor
the capacitive touch field, and achieves is used here, so that no additional bonding further developed from LOCA and OCA
user stability against interference factors. glue is required. The major advantage processes. This bonds and glues touch, glass
In addition, it is not possible for dust to of OCA bonding is that projects can be and display (hard-to-hard) automatically.
enter in-between the PCAP sensor and completed quickly and cost-effectively. This method is particularly suitable for high-
the glass. Due to the increasing demand volume projects with special requirements,
for medical PCAP solutions with customer- AirGap bonding like the manufacturing of medical devices.
specific glass surfaces, DATA MODUL This method was used for resistive touch
is constantly expanding the range and sensors and is the forerunner of bonding Gap filling
optimising quality standards. technology. In contrast to LOCA, in AirGap After the assembly of a PCAP touch
Current bonding technologies such as bonding, a double-sided adhesive tape is monitor/HMI/embedded display in a housing
AirGap, LOCA, OCA, gel and the new applied around the TFT frame, which bonds there is always a gap between the screen
hybrid bonding provide the best possible the TFT and the touch or glass to one and the housing frame that cannot be
optimisation solutions for all display and another. An air gap is maintained between avoided during manufacturing. Particularly
touch variants available on the market. the two components in the process. in the development of medical products,
there are high hygiene requirements. One
LOCA (liquid optical clear adhesive) Gel pads example is that gaps on devices must be
This liquid glue method is flexible and can This method is used in processing frameless avoided. Through gap filling, gaps are filled
be used at all display sizes. It is suited to displays. Gel pads are tailored to the size with a special glue and sealed securely. This
hard-to-hard bonding and cured via UV of the display surface and bond the glass stops impurities or liquids from entering or
light. The LOCA adhesive is used for or touch sensors to the TFT. This would getting stuck in there. At DATA MODUL, a
bonding cover glass to glass-based touch not be possible in LOCA. Diagonals from pick and place machine carries out the gap
sensors and industrial TFT displays with 1.3–14in and mobile applications with filling under cleanroom conditions. The
metal frames (bezels) to a cover glass round memory-in-pixel displays can also special adhesive is suitable for temperatures
(with or without touch). be realised. from -40°C to 100°C and covers all
requirements for medical devices. ●
OCA (optical clear adhesive) Hybrid
Dry bonding or OCA roll lamination applies DATA MODUL is one of a few companies to For further information
a touch sensor film to the cover glass (hard- provide this new process, which has been www.data-modul.com
M
ajor steps forward in microtechnology instructions from clinicians – the reliability of that
and new biomaterials have greatly improved power supply becomes even more critical. Implantable
the biocompatibility of devices that can be medical devices (IMDs) are becoming smaller and
implanted in the human body, thus opening the door lighter, but the need for a battery severely limits how
to a host of therapeutic uses. small they can become and, therefore, how they can
Imagine devices that can monitor the condition be used for diagnostics or treatment.
of highly specific areas of the body, or deliver drug The fact is that if a device is equipped with a battery,
therapy at precisely the right time, or stimulate the power supply accounts for most of the space on the
otherwise impenetrable areas of the brain. The device and often means it has a limited lifespan. For
opportunities are seemingly endless, but there has instance, cardiac pacemakers rely on non-rechargeable
hitherto been one problem that has been hard to batteries due to regulatory restrictions on the use of
solve – power. rechargeable batteries, which a patient might forget
Devices that reside inside the body must be kept to charge or which, due to a technical fault, might not
small, but they must also receive a sufficient and recharge effectively.
continuous source of power if they are to operate “One of the most important things about the
effectively. As these devices increasingly rely on new generation of implantable devices is that we
the ability to communicate wirelessly – to deliver want them to last a long time to enable monitoring,
data about conditions within the body or to receive diagnosis and treatment,” says Fadel Adib, assistant
professor in the Media Lab at the Massachusetts amplification and transmission of the signal. That’s why
Institute of Technology (MIT). “We also want them the battery is the largest part of a smartphone. We
to be small, so that we are not putting a large alien wanted to enable communication without the device
body into a human being. So, we need a long-term generating its own signal, instead reflecting it from
and continuous power source in a small device that outside, because that uses the least power,” he adds.
can operate in different parts of the body.”
The benefits of in vivo networking
Size limitations By looking at power through the lens of communication Fadel Adib
Fadel’s group at MIT focuses on the development of with the device, Adib’s group came up with a solution
new wireless systems and, recognising the application that addresses both needs in a highly innovative way.
of its work in smaller implantable systems for drug So was born in vivo networking (IVN), which can
delivery, long-term monitoring and deep brain wirelessly power and communicate with tiny devices
simulation, he soon came up against the limitations implanted deep within the human body.
on size created by the current crop of systems for Adib had been working on the possibility of
powering these devices. wirelessly powering implantable devices with radio
“When you are designing a tiny device that must waves emitted by antennas outside the body, but the
last for a long period of time and is not anatomically techniques focused on sensors and devices located in
specific, so that they can work anywhere in the human specific areas of the body. The new approach he and
body, you soon come up against the question of how his team, along with Brigham and Women’s Hospital
you power it,” he remarks. “The existing literature (BWH), have developed does not require clinicians to
shows a number of different approaches, all of which know the exact location of the sensors in the body. IVN
have their own limitations.” transmits power over a large area, can power multiple
Researchers have tried a number of ingenious devices simultaneously and trigger a device to relay
approaches to powering IMDs. One that is in the early information back to the antennae that deliver the
stages of development is the biological supercapacitor electrical charge.
under development at UCLA and the University of IVN enables wireless power delivery and
Connecticut. Using graphene combined with modified communication with deep-tissue medical devices
human proteins as an electrode, the system uses thanks to an innovative beamforming algorithm that
electrolytes from in-body fluids such as blood serum can focus its energy towards an in vivo sensor. Using
and urine to power the supercapacitor. In theory, the a multiple-input and multiple-output (MIMO) method
system could provide an endless supply of energy for that multiplies the capacity of a radio link, and a
IMDs at a size far smaller than the existing alternatives. multi-antenna array, the system delivers focused
Body movement is another potential source of power energy in such a way as to overcome the threshold
for IMDs. Whether it is the beating of the heart, the voltage, which hinders the delivery of power, regardless
bellows-like movement of the lungs, or the movement of radio frequency attenuation and despite the sensor’s
of the arms or legs, power is generated constantly just small size. As the radio waves travel they overlap and
by the act of living, so it makes sense that some of combine, and at certain points, where the high points
it could be harvested to power a small device like a of the waves overlap, they can deliver enough energy
pacemaker or an internal sensor. Charged by internal to power an IMD.
vibrations or through wearable piezoelectric energy “One of the biggest challenges was that wireless
harvesters, there is potential for many devices to be signals die exponentially fast in the body,” Adib
powered indefinitely without the need to regularly explains. “The signals are absorbed quickly by
replace batteries. water, and up to 70% of the human body is water.
Adib, however, sees some limitations with many To overcome this, we used power techniques that
of these approaches. combine signals from multiple antennae. It is similar
“Powering a device with body movement can work to the Wi-Fi infrastructure used to increase data rates.”
well in some areas in the body but does not work so “Using IVN, the device can either reflect or absorb
well in the brain, where there is very little movement,” the signal, which effectively creates a zero or a one,
he remarks. “Harvesting power from movement is not, which is the basis for most electronic communication,”
therefore, a universal solution. Generating power from he continues. “It powers the device and enables low-
chemicals within the body also only really works if the power communication with high-fidelity signals.”
device is located in the stomach. A beamformer serves to precode transmitted signals
“We were working on both powering a device and so that they constructively interfere at the receiver,
communicating with it, so we looked at the lowest- which maximises the amount of energy received.
power communication technology that is available. The IVN is the first system to bring the benefits of MIMO
most power-consuming part of communication is the beamforming to in vivo battery-free sensors, and
eliminates the need for the transmitter to be close to or medication. We have not built the device yet, but it is
in direct contact with the body. an example of how the technology could be used.”
To absorb the energy, a battery-free sensor must The extended charging distance that IVN offers, and
convert RF signals in the environment into a DC that this eliminates the need to locate an IMD before
voltage, which is achieved through an energy harvester, charging and communication can take place, will be
or rectifier. In Adib’s experiments, battery-free tags crucial for the development of real-world applications.
fitted with rectifiers were implanted in a pig to evaluate “In-body sensors have no batteries, so they must be
IVN’s ability to deliver power and communicate, both powered before they can send a message, so we had to
in subcutaneous and intragastric placements. It was find a way to focus on them without knowing where in
capable of powering devices the size of a grain of rice the body they are,” says Adib. “Our technology allows
located 10cm deep in tissue from a distance of 1m. us to focus on devices in unknown locations, although
At the moment, implantable electrodes that can the ability to charge the device does depend on how
deliver electrical current for deep brain stimulation are deep it is within the body.
normally controlled by a device similar to a pacemaker, “The deepest, so far, is about 12cm below the skin,
which is implanted under the skin. With a wireless and we can charge that device from 1m away, so the
power source outside the body, this second device system could be at the side of the bed. If the device
would no longer be required. is closer to the skin, it can work from up to 30m.”
“We are hoping to develop end-to-end applications,” The paper on IVN delivered at the Association for
says Adib. “Now, we are looking at extending the Computing Machinery Special Interest Group on Data
device to include a pH sensor, which could monitor Communication conference, in August last year, was
reflux in the stomach. If we can measure and well received, and Adib hopes it will be the springboard
continuously monitor pH, we could design a device for a raft of new therapeutic devices.
that delivers treatment by sending a command to “The research represented the first time a miniature
release part of a drug when a particular threshold computer was put inside a human body,” he notes.
is reached. That kind of device, which senses “There is a real need for these systems to have real-
the environment, could be useful for patients with world applications, and it will enable a paradigm shift
Alzheimer’s disease who might forget to take their that will allow tiny sensors to be used in the body.” ●
Your Experts
in Laser Plastic
Welding.
www.leister.com We know how.
The shape of
things to come
While the world continues to come to terms with the potential of 3D printing, engineers have been
working on introducing a whole new dimension to additive manufacturing processes. Tim Gunn talks
to Dr Andrew Weems of the University of Birmingham, Professor Lorenzo Moroni of Maastricht
University, and Dr Christophe Marquette of Lyon’s 3D Fabric of Advanced Biology laboratory about
what four-dimensional printing can do to disrupt the medical device market.
P
eople care a lot about change. It’s the time, and it allows us to bestow upon them the
everything and nothing that we make and are existential burden of becoming what they are.
made by. It orients our lives, our innermost Like many philosophical categories, what exactly
thoughts and our politics. Change is struggled for, sold 4D printing encompasses is up for debate. Dr Andrew
against, theorised, disproved, weaponised, dreamed of Weems, an expert in shape-memory polymers at the
and feared. Now it can be printed, too. University of Birmingham, suggests that anyone 3D
In one sense, printing has always been an printing a degradable material could argue that they
exemplary form of change. Whether it’s 2D or 3D, were actually 4D printing, simply because degradable
what goes into a printer comes out different. But, materials change through time. Not that he would
as the name might suggest, four-dimensional (4D) personally make such a claim, preferring to reserve
printing adds something extra. From reclining chairs the appellation for objects that go through more
without mechanical parts to advanced implantable controlled changes.
devices that only deform to carry out their functions Weems is currently applying his expertise in
when they reach the relevant area of the body, it advanced materials as part of a team halfway through
creates objects that are able to alter themselves over an EU-funded project to produce a 4D stent. “We can
Sympfiny® – Innovative COP vials – glass- Smart Pack Series – OSD bottles – for
oral delivery system for replacement for Flexible configurations for preservation-free
multiparticulate drugs injectables oral solid packaging ophthalmic solutions
Exceeding your
Expectations.
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become something like child’s play. “We are printing memory polymers with kirigami structures to enable
puzzles, or Lego, and each piece is entrapping a a bifurcated tube to pass through a tight cylindrical
different enzyme,” says Marquette. “We can put one pathway before unfolding in response to a temperature
enzyme close to another, but not close to a third, stimulus. This particular approach needs further study
constructing and changing the order of these pieces to before it can be trialled in a patient, but active origami
see if we get any new features or new functions from has been proposed as a solution for everything from
the system. That’s one more dimension,” he laughs. microsurgery robots to heart catheters.
“I think that one should only talk about 4D Opportunities and obstacles
printing when the change happens as the Whether discussed under the rubric of space-time,
origami, or stimuli-responsiveness, these devices have
3D-printed object is being produced.” immense potential for decreasing the invasiveness
Professor Lorenzo Moroni, Maastricht University of medical procedures and treatments. Children who
once relied on paralytics to stay alive have been freed
Progress in the wider field to inhabit their own bodies without fear of sudden
Weems’s team isn’t the only one working on 3D printing suffocation, and it didn’t require clinicians relearning
shape-memory polymers to improve the quality of how to use and apply external airway splints.
stents. They might be some way from a consensus on “It’s very compatible with what’s being done
what exactly 4D means, but researchers and engineers currently,” explains Weems of his 4D stent. “And the
all over the planet believe it will prove important for other really positive aspect of these materials is that
patients who need implants to support arteries and they take on the geometry of the native vessel. If there
airways. Under an FDA emergency use exemption, was some catastrophic failure in a stent, if something
the technology has already saved the lives of infants had broken during processing, which does happen,
suffering from severe tracheobronchomalacia, it will still take on its original shape when it opens.
a condition that causes the airways to collapse. Compared with materials that just have an elastic
Researchers from the University of Michigan used response it can withstand a little bit more deformation
CT scans to develop 3D-printed splints for three and still return to its optimal, useful configuration
children, including one who couldn’t have food in its without failing.”
stomach without having a heart attack and another That doesn’t mean there aren’t still issues to
whose windpipe had the floppy consistency of a “wet overcome. The prototype for Lee and Kim’s bifurcated
noodle”, according to his mother. kirigami stent is too large for clinical use, for instance.
Unlike airway stents, these resorbable Similarly, Marquette’s work at the 3D FAB Lab has
polycaprolactone devices provide external support, shown promise ‘on the centimetre scale’, but the
preventing collapse or compression but allowing intention is to make devices 100 or 1,000 times smaller.
internal expansion, thus accommodating growth. “The idea hiding behind all this,” he reveals, “is to
In follow-ups over the next three years, all patients inject some 3D-printed high-resolution sensors or
showed significant improvements in their symptoms as active components into the bloodstream.” However,
a result of receiving the experimental treatment. This the team first needs to work out whether its enzymes
time frame is particularly important for children with function in the same way and provide enough of a
tracheobronchomalacia. Though newborns suffering signal when contained in 5–10μm vessels.
from the disease have average life expectancies of days For Weems, the challenge is more dissemination
to weeks, the airways of those that make it to three than containment. “We can put technology in clinicians’
usually grow strong enough to overcome the disorder. hands, and they can say, ‘Oh, that’s really cool, I might
Polycaprolactone is used because it takes around three be able to use it,’ but they approach problems very
years to functionally degrade. differently to how we do. That’s great – they’re doing a
Similarly, Professors Yu-Gong Lee and Taeyoung Kim very different job; but it’s ultimately about convincing
at the Gwangju Institute of Science and Technology, them that what we have is worthwhile.”
South Korea, have used shape-memory technology to At Birmingham, Weems is part of what he calls a
model a unique bifurcated stent for use in branching ‘translational’ team that brings together chemists and
blood vessels. What’s more, they have a whole different clinicians working in very specific areas. It’s taught him
vocabulary with which to explain it. that, “any medical device manufacturer that’s going for
Whereas the fourth dimension is a concept most a novel approach needs to find clinicians who are just
familiar to mathematicians and physicists, kirigami as eager to try new therapies for their patients and
is origami with scissors. Practitioners precisely find new ways to involve new techniques.” We can
cut and fold a single piece of paper to create a three print change, and maybe even hype, but understanding
dimensional form. Lee and Kim’s stents combine shape- is harder to come by. ●
2019
CO-LOCATED
EVENT
S U M M I T & E X P O
Boston
Seaport World Trade Center
T
he tubing market is certainly growing, performance targets on new devices as well thinner walls with the same or more
with continued development being as next-gen redesigns. Smaller tubing and functionality. A good example is the
undertaken to improve all types of thinner walls are being pushed to make company’s eTubing line. It is integrating
medical procedures – from neurology, to procedures less and less invasive. When the knowledge and capabilities of its parent
cardiovascular, to medical robotics. Advances possible, customers are looking for more company, New England Wire Technologies
in technology and science are opening doors performance out of their tubing, whether and New England Tubing, to combine
to new procedures that were not possible in it is physical characteristics, materials or conductors with electrical requirements
the past and also highlighting improvements maybe even including an electrical element into the walls of tubing. This increases
that can be made on existing procedures. within the tubing. functionally of the design, reduces
Minimally invasive surgery has become Every form of minimally invasive surgery device footprint and can also reduce
the preferred choice for scores of surgical uses some kind of tubing that is inserted assembly time.
procedures. It is used in bariatric (gastric into the patient’s body. Tubing can deliver New England Tubing Technologies can
bypass) surgery, hernia repair, urological stents, as in balloon angioplasty; they may customise a tube with added elements,
treatments, colon resection, gallbladder provide a camera, illumination and tools to such as ultra-miniature coaxial cables,
and tumour removal, and is favoured as the manipulate the patient’s internal anatomy, high-frequency cables, thermocouples and
preferred treatment for many gynaecological, as in an ablation or resection; the very high-strength/high-flex alloys to provide
pulmonary and cardiac conditions. Many of design of tubing is what makes minimally more functionality in the same tubular
these surgeries can be done with incisions of invasive surgery possible. cross-section – critical for today’s
no more than a few millimetres. minimally invasive surgeries. The eTubing
Minimally invasive surgery reduces blood Less is more designs can add analogue and digital
loss, shortens recovery time and reduces OEMs are always pushing the transmission of electrical signals for
in-patient time at the hospital. It also envelope when it comes to designs sensor capabilities, powering devices and
reduces the risk of infection, and gives and requirements. New England Tubing temperature/oxygen monitoring features
the patient less scarring and pain, which, Technologies are tasked with meeting by incorporating these customised wires
in turn, reduces the need for pain and these requirements or providing or cables within the wall of the tube itself.
antibiotic medications. alternatives. Recently, the biggest Typical elements for eTubing include:
OEMs are looking for more performance challenge is getting less to do more. ■ power supply
out of their tubing. They are pushing Everyone is looking for smaller tubes with ■ measuring/monitoring capabilities
■ signal carrying capabilities
■ strength members
■ one or more lumen.
Sweat the
small stuff
An interdisciplinary team of scientists at the University of Massachusetts Amherst has produced a
new class of sustainable electronic materials, which may lead to a greener future in biomedical and
environmental sensing. Alexander Smith, a biomedical engineering PhD student and the founder of
the start-up e-Biologics, speaks to Abi Millar about the value of these materials for medical devices.
I
n 1987, the microbiologist Derek Lovley made a “The bacteria produce these protein nanowires
surprising discovery. While digging through the as part of their metabolism and also to communicate
mud of the Potomac River in Washington DC, he with their neighbours,” explains Alexander Smith,
encountered a strain of bacteria with properties that a biomedical engineering PhD student at the
had never been seen before. University of Massachusetts (UMass) Amherst, who
The bacteria, which he christened Geobacter works with Lovley. “Because of that, these microbial
metallireducens, were able to survive without oxygen filaments are electrically conductive, and that’s a
or sunlight thanks to their unusual dietary habits. They pretty interesting property – they’re basically like
‘eat’ and ‘breathe’ metals such as iron, feeding on waste a biologically made electronic material. You can fit
compounds and passing their energy onto metal oxides thousands of these protein nanowires in the width
outside the cell. of one human hair.”
It didn’t take Lovley long to realise the implications: Over the decades since Geobacter were discovered,
since these bacteria ‘eat’ organic compounds, they research in the field has advanced rapidly. Most
could potentially be used to clean toxic waste. By the recently, Lovley’s team has found a way to combine
early 2000s, Lovley had found 70 types of Geobacter, the protein nanowires with a non-conductive polymer,
which were variously used to decontaminate an oil spill producing a flexible electronic composite material.
and a uranium mine. The material in question, which can function even
The possibilities, however, didn’t end there. under harsh conditions, is suitable for manufacturing
When a Geobacter bacterium ‘breathes’, it excretes sensors and electronic devices.
electrons, passing them down tiny wires that protrude Once limited to small quantities of protein nanowires
from its surface. These wires – dubbed ‘microbial (those that were produced naturally), the researchers
protein nanowires’ – make the bacteria a natural are now working on scaling up production, generating
electricity source. the nanowires in commercially useful quantities.
The advantages are obvious. Not only are these protein wind of the possibilities.
nanowires electrically conductive and super-sensitive “I was on a mission to look for technologies
– easily rivalling human-made materials such as carbon at the UMass Amherst campus that could be viable
nanotubes or silicon nanowires – but they’re highly products,” he says. “I came across Dr Lovley’s patent
sustainable to produce. for biological microbial protein nanowires, and as
In fact, protein nanowires could spell the I was reading about them I decided I needed to talk
beginning of a truly green field of electronics, free to this man more. So I sent him an email out of the
from the toxic components that make electronic waste blue, and he agreed to meet with me the next day.
such a concern. While today’s electronic devices are As he was telling me about them I just became more
predominantly considered disposable, they are non- and more fascinated and saw the potential. I said,
biodegradable and difficult to recycle. With the dawn wow, we need to commercialise these, they’re
of electronic biologics, this could be about to change. so cool. Derek said that one of the big challenges,
“The process to make carbon nanotubes and other though, is finding the right application and the right
traditional materials is pretty nasty, requiring toxic businessperson to translate the research. So I rounded
chemicals and reactions,” says Smith. “By contrast, up some business mentors and we formed a team.”
these protein nanowires are produced by the
Geobacter naturally – all we have to do is feed
the bacteria with renewable feedstocks. So we
“The process to make carbon nanotubes and
have this sustainable and inexpensive way to produce other traditional materials is pretty nasty,
the protein nanowires even at scale, eliminating requiring toxic chemicals and reactions. By
a lot of the toxic chemical production that’s used contrast, these protein nanowires are produced
with current technology.”
Another benefit of the nanowires is their
by the Geobacter naturally – all we have to do
versatility. Through tweaking the Geobacter, it is is feed the bacteria with renewable feedstocks.”
possible to produce different types of nanowires
suitable for different forms of biomedical and The result was e-Biologics, a start-up dedicated
environmental sensing. to commercialising the protein nanowires. Five
“Since it’s a biologically made protein, we can months after Smith’s meeting with Lovley, his
genetically modify different strains of protein fledgling company won first prize in the UMass
nanowires so they are sensitive to very specific Amherst 2018 Innovation Challenge, going home
analytes,” says Smith. “One of the biggest challenges with $30,000 in funding.
in sensors nowadays is making them really selective, That summer, he participated in the
so that’s a challenge we can conquer with our protein Berthiaume Centre Summer Accelerator, which
nanowires, by functionalising them with highly provided further funding and gave him a crash
selective molecules.” course in launching ventures. The company is
now moving towards making device prototypes and “Because the sensor is so small and
applying for patents. biocompatible, our vision is that it could be
“My PhD research is focused on developing the placed pretty much anywhere in or on the body
technology for the protein nanowire devices, and with a very small footprint, and would be able to
then my activities with the start-up company will be measure many analytes simultaneously, providing
taking the technology that I’m developing and putting a comprehensives assessment of a patient’s health,”
it to use for practical applications,” explains Smith. says Smith. “Not just diseases, but applications
To begin with, the e-Biologics team is focusing like nutrition and fitness tracking as well. Providing
Alexander Smith on a single biomedical application, which Smith personalised monitoring of a person’s health in real
describes as the original vision for their minimum time is very exciting.”
viable product – something that will pave the way for
more complex biomedical sensors. It is a skin sensor Industrial use
patch, worn like an Elastoplast, which can be used Since the nanowires can also be used as gas sensors,
to detect the early signs of diabetic ketoacidosis there are potential industrial uses in the works too.
Protein nanowires can be stabilised in water, In these cases, the sensor would be integrated into
which makes them ideal for detecting metabolites something like a microchip, which could be used for
in sweat. They are particularly good at gauging gas sensing within chemical processing. This in itself
acidity, with their conductivity changing in could have implications for human health.
response to changes in pH. “During production of industrial materials such
“With the help of my business mentors, I came as fertiliser, if toxic gases are produced and people
up with the concept of a wearable device that inhale them that can make them sick,” says Smith.
would analyse your sweat continuously and non- “So we can make sensors that detect the presence
invasively to measure biomarkers that can indicate of dangerous gases to prevent health problems
the early onset of diseases,” says Smith. “Sure from occurring.”
enough, there’s a condition called diabetic While e-Biologics is still in its early stages,
ketoacidosis, which particularly affects people with the future certainly looks promising. The next
type 1 diabetes and is indicated by changes in pH.” step, says Smith, will be to rent a space in the
The device will be linked to a smartphone app University Of Massachusetts Institute for Applied
that alerts the wearer to the possible onset of Life Sciences, where the company will set up shop
ketoacidosis. It will be marketed to high-risk and continue to produce the technology. He is also
patients with type 1 diabetes, and could ultimately looking to apply for further sources of funding, such
prevent many hospital bills and trips to the as non-dilutive government grants.
emergency room. Over the next few years, the team hopes to
move on to testing their sensing devices with
animals and eventually humans. Eventually, they
“With the help of my business mentors, I came want to move beyond their prototypes into a whole
up with the concept of a wearable device that host of applications.
would analyse your sweat continuously and For Smith, putting these protein nanowires to
good use is “a goal not just for the start-up but
non-invasively to measure biomarkers that
also for my life”. And for his mentor, Lovley,
can indicate the early onset of diseases.” who has spent over three decades focusing on
the Geobacter bacteria, the latest developments
This, however, is only the beginning. As Smith are no less exciting.
explains, the protein nanowires constitute a kind of “Derek has studied these protein nanowires for
platform technology that could be used for all kinds their interesting microbiological properties, but he’s
of purposes in the future. thrilled to see them used in an actual application
“While these protein nanowires are responsive to that is clinically relevant and can help people,” says
pH initially, we can genetically tune them so they Smith. “He loves the interdisciplinary nature of the
can respond to other analytes as well,” he says. project, combining microbiologists with engineers
“The vision is that we could measure many analytes and businesspeople – it’s this whole new start-
simultaneously in a very small space.” up environment that has been super productive
They would look not just at sweat, but also at for research and for translating the research.
other biological fluids such as urine, saliva and At one point he told me, ‘I never imagined that
breath. This could provide an assessment of many these applications could arise when I was studying
diseases, such as Parkinson’s disease, Alzheimer’s Geobacter rolling around in the mud.’ And now
disease and cancers. it’s got the potential to save people’s lives.” ●
Company Info 258 Goddard Rd, Lewiston Maine 04240 -Tel: +1-207-777-1122 / Compoundingsolutions.net
I
n today’s medical market, integrity and physical robustness
front-end decisions that designers that has always been essential.
make can have a lasting impact AlphaWire EcoCable and EcoFlex
on manufacturability, patient and control cables in flexible and
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Selecting the right process aids of equipment.
while designing for manufacturability The AlphaWire Micro Coax series
(DFM) of interventional devices of coaxial cables are available down
such as stents can have a significant to a smaller 50 AWG size with
impact on manufacturing time and outstanding dielectric properties for
costs. Use of traditional FEP medical the low capacitance and consistent
tubing process aids may cause impedance required for coaxial
difficulties and inefficiencies that are applications, such as medical
easily avoided with strategic design probes, endoscopy, oximetry
Lapp Tannehill works alongside a range of manufacturing companies
and concurrent engineering. The use developing many different devices. systems and more.
of flexible polyolefin-based solutions,
such as TE Connectivity’s MT-LWA for emergency release can also be Finding the right partnerships
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efficiencies with an easy-to-peel (without Medical connectors such as the ODU design goes beyond achieving design targets
the use of blades), no-need-to-skive MEDI-SNAP Break-Away connector provide and selecting the right componentry. The
design, or eliminating adhesives and effortless, ergonomic connection, while also right partnerships can go a long way in
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MT-LWA is perfect for reflow applications connector with one pull of a specified force into equal success for patients, practitioners,
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optical clarity and optional controlled shrink and reduces cost and weight. Lapp Tannehill has been partnering
force make it an exceptional process aid for with medical device and equipment
hot jaw bonding and laser-weld applications Fit-for-purpose wire and cable development and manufacturing companies
such as balloon bonding. As medical equipment technology for several decades. As an authorised
becomes ever more capable, intelligent distribution partner for TE Connectivity
The right medical electrical and complex, the need for space-saving medical tubing, ODU medical connectors
connectors for signal and solutions to wire routing and harnessing and AlphaWire medical wire and cable,
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Choosing the right medical connector The AlphaWire ECOGEN and MicroCoax selection, while also ensuring an optimised
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I
t’s no secret that medical devices making things easier for developers,” A creative and collaborative approach
are developing at a rapid rate. Davies says. is the key to achieving these efficient,
Increasingly, smaller, more intricate Partnership with medical device polished products.
solutions are required to reduce the manufacturers has led to the development “We’re not afraid to try new alloys or
invasive nature of surgical and diagnostic of ultra-flexible leads capable of new coatings to meet the requirements
procedures, minimising patient trauma stimulating multiple nerves with the same that developers have, whether that
and limiting recovery time. As well transmitter, as well as composite wire involves doing some preliminary lab-scale
as demanding high-quality products, configurations that combine steerable melting of alloys or trying out different
developers are frequently looking strength members with highly conductive coatings. It’s always rewarding going
for unique materials to solve design- signal-transmission materials. EXERA down the development path with our
related problems. As demand grows, wire is available in a wide range of surface customers,” Davies says.
manufacturers are partnering with treatments. Single-wire configurations can In its quest to help medical device
specialists to help automate their be electroplated with custom thicknesses manufacturers refine and develop new
methods of production. of gold or nickel and layered in polymer, processes and products, Sandvik is at
Sandvik, a manufacturer of ultra-fine PTFE and multilayer coatings. Customised the cutting edge of health technology.
precision medical wire, is satiating this multi-filar arrangements and cabled wire It is also a company willing to help
demand, working with manufacturers are also available. developers of all shapes and sizes.
to develop high-tech medical devices.
According to Gary Davies, production
unit manager at Sandvik, the high “One thing we do, aside from the manufacturing, is
quality of EXERA wire, which is made tweaking certain products to suit the needs of our
with diamond dies by experienced
craftspeople, is the result of a rigorous
clients – whether we are coiling the wire, stranding
development process. “We follow strict it, cutting it to a particular length or stripping the
internal qualification and validation ends. It’s about making things easier for developers.”
guidelines in order to fine-tune processes
to meet our customers’ high-precision
requirements,” he says. Sandvik’s wide variety of alloys, forms, “We’re willing to work with anyone,”
EXERA wire can be used in cochlear thicknesses, arrangements and coatings says Davies. “Not just large corporations,
implants, in lead wires; vascular therapy, provides developers with a range of but smaller innovators, to support them
in guide wires and pacing leads; for options. The configuration and materials and help make their new idea a reality.”
monitoring thermal and glucose levels; used in EXERA wire allows device For Davies, it is motivating to know
and for neurostimulation. manufacturers to automate production that such devices are improving people’s
methods more efficiently. lives in subtle and drastic ways.
Unique designs “Many of our customers are embracing “We’ve had end users come into the
Fulfilling these demands often involves automation. So they’re looking for factory and shared their story about a
altering certain products to unique solutions that can add value to their certain implant that has made their life
design preferences. “One thing we do, products. We work with companies to easier, and it really hits home. It’s great
aside from the manufacturing, is tweaking solve those design-related problems, to know that you’re helping people,”
certain products to suit the needs of our whether that involves using a specific he says. ●
clients – whether we are coiling the wire, type of material, not only on the
stranding it, cutting it to a particular alloy side, but also the coating side,” For further information
length or stripping the ends. It’s about explains Davies. https://exera.sandvik
A
s engineers and medical
professionals continue probing
for improved products to boost
patient care, they face the daunting
challenge of getting new concepts to
manufacturing reality. Often, the ideas are
there to tackle a specific problem or issue
but not the manufacturing know-how.
For Zeus, meeting such challenges is
its strength. One of the company’s guiding The increased layer bond strength of catheters made with the tie layer helps to address the serious
principles is to innovate and lead with safety concern that come with delamination.
new products and designs to address jacket, creating a like-for-like bond Tie layer – versatility and safety
application needs just like these. during jacket reflow. With the tie layer The tie layer is versatile and suitable
bonded to the liner during the coating for a variety of applications, and can
Performance catheter components process, the summary effect of the tie be produced in a variety of durometers.
A core element of Zeus performance layer is to increase the liner-to-jacket While currently offered in a variety
extrusions for the medical industry is bond strength. Preliminary testing has of materials, including Pebax, nylons
its components for catheter construction. shown that the tie layer increases liner- and polyurethanes, Zeus will also
FluoroPEELZ peelable fusing sleeve to-jacket bond strength up to two-and-a- continue to make tie layers available
vastly improved the removal process after half times compared with catheters made in other materials.
the reflow step of catheter construction. without it. Depending on the material In keeping with its history of leading
LCP monofilament is an MRI-compatible and durometer chosen, the tie layer the way, Zeus has identified a tie layer
non-metal braiding material and Zeus’s has been shown to improve catheter to be an ideal solution for those catheter
polytetrafluoroethylene (PTFE) base performance, deliverability and increased manufacturers wanting to secure a PTFE
liners are the thinnest available for use column strength. liner to the ID of a metallic tube, such
as a free extrusion. The tie layer’s most important as a laser-cut hypotube. This versatility
Now, adding to these is Zeus’s new tie advantage is safety. The increased layer afforded by the tie layer allows device
layer – a thin polymeric coating applied bond strength of catheters made with designers and makers to precisely tailor
to the etched OD of the PTFE liner the tie layer addresses the serious safety the performance of their device to deliver
designed to reduce delamination and concern of delamination – the separation life-saving therapies in some of the most
improve mechanical attributes of the of layers within the catheter. Aside from tortuous vascularture.
finished catheter shaft. delamination defects discovered during With industry buzz words like
final inspection – the most costly yield ‘continuous improvement’, Zeus catheter
Catheter tie layer – loss and a major contributor to raising componentry is advancing this industry.
continuing innovation production costs – it carries high liability And, as exemplified by the tie layer, any
This new tie layer represents a significant of delamination problems occurring in a improvement to manufacture, design or
step forward for catheter construction. clinical environment. There, delamination device implementation will undoubtedly
The tie layer is applied as a coating to an failures have direct repercussions for result in improved patient safety. ●
etched PTFE extruded liner – a process patient safety. The increased bond
unique to Zeus. Applied in this way, the strength from the tie layer also supports a Pebax is a registered trademark of Arkema France.
tie layer promotes more uniform adhesion more mechanically consistent device with
of the reflowed jacket to the etched more reliable performance characteristics.
PTFE liner. These attributes lead to more efficient
Secondarily, the tie layer will typically catheterisation procedures and lower For further information
be of a similar or same material as the risk to patients. www.zeusinc.com
Glass
healing
Bouncing, bending and bonding to bone, glass is looking more and more like a miracle material.
The liquid-like solid is showing its worth in everything from healing wounds to replacing intervertebral
discs. Tim Gunn talks to Professor Julian Jones of Imperial College London and Professor Aldo
Boccaccini from the University of Erlangen-Nuremberg about the properties of bioactive glass that
make it so valuable for medical devices.
“H
amburger. Hot dog. Ice cream,” hospital in 1984, your hearing restored by the
whispered Professor Gerry Merwin, unprecedented ministrations of a lunch-deprived
the very hungry ENT surgeon who man, but cry hamburger, hot dog and ice cream?
had just implanted the world’s first Bioglass It was with that calorific mantra that a human-
device into another human being. made material, Bioglass 45S5, first began to bond
“Hamburger! Hot dog! Ice cream!” repeated with living tissues inside a human body. On the
his joyous patient. She could hear again. The surface of the device, a rapid series of chemical
glass prosthesis in her middle ear was conducting reactions were forming hydroxyl carbonated apatite
sound waves, just as the tiny bones she had lost (HCA), which, due to its similarity to bone mineral
to infection once did. She would not be deaf to her – hydroxyapatite (HA) – is able to interact and
second child’s first cries, nor the voice confirming integrate with living tissue. The cells in the stapes
her order at the drive-through. What would you and ear drum were using it as the basis for the new
do as the local anaesthetic wore off in a Florida bioactive bonds that would hold the prosthesis in
15
place as securely as bone itself. Unlike the bioinert Injury luck
alternatives, this implant would neither slip nor “That was an accident,” laughs Professor Julian
be pushed out of place, thus protecting the young Jones, in an offhand reference to the time he made
mother’s ears from further damage. a glass that could heal itself. The team Jones leads
It had been 15 years since materials scientist and at Imperial College London was trying to engineer The gap, in years,
children’s author Professor Larry Hench discovered a bioactive material capable of taking cyclic loads.
between the discovery
Bioglass, but even after he watched over the success He was messing about with one of their latest
of Bioglass and
its first in-human trials.
of its first in-human trials, he could hardly claim that 3D-printed test cylinders. Unlike melt-derived
he fully understood its potential. In fact, over the glasses, it had been formed through the sol-gel
next few years, Hench and his research team began method, a chemical process whereby solid ceramics
to realise that, more than simply bonding to living and metals are grown from small molecules, and
tissue, the material was capable of regenerating it. printed before they have fully solidified. “I was
This too was attributed to the formation of HCA on squeezing it going, ‘It’s almost there, I think that’s
the surface of implants in the body, although that almost what we’re looking for,’” Jones recalls. “It
didn’t explain why synthetic HA was comparatively was just a bit stiff, and by squeezing it I cracked
ineffective. Whereas HA supported new bone growth it across the diameter.”
at the bone-implant interface, 45S5 also did so within As far as Jones was concerned, that crack
the implant itself. showed why ‘almost there’ wasn’t good enough.
Insufficiently intrigued by the fact that the chunk
Second life had not just exploded, he put it down and turned
It was not until the early 2000s that Hench and to his fellow researchers to discuss how to improve
his new research partner, pathologist and tissue on the design. The sol-gel method made it possible
engineer Professor Dame Julia Polak, developed for the team to mix biodegradable polymers into
a clearer idea of what was going on. The most bioactive glass on the molecular level by growing
pronounced healing effects of bioactive glass are them together through a series of chemical
caused by the release of ionic dissolution products reactions. Unlike a composite, the resulting hybrid
as the material reacts with the body. In particular, would act as one material. The team just had to get
as 45S5 glass degrades it releases sodium ions, the mixture right and their bioactive glass would
calcium ions and soluble silica, a process that be able to take the cyclic loads the human body
stimulates osteoprogenitor cells and facilitates the exerts on its constituent parts. After 20 minutes
production of new bone. This realisation marked of brainstorming, Jones picked up his stress-tested
the beginning of what Professor Aldo Boccaccini glass again. “I checked all the others to make sure
calls the “second life” of bioactive glass. “The gene I hadn’t mistaken the one I put down, but I hadn’t.
expression of bone cells was being activated by the The crack was gone.”
ions released from the glass,” he explains. “They
were moulding the formation of new bone tissue “What people want and really need is
by acting directly on the cells.”
Shortly after, Boccaccini’s own team demonstrated
regeneration of cartilage lost due to arthritis.
that ions released from bioactive glass devices could If we can develop better ways of detecting
also promote angiogenesis in soft tissue. As was the onset of arthritis, then these sorts of
clarified later, calcium ions assist in the migration
and proliferation of epidermal cells and accelerate
technologies may translate to that once we’ve
blood-clotting, while silicon ions advance proved them in sports.”
neovascularisation and stimulate the formation of Professor Julian Jones
collagen. For Boccaccini and others, it was becoming
clear that, “If we control particular aspects of the The accident of creating a self-healing implant
chemical composition and the kinetics of releasing material was one of a few strokes of luck in the
ions, these glasses can communicate with different story of bioactive glass. Incredibly, Hench chose
cells and provide different biological responses.” the optimal chemical composition for his Bioglass
Indeed, bioactive glasses are now found in on the first try. Jones and his team’s attempts to
toothpastes and cosmetics, as well as orthopaedic develop the best possible bioactive bone implants
particulates and wound-healing systems. Until also resulted in a glass hybrid that could bounce
recently, however, such materials had not overcome and bend – a perfect fit for repairing cartilage,
their primary limitation. Bioactive glass is still glass, which is even more difficult than regrowing bone.
and glass is far too brittle for many functions At present, sports injuries like a torn meniscus can
required by the human body. take months to heal. Regenerating the cartilage
Bouncy bioglass is requires surgeons to dig into the surrounding bone As Boccaccini explains, the discovery of the effect
flexible (left) and can be
3D printed into scaffolds to release stem cells, but these can only produce of bioactive glass ion products on vascularisation
(centre). When the a dense and fibrous form of scar-like tissue, which made the material applicable across the whole
scaffolds have a certain
pore size they stimulate
lacks elasticity and quickly wears out. By contrast, human body. Cartilage is a notable exception, which
cartilage cells to when Jones’s bouncy scaffolds are printed in the is why it is so difficult to regenerate, but most of the
produce a high-quality correct channel size, they can enhance and guide body is vascularised. “The blood is everywhere, so
articular cartilage matrix
(right) unlike any other stem cells to produce the particular architecture you are not necessarily bound to use glass simply
existing device. of joint cartilage, which grows through microscopic for bone repair,” he says.
holes in the glass as it biodegrades. To take one example, nickel and cobalt ions can
“If you’re repairing bone, you need big channels be added to bioactive glasses to mimic hypoxia and
that bone and blood vessels can grow into,” explains aid wound healing. “In simple terms, when the glass
Jones. “For cartilage you don’t need any of that; what starts dissolving, those ions will absorb oxygen from
you want are channels small enough for individual the area of the wound,” explains Boccaccini. “Low
cartilage cells to communicate with each other.” oxygen content triggers a number of mechanisms,
Furthermore, the material’s ability to bond with recruiting endothelial cells to build blood vessels
tissue and take cyclic loads means that patients and attract oxygen via the bloodstream.” Equally,
could return to pre-injury activity levels within bioactive glasses could be used for drug delivery
a few days of receiving the implant. That would devices that synergistically release therapeutic
be a boon for sportspeople in the short and long dissolution products alongside their drug payloads;
term, minimising recovery time while ensuring or as a coating for wound dressings and other
that the damaged tissue regenerates to meet implants, where they can release antibacterial
the demands of continued stress and activity. ions as required.
Sports injuries are a relatively limited application, In fact, Jones believes ETS Healthcare’s Mirragen
but non-biodegradable variants of the ‘bouncy’ bioactive glass wound dressings have the potential
bioactive glass scaffolds could also be used to to take the chronic wound care industry by storm.
replace intervertebral discs. “Obviously,” admits “There isn’t a good way to regenerate diabetic
Jones, “what people want and really need is ulcers at the moment,” he says, “and bioactive glass
regeneration of cartilage lost due to arthritis. If could be the next big thing.” The product can heal
we can develop better ways of detecting the onset wounds up to 40% faster than its direct competitors.
of arthritis, then these sorts of technologies may Boccaccini is similarly excited by Mirragen, but
translate to that once we’ve proved them in sports.” urges caution. “All these things are coming, but
more research has to be done,” he stresses. “There
Never can say goodbye is still a gap in the data on the long-term effects
Jones and Boccaccini began their work on bioactive of the release of ions and the degradation effects
glasses with Hench in the late 1990s and early of bioactive glasses in realistic in vivo models. It’s
2000s. “He used to say, ‘Oh, I will retire in three the obvious thing to do, but it’s very expensive.”
or four years, so you can take over some of my As Hench once wrote, “Being a pioneer and
research,’” recalls the more Argentinian of the ahead of one’s time is, on the whole, not desirable.”
pair. “But 10 years later, he was still there.” Today, Still, since his death at 77 in 2015, Jones,
only Jones remains at Imperial, but both material Boccaccini and others have been happy to take
scientists have defined and been defined by the on that mantle. However long the next stage
second lives of bioactive glass. of development takes, it is quite a legacy. ●
www.mo-sci.com • 573.364.2338
ISO 9001 • AS9100C
Patented textile-
forming technologies
Secant Group combines textile engineering expertise with speciality manufacturing technology to
create high-performance biomedical structures to facilitate repair and recovery of the body.
S
ecant Group offers several market-
leading capabilities, such as its
patented Drop End technology.
Tubular woven implants are manufactured
with this technology, which drops warp
ends circumferentially within the tapered
region to maintain a consistent density
around the entire construct.
In other technologies, the ends are
dropped next to each other, rather than
circumferentially, leading to regions with
different porosity. The Secant method
is superior for maintaining specific
Secant Group can use patented manufacturing capabilities to customise implantable devices.
characteristics, such as porosity and
flexibility along the length of the textile fine mesh. The coarse and fine mesh a disadvantage with woven textiles is
structure. Tubular woven fabrics may be filaments are then braided together with their lack of flexibility due to the warp
used during surgery to repair or replace the resilient filamentary members to form and weft yarns interlacing at 90° angles,
various damaged or diseased lumens the construct. The finer mesh built with causing them to lock in place.
within the human body; for example, flexible fibres creates small interstices that By tuning the flexibility within certain
in vascular surgery, in which a woven provide a bed adapted for growing living regions of a woven graft using elastic
tubular prosthesis is used to repair a cells in a two-dimensional array across the materials and tensioning techniques,
blood vessel. cell cultivation lattice. Secant can provide areas with more radial
expansion and others with less radial
expansion. By weaving in radial flexibility,
“Another patent granted to the Secant Group is for its
the graft can radially expand to match
supported lattice for cell cultivation technology. It saw the diameter and shape of the artery. In
a need to create a lattice for cultivating living cells to regions where a set diameter is desired,
form living tissue, so surgical implants could act as and no radial expansion is wanted, Secant
can apply greater tension on the weft,
grafts to heal damaged tissue and correct disorders.” which inhibits the yarn from expanding
any further. For example, the region
Another notable patent granted to the This creates a substantial continuous adjacent to an aneurysm needs to
Secant Group is for its supported lattice surface of living tissue that forms a maintain a set diameter so that the
for cell cultivation technology. Secant tube usable as a graft for a coronary hydraulic pressure of the blood as it is
saw a need to create a lattice for cultivating bypass operation. pumped through the artery can relieve
living cells to form living tissue, so surgical pressure on the aneurysm. The same
implants could act as grafts to heal damaged Woven tubular grafts techniques can be used when making
tissue and correct various disorders. One Woven tubular grafts with regions of straight or bifurcated tubular grafts.
example for this application is a tubular varying flexibility is another Secant Visit the Secant Group website via the
support lattice for a coronary bypass graft. Group patent. Woven grafts have address below to learn how it can use
This tubular support substrate is numerous advantages, such as patented manufacturing capabilities to
comprised of resilient filamentary members impermeability, low porosity and small customise your next implantable device. ●
interlaced together to form a coarse mesh bulk, which are important characteristics
and another plurality of flexible filamentary for several medical procedures, such as For further information
members braided together to form a repairing a vascular aneurysm. However, www.secant.com
Make it stick
When choosing a motor, the need to balance multiple factors such as service life, cost, speed and
temperature conditions, as well as the huge range of potential applications of the technology, can
be a challenge. Emma Green speaks with Thomas Mayer from Sonceboz and Carl Bugeja, an
embedded-software developer, about how to effectively navigate decisions about motors and the
magnets that allow them to run.
A
t the heart of many pioneering medical are made of iron laminations with copper wire coils
devices are new designs of electric motor around them. Later, alnico and ferrite, also known as
and motion-control systems. In pushing ceramic magnets, were incorporated. Since magnets
forward their design parameters, technology were expensive and not particularly strong, motor
companies are continually seeking higher efficiency, designers tried to use iron to contain, direct and focus
more speed, and increased power from smaller, the magnetic flux within the motor.
more robust and quieter equipment. It is therefore Magnetic iron is relatively cheap as a bulk material.
up to the designer and manufacturer to ensure However, the machines needed to punch, stack, glue
that motors can meet these needs, regardless of and grind these metal components are expensive.
the particular application and setting. With the advent of more powerful magnets, it is now
Central to motor technology, past and present, are possible to make motors that don’t incorporate iron
magnets. The initial discovery of magnetism began into the switched magnetic circuit. A large diameter
with lodestones, which are very weak, naturally motor has more volume available for magnets and
occurring magnets. Next came electromagnets, which coils, which allows the designer to choose between
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Cross-Roller Rings
Electric Skeleton key
dreams
In an effort to move away from opioids,
How glass opens the door for new implantable devices
A new dimension
www.thk.com
3D printing is revolutionising Light touch
prosthetics and giving
Creating new possibilities
hope to those with life-
with flexible photonics
changing injuries
www.buythatmag.com
Coatings & surface treatment
Old spark,
new ideas
Although the use of plasma treatments for medical For several years now the medical device sector
has been increasingly turning to plasma to coat its
device coatings has been around for some time, in
products. In 2016, industry experts spoke of the
recent years it is enjoying something of a renaissance. growing use of plasma-enhanced chemical vapour
Andrew Tunnicliffe talks with Professor Denis Dowling deposition (PECVD) as a means of depositing
about its potential and its limitations. coatings to protect products against corrosion
and wear.
F
rom the often magnificent lightning displays in Today, plasma has become commonplace
the sky or the aurora borealis, to its use in car during the manufacturing of medical devices.
headlights and the televisions we watch, plasma “Almost every medical device company looking
is everywhere. Said to be the fourth state of matter – at polymer processing will have a use for plasma,”
the first three being solids, liquids and gasses – it is an explains Professor Denis Dowling, director of the
excited gas produced by adding energy to it, causing I-Form Advanced Manufacturing Research Centre
electrons to leave the atom. While natural plasma has at University College Dublin.
been in existence for as long as time itself, it wasn’t Plasma can be used to prepare surfaces prior
until the 1920s that American physicist Irving Langmuir to printing, for adhesive bonding, as well as for
first recorded and then researched its properties. He depositing metals and functional coatings – all of
coined the name plasma to describe the ionised gas as it which have uses in applications ranging from the
reminded him of a blood plasma. Since then it has been fabrication of medical device sensors, to enhancing
used for myriad applications, not least in industry. cell attachment to metallic implants.
F
ormacoat is moving, says its founder producing lower levels of particulates,” Formacoat has also joined with another
and chief executive Mark Gross. explains Gross. coating vendor to offer a chemical grafting
In need of new warehouse space, Formacoat anticipates being at the coating for catheters.
the company’s headquarters will up forefront of delivering coating options and “It does require heat, but the coating is
sticks from its current base in Savage, services to customers that live up to these formed in liquid and is a very good coating
Minnesota, US, to the town of Chaska, new standards. for doing IDs of products,” explains Gross.
some 12 miles down the freeway. “Part of our response to particulate “We are currently performing cutting-
“For some, it’s a longer drive,” Gross generation is that we are going to begin edge research and development towards
cheerfully points out. “For me, it is only doing in-house particulate testing earlier commercialisation with this coating.”
a mile and a half.” in the development process,” says Jesse In the past year, Formacoat has also
New travel arrangements for certain Manley, a research and development developed new methods for encapsulation
employees aside, the move is just another engineer at the company. “We are going with polymers of substrate materials
sign of Formacoat’s burgeoning reputation to do dynamic testing that integrates and has made inroads into creating new
in the coating sphere. Incorporated in not only liquid particle counting, but does heatable coatings with partner vendors.
2002, the contract manufacturer for so with the standard lubricity-durability Looking ahead, Gross and Manley
medical device coating services has pinch testing that we do to qualify all anticipate greater interest among
proven expertise in pairing the right coatings, for all customers.” customers in coatings that do more than
hydrophilic or hydrophobic coating with passively provide lubricity to individual
some of the most intricate and advanced The right coating for the job medical devices. A great example of
clinical instruments. Its success in Because Formacoat does not manufacture this would be Formacoat’s use of a
this area has been demonstrated by or sell coatings – instead sourcing coatings hydrophobic, ‘matrix-entrained liquid’
its expanding customer base and rising from corporate and academic partners – coating, which possesses a high degree
staff numbers. the company has a vast array of options of repellence against materials that might
“We have reached a point where the open to it in order to find the most lie against it inside the body.
space we are in no longer works for us,” appropriate coating for any device. “It has valuable applications for
Gross explains. “So, we are building a “What I learned early on in the antimicrobial activity, but without there
new facility that will increase our square business is that not all coatings are being any drugs involved,” explains Gross.
footage fourfold.” equal,” says Gross. “Bacteria simply can’t adhere to its surface.
That means it is great for dosing and
stripping applications, where you’re trying
“By offering different coatings from different
to remove products or contaminants from
vendors, if one doesn’t work, we can switch to a surface during a medical procedure.”
another very easily.” That coating is still in its nascent
commercialisation stage, but Formacoat
This will provide room enough for new “By offering different coatings from has plenty of other projects to keep it busy
ultrasonic spraying tools and equipment different vendors, if one doesn’t work, as its staff wait to make their move into
for precision coating applications. we can switch to another very easily.” the new facility.
Some expansion space and funds This versatility also allows Formacoat “We have got coatings that are
will support Formacoat’s pursuit to break away from traditional thinking heatable and surface-blocking coatings
to help medical OEMs navigate the surrounding how certain coatings fit that prevent proteins from bonding to
US Food & Drug Administration’s with certain applications. device exteriors,” Gross says, confidently.
position on particulate generation in For example, Gross and his “Our world of coating applications is pretty
certain coatings. colleagues are currently working with much exploding.” ●
“It has pushed coating manufacturers coating vendors to develop soft-touch
to develop new formulas and strengthen coatings that, the CEO says, “feel like For further information
their products so that they are better at peach skin”. www.formacoat.com
T
rusted, high-quality needles are From custom point geometries to
required for interventional procedures specific cannula designs, Argon Medical
such as kyphoplasty, vertebroplasty, OEM offers CNC Swiss Machining, and
bone access and bone marrow biopsy, as a variety of metal processes, such as
well as orthopaedic and spine surgeries. swaging, bending, flaring, electrochemical
Although the need for such bone needles ‘burr-free’ cutting and chemical etching.
is common, finding a specialised needle Another important feature of a bone
that specifically matches your requirements needle is the ergonomic handle design.
can be a challenge because the procedural Handle designs have improved greatly
outcome, ease of use, and patient and over the years to improve needle control
clinician comfort is greatly impacted by and clinician comfort.
the needle’s point geometry, cannula design Additionally, adding custom features to
and handle ergonomics. the handle design, such as a pad-printed
As a leading provider of bone access needles, Argon
Grinding the needle point geometry logo or a specific handle colour, can Medical OEM offers a wide variety of ergonomically
is a critical process in manufacturing a enhance marketing efforts and increase designed handles in many shapes and colours.
perfect needle. This is especially evident brand awareness. and cement delivery, with leading edge
in bone access and bone marrow harvest As a leading provider of bone access design features built in for optimal ease-
needles where the point geometry directly needles, Argon Medical OEM offers a of-use and patient outcomes.
affects insertion force and patient comfort, comprehensive range of ergonomically Packaging is another important
and can impact the overall success of designed handles in a variety of shapes consideration for your bone needle project.
the procedure. and colours. Packaging options range from bulk non-
sterile to custom single-pack sterile.
Although sourcing your needle bulk
“Grinding the needle point geometry is a critical non-sterile might seem to be the easiest
process in manufacturing a perfect bone needle.” and least-expensive solution, partnering
with a supplier in order to provide a
Argon Medical OEM provides a wide Off-the-shelf and sterile, private-label-finished device can
variety of point geometries, including: packaging options help reduce overall lead time and total
the double-diamond point designed to Some projects prioritise speed and time-to- cost of ownership.
easily penetrate hard bone; an industry- market, when there simply isn’t enough Argon Medical OEM offers a wide variety
leading ‘match-ground’ tip where the time or budget to source a customised of both custom and standard packaging
needle and stylet are uniquely matched bone needle. For such situations, there options, including form-fill-seal, vacuum
one-to-one during grinding, for a perfect are off-the-shelf options that are ideal. forming blister trays, peel pouching, and
needle point; and electrochemical grinding Argon Medical OEM has a vast portfolio private label and custom packaging.
and notching for custom features specific of ready-to-order needles specifically
to customer needs. designed for bone access, bone biopsy Quality as standard
Argon Medical OEM is a proven quality
Cannula and ergonomic supplier of needles for bone, biopsy and
handle design vascular access, and a respected leader
Cannula design is also an important in medical device manufacturing, with
feature for bone needles. Some design custom and standard product offerings
options to consider are shaping the for components, accessories and private-
tubing or wire to strengthen the hub label-finished devices.
bond, modifying the funnel entry for Argon’s experts are available for the
accepting a device into the tubing inner company’s clients to contact and discuss
diameter, designing the cannula to their projects. ●
capture and retain outstanding-quality
bone marrow specimens, or adding For further information
Argon Medical OEM provides a wide variety of point
centimetre depth markings. geometries to cater to customer needs. www.argonmedicaloem.com
Cancer detector
Cancer DNA changes in response to its environment, favouring alterations that help it survive
long term. These include large and small changes, and the latter can be almost invisible.
Chrissy O’Keefe and a team at Johns Hopkins University have created a digital microfluidics
platform to help detect these changes. She talks to Kerry Taylor-Smith about how this
technology could revolutionise cancer detection.
I
dentifying scientific markers of cancer is key to HYPER-Melt – or high-density profiling and
early disease detection and treatment planning enumeration by melt – is a digital, microfluidics-based
– often possible long before a diagnosis has been platform that allows researchers to manipulate and
made or symptoms develop. It can also help doctors analyse minute volumes of fluid. By separating blood
to track disease progression and guide treatment in samples into smaller and smaller chunks, the device
established cases. makes them easier to individualise and analyse. This
However, searching healthy cells for small changes makes it easier to identify disease-carrying DNA and
to DNA in cancer cells is akin to searching for needles to separate it from healthy DNA.
in haystacks. That’s because while some changes are HYPER-Melt is the brainchild of Chrissy O’Keefe,
significant – and relatively easy to detect – others are a PhD student who has been under the mentorship
so small they evade analysis. And it’s these changes of Professor Jeff Wang, a microfluidics expert in the
that can give cancer DNA an edge and affect patient university’s Department of Mechanical Engineering
outcomes – early detection can boost survival rates by and at the Institute for NanoBioTechnology (INBT),
as much as 90% in some cancers. In what could signal and senior INBT research scientist Tom Pisanic.
a major breakthrough for oncology research, a team O’Keefe and her team have published their
from the Department of Biomedical Engineering at work on HYPER-Met in a Science Advances paper
Johns Hopkins University has developed an innovative entitled ‘Facile profiling of molecular heterogeneity
device to help make identifying these small changes by microfluidic digital melt’. The research is the
easier and more efficient. culmination of more than five years’ work in the field.
allows us to acquire additional sequence information are seeing more and more digital microfluidics
about each amplicon,” says O’Keefe. “High-resolution being used in cancer studies to detect single
melt measures sequence variations by using an nucleotide polymorphisms and rare mutations,
intercalating dye to detect changes in fluorescence especially in liquid biopsies.”
during a thermal ramp. For example, in this study
we looked at methylation changes – an epigenetic Bringing the device to market
modification that affects gene expression. High- Each of the prototype devices consists of a
Chrissy O’Keefe resolution melt allows us to assess the whole range single polydimethylsiloxane (PDMS) pattern layer
of potential methylation changes, even those relating sandwiched between glass, and is made using an
to unknown targets. One of the largest technical ultra-thin soft lithography technique. PDMS has
challenges in developing this platform was detecting several advantages, such as ease of fabrication,
real-time variations in fluorescence from thousands of biocompatibility and optical properties, says O’Keefe.
nanolitre-volumes in parallel. Once acquired, though, “In addition, the gas permeability of PDMS
we can obtain the sample’s entire sequence profile.” allows rapid, vacuum-assisted loading. Glass, which
Hyper-MELT could offer clinicians significant can be easily bonded to PDMS, serves to provide
cost and time savings compared with other current a flat, rigid surface for heating while maintaining
technologies, such as sequencing, says O’Keefe. optical transparency.”
“Sequencing, which is commonly used for genetic Having a beta-ready version of HYPER-Melt
profiling, can provide exact sequence information,” available within three years is a key target.
says O’Keefe. “However, it is an expensive technology “There are still many improvements that we need
and it also takes a long time to achieve the requisite to make before a packageable version of HYPER-Melt
sensitivity (<0.1%) for challenging samples with rare is ready for market,” O’Keefe concedes. “One major
molecules, so it is not particularly suited to clinical use. milestone would be to establish sufficient sensitivity
“By comparison, HYPER-Melt can achieve much and specificity of the platform in a clinical setting. If
higher sensitivity – 0.00005% – with much lower cost; the platform demonstrates sufficient performance, then
in fact, for roughly the same cost as a microtiter plate. we can start to tackle scalable manufacturing methods
In addition, it has a simple, rapid workflow with few and high-throughput assessment of samples.
hands-on steps, and provides an easy-to-interpret “Currently, one of the device’s biggest drawbacks is
result, making it an efficient and relatively simple the relatively low throughput of the system. HYPER-
means for molecular profiling.” Melt can analyse roughly five samples at a time,
which limits its use in large studies that require the
“Cancer is constantly changing and evolving assessment of hundreds to thousands of samples.
to ensure it can survive and thrive in its We’re therefore looking to improve the throughput for
larger-scale studies by focusing on developing a more
environment – in the body. We wanted to
advanced thermal-optical platform.”
develop a technology that could detect and O’Keefe and her team are working with partners
quantify this variability so we could better at Johns Hopkins University and other medical
understand tumour evolution.” institutions to advance and refine the HYPER-Melt
technology and usability to prepare it for market.
O’Keefe said HYPER-Melt was aimed at achieving The team hopes to evolve the technology so it can be
the outcomes of digital PCR and sequencing, and then used as a diagnostic tool to detect tumour-derived DNA
building on these outcomes in terms of developing in liquid biopsies. “We believe that the high sensitivity
better sensitivity, efficiency and reliability. of this platform, coupled with the multidimensional
O’Keefe says the pace of development in data set, can improve early detection of some types
microfluidics is presenting exciting opportunities for of cancer, especially those without reliable screening
the scientific community. The improved performance techniques,” she says.
and reliability of commercial microfluidic technologies, Follow-up studies are focused in particular on lung
such as ddPCR, have sparked a boom in research. cancer and ovarian cancer. Using lung cancer as an
“One simple advantage of digital techniques like example, O’Keefe says the technique could be used
microfluidics is absolute quantification,” she says. following a CT scan to provide secondary, non-evasive
“Researchers can simply count positive chambers to analysis, potentially replacing the need to run a biopsy.
exactly quantify their sample without using standards, In the case of ovarian cancer, which does not currently
and this enables more accurate measurements for have a reliable diagnostic technique that can be used
applications such as copy number variation. prior to symptom evolution, there is real potential to
“Another powerful advantage is the ability to develop new biomarkers that could pave the way for
detect extremely rare molecules. As a result, we early detection, diagnosis and treatment. ●
www.ami.international
Bringing the plastics industry together. @Contact_AMI #AMITubing
Hemodialysis
Drug Delivery WE HAVE
Infusion Pumps
Heart/Lung Machines
YOUR
Blood Processing
SENSOR
Celebrating the
PAST
Changing the
introtek.com FUTURE
Filtration & fluid control
Liquid flow
A number of disposable sensors are now available to monitor fluid control in medical devices,
and these tend to be low-cost because there are no electronics located in the sensor. IVAM CEO
Dr Thomas R Dietrich talks to Kerry Taylor-Smith about the potential of these sensors for mobile
and point-of-care diagnostics.
D
uring medical treatments, the outcome Smart chips
of therapy and the overall well-being of a Disposable liquid flow sensors containing smart
patient so often depends on the reliable and chips could be a game-changer in the biomedical
continuous administration of drugs or intravenous field, from controlling the flow of valuable ingredients
fluids at low or ultra-low flow rates. However, such in bioreactors to monitoring infusion therapies at
procedures and therapies are faced with the same low and ultra-low flow rates in a clinical environment.
challenges – precisely measuring and regulating They have been designed for single-use, high-volume
lowest flow rates of medicines and/or fluids down biomedical applications such as drug delivery
to the microlitre per hour. systems, and their in-built failure detection features
Smart infusion pumps provide well-controlled drug can help counteract failures such as cross flow
delivery over an extended period of time, but are and extravasation.
unfortunately susceptible to failure. The technology Smart chips within the sensor can combine
lacks the ability to directly measure the flow rate of microelectro mechanical systems (MEMS) and CMOS
the drug inside tubing, leading to undetected failures (complementary metal-oxide-semiconductor, a class of
or oversensitive pumps giving false alarms. integrated circuits) on a single silicon wafer, and have
Typical failures include occlusion (a blockage or the potential to improve diagnostics and automation.
closing of the blood vessel or a hollow organ); air in This unique technology is safe and reliable, not to
the line; free flow; cross flow, where multiple infusions mention highly precise, and is capable of detecting the
are taking place at the same time; and infiltration smallest change in liquid flow rate in real time at the
or extravasation, where intravenous fluid seeps into point of interest. The integration of single-use liquid
tissue surrounding the canular inserted in the vein. flow sensors within medical devices, such as urinary
catheters or infusion sets, is simple: the sensor chip Intelligent, compact and cost-effective
is completely isolated, encased in a plastic housing – Single-use liquid flow sensors have the potential to
meaning it cannot come into contact with bodily fluids revolutionise drug delivery. They are considered more
or medications – that can be secured in the fluidic line effective as it is easier to oversee and regulate the flow
using standard Luer lock fittings. The sensor is also of medication or IV fluids, and their smart chips are
low-cost – it has been stripped back to a bare minimum helping to improve diagnostics and automation. The
without sacrificing mechanical, electrical and fluidic result is better patient treatments, improved safety
connections, making it ideal for disposal after use. and support for overworked hospital staff.
The straight, open-flow channel has no moving parts “Treatments will become more effective as
(meaning nothing to break or fail), which provides they become easier to monitor and control,” says
excellent reliability, and its small size results in efficient Dietrich. “Patients’ safety is improved by the automatic
and highly repeatable measurements in real time, detection of failure modes like clogging, free flow, air
offering unprecedented reliability and safety. It can, bubbles, or leaks in the tubing connection.” This serves
for example, spot occlusion in a matter of seconds to increase the accuracy of drug delivery and automatic
by noticing a decrease in flow rate even at ultra-low diagnostic equipment.
flow ranges. Medical-grade wetted materials also Such single-use liquid flow sensors can detect a drop
offer excellent chemical resistance and outstanding in a primary infusion flow due to cross-flow errors from
biocompatibility as well as sterilised operation. a secondary line where multiple infusions are taking
“A disposable liquid flow sensor provides liquid place simultaneously, and includes bubble detection
flow measurement capability from inside medical to identify air inside the infusion tubing.
tubing, such as an infusion set or a catheter,” Furthermore, the sensors are so sensitive that they
explains Dr Thomas R Dietrich, CEO of IVAM, an can even detect a heartbeat, a direct indication of an
international microtechnology business network and intact connection of the infusion cannula to the vein
technology marketing expert based in Dortmund, of the patient. The absence of a pulse could indicate
Germany. “Because of its low cost, it is suitable for an interrupted connection caused by a kinked
disposable applications.” tube, ruptured tubing or a dislodged cannula, which
could lead to infiltration or extravasation (leaking
Treatments will become more effective as they of intravenous fluid into the tissue surrounding the
become easier to monitor and control. Patients’ vein). Such incidents can occur when damage is
caused to the vein during catheter insertion and can
safety is improved by the automatic detection cause irritation if the fluid is a non-vesicant agent, or
of failure modes like clogging, free flow, air damage to nerves, tendons and joints if the fluid is a
bubbles, or leaks in the tubing connection. vesicant agent such as a chemotherapy drug.
These intelligent, compact and cost-effective liquid
Drug delivery from an infusion set, an infusion pump flow sensors have the potential to change drug delivery
or other medical devices can be measured precisely from the ground up, offering safer, more mobile and
and in real time. “Inside a disposable liquid flow sensor, reliable care in hospitals and peoples’ homes.
a microchip measures the flow inside a fluidic channel,” “Disposable liquid flow sensors make the use of
says Dietrich. “Flow rates, typically in the range of zero point-of-care diagnostic tools affordable for everyday
to several 100ml per hour are measured with a typical use,” says Dietrich. “Even patients and family members
accuracy of 5% of the measured value. Inert medical- without any medical education can use automatic
grade wetted materials are used to ensure sterile equipment for diagnostics and drug delivery.”
operation with no contamination of the fluid.” The use of these devices at home is made possible
The sensors’ measurement method is based on a as the sensors are cheap and easy to use. “This will
micro-thermal principle; an incredibly tiny heating give elderly and chronically ill people the opportunity
element on the chip releases an insignificantly small to stay longer at home and avoid long clinical stays
amount of heat into a bypassing liquid to obtain a or movement to nursing homes,” explains Dietrich.
thermal flow measurement. The shape of its heat cloud
is monitored by two temperature sensors positioned Multiple benefits
symmetrically up and downstream of the heat source, It is known that being mobile can reduce the length of
which detect minute temperature differences with a patient’s hospital stay while simultaneously improving
incredible sensitivity: these fluctuations are directly their quality of life. However, ambulatory infusion
related to the flow rate inside the fluidic channel. pumps can be problematic in terms of ensuring the
Using this principle, liquid flow sensors can required flow rate is accurate – during a typical day
continuously and reliably measure low flow rates it can be difficult for a patient to follow the handling
typical of medical applications. instructions that ensure the specified performance,
Medical Design & Manufacturing (MD&M) East is the largest and longest-
running medtech event on the East Coast. At MD&M East, you’ll source
from the region’s largest collection of cutting-edge suppliers, deepen your
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of professionals who can help you advance your projects.
resulting in real-life flow rates deviating drastically excreted fluids are also being monitored – as well as
from the intended values. overcoming other common failures related to current
The use of a single-use liquid flow sensor could infusion technology quickly and reliably.
help overcome this by allowing the continuous But these sensors aren’t just for administering drugs
delivery of highly concentrated medication over and fluid to the body, they can also measure and record
several days. This could be especially useful for things coming out of it. They can also help to diagnose
those receiving chemotherapy where the constant acute kidney injury (AKI) by automatically measuring
administration of chemotherapy drugs over time has and recording urine output, a task currently carried
a better pharmacodynamic influence on effectiveness out manually at regular intervals by nurses. Using
and toxicity compared with traditional bolus injections disposable liquid flow sensors in this manner could
every day. There is even the potential for these allow for a timelier diagnosis and potentially prevent
single-use liquid flow sensors to be incorporated into the onset of AKI, while also eradicating human error
wearable drug delivery devices, further enhancing a and freeing up medical staff’s time.
patient’s quality of life while they undergo treatment. Integrating disposable liquid flow sensors into
Another issue is the clogging of the restrictor of the infusion tube sets has the potential to progress infusion
pump – usually a thin capillary in the pressure drop therapies and allow for controlled drug delivery on
element – or at the injection site. It can take hours a much broader scale. Measurements and vital signs
before an occlusion is noticed by the medical team could be obtained and stored automatically and
or the patient themselves, but the use of a disposable electronically, eliminating human error and saving
liquid flow sensor within the infusion set can spot such valuable time, which medical staff can dedicate to
a failure much more quickly – even within seconds. actually treating patients.
Such disposable liquid flow sensors can also prove They could detect currently unnoticed failures and
useful in treating babies and young children who maybe even prevent them, increasing patient safety
require much smaller doses of drugs due to their low and well-being. Introducing such a ground-breaking
body weight. Once integrated into an infusion set, the technology could also present massive savings for the
single-use liquid flow sensor allows for the accurate healthcare system, while decreasing workloads and
monitoring of administered flow rates – critical if stress for hospital staff. ●
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Cutting-edge
porous solutions
Jack Chan, global marketing director for medical segment at Porex (Filtration Group), explains
how the company’s sintered POREX Virtek PTFE solutions are designed to address today’s diverse
medical device challenges.
W
hether used to treat Sintered PTFE: touch strength and able to
illnesses, injuries or anywhere and versatile work
in-between, medical devices Design manufacturers seeking to alone.
are essential tools that help to improve increase safety, functionality and
health and well-being, and save the lives reliability in current and next-generation Furthermore, using expanded PTFE
of billions worldwide. As critical as it medical devices can utilise a sintered (ePTFE) films, often regarded as the
is to have access to these devices, it polytetrafluoroethylene (PTFE) industry standard, actually prevents
is also vital that they are functioning membrane as a component. This durable, effective assembly and can even cripple
properly to safeguard both patients and high-performing technology, which more production during rapid medical device
medical professionals. effectively vents, diffuses and filters air,
The medical-grade PTFE hydrophobic material
Recently, the EU updated its current gas and liquid, allows medical devices provides a high bacterial filtration efficiency of
99.99% or higher, superior water-entry pressure,
directive for the regulation of medical to perform exactly the same every time.
optimal airflow and a fluid barrier.
devices. The EU’s medical device The medical-grade PTFE hydrophobic
regulation (MDR), set to come into material provides a high bacterial manufacturing processes, due to their
effect in May 2020, requires medical filtration efficiency of 99.99% or higher, delicate nature. Sintered PTFE, which
device manufacturers to provide more superior water-entry pressure, optimal can retain its properties through the
in-depth clinical data to prove safety and airflow and a fluid barrier. rigours of high-speed automation or
performance claims, and more stringent Sintered PTFE, a membrane featuring heat, pressure or vibration welding, can
equivalency standards, in order to get an open-cell, omnidirectional 3D pore be used in a wide range of applications.
their products to market. Thus, it is structure that is design-flexible, is This material is optimal for infection
imperative that manufacturers carefully extremely versatile. It can be tailored control, injection therapy, and medical
consider the components at the core in thickness, porosity and pore and pharmaceutical packaging, among
of their medical device design to ensure volume to individual device needs. The other applications that promote safer
the safety of individuals in any healthcare unique composition, comprised of well- medical device usage and performance.
environment, whether in a hospital or controlled particles, creates additional Components, particularly those that
laboratory facility. robust strength. enable venting, play a critical role in
how well medical devices function and
perform. POREX Virtek sintered PTFE
“POREX Virtek sintered PTFE venting solutions
venting solutions are designed to address
are designed to address today’s diverse medical today’s diverse medical device challenges
device challenges.” and replace the production and operation
of faulty, unreliable devices that can harm
When a medical device is not outfitted This, in turn, permits greater durability the individuals they are meant to aid.
correctly, everyday procedures can and reliability of the porous PTFE Learn more about the applications for
present critical risks. For example, an components, potentially extending their POREX Virtek PTFE solutions that are
instance in which a defective vent causes use and the lifespan of the medical device creating a safer, healthier and more
a safety IV catheter to leak can expose as a whole. The sintered PTFE material productive world at the Porex website. ●
healthcare professionals to blood-borne is unlike other porous PTFE membranes
pathogens, putting them in harm’s way. that product designers and manufacturers References available on request.
When properly designed with porous may use to vent medical device
venting components, medical devices applications. Traditional porous PTFE
such as the arterial syringe, IV catheters membranes often require a supporting
and others can prevent an incident like layer or scrim to reinforce the strength, For further information
this from occurring. whereas sintered PTFE is superior in www.porex.com
In Vitro Diagnostics
Innovation in Miniature
Many
hands make
light work
The global market for sustainable packaging is rapidly developing. However, medical device
companies are still lagging behind their personal-care, food service and shipping counterparts.
Peylina Chu, executive director of Healthcare Plastics Recycling Council, speaks to Emma
Green about key principles to consider in bringing the medical device industry up to speed.
I
t is estimated that one million tonnes per year Over the past few decades, there has been growing
of non-infectious medical plastics are available awareness of the environmental hazards related to
for recycling in the US, with equivalent amounts the disposal and recycling of packaging, numerous
in Europe and Asia. However, notwithstanding its government initiatives and increasingly stringent
Opposite page: environmental impact, plastics have offered huge regulations. Despite these drivers, the complex and
Northshore OR bags benefits to the industry. These include enhancing dynamic nature of the medical device industry makes
specifying their use
for recyclables or
patient safety and making lighter packaging to save it more difficult to implement environmentally
hazardous waste. fuel and costs when transporting supplies. friendly practices into the supply chain.
Implant Syringe
getting this buy in from recyclers.
“They have a tighter spec, and in a lot
of cases the materials are sterile,” Chu
The implant syringe is used to place rod-shaped, retarding explains. “The material is also denser,
tablets into the tissue coatings of the patient. The tablet is so if it’s properly sorted it can actually
intserted through the needle. have a higher market value.”
EASY USAGE
Although the HPRC is only concerned
After removing the safety clip ant the protective with recycling efforts, this is addressed
cap the implant is placed on the disgnated area from multiple angles because of the
and the tablet is injected into the tissue. variety of companies involved. This
includes suppliers, medical device
BENEFIT & CONVENIENCE
manufacturers, academic healthcare
- Smooth and constant injection process
facilities, healthcare systems and
- Injuries in the fabric layers are avoided
3UHÀOOHGV\ULQJHUHGXFHVWKHULVNRIPLVXVH recyclers. “I like to say that we’re an
- Less pain for the patient inch wide and a mile deep,” Chu says.
1RULVNIRUWKHXVHUWKURXJKLQWHJUDWHGQHHGOHSURWHFWLRQ “We only focus on recycling but we
look at recycling from a lot of different
APPLICATION AREAS
perspectives, and I believe that our
Hormone implants
Vaccination group does some quite meaningful
things for the industry.”
One of the surprising aspects of
the HPRC is that members are often
companies who would not otherwise
be working together. “Even though this
group includes competitors, this is an
area where they can come together and
see that by collaborating they’ve got a
better chance of being successful in the
industry,” explains Chu.
Central to the success of this
cooperation is the enthusiasm and
dedication of the individuals and
Contact Gaplast | Wurmansauer Strasse 22 | 82442 Saulgrub-Altenau | Germany
phone +49 (0)8845 7413-0 | e-mail info@gaplast.de
companies involved. “They are
individually passionate about the
CNC Tooling
environment and the planet but at the end of the day, it’s got
to make sense for their own business,” Chu says.
The result of this collaboration has been a number
of publicly available resources for individuals and
organisations interested in expanding their sustainability Controlled
efforts. “We have a toolkit that’s free for hospitals to Environment
download, it’s called HospiCycle,” explains Chu. “It’s for
hospitals that are interested in starting up a recycling
programme or improving or expanding upon an existing
Nowhere are the stringent requirements of
recycling programme.”
cleanliness, consistency and continuing
This also includes resources to help aid the design of more performance more important than in the
sustainable design methods. “We also have guidance for medical industry – and nowhere is it more
manufacturers, talking about how designing for recycling is important to work with the company that
really important,” says Chu. “There’s things that make it easy understands those needs.
to recycle, and things that make it more difficult to recycle.” Phase 3 Plastics specialise in the design and manufacture of
customised thermoformed packaging.
Across the pond We offer a product that provides the practical solutions to
To date, the majority of the work of the HPRC has been packaging needs using the latest CAD, computer tooling
conducted within the US. However, in recent years the and clean room technology. We are confident that our
coalition has begun to expand its remit to Europe. Chu is experience and expertise offer the best possible service
from initial concept to final result.
acutely aware of the large differences between countries in
Europe, as well as those between Europe and the US.
Phase 3 Plastics
Interestingly, the environment within Europe has tended
2-4 William Street
to be permissive rather than restrictive in integrating
Southampton
recycling into working practices. “In some ways, the
Hampshire
regulatory landscape, economy and healthcare systems
SO14 5QH
actually help the recycling scenario in Europe compared
United Kingdom
with the US,” Chu says. “We’re finding that some of the Tel: +44 (0)23 8022 9844
challenges that we find within the US aren’t as big of an Fax: +44 (0)23 8023 2928
issue, or even an issue at all, within Europe.”
For further information contact: Terry Lucas, Sales Director on
Technological progress within Europe has also been
beneficial for the aims of the HPRC. “There are a lot more +44 (0)23 8022 9844 or sales@phase3plastics.co.uk
drivers and I think there’s greater urgency and advancement www.phase3plastics.co.uk
in technology in Europe than in the US.”
F
or the medical device manufacturer, manual is essential to provide the packaging
packaging is one of many issues to engineer with the ability to train others
be considered when launching a (maintenance, calibration, operators), as
new device. However, all too often the well as to find IQ data recommended by
packaging, as well as its core process the OEM.
elements, is afforded little attention
on the project timeline. Just as any The importance of OEM training
deficiency in the medical device itself Training at the OEM factory – which is
can result in a recall, so can the failure free at Atlas Vac – can offer numerous
of the packaging performance. advantages. Something as simple as
The capabilities and productivity of the reviewing an IQ checklist, and the related
latest tray sealers have been enhanced equipment features, can save a packaging
with automatic shuttles, safety-rated light engineer hours of backtracking should
curtains, servo-driven presses and, most someone who is uninformed install the
importantly, data acquisition. This can equipment incorrectly upon receipt.
result in better payback on the capital The new Model 1830S All Electric Medical Device OEM factory training is essential, as well
Tray Sealer from Atlas Vac Machine.
equipment investment – but only if the as required by ISO, for the maintenance
features are fully understood and utilised. operation so the operator can provide tech supporting the equipment. Predictably,
As with most validated capital additional value-added labour internal to injuries can occur where an untrained
equipment, a tray sealer is in operation each cycle period. Servo presses produce technician who knows nothing about the
for years, and often well over a decade a different and more exact sealing pressure controls and functions bypasses all the
or even two; therein lies a drawback. profile compared with pneumatic systems. safety systems in a trial and error attempt
to address some reported ‘malfunction’.
“Something as simple as reviewing an IQ checklist We often see third-party calibration
services brought in who are ISO 17025
can save a packaging engineer hours of backtracking certified, but have zero familiarisation or
should someone who is uninformed install the training (an ISO requirement) in the
equipment incorrectly upon receipt.” operation, maintenance and calibration
of Atlas Vac tray sealer control systems.
When it is time to acquire new Important advances have been made in This has resulted in damaged components,
equipment, user specifications are often data acquisition, down to the exact details adjustments to system components
based on equipment perceptions and rigid of each package that is sealed at this nexus specifically designated as ‘non-adjustable’,
processes rooted in older technology. of device, package and label before it leaves undocumented software modifications, and
Understanding what is available now and the clean room. Potentially, such data incorrect temperature, pressure or timing
how it can be applied productively may capabilities challenge the upstream and performance. This results in customer
create some competitive advantages if downstream systems to integrate thinking packaging sealed unknowingly at inaccurate
curiosity overtakes rooted perception. to the betterment of the enterprise. recipe values. Atlas Vac offers technical
Remember, the equipment designer has Given that these new features may not support for your designated third-party
been listening to many ‘voices of the have been available on an in-use tray sealer calibration service provider.
consumer’ as a guide to what features that has been in the facility for 10–20 years, Providing production with the most
are valued in this specific market. it would be a wise (but too frequently advanced equipment is an investment
overlooked) step to take a day to learn the that will payoff over the next decade
Multiple benefits details for proper set-up, use and calibration (or two), but free training is priceless
Automatic shuttles provide repeatable cycle of a newly acquired tray sealer. Yes, it is all in more ways than one. ●
times, while reducing package component in the equipment manual (which is often
displacement and repetitive motion injury. shelved, skimmed and/or lost), and a hand- For further information
Light curtains provide safe hands-free in-hand review through the equipment www.atlasvac.com
Contact us today!
610.347.5109 or visit us at www.brentwoodindustries.com/medical
/medicc al
Company insight
D
entsply, a US-based company,
and Sirona, a European-based
company, formed Dentsply Sirona
in 2016. Dentsply Sirona manufactures
professional dental solutions that include
preventative, restorative, implants,
imaging services, treatment centres and
software solutions. Dentsply Sirona’s
headquarters are in York, Pennsylvania,
US, a short one-hour drive to Brentwood’s
Specialty Products Group located in premium look that
Reading, Pennsylvania. was easier to use and
significantly reduced
The challenge costs compared with its
On 25 October 2017, Dentsply Sirona current packaging.
came to Brentwood looking for an Brentwood’s engineers Dentsply Sirona wanted to make sure that the packaging
improved packaging solution to its developed a detailed action plan design reflected the company’s global brand image, so an
additional aspect in the design was making the lids of all
current off-the-shelf injection-moulded and began work on the first round the packaging a specific blue colour.
polycarbonate boxes sourced from of designs. They produced concept
China. These boxes held the company’s drawings within 24 hours (beating other and dentures. The abutment design
restorative dental products including companies by several days). Brentwood’s is a nested, sliding tray that can be
crowns, abutments, screws and dentures. quick turnaround time was a critical factor opened with a thumb, moving forward or
For the new packaging designs, Dentsply in decision-making for Dentsply Sirona’s backward. This design keeps the implants
Sirona wanted to focus on a premium product line manager in Spain. secure during transport and allows
look, easier-to-use packaging, and a Dentsply Sirona held focus groups the dental care provider to access the
solution that reduced costs. These to test the original designs and identify abutments with ease.
new packages will be used for Dentsply areas of improvement. A pivotal design Since these customised boxes will
Sirona’s Atlantis product line, a fully change involved the condition that the eventually be available worldwide,
customisable treatment box tailored to abutment trays needed to be opened Dentsply Sirona wanted to make sure
each patient’s specific implant needs. with one hand. Brentwood’s team of that the packaging design reflected
designers delivered new concepts to the company’s global brand image. This
The solution Dentsply Sirona’s product line manager additional aspect in the design involved
Brentwood and Dentsply met for the within 24 hours. Three days after the making the lids of all the packaging a
first time within 12 hours of receiving the designs were provided, a 3D prototype specific blue colour. Brentwood’s team
initial project specifications. Brentwood part was also sent to the product line worked with several material suppliers to
understood that Dentsply wanted a manager at no charge. formulate the perfect blue material that
matched the Pantone colour of Dentsply
The result Sirona’s brand. Each tray and box
Brentwood’s team of engineers developed packaging includes a clear bottom and
multiple aesthetically pleasing package Dentsply Sirona blue lid.
designs, abutment trays that are easy to In summary, Brentwood’s talented
open with one hand and a solution that packaging design engineering team
reduced costs for Dentsply Sirona. successfully met the unique and
The new packaging line includes three challenging needs of Dentsply Sirona. ●
different styles of abutment trays to
Three days after the designs were provided, a hold screws and implants, and two For further information
3D-printed prototype part was sent to Dentsply
Sirona’s product line manager in Spain at no charge. different-sized box designs to hold guides www.brentwoodindustries.com
Chains of command
Heavy regulation from design to delivery can make logistics highly challenging.
Optimising the shipping process provides time and cost savings, as well as the ability to
offer exceptional customer service. Kim Thomas talks to Bruce J Stanley, president-principal
at the Stanley East Consulting Group, about key strategies designed to maximise the efficiency
of logistics procedures.
A
n efficient, well-oiled supply chain is The biggest concerns, he says, continue to
essential to the smooth operation of any be geopolitical issues, and regional regulation
business, whether that business is selling of medical devices and healthcare. There was
food, cars or clothing. However, it is particularly an optimism in the industry a few years ago that
important in the world of medical devices, a sector companies “could create a product and ship it
that is highly regulated and where companies anywhere around the world like it was Amazon”,
typically carry large amounts of inventory. but this has proved not to be the case.
Bruce J Stanley, president-principal at the Stanley More recently, Brexit has made it harder
East Consulting Group, has a wealth of supply chain to know where to place facilities to serve EU
experience in the healthcare industry, and now countries. Before Brexit, “You could put a facility
advises global biotech, medical device and pharma anywhere in that geopolitical area.
businesses in the management of their supply Now it is not so easy any longer. If anything,
chains. So what does he see as the main challenges Stanley adds, “The geopolitical and regulatory
facing medical device companies aiming to make issues are probably even more paramount today
their logistics procedures as efficient as possible? than they were five years ago.”
This is why one of the major pieces of advice he organisations to manage their data. Although he
gives clients is, “Stay close to your regulating body, agrees about the importance of security, he is
whether it is in London, whether it is in Washington also a strong advocate of making use of the global
DC, whether it is in Singapore.” It doesn’t matter standards organisation GS1, which he describes
how innovative the client’s logistic model is, he says, as an “industry forum that helps create the
“The reality is you have still got to play by the local mechanisms so that organisations, companies,
regional jurisdiction because if you don’t, you won’t hospitals and governments can actually have
be able to ship the product.” consistent, clean data.”
They can even take into account what regulations another area that he believes is essential is stock
government agencies are creating and how that keeping unit (SKU) rationalisation.
affects manufacturers upstream, to the extent “You see any kind of company and they say, ‘We
that now they have, “good predictability on product have been making this for 50 years and everyone
flow, product consumption, product usage and, loves it’, and the reality is that they may not love
for that matter, product discontinuation with some it as much as people think,” he says. “Companies
degree of certainty that they couldn’t do before”. that tend to be state-of-the-art now are the ones
Bruce J Stanley that make the hard choices on SKU rationalisation.
Look beyond healthcare for They look at their cost. They look at their sale
data analysts price. They look at their market, they look at
In a world where collecting and understanding their gross profit on those products.”
data has become essential to keeping the supply It is a very hard decision to make, he
chain running, the key skill set, says Stanley, is acknowledges, but one that is “crucial to this
that of the data analyst. optimisation of supply chain, because it affects
“You just can’t have anyone looking at data,” everything from the end-user patient all the way
he says. “Now you need analysts who can ask, upstream to the supplier or the items that the
‘How do we use this in such a way that actually manufacturer makes on behalf of the patient”.
creates optimisation up and down the network?’” So, what are the big mistakes Stanley sees
Data analysts, he notes, “can pick trends, and businesses making time and time again?
predictability is hugely helpful”. “The first one is that they are going to latch
This makes it imperative, he says, that businesses on to what they think is the new state-of-the-art
employ staff with excellent data analysis skills. technology and never really take a pause to see
“In healthcare you see a lot of data analysts how that is going to affect how they work and
coming from banking, because people in healthcare what they do, and their market, their customers
realise that these people think differently than we and their product line,” he says. “So in many
do. It is one thing to have an esoteric view of, ‘Well, cases, the biggest mistake they do is apply new
we are in healthcare because we help patients and technology on old processes. And then there is
cure cancer’, but in order to optimise the system just a mishmash and it never works right.”
or process you need people to think differently.” It is surprisingly common, he adds, for
Stanley and his colleagues have done a lot businesses to implement technology without
of work with the banking industry, learning how understanding how it is going to help their
its approach to data analytics could be applied bottom line.
to healthcare. “Often I have asked a lot of CEOs and company
“They deal with billions of bits of information leaders, ‘How do you work? How do you know what
routinely – financial, transactional and customers you do?’ And I am shocked many times that good
and identifiers, all the kind of stuff that healthcare companies with good leaders can’t really tell me
wrestles with,” Stanley explains. “So I always how they work.”
encourage healthcare providers and manufacturers Too often, he says, companies “have never
to look to these other industries that may not seem done the heavy lifting to do a self-assessment
connected, but are really connected when it comes and research what they do, how they do it, and
to the capabilities of the people that do the work.” what the costs are.” Once you have that knowledge,
At the same time, it is more important than he says, ”Bringing in systems is so much easier
ever to understand the different regulatory because then you go, ‘Well, this one really helps
environments under which data is held. us get to that level’. So that is probably the biggest
“Data is protected differently from region mistake – that people want to rush to new
to region around the world,” Stanley points out. technology because they think it is great.”
“Companies that are global always have to always Ultimately, he says, success is predicated
take that into consideration.” on mastery of the business’s core data.
This is another reason, he says, why he “Once I know with crystal clarity what my
encourages global clients to have a presence customers are, where they are, what their needs
in the country where they are doing business. are, where they are moving – because they could
be moving to a new technology or new procedure –
Sometimes you have to make once I have got that in my hands, all the other things
hard choices are somewhat ancillary because it will tell you where
Although Stanley sees good management of data to go. It will become so obvious to someone looking
as integral to successful supply chain management, at that data that the rest of it is simple.” ●
T
urkish Cargo maintains its ongoing All in regulation
activities in order to realise the The company regularly monitors sector
best transportation of time and requirements in order to transport
temperature-sensitive pharma and according to Operational Quality and
healthcare products, to make the Turkish Pharma GDP standards, completes the
Airlines network even more integrated via deficiencies and continues to realise
Envirotainer operation requirements by activities in this direction.
adding QEP accreditation to its most In this respect, the company is a
important stations. member of Pharma.Aero, which aims
Envirotainer’s QEP accreditation to achieve excellence in reliable end-to-
is proof of the brand reliability within end air transportation of pharmaceutical
the temperature-controlled freight products. CEIV Pharma certificate is
industry, and the result of hard work accepted as the standard by the Pharma.
and dedication to the customers. Aero organisation.
Negotiations with Dokasch-TS, an active In order to keep up with the times,
container supplier, have been concluded some investments should be made
successfully and the operation started. continuously in pharma air cargo.
Turkish Cargo’s biggest difference The investments must first be made into
on cargo business is its network the facilities, training, and certification
that enables customers to send required to transport pharmaceuticals
Turkish Cargo operates the best equipment to
pharmaceuticals shipments to almost ensure that pharmaceuticals maintain temperature.
safely and securely. Recent cold-chain
260 destinations, with new passenger technology developments provide ensuring
routes consistently opening in Europe risk mitigation and lane assessment. temperature condition that are maintain
and Asia. In order to ensure a high level SOPs cover handling, storage within acceptable limits during transport.
of reliability and security throughout and transportation processes Using the right cold chain equipment
pharmaceutical shipment, QEP of pharma shipments. is important to reassure pharmaceutical
accreditation provides the improvement
of ramp-handling processes.
“Turkish Cargo has increased the number of
The only way is up QEP-accredited stations to 40 for handling
Turkish Cargo has increased the number pharmaceutical products.”
of QEP-accredited stations to 40 for
handling pharmaceutical products; Turkish Cargo was awarded IATA’s products maintain optimum temperature.
moreover, last in/ first out procedure, Pharmaceutical and Healthcare Products Cold chain equipment can be used
prioritised loading and unloading, Transportation certificate ‘Center of especially healthcare products. In this
a total of 90 minutes on tarmac for Excellence for Independent Validators’ way, Turkish Cargo builds a bigger and
transit shipments, quick ramp transfer (CEIV) at its Istanbul Hub, in more special dedicated pharma facility
and thermal dolly are implemented August 2016. at Istanbul Airport. ●
to minimise the ambient exposure in The company successfully maintains
the pharmaceutical-handling process. the recertification process that will be
Also, specific SLAs/SOPs are signed performed by IATA every three years.
with esteemed global solution partners The process of CEIV Pharma-certification For further information
and valuable forwarding agencies for for new airport has already begun. www.turkishcargo.com
A
irBridgeCargo (ABC) is a global operations and procurement – helping it with effective connections to
cargo carrier with an expanded to reinforce the handling procedures and deliver cargo worldwide
international route network control processes required during all stages ■
tailor-made logistics solutions based
that connects customers in the of transportation. Creation of special on your individual requirements
largest trans-regional markets of Asia, services is proof of ABC’s commitment ■
sophisticated, cohesive and
Europe and North America, and covers to every single detail before and during forward-thinking approach based
more than 30 major cargo gateways, transportation, especially for pharmaceutical on peer learning and networking
accommodating trade flows worldwide. goods that require special attention. through industry-related initiatives:
All the flights are operated via ABC’s
cargo hub in Moscow Sheremetyevo
airport, which features up-to-date
“ABC’s cargo hub features up-to-date equipment
equipment and guarantees seamless and guarantees seamless connection throughout
connection throughout the airline’s the airline’s expanded international network within
expanded international network within
a 48-hour delivery time – including
a 48-hour delivery time.”
handling – all managed by highly skilled
and qualified ground-handling personnel. Benefits and special solutions these are Pharma.Aero, Pharma
ABC’s fleet consists of 18 Boeing 747 of abc pharma include: Gateway Amsterdam (PGA) and others
freighters, and is one of the youngest ■ exact temperature monitoring from ■
24/7/365 Control Tower (CT) operation
and most modern in the airline industry. acceptance to delivery to monitor and manage transportation
Operating in the market since 2004, ■ special packaging solutions and thermal of special cargo consignments
ABC is committed to catering to the blankets for palletised shipments ■
adoption of the latest digital
needs of its customers worldwide with ■ abc pharma Active and abc pharma technologies (Sky Fresh for automated
high-quality services. The excellent Passive solutions – the first is for time and notifications, temperature data
operating advantages of ABC’s freighter temperature-sensitive pharmaceutical loggers to monitor consignment
fleet, the performance of its highly skilled products that need to be shipped in conditions and more).
personnel, and constant improvements active containers (including dry ice
to its internal processes enable the technologies) and the second is for Continuous improvements guarantee
airline to carry all types of air cargo prepackaged pharmaceutical products the best logistics solutions
in full compliance with global industry ■ dedicated, skilled staff trained From vaccines, laboratory equipment
standards, including those requiring in handling healthcare products and MRI/MRT machines to blood samples
observance of special handling conditions, ■ full compliance with IATA TCR and beyond – ABC, will always find the
such as temperature-sensitive products. and CEIV certifications best logistics solutions to cater your
The company is constantly reviewing ■ Envirotainer QEP-accredited stations needs and expectations.
its existing service offers in order to within ABC network ABC aims to continuously improve
realign them with both market and ■ customer service support, online track its service quality, embracing all the
customer expectations. and trace option for all shipments company’s key components – equipment,
■ Boeing 747-8 and 747-400 with three personnel, technologies, internal
abc pharma – a part of the compartments enabling different processes and procedures – with
mission to heal temperature settings from 4°C to 29°C implementation of the recent
ABC is the best partner when it comes to ■ fast temperature pull down times developments and cooperation with
an in-depth knowledge of the healthcare after take-off partners, sharing its values in terms
and pharmaceutical industry. ABC has ■ temperature-controlled facilities at of high quality standards. ●
developed a special abc pharma product the majority of stations throughout
as well as verticals within the company the ABC network
comprising dedicated and qualified staff ■ high-tech pharma hub at Moscow For further information
at all levels – sales, customer service, Sheremetyevo International Airport www.airbridgecargo.com
www.airbridgecargo.com
Product showcase
Glass versus plastic they interface, leading to Advantech Medical DMS is to Custom-
undesirable results. become the strategic partner manufactured
Accu-Glass’s precision of the leading healthcare radiopaque
glass manufacturing process providers. Advantech provides clad wires
is capable of holding tolerances a wide range of customised
as low as ±1μ. This lends itself medical-certified computing
to processes and applications solutions. Its product portfolio
requiring highly controlled includes medical computing
volumes, flow rates and systems, medical panel PCs/
Accu-Glass’s products have many physical barriers. Large AIOs, medical tablet PCs and
advantages over conventional plastic. quantities of glass parts may fitness computing consoles. With
Many advances in manufacturing be produced with a known size strong customisation capability
technology have brought tolerance at a time and cost- and experience in medical-grade
forth new products made effective rate. systems, Medical DMS not only
from glass, which may have delivers qualified medical Anomet’s clad composite wires offer
significant advantages over Further information computing products to its an alternative to typical medical wires.
Accu-Glass
conventional plastics. customers but also acts as the Anomet Products has introduced
www.accu-glass.com
Glass is a clean and strategic and innovative partner custom-manufactured clad
inexpensive material that is for medical customers. composite wire − an effective
easily manufactured for single- Advantech medical Reasons to choose Advantech alternative to solid precious-
use applications that are equipment builders for your next project include: metal wires with marker bands
frequently required in the ■ complete and integrated − to improve the visibility of
medical field. Some of its back-end infrastructure to implantable devices. This clad
benefits include: streamline design-in processes wire is a proven alternative to
■ can be shaped, cut, ■ expert engineering, project wires typically used in medical
polished and marked management and design disciplines, such as:
■ is clean, clear, strong and capabilities for efficient ■ cardiac rhythm management
can be sterilised Advantech product portfolio includes product development (pacing and defibrillation)
a range of medical computing systems.
■ is inexpensive, making ■ broad customisation ■ neurostimulation
it perfect for disposable Advantech has been delivering scope for diverse needs ■ vascular therapy (stents,
medical or clinical IoT products for over 30 years. in vertical markets catheters and guidewires)
laboratory applications. To best serve its outsourcing ■ global design, service and ■ biosensors
customers, Medical DMS – a manufacturing centres ■ monitors.
Choosing glass over dedicated team – was created ■ reliable and long-lasting
plastic may be a way to avoid to provide professional design solutions Anomet radiopaque clad
undesirable chemical reactions customisation services for ■ one-stop shopping and a faster wires allow original equipment
and unwanted alterations in the industrial-grade computing time to market manufacturers (OEMs) to specify
properties of the fluid collection systems. Advantech specialises ■ trusted business model with the degree of visibility they
or storage method. A wide range in the design and manufacture global partner desire under fluoroscopy by
of custom shapes, containers and of high-quality industrial ■ technical feasibility study selecting the radiopaque alloys
collection devices are available in hardware and tailored software ■ new product developments and cladding thickness best
glass. Glass offers a non-leachable that fulfil exact needs for (CPU cards, chassis suited to their products. Easier
interface between liquid (such sectors such as gaming, and systems) to see than solid wires with
as fluids, drugs or chemicals) healthcare, portable devices, ■ design verifications marker bands, they are offered
and container (such as syringes, retail and embedded systems. ■ changes management in sizes between 0.05mm and
capillary tubes or ampoules). DMS offers not only ■ EOL or LTB management 1.52mm (outside diameter) for
Disposable devices are collaborative design, flexible ■ product life-cycle management use with stents, guide wires and
commonplace in medical manufacturing and European ■ refined design, manufacturing related devices.
and electrical industries. Glass support, but also a service that and quality processes Featuring platinum-iridium,
devices offer the advantage gives customers a dramatic to meet the medical tantalum and tantalum-tungsten
of being chemically inert, non- market advantage. Embracing customer’s requirements alloys, as well as similar alloys
leaching and stable at a wider the value of altruism, the ■ medical product safety and metallurgically bonded to high-
range of temperatures than company is as a long-term EMC certifications. strength wires, such as 316LVM
plastic. Leachables from plastic partner that helps customers stainless steel, nitinol and
Further information
have the potential to chemically maintain prosperity, now and Advantech Europe MP35N with cladding thickness
alter the substance with which in the future. The mission of select.advantech.com/dms of 2% or higher, Anomet
radiopaque clad wires have a 9001 and AS9100), Apple Rubber ■ autoclaves
smooth, consistent finish. They can assure precise quality control ■ DNA analysis
are supplied on spools and for every product. ■ respirators
manufactured to precise ■ incubators.
OEM specifications. Further information
Apple Rubber
Anomet is well known as a In conjunction with Backer
www.applerubber.com
leader in innovative composite Calesco’s foil heating elements,
metal products. Founded in Apple Rubber takes the proper it is usually necessary to
measures to ensure high-quality
1976, it specialises in the products and processes that meet From concept arrange some form of control
manufacture of custom-clad and exceed expectations. to solution to ensure that the desired
metal composites featuring must be tested – from raw temperature is maintained. A
a true metallurgical bond. materials to finished products. foil element has a tiny mass and
The company is dedicated Apple Rubber has a refined is quickly heated, so accurate
to developing new products testing process that includes temperature control is needed.
using advanced metallurgical vision-measuring machine This can be achieved in many
technology, resulting in long- dimensioning, durometer, different ways, depending on
lasting, reliable, cost-effective tensile, density and FTIR customers’ needs. Backer
materials. With material costs testing. These tests are Calesco can confidently design
Backer Calesco’s heating products,
today representing 90% of the a confirmation for the together with its control devices, offer and fit thermal-management
complete solutions.
overall cost of products, Anomet manufacturer and customers systems (such as rigid/flex
specialises in helping to reduce that the parts leaving the Backer Calesco develops new PCB controllers), a negative
costs, while improving material facility are exceptional and products and solutions in close temperature coefficient,
properties and quality. meet set specifications. cooperation with its customers, thermostats, temperature
Producing clad wire, rod, Apple Rubber operates state- transforming client requests fuses and sensors directly to
bars, ribbon and plates, Anomet of-the-art custom moulding into working solutions. The elements, in accordance with
Products offers a wide range of in-house, allowing them to process is successfully achieved customer specifications. This
metal alloy compositions that produce the highest-quality through a combination of the helps to ensure reliable control.
are available with virtually any moulds at the lowest cost and company’s broad experience,
ratio or thickness. The major with the shortest lead times. advanced design tools and Further information
Backer Calesco
industries the company serves To ensure quality control, it efficient production capabilities.
www.backercalesco.com
include aerospace, automotive, uses sophisticated CAD and Backer Calesco supports
appliance, corrosion protection, CAM software to efficiently many segments of the life
defence, electrochemical, design and manage the sciences and medical industries, Innovation partner
electronic, industrial, medical, fabrication and machining of offering a variety of heating for med-tech
and oil and gas. custom rubber moulds. The options. By understanding that applications
quality of the moulds is verified new tools and equipment are
Further information with contact, optical and laser integral parts of advancing the
Anomet Products
measuring equipment. A high- industry to make new scientific
www.anometproducts.com
quality product starts with a discoveries, and recognising the
high-quality mould. importance of technological
Precise quality Cleanroom facilities offer advancements, Backer Calesco
control heightened quality assurance, is able to develop and design
Quality control is a crucial allowing manufacturers heating solutions that work in Cendres+Métaux manufactures high-
aspect of any manufacturing to completely produce and the medical field. Its expertise precision implantable components
processes to ensure customers package products that cannot regarding heating products Sophisticated solutions in the
are receiving exactly what risk contamination, such as allows it to produce heaters field of medical device implants
they’re looking for. Apple medical devices and electronic that can meet individual often require a range of skills
Rubber takes proper care in components. Apple Rubber’s heating specifications, and that a single company can
providing customers with Class 10,000, ISO 7-certified among Backer Calesco’s hardly master alone. Such
precise, high-quality products cleanroom facilities feature customers are globally developments require close
through rigorous product and cleanroom processing, recognised companies. Typical cooperation with partners
material testing, broad ranges LSR moulding and full- applications include: who offer complementary
of experience, superior design lot traceability. ■ surgical tables and beds competencies. Cendres+Métaux,
knowledge and state-of-the-art Through advanced technology, ■ sterilisation equipment a Swiss manufacturer of
mould making. In order to meet rigorous testing and certified ■ research equipment high-precision implantable
quality standards, everything quality control systems (ISO for laboratories components, has specialised in
offering related skills and such as casting, forming, performance requirements ■ proof of concept
services to further the market turning, milling or injection adequately. As a result, designs ■ detailed design
success of its customers. moulding, through to surface have become very complex, with ■ prototyping
Cendres+Métaux is a treating, cleaning, assembly, different materials required in ■ soft tooling
valued engineering partner packaging to supply chain and different areas of the catheter. ■ production tooling
for numerous manufacturers end-to-end order management. For example, for a typical ■ product roll-out.
of medical devices, ranging balloon catheter the inner
from maxillodental implants Futher information diameter needs to be very The proof of concept,
Cendres+Métaux
to cardiac pacemakers, joint smooth and lubricious so that a prototype and soft tooling
www.cmsa.ch
respiration vascular prostheses guide wire can slide with minimal phases are typically staged as
up to highly sophisticated effort along the tortuous path serial path functions, each with
devices such as permanently Innovation required of the anatomy to the treatment a design feedback loop. Using
implanted hearing aids, or site. Though fluoropolymers are 3D-printed moulds allows
interface connectors for traditionally used as lubricious Currier Plastics to combine
haemodialysis patients. catheter liner materials, they these three phases into a
Medical technology present bonding and processing single one, which means a
developments require the challenges. A proven alternative significant reduction in the
interdisciplinary cooperation would be HDPE loaded with product development cycle.
of partners with comparably Compounding Solutions’ Mobilize The lead time to print a
high levels of competence technology. Mobilize effectively 3D mould is virtually as short
in the field. An important reduces the coefficient of friction as 3D printing a part, and
prerequisite is an in-depth of the catheter inner layer. in some cases it can be less
experience with the rules Compounding Solutions develops Polyolefins are also suggested than 24 hours from design to
and prescriptions governing innovative materials for manufacturers. as they are easier to process and mould print. Some secondary
the activities related to the The medical device industry bond with traditional equipment. operations may be required, but
development and approval is trending towards minimally The healthcare industry these are minimal and typically
of medical technology products. invasive surgical techniques, demands that OEMs and only add a few hours to the
In the early stages of such a which requires the development suppliers produce devices phase before the moulds can
project, an assessment of the of devices that are smaller engineered to diagnose and be run in an injection or blow-
basic feasibility of expectations and materials that are stronger. treat patients using innovative moulding press.
and of the processes that Devices for vascular and other design, requiring state-of- Design iterations can quickly
might be suited to master such applications continue the-art manufacturing and be realised, improving final
the production of the desired to reach deeper into the technology. In order to support part performance and avoiding
device often plays a decisive anatomy with more therapeutic the changing needs and costly production tool rework.
role. This, in turn, means that technology, and medical requirements of medical device 3D moulds can be tested prior
a positive outcome of such a device manufacturers are manufacturers, Compounding to releasing the design for
project is more likely the earlier demanding polymeric tubing Solutions has developed hard tooling, and because the
in the development process that boasts greater precision, innovative materials such as parts are made with the actual
the partners begin to cooperate. tighter tolerances and Mobilize, ReZilok and ReZilient. engineering-grade material,
For such endeavours, increased functionality. they can be tested for
Cendres+Métaux can contribute In catheter design, the Further information compliance, including
Compounding Solutions
a host of very experienced designer must not only consider
www.compoundingsolutions.net
specialist teams along the the functional requirements
whole value chain. The number of the application but also be
and extent of customer projects cognisant of the manufacturing Accelerating product
that the company has been process required to produce development
able to foster until market the device. The designer must One of the challenges of
maturity and successful identify the key performance providing custom manufacturing
commercialisation underscores requirements of the medical services is providing a high-
its role as a competent and tubing, such as flexibility, quality product in as short a
trustworthy partner for new lubricity, clarity, kink resistance, time span as possible. Speed
development undertakings. push strength, torque transfer to market wins.
Cendres+Métaux masters characteristics, hoop strength, The phase-gated product
the full range of manufacturing radiopacity and bondability. development cycle goes:
technologies in its sector, from Generally, a single polymer ■ concept
The lead time to print a 3D mould is
basic production processing, material will not meet all of the ■ initial design virtually as short as 3D printing a part.
functional assemblies, chemical they are continually searching throughout each process using
compatibility and stability, for new tools to improve a system based on ISO 9001
pressure and leak tests, minimally invasive procedures. standards, and advanced
life-cycle tests and more. With this demand in mind, CWT statistical process control
Currier’s moulding expertise also provides services such as is used to monitor material
includes blow moulding and coiling (custom coils, continuous properties and mixing, moulding
injection moulding. The company coils and reinforcement coils), operations and final product
is ISO 13485:2016-certified and wire forming for medical conformance to specification.
FDA registered with a Class device parts or subassemblies, Da/Pro Rubber’s products meet The final proof of the success
8-certified cleanroom at its grinding, fine-wire assemblies, demanding standards. of these efforts is the part itself.
New York manufacturing site. laser and plasma welding, and Its facilities are located To ensure quality, all parts are
It offers design, blow moulding custom compression springs. in Oklahoma, California and visually inspected to check that
and injection moulding all from While wire technology’s Massachusetts in the US, as they conform to design criteria.
one team. uses are vast, it is not a rapidly well as Singapore, and it has In addition, leak and deflection
evolving industry. Rather, it is ISO 9001-certified facilities testing for diaphragms and
Further information the design and application of and a Class 10,000 cleanroom. insulation testing for connector
Currier Plastics
the wire and tubing in medical Known for high-precision, close- inserts may be specified.
www.currierplastics.com
products that continue to tolerance moulding services, Whatever the customer’s
change. In spite of this, CWT’s Da/Pro Rubber can manufacture moulding needs, Da/Pro has
Down to the wire team of designers continue LIM/LSR products to these same the expertise, experience and
to push the boundaries of demanding standards. world-class service necessary to
conventional wire processing. The compression and find a solution.
CWT provides flexibility with transfer moulding consists of
its micro-laser welding machines, proprietary processes developed Further information
Da/Pro Rubber
which are capable of rotary and by Da/Pro Rubber. The presses
www.daprorubber.com
stationary welding. The latter are designed to adjust for
option is typical for custom compound or part-configuration
prototypes and small orders, variables. The moulding Solving resuspension
but automated rotary welding process is computer controlled with advanced
CWT offers micro-coiling services for is used in larger production runs and monitored to maintain technology
wire used in medical device parts. to ensure quality, consistency consistent moulding conditions,
In a world where wireless and quick turnaround times. assuring the duplication
dominates discussions about Another of the company’s of the product throughout
technological advancement, the capabilities is its printing the moulding cycles.
lowly wire is easily forgotten. prowess. With 360° rotational When it comes to material
However, in the medical device printing, it can provide marking development and qualification,
industry, it is an essential indicators and product logos Da/Pro staff chemists
component in the development on a variety of medical devices are available to develop
and manufacturing of and components. CWT boasts organic, inorganic or silicone
life-saving equipment. an ISO Class 7 cleanroom compounds to satisfy specific
US-based Custom Wire for assemblies and packaging customer requirements. Dexter has an ISO 13485 certification for
Technologies (CWT) is a to ensure products meet the The physical properties of all medical device quality systems.
leading medical device original cleanliness requirements rubber compounds that are The challenge of using
equipment manufacturer demanded by customers. critical to the function of the magnetic beads in assays for
(OEM) with experience in moulded product are monitored the life science and IVD (in vitro
diagnostic and interventional Further information in the Da/Pro Rubber laboratory. diagnostics) fields is maintaining
Custom Wire Technologies
guidewires. As the company’s Da/Pro has a complete a consistent bead concentration,
www.customwiretech.com
name suggests, it is equipped to in-house engineering and finding a verification
customise its wire products for department to assist with process that measures successful
a variety of applications, such as Quality rubber the mouldability of components. separation and resuspension.
guidewire coils and assemblies, products The company’s CAD/CAM The use of magnetic beads
Kirschner wires and profile Da/Pro Rubber manufactures capabilities guarantee to isolate DNA, RNA, proteins
ground-custom tubing. custom products including effective precision tooling and other biomolecules
Many of CWT’s clients are diaphragms, seals, connectors, at competitive prices. for particle separation is a
OEMs providing innovative custom shapes, rubber-to-metal To ensure product common practice among many
solutions to their customers, and parts and more. consistency, quality is monitored healthcare professionals.
Ultra-small NFC LCP is a homogenous material Fluigent has recently Implantation syringes are
sensor modules and can be easily machined with introduced the new PX used for the application of
UV lasers with a precision down pressure controller for medication (for instance, in
to the micrometre scale. Cavities integrated fluid handling in cancer therapy) when the
and openings for recessed OEM systems. This series of treatment is necessary over
components can be integrated. miniaturised systems combines a long period of time. The
PBS and sulphuric acid the excellent performance medication is delivered in the
soak tests with an embedded, of the patented, field- form of a rod-shaped tablet
moisture-sensitive test chip proven Fastab technology placed subcutaneously. This
Miniaturised NFC sensor module. have demonstrated long-term for optimal flow control procedure is often very painful
DYCONEX has developed a stability (over 14 months) with the robustness required and usually requires a local
novel approach that delivers in aggressive environments. in demanding industrial anaesthetic. There is also the
miniaturised, hermetic, biostable LCP allows miniaturised environments at an chance that the medication can
and highly reliable smart-sensor smart sensor modules used affordable price. either be pushed deeper into
modules as small as 6mm in in medical, food processing, The PX module is a CE the tissue than necessary or not
diameter and 2.5mm in height. pharmaceutical, chemical and RoHS-compliant single deep enough, resulting in the
The tiny modules are based on or industrial applications. controller available in three tablet sticking out of the tissue.
liquid-crystal polymer (LCP), a pressure ranges: PX-1 at Thanks to Gaplast’s
thermoplastic dielectric material Further information 0–1,000mbar, PX-2 at innovative syringe application
DYCONEX
with very-low water absorption 0–2,000mbar and PX-V at system, this is no longer the
www.mst.com/dyconex
(less than 0.04%), high chemical -600–0mbar (vacuum). It has case. The function of the
stability and low thermal been designed to maximise implant syringe ensures that
expansion. LCP is best suited Precise pressure versatility with its dual- the drug is reliably placed in
as both a substrate material control for interface USB and RS232 the puncture channel and not
and an encapsulate. LCP’s fluid delivery ports, and is delivered with a pushed deeper into the tissue,
permeability for water and gases Fluigent is well known for its full software package (SDK) enabling safe and precise
is the lowest among all polymeric high-quality and innovative to ease integration into injection of the medication
materials. With proper design fluid delivery systems based Windows or Linux-based into the subcutaneous tissue.
considerations, LCP packages on pressure actuation. Using software platforms. This has, of course, greatly
increased the comfort for the the mid-position, and then 10993-compliant, DEHP-free economies of scale –
patient and a local anaesthetic new tubing can be inserted. and are made without natural IMT can offer customised
is no longer necessary. Reversing the procedure rubber latex. The luer is also glass components at
The reliable and simple closes the clamp over all ISO 594-2 compatible. competitive prices.
application is also of particular four tubes and retains IMT has over 50 years’
benefit to the doctor. In them securely in position Further information experience as a supplier of
Halkey-Roberts
fact, the syringe received during use. custom-made glass components
www.halkeyroberts.com
the German Packaging This, and many other exciting for a wide range of optical
‘Functionality and new products designed for and sensor applications
convenience’ award due to use by the medical equipment Cost-effective including delineated optics,
its “innovative combination manufacturing industry, glass components reticles, gratings, mirrors
of medical packaging and can be seen on the new and filters. The company’s
syringe applicator”. Geeplus website. core expertise is the coating
and structuring of thin films
Further information Further information using microlithography.
Gaplast GeePlus
Its production environment
www.gaplast.de www.geeplus.com
IMT produces customised high-
– which includes 1,300m²
precision, low-cost glass components. of cleanrooms and a fully
New changeover Adaptable and Glass remains the material of automated process line for
valve with reliable luer valves choice for many biophotonic 200mm glass wafers – is
four channels and microfluidic applications. well suited to the mass
It is inert to most chemicals, production of lab-on-a-chip
has unsurpassed well-defined glass components, flow cells
optical properties, and has containing microchannels,
good temperature and pressure and metallic and dielectric
The MLVs are currently available in stability. However, glass microstructures, in
four configurations.
components also have combination with waveguides
Halkey-Roberts Robertsite a reputation for being and gratings.
Male Luer Valves (MLVs) are prohibitively expensive to
ideal for flushing and drainage manufacture, which means that Further information
IMT
applications, IV solutions using them as a consumable
www.imtag.ch
All of GeePlus’s products can and home healthcare. They or semi-consumable in high-
be found on its new website.
incorporate proven valve quantity applications is not
The new PT24-2CO pinch technology, are high flow, and cost-effective. In several cases, Non-invasive
valves from Geeplus have a eliminate dripping and leakage it appears to be the cost of the free-entry fluid
new changeover design with when disconnected, with no consumable glass components flow monitoring
two NO and two NC channels. clamping required. that prevents a new analytic
Available in a wide range of The MLVs are currently method or technology from
operating voltages, the PV24 available in four configurations: entering the mainstream.
can be supplied with different female luer lock, a 0.125in barb, Realising the market
springs in order to develop the a 4mm tube port and a 6.6mm potential of high-precision
required force to close the NC tube port. They are designed but low-cost glass components,
channels when the device is to attach directly to tubing. IMT of Switzerland is applying
Introtek’s IntroFlow flow-detection
de-energised. Ideally suited The MLV with female luer the foundry concept to the devices incorporate the latest
to use with tubing that has a lock can be attached directly production of glass components ultrasonic technology.
diameter of up to 3mm and to a syringe or male luer for life sciences, such as Introtek’s IntroFlow non-
wall thicknesses ranging connector. All four valves can microchannels, through-holes, invasive flow detection
0.5–1mm, the pinch valve be used to access a mating electrodes and waveguides. devices incorporate the latest
has a tubing clamp that female luer connector or luer- By combining the ultrasonic technology for flow
secures the tubing in place activated valve. development and production measurement. The non-invasive
during operation. The MLVs are made of of glass components for many concept provides a platform
To replace the tubes, a clear polycarbonate body, companies at one site and for non-contact measurement
the specially designed clamp a clear silicone valve stem, applying manufacturing where safety, hygiene and
can be lifted, rotated through and a clear polypropylene technologies from the cleaning are of concern. This
90° to clear the tubing channels luer and retainer. All materials semiconductor industry – free-entry sensor is designed
and raise the pinch bar to are gamma-resistant, ISO and thereby reaching attractive for easy tube installation and
can be accommodated for in Sablé, Dagneux and cutting-edge inspection and be shipped quickly to aid in
various tube sizes. Pouzauges. The company also calibration systems, it can product evaluations.
Fully integrated electronics owns a fourth gamma plant in ensure that customers’ most
Further information
yield the smallest footprint, Tallinn, Estonia. IONISOS has exacting requirements are met. John Evans’ Sons
with a simple interface three ebeam plants in Europe: The engineering group www.springcompany.com
to medical and industrial one in Chaumesnil, France; consists of skilled
applications. another in Taracon, Spain; professionals with broad
The standard configuration and a third cross-linking plant experience in the design and Interconnection
outputs a voltage frequency in Bautzen, Germany. It has development of all types of expert
that is proportional to liquid- two EO plants in France, springs. The group is backed by
flow velocity. Absent tube and at Gien and Civrieux. an unusually high level of
air detection are fault outputs Additionally, IONISOS expertise – due to having more
for added value. Features of is a service provider for than 160 years in business –
the devices include: sterilisation, decontamination and the latest in spring
■ non-invasive ultrasonic of medical devices, implants, manufacturing equipment.
■ integrated electronics packaging for drugs, raw The company provides three Keystone manufactures products suitable
■ dry coupled materials, drugs, API, different types of spring: for a huge range of applications.
■ compact, free-entry design cosmetics and cross-linking ■ Constant-force springs For more than 71 years,
■ low cost polymer applications. provide a smooth range of Keystone Electronics has
■ fast output-response time motion and a constant load been manufacturing quality
■ low power consumption Further information in the extending or retracting interconnect components and
IONISOS
■ high EMI and RFI direction. This spring design hardware for original equipment
www.ionisos.com
noise immunity. has no inertia to overcome designers and engineers
when considering the initial- worldwide. Be it portable
The options for the devices Motion control and position starting forces. ultrasound devices, defibrillators,
include a wide range of tubing counterbalancing Constant-force springs are implantable pacemakers or
sizes (custom prototypes), through precision compact and mount easily mobile electrosurgical instruments,
custom configurations and spring products to existing hardware. Keystone’s precision capabilities
options available upon request. ■ Spiral torsion springs allow reach the highest standards.
The applications for the devices rotation in two directions While its full line of
include medical technology, the and a ‘return to centre’ catalogue-M65 products meet
biopharmaceutical industry, capability. Spiral torsion most standard requirements,
liquid dispensing, and fluid- springs are normally used in modifications and custom
handling and process technology. applications requiring less fabrications are manufactured
than 360° rotation. They are to meet special needs.
Further information John Evans’ Sons serves many of the generally used to obtain a Keystone’s engineering team
Introtek world’s largest medical companies.
large amount of torque with uses manufacturing equipment,
www.introtek.com
John Evans’ Sons is ‘America’s a small amount of rotation. including progressive dies,
oldest springmaker’. Founded ■ Helical spring or wire four-slide stamping, wire-
French leader in in 1850, the company forms and custom spring forming, in-die tapping and
sterilisation services manufactures precision springs, assemblies can be designed high-speed blanking, along
wire forms, mechanical to meet challenging with automated machining,
assemblies and stampings. space and mounting to produce tight tolerance
It is a leading manufacturer configurations. The standards and custom products:
for the medical-equipment company is experienced ■ Battery clips, contacts
industry and has provided with many stainless and alloy and holders: cylindrical,
spring assemblies for many materials used in critical coin-cell, 9V, lithium-battery,
of the world’s largest medical applications. steel, aluminium and plastic
IONISOS has the facilities for ionising medical corporations. holders; battery contacts
radiations and EO. Evans’ quality assurance John Evans’ Sons is and component clips; and
IONISOS is a leading service procedures have been surveyed eager to discuss the design battery straps.
provider for treatment using and approved by more than requirements and spring ■ Fuse clips and holders:
ionising radiations and ethylene 300 of the world’s largest challenges in clients’ various auto fuses; subminiature;
oxide (EO). It has nine plants corporations. By employing design and prototype phases. midget fuses; cylindrical
in Europe. There are three ISO 13485:2003 and ISO Many choices of springs and glass 2ag, 3ag and 5ag; and
gamma plants in France, based 9001:2008, in conjunction with reels are stock items that can 5mm-style fuses.
■ Terminals and test points: as an isolated development categories. This critical feature
PC quick-fit; male and female; project. You need to consider secures parameters from
solderless; PC test points and interrelations with experts alteration and accidental loss.
screw terminals; and SMT/THM from a medical background, All parameter changes are
test points. regulatory experts, and recorded and saved in a log.
■ Spacers and standoffs: nylon, various other stakeholders This feature makes it possible
brass, aluminium and ceramic who provide support during to track who accessed
materials; and clear hole, Developing medical device software
development and once the information, and where and
swage or force-fit, hinged calls for a specialised approach. software system is used live. when data for process
and threaded styles in imperial manufacturers frequently hire ■ Do not underestimate the modifications were initiated.
and metric threads. software development companies maintenance effort once the A newly developed web-
■ Panel hardware: handles; to create this component. medical device software is based human-machine interface
mounting screws; fan and However, software development live. Changing medical device (HMI) makes integrating the
finger guards; LED spacer companies are not always software requires a sound Basic S quick and intuitive.
mount and lens caps; knobs familiar with the regulatory impact analysis and should be Digital, as well as analogue
and instrumentation cases. requirements for medical device understood as a project itself. signals, are clearly displayed
■ Pins, plugs, jacks and software, especially when it graphically and in real time.
sockets: USB and firewire comes to the maintenance Further information This new functionality makes it
Knoell
plugs and sockets; banana, requirements in the post- possible to detect which signals
www.knoell.com/en/business-
audio and phono plugs; binding market phase. units/medical-devices are on and off in the Basic S
posts; test and micro jacks; A sole software developer system at all times. Process
micro and push-in pins; and is often not prepared to support parameters can be set using
modular Rj45 jacks. a medical device manufacturer Medical-standard the web HMI or directly with
■ PC board and multipurpose throughout the whole life welding the LCD display on the front
hardware: computer, cycle of the medical device of the system.
threaded and mounting containing its software. To The Basic S can be operated
brackets; PCB accessories; avoid the failure of such with the innovative, modular
clamps; ties; grommets; projects and frustration on both Leister laser optics. In contrast
bushings; bumpers; washers; sides, software development to the BT line, premium AT
eyelets; rivets; tool kits companies need to become optics offer fibre connection
and turret terminals. software development partners. monitoring, laser power
■ Terminal board They need to understand measurement and pyrometer
The Leister Basic S is essential for
and strips: scored and the needs of medical device effectively welding plastic components. functionality. In April, the new
turret terminal boards; companies and be prepared The new Basic S from Leister Leister Basic S was presented
and terminal strips. for long-lasting relationships. is the perfect integrable plastic for the first time at MedTec
The following key rules should laser-welding system for the Europe 2018 in Germany.
Keystone is ISO be considered by software medical industry. Incorporating
9001:2015-certified by DNV development companies when a unique, state-of-the-art Further information
Leister
Certifications under the RAB developing software that is a for cooling system that was
www.leister.com
and RvA accreditations, and a medical device or is intended developed in-house, the Basic
compliant with RoHS and to be part of a medical device: S is set to redefine the market.
REACH directives. It is ■ Employ considerate software The permanent cooling of Custom solenoid
headquartered in the US developers who wish to the laser ensures the precise valves improve
with offices in Canada, think about a robust software and repeatable welding of medical device
Europe, Australia and Asia. architecture before they plastic components. performance
start programming, and who To ensure products can and design
Further information document their decisions be welded in accordance with With over 20 years’ experience
Keystone Electronics
and source code. stringent medical industry in manufacturing medical
www.keyelco.com
■ Think about regulatory requirements, the Basic S is application solenoids, LISK
requirements and risks coupled with powerful software has grown its expertise
Helping companies related to the software that can record and output and knowledge of customer
to evolve system from the beginning. all welding-process data and requirements, and created strong
Innovative solutions in They are important inputs parameters in a single file. partnerships with its clients.
the medical device industry to your software design Newly developed management The company’s solenoids help
often contain software. For and architecture. profiles divide users into its medical device manufacturing
this purpose, medical device ■ Do not view the project operator, expert and service partners to use energy more
efficiently, and build more ■ assistance with e-MDR Ming Tai is capable of found in numerous medical
compact and portable equipment. ■ assist with the UDI for providing customers with devices on the market today.
LISK’s expert solutions are used medical devices technical support during the The company has melting
in dialysis equipment, and for ■ FDA labelling guide reviews development procedure and capabilities for temperatures
the critical control of fluid and for food products, and dietary prototype, through to trial up to 1,600°C and quantities
ventilation applications. In-house and nutritional supplements runs, mass production, spring from a few kilograms up to
design customisation enables mounting and assembly. Each several thousand kilograms
Further information
the company to optimise its manufacturing procedure, annually. Its unique in-house
mdi Consultants
compact, low-energy proportional info@mdiconsultants.com including steel strip slitting, capabilities allow it to melt
control solutions. www.mdiconsultants.com heat treatment, edge trimming larger quantities in a variety of
Key features of the solenoid and forming process, is a crucible types. Customers look
valves include: consistent production and to Mo-Sci when they need high-
■ proportional flow control Developing high- completed in-house to ensure purity implant or medical-grade
■ long-life-cycle-tested product quality springs the highest quality is achieved. glass materials, or custom glass
■ custom preset and Ming Tai also has precision compositions specific to their
adjustments enabled instruments to do force, torque application needs. Other
■ low noise operation and product-life testing to service capabilities offered
■ interface can be changed ensure quality. Ming Tai is include glass analytics,
to customer application. certificated with ISO 9001:2008 coatings, spheroidisation and
and RoHs. There are a number glass development.
Further information
of different spring design Mo-Sci also serves the
LISK
www.gwlisk.ie possibilities for a given aerospace, energy, automotive
application, and Ming Tai and defence industries among
suggests consultation with others. MO-SCI is ISO 9001 and
Ming Tai Industrial is an expert in
More than just FDA producing medical device springs. one of its engineers early in AS9100-certified.
regulatory assistance Ming Tai Industrial is a the design phase.
mdi Consultants has been in the professional manufacturer of Ming Tai is pleased to create Further information
Mo-Sci
regulatory business for over 40 steel strip springs for medical an optimised solution for any
www.mo-sci.com
years and has the expertise to device applications, including spring demand. Custom designs
provide exceptional professional constant force springs, are available as well.
aid in: constant torque springs, Protect patients
■ US FDA compliance, constant force springs for Further information and brands
Ming Tai Industrial
regulatory strategy carbon brush, power springs Recent controversy surrounding
www.powerspring.com.tw
development and clinical and prestressed power springs, the safety of medical devices
trial development/ variable force springs and has made it clear that the
management, as well as spring-strip tubes. Medical-grade industry needs to put quality
QSR/CGMP compliance As of today, Ming Tai has custom glass and safety first.
■ assist with MDSAP helped lots of medical device manufacturing Medical device recalls
implementation and manufacturers to successfully Mo-Sci specialises in cost the industry $2.5–5
certification preparation develop new products. All manufacturing technical billion a year, and companies
■ on-site audits – mock FDA innovative products include glass materials such as glass associated with a recall can
audits by lead auditors that a pen-type drug injector, powders, microspheres, and expect an average 10% drop
are ex-FDA investigators highly adjustable monitor-and- ingots specifically designed and in share price.
■ PMA/ANDA/NDA/510(k) keyboard-integrated medical manufactured for the medical Lost revenue and increased
application submission workstation, highly adjustable industry. Mo-Sci materials, like spending on public relations
services – mdi has a 100% patient bed trapeze, highly bioactive glass and precision and crisis communications are
success rate after more than adjustable patient bedside glass microspheres, can be inevitable additions to the cost
and orthopaedic. If a client designs multiparticulate drug. The it through cleaning, disinfection
it, Protomatic can make it with oral syringe is connected to or handling. A well-thought-out
any material, including aluminium, the container so that the drug system solution is a key factor
titanium, medical-grade plastic and can be precisely dosed, drawn for reliability and completes
stainless steel. and administered. A plastic the individual application.
part in the syringe allows The special cable
Further information the dosage to be set safely manufacturer SAB is expanding
Design it, and Protomatic can
Protomatic Medical
make it from any material. and transparently. This its range of medical cables with
www.protomaticmedical.com
control (CNC) contract easy handling means the a new plug-and-play solution
manufacturer specialising in multiparticulate drugs can be with over-moulding, made
orthopaedic, cardiovascular An innovative oral administered as precisely and of medical-grade silicone or
and medical devices. It ‘always delivery system safely as liquid drugs. With the thermoplastic elastomers as a
strives to enhance product oral syringe, users can rely on consistent implementation of
quality, while also improving a trusted and proven system market requirements. In order
the quality of human lives’. that is standard with liquid to achieve a secure and smooth
Gearing the company’s drugs. Moreover, it is spill- material connection between
manufacturing capabilities proof, clog-resistant and has the electrical line and the plug,
to the medical industry enables a chew-resitant outer shell. all the necessary components
it to reduce development time, The Sympfiny system makes for
The system can equally are fine-tuned to each other.
bringing about faster easier treatment of children. be used for dry powder or The results flow directly
commercial launches. It has It is often difficult to orally microsphere drug formulations. into production. This benefits
proved itself as a provider of administer the correct The reusable syringe comes the manufacturers of medical
quality orthopaedic devices, amount of medicine to children in two sizes and has selectable components as they can rely
forming long-lasting accurately and safely. Young dose settings. The 1ml and 2ml on the proven support of the
partnerships with customers patients refuse the medicines variations have been tested for biocompatible base material
that require high-quality, because many of them dose accuracy and satisfy the prototype and 0 series through
precision medical products. are bitter tasting. To solve requirements of ISO 7886-1 manufacturing lengths starting
Protomatic manufactures this problem, a new way 2017. The system fits common at 100m.
orthopaedic tools, of administering drugs has bottle sizes and can be prefilled “This can only be achieved
cardiovascular pump been developed, known as or filled at a pharmacy. through constant dialogue
components and precision multiparticulate drugs: tiny with customers,” explains
Further information
medical device components spheres, measuring 0.1–0.6mm, Marc Gerlatzek, SAB’s medical
Röchling Medical
for diagnostic instruments, with a protective coating. The www.roechling.com/medical/ product mananger. “We count
and is an ISO 9001:2015 and coating neutralises the taste pharmaceutics/sympfiny on our material diversity,
ISO 13485:2016-registered of the active ingredient without experience and constant
company. Its talented, impairing its effectiveness. Over-moulded investment in the machine
dedicated staff take pride Together, HS Design cable solutions for park at our site in Viersen.”
in the superior quality of its from Gladstone, US, and medical technology Possibilities for over-moulded
wares. Among the products the medical division of plugs and nozzles are available
created at Protomatic are: the Röchling Group have for almost the complete cabling
■ cardiovascular medical developed the new drug solution of the SABmed Line
equipment components delivery system Sympfiny material family. Medical cables
■ trocar devices (registered trademark), with the flexible and smooth
■ tunellers and cannulas specifically designed for this SAB Bröckskes offers a comprehensive SABmed T can be engineered
■ peristaltic pump components new way of administering range of quality cable solutions. and customer customised to
■ left ventricular assist drugs. It allows simple and Cable system manufacturer and produce thermoplastic and
device components reliable administration, and cable specialist SAB Bröckskes elastomeric materials with
■ surgical tools the exact dosage of the drug. offers high-quality cable solutions better haptics than
■ sampling components This innovation makes the with high material diversity as a conventional thermoplastics
■ optical stages, lenses safe treatment of children plug-and-play solution for system If a medical cable with UL
and filter holders. considerably easier. equipment, even for prototypes approval is needed then the
Sympfiny consists of a and small series. material SABmed S UL is used.
Protomatic also offers container for the drug, and Connection cables for The base material can be
CNC precision machining an accurately fitting oral medical devices and treatments offered as a platinum cross-
for all medical industries, including syringe for drawing and are often subject to demanding linked variant, with an ultra-
biomedical, dental, cardiovascular administering the requirements in daily use, be flexible sheath or with a non-
adhesive surface. New devices. Eclipta’s easy assembly disposable and reusable sides,
developments, such as and high-density design scalability, customisation and
autoclavable USB 3.0 cables, makes it the ideal connector the possibility to be reworked
are already being designed by system for disposable on the reusable side.
SAB Bröckskes with an outlook medical applications.
to possible over-moulding. For electrophysiology Further information
Smiths Interconnect
Manufacturers of medical catheter applications, Eclipta
www.smithsinterconnect.com
devices will be able to use connectors bridge the gap
this complete system solution between the catheter and the
as a tailor-made plug-and-play extension cable. Quality guide wires The cross-roller ring RF.
product from a single source, A standout feature of Eclipta rings, with a particular suitability
allowing greater design is the fact that the printed as rotary bearing for robots.
freedom in the development circuit board (PCB) acts as The cross-roller ring RF reduces
of devices. the contact in the connector. the total weight of a construction,
SAB Bröckskes is a world- Since the board is part of a due to its unique design with
leading manufacturer of cables disposable device, it eliminates SP Medical offers a wide range of guide a flange. It also allows direct
and wires, cable harnessing the cost of using a contact wires for use in angiography, cardiology, mounting to the shaft and
urology and gastroenterology.
and temperature measuring system. In addition, its plug- housing, making a housing flange
techniques. More than 60 and-play design provides SP Medical is a Danish unnecessary, which reduces the
years of experience in cable effortless termination and company with more than 30 number of assembly steps and
manufacturing, as well as virtually eliminates the years of experience in the parts required.
in temperature measuring potential contact damage development, manufacture THK’s cross-roller rings are
techniques, has turned a one- associated with the termination and sale of guide wires for particularly powerful cylindrical
man business into a company process. An added benefit the medical industry. Over roller bearings for momentary
with almost 500 staff members. of incorporating the the past 30 years, SP Medical loads and loads from all directions,
The strength of SAB board inside the connector has built up its knowledge of including those from the axial and
Bröckskes is not only the is the ability to add active- polytetrafluoroethylene-coated radial directions. This is achieved
manufacturing of standard surface mount components, products and medical devices by the crosswise arrangement of
cables, but also the such as electrically erasable for leading suppliers, such the cylindrical rollers, which roll in
construction of special items. programmable read-only as those that supply sterile- right-angle ground raceways.
Every year, SAB manufactures memory (EEPROM), to packed guide wires, or offer THK offers the cross-roller ring
more than 1,500 special cables either side of the board. guide wires on an original RF with or without an inner flange.
on the requests of customers. Eclipta’s storage/processing equipment manufacturer basis. With an inner flange, the bearings
temperature range is -40°C to It is SP Medical’s goal to are offered with inner diameters
Further information
SAB Bröckskes 135°C, which allows use with offer its customers a complete of 20–95mm, and without
www.sab-cable.com standard sterilisation protocols, range of high-quality guide wires an inner flange that has inner
including autoclave, ethylene and special features, if required. diameters of 40–120mm.
A reliable, cost- oxide (EtO) and STERRAD. The company focuses on
Further information
effective and Its high-mating lifetime of up core competency within the THK
disposable to 2,500 cycles increases the discipline of its guide-wire www.thk.com
connector system mean time between failures manufacturing process, so
(MTBF), and the fingerproof as to be able to offer optimal All the information
contacts on the reusable side professional consultancy in one place
contribute to the safety of and development to all of The Organisation for
patients and medical personnel. its customers at all stages Professionals in Regulatory
Eclipta is suitable for disposable Eclipta has been developed of their projects. Affairs (TOPRA) is the one-
medical applications. to deliver benefits to healthcare stop shop for EU training
Smiths Interconnect’s Eclipta providers, while addressing Further information resources on medical devices,
SP Medical
ECL series features high- their real-world manufacturing in vitro diagnostics and
www.sp-medical.com
performance, edge-card process needs, as its combination products.
technology designed to component design facilitates The company provides:
enable quick and reliable easy assembly and increased Cross-roller ring ■ essential overviews of
connections, while delivering labour efficiency. Additional for robots medical device regulatory
the serviceability and benefits include the mass With the new cross-roller ring RF, affairs for new recruits,
affordability required by a termination of catheter wires THK is expanding its already large, and intensive introductory
broad range of critical medical directly to the PCB in the unrivalled range of cross-roller courses for those committed
to building a career in medicines, devices and veterinary verify and manufacture Class I,
this speciality regulatory affairs’. II and III medical devices.
■ topic-focused continuing Organised with the Health It offers a wide variety of
regulatory education Products Regulatory Authority services, ranging from short-run
and development courses, (HPRA) Ireland, the programme prototypes and preproduction
and masterclasses for will cover topics such as units to long-range production.
senior professional as the impact of technology, Value-added services include
well as a highly respected implementing new medical devices experienced engineering staff
Regulators will look for extraction
master’s qualification and in vitro diagnostic regulations. to develop electromechanical conditions that demonstrate a device
in medical device Delegates will have the chance to: and electro-optical equipment, has been challenged.
regulatory affairs ■ benefit from an extensive from concept to full production; Full characterisation of all
■ small-scale roundtables EU-focused programme hardware and software design; chemicals is required for an
to summits and international ■ meet regulators from around packaging; qualification testing; accurate assessment of risk,
symposia where regulatory the world and printed circuit board and it is WuXi AppTec’s goal
leaders and influencers ■ network with innovators and layout, from through-hole to identify all of the potential
network with regulators opinion leaders in healthcare to surface-mount. chemicals that could come out
and policymakers. regulatory affairs Whether a client is looking for of your product. Using multiple
■ share experiences with peers a complete turnkey solution or analytical methods, WuXi
TOPRA is the gateway to and discuss potential solutions is just supplementing its internal AppTec’s team of chemistry
building an extensive European- to regulatory issues capabilities, TRICOR has the experts work tirelessly to
focused network of medical device ■ navigate the practical background and flexibility understand your materials,
and IVD professionals from across implications of disruptive to meet every requirement. processes and products to
the world. technologies and a changing TRICOR offers customers detect a full range of organic,
Join TOPRA and the vibrant regulatory landscape. the opportunity to confidently semi-volatile and volatile
community of over 1,000 medical outsource project needs. chemicals, providing you with
Further information
device professionals in the Medical the data you need to make
TOPRA
Technologies Special Interest Further information informed decisions and meet
www.topra.org
TRICOR Systems
Network; take part in the current regulatory requirements.
www.tricor-systems.com
members-only online community Some benefits of using WuXi
discussions; access free SPIN High-quality AppTec include:
webinars on a wide range electronic Analytical chemistry ■ 80–85% of the time, the
of topics, including vigilance manufacturing – unknowns are company is able to meet
changes, incident reporting and and design unacceptable biocompatibility systemic
clinical evidence requirements. In accordance with ISO 10993- endpoints with chemical
Read the latest legal news and 1, ‘Biological evaluation of characterisation and
developments in the monthly medical devices – evaluation risk assessments.
‘MedDev update’ newsletter, and and testing within a risk ■ Unknowns can delay testing
in-depth review articles in the management process’, material up to 27 weeks and can cost
peer-reviewed Regulatory characterisations should be more than $75,000.
Rapporteur journal. considered for every device. ■ WuXi AppTec has
The theme of this year’s Extractable and leachable completed more than 4,500
TOPRA Annual Symposium, TRICOR Systems provides award- studies are conducted to get material characterisations.
30 September to 2 October, winning contract manufacturing. a full characterisation of all
is ‘Europe at the forefront of TRICOR Systems, a US full- chemicals, which is then WuXi AppTec Laboratory
global healthcare regulation – service contract manufacturer, used to create an accurate Testing Division’s medical device
Driving innovation through is a US FDA-registered, ISO assessment of risk. platform is the leader in complete
convergent approaches in 9001:2015, AS9100D and The expectation is that all identification – to WuXi AppTec,
ISO 13485:2016-certified chemicals are identified, so unknowns are unacceptable.
electronic design and medical avoiding unknowns in chemistry Let its team design a chemistry
manufacturing facility. reports is paramount. If unknown programme tailored to meet your
Founded in 1976, TRICOR chemicals are listed in a report, analytical needs.
has successfully provided high- be prepared for regulators
quality products and services to require you to complete
Further information
to the medical marketplace. the identification – complete
WuXi AppTec Laboratory Testing
TRICOR possesses the material characterisation Division Medical Devices Platform
TOPRA is the one-stop shop for a
range of EU training resources. expertise to design, develop, cannot exist with unknowns. medicaldevice.wuxiapptec.com
Argon Medical ......................... 116 Gaplast ................................... 132 mdi Consultants .......................... 23
www.argonmedical.com/oem www.gaplast.de www.mdiconsultants.com
Atlas Vac Machine ................... 135 Geeplus ................................... 111 Medical Technology Ireland ....... 158
www.atlasvac.com www.geeplus.com www.medicaltechnologyireland.com
Compounding Solutions .............. 95 John Evans’ Sons ........................ 29 Ming Tai Industrial Co................. 41
www.compoundingsolutions.net www.springcompany.com www.powerspring.com.tw
Da/Pro Rubber .......................... 37 Lapp Tannehill ............................ 96 New England Tubing Technologies ..91
www.daprorubber.com www.lapptannehill.com/medical www.newenglandtubing.com
Phase 3 Plastics ........................ 133 SAB Bröckskes............................ 79 Trilogy Writing & Consulting ....... 24
www.phase3plastics.co.uk www.sab-cable.com www.trilogywriting.com