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The Magazine for Medical Product Design & Manufacturing
The Next Big Thing
in Cardiology
page 14
Biomaterials Worthy
of Olympians
page 22
Laser Drilling
Fundamentals
page 26
Spotlight on
Medical Moulding
page 44
Medical Filtration
page 48
The Future of Medtech
Brace yourself for massive change in the workplace.
page 18
EMDT1207 001 1 7/12/12 5:06:53 PM

EMDT1207 002 2 7/12/12 5:07:24 PM
emdt.co.uk European Medical Device Technology July/August 2012 | 3
CONTENTS
FEATURES
INDUSTRY
PERSPECTIVES
14 TAVR: Still the Next Big
Thing in Cardiology?
After being on the mar-
ket in Europe for years,
transcatheter aortic valve
replacement is ready for
takeoff in the United
States. Questions remain,
however, about its global
market potential.
Brian Buntz
SPECIAL REPORT
18 Re-engineering Medical
Technology from Top to
Bottom Line
Teleporting into meet-
ings, collaborating with
economists . . . welcome
to the future of medical
technology development
and manufacturing.
John Brosky
MATERIALS
22 Developing Biomaterials for
Sports-Related Bone Injuries
Its different for athletes:
biomaterials for sports-
related orthopaedic
applications should have
a composition similar to
the bones constituent
materials. Ideally, they
should stimulate and
facilitate regeneration of
new bone and gradually
dissolve in the body.
Xiang Zhang
MANUFACTURING
26 Tiny Triumphs: Laser Drilling
Micron-Sized Holes
Advances in medical
technology require ever-
smaller holes in devices.
Laser drilling achieves
strict size and tolerance
requirements in an eco-
nomically viable process.
David Gillen and David Moore
COLUMNS
REGULATIONS AND
STANDARDS
10 Proposed Guidance on
IVD Clinical Evidence and
Performance Evaluation
This article discusses
three proposed Global
Harmonization Task
Force guidance docu-
ments that cover clinical
evidence for IVD devices.
Maria Donawa
REGULARS
6 Online Contents
7 A Note from the Editor
8 Breakthroughs
50 Advertiser Index
Cover: Composite image by Tim Burns
Crystal Ball: Pixel Embargo/Shutterstock
Robot: Sarah Holmlund/iStockphoto.com
40 Engineering Insight
42 First Look
44 Spotlight: Moulding
46 In Focus: Connectors
and Wires
48 In Focus: Filtration
MARKETPLACE
22
SPECIAL
SECTIONS
ORTHOTEC EUROPE
31 Investment Hub Debuts
33 Exhibition Highlights
WORLD MEDTECH
FORUM LUCERNE
34 A Novel Platform
36 Exhibition Highlights
July 2012
Volume 3 Number 4
NEXT ISSUE:
Reimbursement
Miniaturisation
MEDTEC Ireland
PRODUCT FOCUS:
Metal fabrication
Product design
Precision power supplies
26
EMDT1207 003 3 7/10/12 4:48:05 PM
4 | July/August 2012 European Medical Device Technology emdt.co.uk
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Sr. Vice President/Exec. Director, UBM Canon Events
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Vice President, Production Operations, UBM Canon
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Vice President, Marketing, UBM Canon
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Editor in Chief
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Associate Editor
Camilla Andersson
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Editorial
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EDITORIAL ADVISORY BOARD
K. Al-Lamee
Managing Director, Aterius Ltd; and
Director, KAL Biomaterials Consulting,
Leeds, UK
S. Donell
Consultant Orthopaedic Surgeon, Norfolk
& Norwich University Hospital
Colney, UK
Honorary Professor, University of East
Anglia
Norwich, UK
S. Dunkerton
Director, HealthTech and Medicines
Knowledge Transfer Network; and
Business Manager, Processes, TWI Ltd,
Great Abington, Cambridge, UK
P. Galavotti
Consultant, Nexion srl,
Mirandola (Modena), Italy
T. Gourlay
Professor of Medical Diagnostics and
Bioengineering, Bioengineering Unit,
University of Strathclyde
Glasgow, Scotland
R. Gray
VP Quality and Regulatory,
Donawa Lifescience Consulting,
Rome, Italy
O. Grndahl Hansen
General Manager, PVC Information
Council,
Copenhagen, Denmark
R. Hall
Medical Packaging Consultant,
Shannon, Co. Clare, Ireland
D. Hill
Director, Ronin Solutions Ltd,
Jarrow, Tyne-and-Wear, UK
D. Hodgins
Managing Director, European Technology
for Business Ltd,
Codicote, UK
J. Hoffmann
Founder and President, InterTech
Development Co.,
Skokie, IL, USA
C.J. Kirkpatrick
Director, Institute of Pathology, Johannes
Gutenberg University,
Mainz, Germany
M.B. Leahey
Executive Director, Medical Device
Manufacturers Association,
Washington, D.C., USA
S. Loznen
Chief Engineer, Electronics and
Telematics Laboratory, Standards
Institution of Israel,
Tel Aviv, Israel
C. Mason
Regenerative Medicine Processing
Unit, Advanced Centre for Biochemical
Engineering, University College,
London, UK
C. Mathews
Director, Team Consulting Ltd,
Ickleton, Cambridge, UK
R. Moore
Manager, Nanomedicine and
Life Sciences, The Institute of
Nanotechnology,
Stirling, UK
W.A. Morton
President, Medical Device
Consultants Inc.,
Attleboro, MA, USA
M. Reinikainen
Managing Director, Abnovo Ltd
Weybridge, UK
A. Schneider
Group Manager, Biomedical Competence
Centres, Fraunhofer IBMT Institute for
Biomedical Engineering,
Sulzbach, Germany
S. Sorrel
President, MedPass International,
Paris, France
M. Tavakoli
Consultant and Technology Manager;
and Technical Director, HealthTech and
Medicines Knowledge Transfer Network,
TWI Ltd,
Great Abington, Cambridge, UK
J. Vienken
Vice President Biosciences, Dept.
International Marketing and Medicine,
Fresenius Medical Care,
Bad Homburg, Germany
D.F. Williams
Emeritus Professor, University of
Liverpool, UK, and Partner, Morgan &
Masterson,
Brussels, Belgium
L. Woo
Distinguished Scientist Emeritus,
Baxter Healthcare Corp., and Founder,
LWoo Associates LLC,
Libertyville, IL, USA
J.A. Woolston
Director, Astwood Projects,
Redditch, UK
The Editorial Advisory Board of European Medical
Device Technology is a distinguished group of
specialists representing various facets of medical
device and diagnostics design and manufacturing.
Members of the board review manuscripts,
suggest subject matter pertinent to the profession
and answer questions when they arise.
EMDT1207 005 5 7/12/12 5:08:52 PM
ONLINE CONTENTS
CURRENTLY ON
VIEW AT
emdt.co.uk
Drug Device Combinations: Which CGMPs to Follow?
The evolution of the medical device industry over the last five years
has been rapid with an increasing number of drug device combina-
tions. With these novel
products come the novel
challenges of satisfying the
relevant notified bodies
and competent authori-
ties throughout Europe.
This article describes how
manufacturers and designers should treat their
drug devices differently from conventional medical devices and
which CGMP they should follow.
Find out more on emdt.co.uk: bit.ly/MmsF9S.
A Cut Above in Urinary Catheter Fabrication
Eighty percent of urinary tract infections (UTIs) are associated
with the presence of a urinary catheter. Alarmingly, patients with
a UTI are also three times more likely to die;
the fatality rate from urinary tractrelated
bacteraemia is around 13%. Infection is due
to encrustation of the urinary catheter. It has
been suggested that urinary catheters with
smoother drainage apertures are less prone to
struvite formation and subsequent encrusta-
tion. This article describes an ultrasonic cutting technology that
produces smooth apertures and eliminates problems associated
with debris.
Learn more here: bit.ly/NoRh4T.
Value Creation in Medical Devices
Medical devices traditionally have been characterised as a high-
growth market with low price pressure.
However, several trends are creating a new
competitive dynamic characterised by slower
growth, increasing price pressure and new
purchasing habits. In this new financial envi-
ronment, companies must build a clearer
understanding of the specific needs of different
customers and design targeted offers. This article describes how
companies can best achieve that.
Read more in this article from Marakon Healthcare Practice:
bit.ly/MmstY4.
Scan Me By scanning
this QR code with your
smart phone, you can
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web page where you can
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A NOTE FROM THE EDITOR
Norbert Sparrow
norbert.sparrow@ubm.com
twitter.com/emdt_editor
SOME 40,000 MEDICAL-RELATED APPS
are available for download, and countless
more are on the way, which begs the question:
How do you reconcile the regulatory require-
ments that govern medical devices with the
fast and furious pace of app development?
That dichotomy has fueled a rambunctious
debate in the social media space and else-
where. Too often, the conversation sounds like a dialogue de sourds.
Many app developers are new to the medical space and are taken
aback by the regulatory hurdles that suddenly appear when medical
virtues are assigned to a product. US FDA is a popular villain.
FDAs current regulatory process was created when the floppy
disk was aroundancient history in the tech world, says Joel White,
Executive Director of the Health IT Now coalition, quoted in a
recent article in USA Today. Casting US FDA as an impediment to
innovation is not a new construct, of course. (The verdict is not quite
as harsh for Europes more-flexible regulations.) Do White and his
acolytes have a point? That depends largely on whom you ask.
Healthcare apps are putting consumers in control of their own
health and empowering them to demand change in the healthcare
system as a disruptive force, says Paul Sonnier, founder and Curator
of the influential Digital Health group on LinkedIn.
Where Sonnier heralds a positive disruptive force, Erik Vollebregt,
a medtech legal specialist based in Amsterdam, and Bradley Thomp-
son, Member, Epstein Becker & Green, caution against naivet.
App developers are unfamiliar with the CE system for software
development . . . and dont like the constraints of quality systems,
says Vollebregt. Thompson notes that these new entrants are tell-
ing regulators, you dont understand us. In fact, these newcomers
to the medtech space don't know what they dont know. US FDA
has been regulating standalone software for many years, Thomp-
son explains. This is not nearly as new to FDA as some of the new
entrants believe. Rather, the new entrants face a learning curve to
catch up with traditional medical device manufacturers, he says.
We are in a disruptive new world, and many good things will come
from that. But claiming that an app has medical benefits carries a cost.
The regulations are there to protect patients and make sure medical
devices are safe and effective, says Roger Gray, VP Quality and Regu-
latory at Donawa Lifescience Consulting. Why should a particular
type of device be exempt from these requirements?
A conversation, clearly, to be continued.
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BREAKTHROUGHS
GO TO MEDTECHINSIDER.COM FOR DAILY UPDATES ON R&D BREAKTHROUGHS, INDUSTRY
NEWS, REGULATORY UPDATES AND MORE
A European Commissionfunded project
titled Endure focuses on developing a new
type of hip implant that is metal-free and
provides bone-like elasticity.
An international team of 10 partners,
which include companies, research organi-
sations and universities, collaborated to
develop a hip implant that demonstrated
good wear resistance in initial tests. Dur-
ing the tests, a robot simulated various
movements while wearing a prototype of
the implant, according to the Fraunhofer
Institute for Manufacturing Engineering
and Automation IPA.
Hip implants can provide great relief to
patients with damaged hips, but research-
ers continue to search for a solution that
does not need to be replaced every few
years and does not contain metal. Metal-
on-metal implants can raise ion levels in
the blood when the metal ball rubs against
its metal socket, releasing debris. While
designed to improve durability compared
to conventional implants, which need to be
replaced every few years, the recent MoM
hip implant scandal indicates that sometimes
these implants may need to be replaced more
often. The new implant developed during the
Endure project could potentially solve some
of these issues, since its said to be more
robust than other metal-free options.
The implants hip socket is made from
carbon fibre-reinforced PEEK. Ceramic is
used in the femoral head of the implant. A
hydroxylapatite coating was added at the
interface to the bone.
Thanks to the new combination
of materials, the transmission of force
through the PEEK hip socket to the
pelvic bone is modeled on natural con-
ditions. And there are no metal ions
released,notes Fraunhofer IPA engineer
Jasmin Hipp.
Fraunhofer Institute for Manufacturing
Engineering and Automation IPA is one
of the project partners. The other partners
include Aurora Medical, Medicoat, Hunt
Developments, Ala Ortho, CeramTec,
Invibio, Biomatech and the Universities of
Gothenburg and Southampton.
Besides the new combination of materi-
als, the researchers made several other
modifications to the design compared
with typical hip implants. In particular, the
prosthesis attaches to the bone without
cement. Using a press-fit and an integral
scaffold-type structure on the surfaces
of the implant that contact the bone, the
hemispherical ball and socket are tapped
onto the femoral head and into the acetab-
ulum and anchored in place.
medtechinsider.com/archives/27831
A new type of prosthetic retina could
restore vision to patients with age-related
macular degeneration, the most common
cause of blindness in the developed world,
according to researchers at University of
Strathclyde. The wireless
device is less bulky than
existing devices. Cur-
rent prosthetic devices
require complicated sur-
gery, and the new device
could result in much
simpler procedures.
The device is being
developed by research-
ers at the University
of Strathclyde and
Stanford University. A
study on the implant was published on
13 May 2102 in the online edition of
Nature Photonics.
The retina implant is made of thin
silicone. It converts pulsed near infrared
light into electrical current that stimu-
lates the retina and elicits visual percep-
tion. Conventional prosthetic retinas are
powered by coils. Video
goggles deliver energy
and images directly to
the eye.
Part of the inspira-
tion for the device was
cochlear implants,
devices for people
with hearing loss. The
retina implant is simi-
larly designed, but has
a camera instead of
a microphone and is
designed to deal with millions of light-
sensitive nerve cells.
medtechinsider.com/archives/27944
Prosthetic Retina Could Restore
Sight to Blind Patients
New Materials Combination Imparts High
Durability to Metal-Free Implant
An implants hip socket is made from carbon
brereinforced PEEK. Ceramic is used in the
femoral head of the implant. A hydroxylapatite
coating was added at the interface to the bone.
This image shows a single pixel of
the chip implanted to treat blindness
(left); an array of photodiodes
making up the chip (centre); and the
chip itself (right).
EMDT1207 008 8 7/10/12 4:53:21 PM
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REGULATIONS AND STANDARDS
Dr Maria E. Donawa
A physician, pathologist and pharmacist with nearly 30 years
regulatory experience, Maria E. Donawa worked with US FDA
before becoming President of what is now Donawa Lifescience
Consulting, a full service European CRO and international consultancy
company that provides regulatory, quality and European Authorised
Representative services to life science companies.
Maria Donawa
T
he Global Harmonization Task Force (GHTF; www.ghtf.
org), created in 1992 in an effort to promote the inter-
national harmonisation of medical device regulation, is a
voluntary group of representatives from national medical device
regulatory authorities and the regulated industry. GHTF develops
guidance documents that provide a model for the regulation of
medical devices that can then be adopted by regulatory authori-
ties. The model, which is based upon a set of Essential Principles
of Safety and Performance, is closely aligned with the European
medical device regulatory framework.
The GHTF soon will be replaced by the International Medical
Device Regulators Forum (IMDRF), created in February 2011 to
discuss future directions in medical device regulatory harmonisa-
tion. In contrast to the GHTF, membership is limited to representa-
tives from medical device regulatory authorities; however, IMDRF
may permit nonregulator stakeholders to join working groups.
Fortunately, IMDRF has stated that it will develop a formal strat-
egy for the management and maintenance of GHTF documents.
Therefore, proposed documents, such as the ones discussed in this
article, should be made final either under the GHTF during a tran-
sition period or under the responsibility of the IMDRF. Additional
information on this organisation can be found at www.imdrf.org.
Guidance on key denitions and concepts
The proposed document, Clinical Evidence for IVD Medical
DevicesKey Definitions and Concepts, dated 16 September 2011,
can be obtained from the GHTF website at www.ghtf.org/sg5/sg5-
proposed.html. As with all three proposed documents discussed
here, the contents could change as a result of comments received
or further deliberations during development of the final document.
Readers should remain alert regarding the issuance of the final
document.
The proposed document provides definitions and explanations
for the following terms:
Clinical evidence of an IVD medical device 0
Scientific validity of an analyte (measurand) 0
Performance of an IVD medical device, including analytical 0
performance and clinical performance
Performance evaluation of an IVD medical device 0
Clinical utility of the IVD medical device 0
Intended use/purpose 0
In addition, it attempts to illustrate, with a figure consisting of
two overlapping circles, that scientific validity and clinical perfor-
mance are common elements of clinical evidence and clinical utility.
For example, clinical evidence of an IVD medical device is
defined as all the information that supports the scientific valid-
ity and performance for its use as intended by the manufacturer.
The term performance evaluation of an IVD medical device
is defined as the assessment and analysis of data to establish
or verify the performance of an IVD medical device. The pro-
posed document also explains that performance evaluation data
are typically generated from verification and validation stud-
Manufacturers of IVD devices should be aware of three proposed Global Harmonization Task Force
guidance documents on clinical evidence for IVD devices. The documents cover definitions and
terminology, determining scientific validity, performance evaluation and clinical performance studies.
Proposed Guidance on IVD
Clinical Evidence and Performance
Evaluation
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REGULATIONS AND STANDARDS
ies (including, where appropriate, clinical performance studies
using human specimens) or obtained from a literature review that
confirms the performance characteristics of the product. This
explanation is particularly useful in clearly placing clinical perfor-
mance studies using human specimens within the scope of valida-
tion studies. It is also consistent with the requirements specified in
the In Vitro Diagnostic Medical Devices Directive (IVDD; 98/79/
EC). That is, the conformity assessment procedures of the IVDD,
such as Section 3, indent 11 of Annex III, specify that performance
evaluation data should originate from studies in a clinical or
other appropriate environment or result from relevant biographi-
cal references.
Scientic validity and performance evaluation
The proposed document, Clinical Evidence for IVD Medical
Devices - Scientific Validity Determination and Performance Evalu-
ation, dated 16 September 2011, can be obtained from the GHTF
website at www.ghtf.org/sg5/sg5-proposed.html. The purpose of
the document is to provide guidance on how to collect and docu-
ment clinical evidence for an IVD medical device as part of the
conformity assessment procedure before placing the device on
the market, as well as to support its ongoing marketing. It is also
intended to provide guidance to regulators and others when assess-
ing clinical evidence provided by manufacturers.
The principal areas covered in this document are: definitions,
general principles of clinical evidence, scientific validity determina-
tion, performance evaluation (including analytical performance
and clinical performance) and clinical evidence report. Appendix A
provides a possible format for a literature search report. Appendix
B includes a flow chart illustrating possible methodology for docu-
menting, screening and selecting literature within a literature search
report. The definitions provided in the document, such as diagnos-
tic sensitivity, diagnostic specificity, examination and others
are consistent with the European harmonised standard, EN ISO
18113-1:2011, In vitro diagnostic medical devices - Information
supplied by the manufacturer (labelling) - Part 1: Terms, definitions
and general requirements (ISO 18113-1:2009).
Section 5.0, General Principles of Clinical Evidence, provides
useful concepts regarding clinical evidence and its importance
and also information on methods for generating and document-
ing clinical evidence for an IVD medical device. For example, the
section points out that gathering information to support clinical
evidence begins during the research process for the IVD device,
consisting of two major phases: identification of the scientific
validity of the analyte (measurand) and the performance evalua-
tion of the device.
A flow chart in this section provides an overview of the stages
involved in assessing clinical evidence. Section 6.0, Scientific Valid-
ity Determination, discusses when it is necessary to determine
scientific validity, the potential sources upon which to base scien-
tific validity and important principles in the appraisal and analysis
of scientific validity information.
Performance evaluation
Section 7.0, Performance Evaluation, of the proposed document
on scientific validity determination and performance evaluation,
places IVD medical devices into three categories: established and
standardised tests, established and nonstandardised tests, and novel
tests, referring to these categories when providing guidance on the
type of analytical performance data, and, where appropriate, clini-
cal performance data that should be generated. Section 7.1, Ana-
lytical Performance, explains that analytical performance, namely
technical test performance, generally using human specimens, is
always expected for IVD medical devices. The document states
that analytical performance data may include data to demonstrate
accuracy (trueness and precision), analytical sensitivity, analytical
specificity, linearity, limit of detection and limit of quantitation,
cut-off, measuring range, carry-over, determination of appropriate
specimen collection and handling and endogenous interference on
assay results.
The guidance provided in Section 7.2, Clinical Performance,
is analogous to guidance on clinical evaluation 1
,
2 applicable
to medical devices other than IVD medical devices. The section
begins by stating that for many IVD medical devices, clinical
performance data typically would not be expected, such as for
established and standardised tests and assay migration between
instruments that meet certain criteria. It may be required for
established and nonstandardised tests and typically required for
novel tests. In addition, for high-risk IVD medical devices, design
changes that may affect the performance claims of the device
also may require clinical performance studies. Another important
point is that clinical performance only should be conducted once
the analytical performance of the device has been established and
determined to be acceptable. The potential sources of clinical
performance data can be derived from clinical performance stud-
ies, literature and experience gained by routine diagnostic testing.
Each of these data sources is discussed in this section; however, a
separate guidance document has been developed for clinical per-
formance studies and is discussed next. Once clinical performance
data have been identified, the data must be appraised to deter-
mine the relevance and quality to address questions about the
IVD medical device and the datas contribution to demonstrating
the devices clinical performance. A clinical performance analysis
collectively evaluates all of the appraised information, in terms of
weight and significance.
Clinical performance studies
The proposed document, Clinical Performance Studies for In
Vitro Diagnostic Medical Devices, dated 26 January 2012, can
be obtained from the GHTF website at www.ghtf.org/sg5/sg5-
proposed.html. It begins by stating that the purpose of a clinical
performance study is to validate aspects of IVD medical device
performance, which cannot be determined by analytical testing, lit-
erature or previous experience gained by routine diagnostic testing.
A discussion of all sections of the document is beyond the scope of
EMDT1207 012 12 7/12/12 5:13:43 PM
this article; however, three are discussed below.
Section 6, Clinical Performance Study Design Type, discusses
the types of clinical performance study designs as observational
or interventional. An observational study refers to a study in
which test results are not used for patient management and do
not impact treatment decisions. Interventional studies are those
in which test results may influence patient management decisions
and may be used to guide treatment. An observational study is
further characterised as having a single time-point, longitudi-
nal, retrospective or prospective design. Readers should refer to
the proposed document for a full description of these types of
designs. The proposed document also lists several practical exam-
ples of each type.
Section 7, Clinical Performance Study Design Considerations,
discusses the effect that the test purpose, such as diagnosis, screen-
ing or monitoring, will have on the study design, such as sample
size. This section also discusses the use of different types of samples
in clinical performance studies, including purposefully-collected,
leftover and archived specimens. Other parts of this section provide
guidance regarding site location, statistical design, potential risks
and ethical considerations, including informed consent and ethics
committee involvement.
Section 8, Clinical Performance Study Protocol, provides a
useful list of important information that should be provided
regarding study design such as: purpose, objectives, study popula-
tion, description of test method(s) and interpretation of results,
site training and monitoring, specimen type, specimen collection,
preparation, handling and storage, inclusion and exclusion criteria,
limitations, warning and precautions, data collection/management,
data analysis, required materials and number of study sites.
Word of caution
The content of the GHTF IVD medical device proposed docu-
ments discussed in this article could change before publication as
final documents. Nonetheless, even as proposed documents, they
provide useful interpretations concerning important principles and
concepts that are consistent with European regulatory expectations
regarding IVD performance evaluation data. Manufacturers using
these proposed documents, and eventually their final versions, in
their efforts to meet European requirements will need, however, to
always base their actions on the laws and regulations in member
states which transpose the requirements of the IVDD, European
harmonised standards, relevant European guidance documents
when they become available and the results of any consultations
with Notified Bodies or competent authorities. 1

References
1) Global Harmonisation Task Force, Clinical Evaluation (May 2007),
www.ghtf.org/sg5/sg5-final.html
2) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies
(MEDDEV 2.7.1 Rev.3, December 2009); http://ec.europa.eu/enterprise/
sectors/medical-devices/files/meddev/2_7_1rev_3_en.pdf
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INDUSTRY PERSPECTIVES
C
ardiologist and inventor of the
iPhone ECG, Dave Albert, MD,
describes it as a big deal.
Celebrity cardiothoracic surgeon Meh-
met Oz, MD, calls it a complete para-
digm shift, the cardiology equivalent of
landing a man on the moon.
For cardiologist Eric Topol, MD, of
Scripps Health (San Diego, CA, USA), it is
nothing short of life changing.
It is probably one of the biggest new
product launches in the cardiac device
space since drug-eluting stents, says
Venkat Rajan, Industry Manager for Frost
& Sullivans medical device team in North
America.
It is transcatheter aortic valve replace-
ment (TAVR), also known as TAVI
(transcatheter aortic valve implantation).
Available in Europe since 2007, the tech-
nology currently is only available to US
patients with severe aortic stenosis who
are deemed inoperable. That is changing,
as a much broader patient population
becomes eligible for the procedure.
TAVR is indeed a game-changer,
says James Beckerman, MD, cardiologist
at Providence St. Vincent Heart Clinic
(Portland, OR, USA). It is maybe not [the
cardiology equivalent to] landing a man
on the moonthat will be the day we fig-
ure out how to prevent aortic stenosis. But
in the meantime, TAVR will help more
patients with critical aortic stenosis to live
longer, fuller lives.
Much of the enthusiasm is based on
the fact that inoperable critical aortic
stenosis was thought to be untreatable
for decades.1 In aortic stenosis, calcium
deposits hinder the opening of the hearts
aortic valve. Having aortic stenosis is
like standing on a plateau that is get-
ting smaller with time, Beckerman says.
As it becomes more severe, any wrong
moveor any move at all once it becomes
criticalsets you up for a long fall [from
which it] is hard to recover.
The problem is huge. Aortic stenosis is
the most commonly diagnosed heart valve
conditionroughly 300,000 patients
worldwide have been diagnosed with the
disease, about one-third of whom are not
eligible for open-heart surgery. More than
half of patients diagnosed with the disease
die within two years, says US FDA.
Standard treatment for severe aortic ste-
nosis is surgical aortic valve replacement
(AVR). The procedure typically takes
between six and eight hours and patient
recovery time can last months.
By contrast, TAVR can be performed
in an hour or two and patient recovery is
typically a matter of days. Still, the clinical
potential is uncertain. My concerns are
that we dont know where to draw the line
(such as in younger patients) and that it is
a very expensive procedure approximat-
ing the cost of open-heart surgery, Topol
adds. I would have been even more excited
about TAVR if this great innovation also
dramatically cut the cost of replacing the
aortic valve, he says. Maybe someday?
A short history of TAVR
The idea of minimally invasive valve
replacement dates back to the late 1980s.
In 1989 at an interventional meeting in
the United States, Danish cardiologist
Henning Rud Andersen, MD, claimed
that heart valves could be implanted in a
closed-chest procedure. After returning
to Denmark, Andersen developed a valve-
stent device with metal wire and pig valves
from a butcher shop. He used the device in
a pig to demonstrate the feasibility of the
technique, and ultimately performed more
than 40 valve-replacement procedures per-
cutaneously in animals. The technology
ultimately ended up benefiting his father,
who had a transcatheter valve implanted.
The next TAVR breakthrough came
when renowned pediatric cardiologist
Philipp Bonhoeffer, MD, performed the
first human percutaneous heart valve
implantation in a 12-year-old patient in
After being on the market in Europe for several years, transcatheter aortic valve replacement (TAVR) is
ready for takeoff in the United States. Questions remain, however, about its ultimate global market potential.
Brian Buntz
TAVR: Still the Next Big Thing
in Cardiology?
Edwards Sapien transcatheter heart valve.
EMDT1207 014 14 7/12/12 5:15:26 PM
France (although this procedure involved
the pulmonary rather than aortic valve).
The first transcatheter aortic valve replace-
ment was performed on a human patient in
April 2002 in Rouen, France, by interven-
tional cardiologist Alain G. Cribier, MD.
Edwards sets sights on TAVR
Intrigued by the technologys potential,
Edwards Lifesciences (Irvine, CA, USA)
became one of the first companies to pur-
sue the commercial development of a per-
cutaneous aortic valve. Shortly after the
company was spun out of Baxter in 2000,
the firm launched a small internal R&D
project known as Patriot to investigate its
potential. A couple of years later, Edwards
learned of an Israeli startup, Percutaneous
Valve Technologies (PVT), cofounded by
Cribier, that was closer to commercialising
TAVR than it was. Edwards bought PVT
in 2004, and launched its TAVR device in
Europe in the spring of 2007.
Medtronics CoreValve connection
Medtronic also had launched an internal
programme to develop percutaneous heart
valves and sought to accelerate commer-
cialisation of the products through acquisi-
tion. In 2009, the company acquired two
TAVR firms: CoreValve (Irvine, CA, USA),
for US$700 million, and Ventor (Netanya,
Israel), for US$325 million. CoreValve,
which was initially founded in Paris in 2001,
was a venture capitalbacked company that
had launched a self-expanding nitinol-frame
TAVR platform in Europe in the spring of
2007. Ventor, which was founded in 2004,
had been developing an aortic replacement
valve known as Embracer that can be deliv-
ered through the transapical approach as
well as a percutaneous, transfemoral tech-
nology called Engager.
Although Medtronic ultimately spent sig-
nificantly more on the acquisition of Core-
Valve than Edwards spent on PVT, both
companies got a fairly good deal, Rajan
says. Edwards move in 2004 was probably
a little riskier because the market wasnt
talked about as much at that time, he says.
[No one] realised that this market was
going to be as big as it is and have [such]
potential, he adds. Edwards got into the
market early at the right price. Once buzz
started building and it was less of a risk,
Medtronic had to pay a little bit more but [it
is] on the market in Europe and should be
second to market in the United States.
The CoreValve device features a sub-
stantially different design than the Sapien,
although it is implanted in a similar
manner. The CoreValve is self-expanding
whereas the Sapien has a balloon-based
expandable design.
Rajan does not view being second
to market as a major disadvantage for
Medtronic, especially when you consider
its presence in the cardiovascular market-
place. Medtronic is equated with cardiac
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INDUSTRY PERSPECTIVES
Their new Resolute stent has had some
strong ground game. They obviously have
their pacemakers and ICDs, as well,
Rajan adds. Unless Edwards has some
kind of safety issues, it should hold the
top share, but Medtronic should pick up a
good chunk, he says. Both Edwards and
Medtronic are highlighting transcatheter
valves as flagship opportunities for the
next five years and outward.
TAVR on the global stage
The potential is high for TAVR adoption
in emerging markets, according to Rajan.
It is, however, coming in at a higher
price point than traditional valves, Rajan
says, which might limit adoption outside
of Western Europe, Japan and the United
States. But, over time, you can definitely
have significant utilisation outside of those
geographies, he adds.
The relative ease of use of TAVR prod-
ucts bodes well for their global adoption.
It is an interventional approach that is
pretty straightforward, so [it could be
performed] by an interventional cardiolo-
gist or cardiac surgeon or even some other
interventionist, Rajan says. In some of
these emerging markets, where they may
not have full cardiac surgery capabilities,
you could see a technology leap.
The largest share of the TAVR market
currently is in Europe and is controlled
by Edwards Lifesciences and Medtronic,
although a number of other companies are
vying for market share. As many as 30%
of European patients with aortic stenosis
are treated with TAVR, according to Keith
Dawkins, MD, Global Chief Medical
officer for Boston Scientific. The Millen-
nium Research Group (MRG) predicts the
European market will grow at just under
20% per year through 2015. Germany
boasts the largest number of TAVR pro-
cedures; because it is a maturing market,
MRG estimates that growth will hover
around 12% through 2015. By contrast,
the TAVR market in France is expected to
grow at an average rate exceeding 30% in
the next few years. There were restrictions
on the use of TAVR in France, resulting in
pent-up demand among eligible patients.
Sapien and CoreValve technologies,
both of which debuted in Europe in 2007,
are the most mature TAVR technolo-
gies. Edwards Lifesciences launched the
second-generation Sapien XT valve in
Europe in early 2010. That product was
developed to treat a wider patient group
and to reduce vascular complications; it
features a lower-profile delivery system
than the first generation of the device. The
valve also is being investigated in the first
TAVR clinical trial in Japan.
TAVRs new frontier
The United States represents TAVRs
next conquest. Investment banking
firm Canaccord Adams estimates
that the US transcathether valve
market could be worth US$2.5
billion. At present, Edwards
Lifesciences has a lock on the
US market, as its first-
generation Sapien device
is the only TAVR prod-
uct approved by US
FDA, although
it has only
been indicated
for a subset of
patients. Medtronic
anticipates receiving
US FDA approval for
CoreValve in 2014. The
regulatory agency first
approved Sapien in November 2011, when
it cleared the way for its use via transfem-
oral delivery in inoperable patients with
severe symptomatic aortic stenosis.
US FDAs decision to approve the Sapien
device could substantially open the market
for TAVR, assuming that the indications
for use continue to expand. By Edwards
estimates, the US market for these devices
could be as high as 100,000 patients per
year.
Of note is the fact that, when Sapien
was first approved for commercial use in
the United States, the device was already
available in 41 countries, including most
of Europe. US FDAs decision to approve
the device boosted Edwards transcath-
eter valve sales 67% in the first quarter
of 2012 to US$122 million, according to
Michael Mussallem, chairman and CEO.
2
The legal and competitive landscape
Medtronic and Edwards have been bat-
tling one another in the courts, with each
side accusing the other of patent infringe-
ment related to TAVR. Patent litigation
is standard for the cardio market, Rajan
says. If you look on the stent side and
even at implantable defibrillators, patent
litigation is a common competitive tool
that these companies use.
Another consideration for both Sapien
and CoreValve is the steep learning
curve for physicians. A study at
the Mayo clinic reported that
physicians may need up to
30 procedures before they
achieve proficiency.
Valve positioning
depends largely
on the physician,
and the valves are not
repositionable, which
makes optimal positioning of
the devices critical. In addition, the two
devices also are susceptible to paravalvu-
lar leaks after implantation. Boston Scien-
tific hopes to address those issues with its
Lotus valve, which is designed to minimise
aortic leaking and is both fully reposition-
able and retrievable prior to release.
Also competing in the European market
are the German firm JenaValve Tech-
nology and Swiss-based Symetis, both
of which received a CE mark for their
TAVR products in late 2011. Other play-
ers looking to enter the market include
Direct Flow Medical and Heart Leaflet
Technologies. Medtronic is also readying
its Engager device to expand its European
product portfolio. Some of the smaller
TAVR players could ultimately be acquisi-
tion targets for big device companies look-
ing for growth opportunities.
Meanwhile, Edwards is working on
Sapien 3, its next-generation balloon-
expandable valve that is designed to reduce
paravalvular leaks. In addition, Edwards
is working on developing a low-profile,
repositionable self-expanding valve that
Medtronics 29-mm
CoreValve device.
EMDT1207 016 16 7/12/12 5:15:39 PM
As more clinical evidence and infor-
mation becomes available on transcath-
eter valves, the procedure probably will
become safer and more widespread.
Rajan predicts that future generations of
TAVR technology will address some of
the glitches of existing products. But,
TAVR wont completely cannibalise the
traditional valve market, he says. If a
patient is healthy enough, ideally he or she
should be getting one of the traditional
valves. Given the dynamics of TAVR in
terms of ease of implantation, however,
it is a significant opportunity, says Rajan.
Editors note: Visit mddionline.com
for the full version of this article, which
includes a section on the decision by the
US Centers for Medicare and Medicaid
Services to cover the Sapien device.
References
1.http://www.nejm.org/doi/full/10.1056/
NEJMc1108223.
2. http://seekingalpha.com/article/524551-edwards-
lifesciences-corporation-s-ceo-discusses-q1-
2012-results-earnings-call-transcript.
Brian Buntz
is Editor at Large of EMDT sister publication MD+DI
makes use of a motorised delivery system
to enable deployment by a single clinician.
Other players looking to enter this
market include St. Jude Medical, whose
Portico valve has been generating some
buzz. Boston Scientific is another inter-
esting competitor because it wasnt in the
traditional valve segment, adds Rajan.
They saw this as enough of an opportu-
nity that they made some strategic acqui-
sitions, and they have a product that is
being evaluated.
At present, US FDA has approved
TAVR only for patients with severe aor-
tic stenosis who are deemed inoperable.
On 13 June 2012, the agencys Circula-
tory System Devices Panel voted 110
to expand the indication for the Sapien
to include high-risk patients with severe
aortic stenosis who are deemed suitable
for surgery. One panel member abstained
from voting. In addition, the panel voted
102 that the device is safe and 120 that
it is effective. As a result, Sapien probably
will be given the go-ahead for patients
who are at high risk for surgery. The
broader indication for high-risk patients
would enable clinicians to have more flexi-
bility with respect to delivery of the device
and, for the first time, enable transapical
delivery in addition to the current femoral
approach.
The future of TAVR
Future generations of the devices must
address risk of strokes, vascular complica-
tions and aortic insufficiency, which were
side effects for some patients implanted
with early versions of the valves. In addi-
tion, questions regarding the valves dura-
bility compared with those implanted by
open-heart surgery must be answered.
The TAVR market is likely to be strong
in the long term, potentially outpacing
demand for other cardiovascular products
such as stents, balloons and pacemakers.
I think it definitely is a strong long-term
opportunity, Rajan says. You have all
of these factors that are well profiled in
terms of the addressable patient popula-
tion who currently are not qualified for
valve replacement.
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EMDT1207 017 17 7/12/12 5:15:46 PM
SPECIAL REPORT
T
he way we develop medical devices
is changing now, not later. Brace
yourself. The view from your desk
is going to change dramatically.
You will have a new boss as a genera-
tional change sweeps in a new breed of
executives.
You will not recognise the people sitting
next to you, nor understand what they are
talking about, as biologists, economists,
software developers and medical doctors
join your work team.
Your desk and its files will be moving
online into a world of virtual meetings and
shared documents.
Cost, co-location, collaboration and con-
vergence are the themes that will dominate
the re-engineering of medical technology
and the ways that you work.
Consider this vision of the future: Your
next meeting will be with a robot. Mov-
ing beyond tele-conferencing, colleagues
from distant work sites will visit by
tele-porting into a robot.
Think of it as Skype on wheels,
says Daniel Kraft, MD, who chairs
the medicine track for Singularity
University. You can beam your-
self into an office as a virtual
visitor, interacting with people
on your work team.
Dr. Kraft is more comfortable
than most at embracing
such startling changes to
work lifehe leads
graduate studies
on disruptive
technologies at Singularitys campus based
at the NASA Research Park in the heart of
Californias Silicon Valley.
This is more than looking someone in
the eye to know what they are thinking,
he says, suggesting that with the sensing
capabilities for vital signs already available
in smart phones, the robot visitor could
know exactly how you feel about the pro-
posed changes to a project by monitoring
your breathing and heart rate.
Blueprint for the future
Now, lets beam down to the new GE
Healthcare facility in Buc, France.
At its peak 130 engineers were working
on the project. The development centre
dedicated to this single programme covers
15,000 square feet in a renovated airplane
hangar built by Gustave Eiffel at the turn
of the century.
The investment in the workspace cost
8 million for the renovation alone, which
is not included in the total 18 million
cost of the project.
This is change on a large scale, a mas-
sive effort for co-locating diverse teams
centred on the redesign of a medical
imaging system that began rolling off the
production line in May 2012.
The company promotes the new system
as a way for surgeons to re-invent the
way they work. Behind the scenes, the
re-engineering of the Discovery IGS 730
is a landmark case study in how medical
technology companies can reinvent the
ways that they work.
Teleporting into meetings, collaborating with economists, learning frugal engineering . . .
welcome to the future of medtech development and manufacturing.
John Brosky, Contributing Writer, Paris
Re-engineering Medical Technology
from Top to Bottom Line
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EMDT1207 018 18 7/10/12 4:57:40 PM
At the recent European Connectathon
in Bern, Switzerland, a five-day marathon
for testing the interoperability of medi-
cal devices with health IT, another major
player, Abbott Diagnostics, was putting its
OneLab system through the paces.
This new laboratory IT solution combines
innovative tools for high-volume laboratories
to turn results from in vitro diagnostic tests
into reportable results for clinicians.
The lead software engineer from Abbott
says that his group does not interact
directly with colleagues in biology and
chemistry but that increasingly the design
briefs show the impact of these sciences.
It depends on where you are in the
hierarchy of your organisation, he says,
preferring to stay anonymous within that
hierarchy.
We are not yet at the event horizon
where software meets biologywe still
have a layer or two protecting us, he
says. But this is happening for more and
more software teams.
Meet the new boss
It is easy to get lost on your way to the
future. Its fun to talk about, but it can
True to the finest tradition in medical
technology, the programme began with
an idea from an engineer: why not slide a
motorised base under the gantry of the com-
panys high-end Innova imaging system used
to guide complex interventional surgeries?
Spurred by fierce competition from Sie-
mens and Philips to build hybrid operating
rooms, GE Healthcare put its formidable
strength behind the idea.
In less than two years, the project was
completed and presented to customers at
the meeting of the Radiology Society of
North America in November 2011. The
system received 510(k) clearance from US
FDA in February 2012, and is expected
to receive a CE mark for commercialisa-
tion in Europe once the production line is
certified this summer.
Discovery IGS 730 differentiates the GE
Healthcare offer to hospitals by breaking
the paradigm of fixed imaging systems for
surgery that are anchored to the floor or
hung from the ceiling.
Here is a massive gantry that glides into
position when needed and parks itself in a
corner when an interventional procedure
needs to be converted to open surgery.
Twelve patents were filed in the process
of development and 31 permanent full-
time employees were hired, staying on to
generate more products.
Lifting the roof on the erstwhile air-
plane hangar, which GE Healthcare has
named AgiLabs, reveals a workspace of 11
development labs that feature key elements
for the future of medtech.
Industrial partners moved teams into the
new development facility. Experts in robot-
ics and holonomic laser guidance systems
from prestigious academic institutions were
given desks in dedicated lab spaces. And
customers were invited to participate in the
development process with surgical teams
flown in from around the world to recreate
procedures on phantoms in what is called
the Validation Lab, which looks and feels
like an operating theatre.
Merging traditional medtech with new
teams of actors is affecting not only the
heavy metal of radiology but the more fluid
sphere of biomedical engineering, as well.
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SPECIAL REPORT
make your head spin. Usually someone
ends the blue sky talk by bringing everyone
back to Earth with a practical reminder
that medtech is all about making money.
In fact, the business of medical technol-
ogy is a great starting point for under-
standing the changes shaping the future
medtech space.
Making money is the first item on the
to-do list for the new boss, according to
Ulrika Hagle with Korn/Ferry Interna-
tional, who searches the world for new
executive talent to lead medical technology
companies.
There is a massive shift in recruiting
today to find people who can instil a bot-
tom-line focus for companies, says Hagle
in a call from Singapore. Today, all CEO
recruitment is about the bottom line.
We are seeing a generational change,
she notes. For years medical technol-
ogy companies were used to double-digit
sales growth and high margins. That has
slowed to low single-digit growth and this
translates into companies recognising the
need to act differently. The work culture
needs to change in fundamental ways, and
this is happening now.
Managers who are technical experts
with a top-line focused on driving sales are
giving up their desks to executives who are
change agents, who can instil a bottom-line
focus, and who are true marketers lead-
ing the company into new opportunities in
emerging markets, especially in Asia.
The pressure is coming from the cus-
tomer, hospitals that have shifted from
being clinical to financial buyers. Products
that used to be sold directly to surgeons or
physicians are now purchased by procure-
ment groups and hospital committees.
The more the product is commoditised,
the higher the price pressure, says Hagle.
Market dynamics are forcing the new
CEOs to reassess products in a new light,
challenging research and development on
planned product features.
They have to ask if a product really
needs all the bells and whistles the com-
pany can offer, not only from a users
point of view, but under the scrutiny of
health economics, she says, suggesting
that maybe they can build a Rolls Royce,
but perhaps all that is needed is a Ford.
The move towards emerging markets
will force a streamlining of product design
with fewer sophisticated features, and will
encourage companies to develop a globally
more homogenous product line.
Working with a new cast of
characters
In the new world of health technology
economic assessments, cheaper is not the
only answer.
New products from R&D can shoot
for higher standards as long as that prod-
uct can measure up against increasingly
demanding requirements, according to
Joerg Vienken, Vice President for Bio-
Sciences at Fresenius Medical Care.
Higher quality is related to a higher
price, he says. But winning that price
brings new kinds of actors into the space,
ones we might not be thinking about yet,
such as quality managers.
Franois Berger, MD, says he regrets
overlooking these new actors when plan-
ning the new Clinatec centre that opened
in Grenoble, France, in December 2011.
A professor of oncology at Grenoble
University Hospital, Berger is also Direc-
tor of Clinatec, which he describes as a
unique conjunction of technologists and
engineers, biologists and practitioners.
Dedicated to creating highly innova-
tive nano-devices for diagnosing and
treating neurological disorders, the new
50,000-sq-ft facility is fully powered
with high-end imaging systems, multiple
development labs and a fully accredited
operating room. It brings together teams
of experts from diverse sciences.
Yet if he had to do it all over again, Berger
says he would bring in more bureaucrats.
We underestimated [the need for]
participation early in the process of
regulatory expertise, medico-economic
assessment, quality control and quality
management, he says.
Increasingly, including these capabilities is
crucial to de-risk medtech projects, he adds.
Just because a product is innovative,
even if we have validated the project
preclinically, it is not necessarily going to
be welcomed by a large medical device
company, says Berger, unless the devel-
oper can show a regulatory pathway and
make a case for reimbursement.
Another player who needs to be involved
early on when developing new medical tech-
nologies is the customer, he says.
The traditional medtech model no
longer works, he says. We are successful
at developing products from a technical
point of view. We know how to get the CE
mark. But without the involvement of doc-
tors, these products [will be] missing a lot
of elements needed in the clinic.
As a result, many projects are being
financed for development in Europe but
few deliverables are validated and have
an industrial value, says Berger. The
problem is that these devices are funded
for a prototype but are not financed for
preclinical development and are poorly
adapted to medical reality.
Now, its personal
The million-dollar research work in
medtech has always seemed like the poor
cousin to the billion-dollar efforts in the
pharmaceutical industry.
Yet, as medical treatment becomes
more personalised, the two industries are
converging.
There are already examples of this bio-
tech-medtech fusion. In the well-funded
The profound impact of companion in vitro
diagnostics, combining microuidics with
chemistry and biology on lab-on-chip devices,
has now altered the course of drug development.
EMDT1207 020 20 7/10/12 4:57:57 PM
field of oncology, we have seen biomark-
ers that illuminate a tumour to facilitate
a biopsy performed with medical devices.
And nanoprobe devices are being devel-
oped to deliver pharmaceutical therapies
to precise locations within the body.
The profound impact of companion
in vitro diagnostics, combining micro-
fluidics with chemistry and biology on
lab-on-chip devices, has now altered the
course of drug development.
We will see more collaborations as the
man-machine interface reaches the cel-
lular and even the molecular levels.
Both Vienken and Berger are focused
on surface interactions, the moment
where man-made materials created by
engineers such as polymers trigger reac-
tions of natural cells and molecular reac-
tions, areas of expertise for biologists.
Another opportunity to adapt medi-
cal devices to the individual needs of
patients circles around the development
of innovative new sensors, according to
Vienken.
We will only be able to manage what
we can measure, and we can only meas-
ure if we have sensors of all kindsfor
blood pressure, allergies, infections or
individual behavioursto identify acute
behaviours, he says.
The market opportunity is enormous,
he adds. As we do not have the people
needed to provide care for a growing
population of elderly citizens, we will
need to support the staff with medical
devices.
This support is only possible if you
have sensing technology, which is con-
nected to a transmission technology, like
mobile phones, says Vienken. This
transmitted data needs to be actionable,
so we need IT, but it cannot be central-
ised, so it needs to be proximate to the
devices. This requires miniaturisation of
electronics. We also need safety controls,
algorithms. It soon becomes a complex
technology. It also complicates the ability
of a co-located, collaborative team to work
together.
There needs to be a shared working lan-
guage. As an engineer, you must be able to
express yourself in a way that a medically
trained person can understand. Jargon and
abbreviations become a barrier to under-
standing, says Vienken. Those companies
who can find a common language among
different disciplines will be successful.
This is a revolution, says Berger, who
acknowledged that putting together a team
of engineers and medical biologists took
two years at Clinatec before they under-
stood each other well enough to accelerate
the work processes.
The future is always a work in progress. 1
John Brosky
is a freelance writer based in Paris covering the medical
technology industry.
Wherever Alla Shankar
builds a new insulin
production facility
MULTIVACs packaging specialists are already there.
In over 140 countries worldwide.
www.multivac.com
EMDT1207 021 21 7/10/12 4:58:00 PM
MATERIALS
Its different for athletes: biomaterials for sports-related orthopaedic applications should have a composition
similar to the bones constituent materials. Ideally, they should stimulate and facilitate regeneration of new
bone and gradually dissolve in the body.
A
thletes, especially those compet-
ing at the Olympic level, are
keenly aware of the damage that
high-intensity training can do to the body,
especially to bones. Novel biomaterials
technology may help fractures to heal better
and faster, thereby helping athletes to renew
their training regimen and sports activity
more quickly.
When it comes to sports-related bone
injuries as opposed to diseased tissues, new
biomaterials should be formulated to serve
as a template, stimulating and facilitating
new tissue growth quickly during the heal-
ing and recovery process. Before looking
at new developments in biomaterials, we
will discuss basic fractures and fracture
mechanics and the fundamentals of bone
deformation at the nano and micro level.
Basic fractures and fracture
mechanics
Figure 1 shows a bone fracture. A force
applied to one side of the bone leads to bone
fracturing. At least two types of stress have
been applied: compressing stress at and
towards the damage point on the left, where
the force is applied, and tensile stress on the
opposite side, which forces the opening of
the fractured bone. Shearing stresses also
contribute to the fracture, as indicated by
the irregular fracture surfaces.
Fracture mechanics recognises three
basic modes of fracture (Figure 2). Mode
I is the opening fracture, mode II is
known as in-plane shearing and mode III
is out-plane shearing. Of the three frac-
ture modes, the most serious is mode I.
Normally, bone-related damage and/or
fractures often involve a combination of
two or three modes, as indicated in Figure
2. In addition, there are different types
of stresses, including tensile, compressing
and shearing forces.
What determines if a bone is going to
fracture or not? The concept of fracture
toughness KIC, in fracture mechanics, is
defined by the following equation:
KIC = [s]
c
(a)
1/2
eq (1)
s
c
is critical failure stress for a given
defect size a. This means that fracture
stress and defect size determine the frac-
ture toughness of a material. Failure stress
in human bone varies approximately from
1.5 MPa.m
1/2
for a weak bone up to 3.5
MPa.m
1/2
or slightly higher for a healthy
strong bone at a normal loading rate rang-
ing from 0.55 to 2.75 MPa.m
1/2
s
-1
(refer-
ence 1). The higher the KIC, the tougher
the bone. Older people tend to have a
lower KIC than younger people.
Defects always exist. However, it is the
largest defect that is a decisive factor for a
Xiang Zhang, Ceram, Stoke-on-Trent, UK
Developing Biomaterials for
Sports-Related Bone Injuries
I
m
a
g
e
:
s
a
i
n
t
h
o
r
a
n
t

d
a
n
i
e
l
/
S
h
u
t
t
e
r
s
t
o
c
k

EMDT1207 022 22 7/10/12 5:01:24 PM
given stress. Defect a in equation (1) also
represents a crack developed from a defect.
Figure 3 plots the maximum defect (or
crack) size as a function of critical stress s
c

applied for a given fracture toughness KIC.
For example, at applied stress of say 100
MPa, a defect greater than 72 m will lead
to failure if a bone has a fracture toughness
KIC of 1.5 MPa.m
1/2
(the blue line in Fig-
ure 3); the other two bones have a fracture
toughness KIC of 2.5 and 3.5 MPa.m
1/2

and are safe (the red and green lines in Fig-
ure 3). They will fracture at a much higher
stress166 and 233 MPa, respectively, at
the same 72-m defect size.
Deformation speed effect on bone
fracture
Bone deformation (Figure 4) is represented
by a typical stress s and strain curve.
Mechanical properties change with defor-
mation speed, shown here in fracture stress;
Youngs modulus, which is defined by the
initial linear slope; and total energy up to
fracture Ec, which is the energy of integra-
tion under the stress and strain curves up to
fracture:
Ec = d eq (2)
Reported failure stresses vary with frac-
ture speed. At a lower speed, bone will not
fracture until stresses above 100 MPa are
reached; at high speeds, fracture could occur
with stresses as low as 50 MPa.2
,
3 In addi-
tion, less total energy is required to fracture
bone at a high speed. Fracture toughness
will have the same effect, i.e., a higher speed
means lower fracture toughness. In sports,
accidents often occur unexpectedly at high
speed. Therefore, any measure that can
lead to a reduction in the impact that speed
causes will greatly and effectively minimise
the probability of bone fracture.
In the following two sections, we will
discuss the fundamentals of time-dependent
behaviours of bone fracture that are relevant
to biomaterials.
Fundamentals of nano and micro
levels of bone deformation and
fracture
The structure of bone has been well docu-
mented. It mainly
consists of two
basic components:
collagen and
hydroxyapatite
(HA) nano crystals.
Collagen is made
up of three poly-
peptide strands,
approximately 300
nm long and 1.5
nm in diameter
(about 1/1000000
the thickness of a
human hair), and
forms aggregates
such as fibrils. HA
is a nano crystal
platelet approxi-
mately 1 to 2 nm
thick, 10 to 50
nm wide and 30
nm long.
4
These
two elements are
the basic building
blocks of human
bone from the nano
and micro to the
macro scale. The
volume fraction of
collagen, assigned
as fc, is given by eq 3:
fc = (- h)/(c-h) eq (3)
where bone, collagen and HA densities are
, c and h, respectively.
Taking collagen density c = 1.19 g/cm
3

(reference 5) and HA crystal h = 3.155
g/cm
3
,
6
the volume fraction of collagen
varies as a function of bone density (Fig-
ure 5). In a typical range of compact bone
density between 1.9 and 2.0 g/cm
3
, col-
lagen is a predominantly continuous phase
acting as a matrix (> 50% by volume). It is
easy to imagine how collagens, which have
a fibre-like structure, and platelet-shaped
HA are organised. HA crystals are densely
packed and, in very large numbers, occupy
the spaces between collagen fibres.
Collagen is an organic polymer (polypep-
tide) with visco-elastic properties, a unique
Force
Mode I
opening
Mode II
in-plane shearing
Three fracture modes
Mode III
out-plane shearing
50
0
0.4
0.8
100
M
a
x
i
m
u
m

d
e
f
e
c
t

(
m
m
)
Fracture stress (MPa)
Fracture toughness KIC (MPa.m
1/2
)
150 200
= 1.5
= 2.5
= 3.5
Figure 3: The maximum defect (or crack) size is plotted as a function of critical
stress s
c
applied for a given fracture toughness KIC.
Figure 2: There are three basic modes of fracture; bone-related damage often
involves a combination of two or three of them.
Figure 1: In the bone fracture shown here,
compressing stress (left) combines with tensile
stress on the opposite side.
EMDT1207 023 23 7/10/12 5:01:34 PM
MATERIALS
characteristic of polymeric materials. This
structure determines the time-dependent
fracture behaviourthe higher the speed of
an accident, the more brittle the bone frac-
ture. This is critical to determine whether
or not a bone is tough and strong. A higher
proportion of collagen in a bone means
greater toughness. On the other hand, HA
is a rigid filler, providing bone with the
required stiffness and strength. In 1 mm
3
of
bone, there can be 200 million to 1 billion
nano HA platelets, which are individually
distributed within the collagen matrix. It
is clear that all mechanical property varia-
tions are rooted in deformation and frac-
ture of collagen fibres and HA at the nano
scale first and then at the micro and mil-
limetre scales. Collagen plays a dominant
role with the capacity to deform at much
larger scales than HA. Importantly, col-
lagen fibres sharing deformation, as most
polymers do, determine the fracture tough-
ness of the bone. In sports injuries, the
damage and fracture of the bones nano and
micro structures are predominantly relevant
to collagen, and HA is of secondary impor-
tance. This is different from other diseased
bones. A fundamental understanding of this
will guide future development of biomateri-
als for sports injuries.
Development of new biomaterials
Having discussed the basic nano and micro
structure of collagen and HA and mechani-
cal and fracture
mechanical proper-
ties, the question is
what kind of bio-
materials are best
suited to attend to
the biological needs
of sports injuries?
Biomaterials
for sports injuries
should be formu-
lated differently
than materials for
diseased bones.
Ideally, the bio-
materials can act
as templates and
stimulate and facil-
itate regeneration
of new bone. A
formulation should
have properties
and a composi-
tion similar to the
bones constituent
materials. Addi-
tionally, the new
biomaterials should
be bioresorbable,
acting as a tem-
plate that gradually
dissolves in the
body. (Permanent
replacements were
discussed in a previous publication.)
7
Collagen fibres are the key materials
that are predominantly damaged in sports
injuries. Therefore, the new biomaterial
system should contain at least a biopoly-
meric material that will serve as a template
for the required mechanical properties
and be able to induce and facilitate col-
lagen regeneration. In addition, the system
should be able to promote new HA forma-
tion and new collagen regeneration. For
example, a combination of polyester, such
as poly(-hydroxy acids), and calcium
phosphate can do the job (this does not
preclude the use of other suitable materi-
als). Polyesters are commonly used biode-
gradable materials that act as a template
for collagen; appropriate calcium phos-
phates are also highly bioactive, which
facilitates new HA formation.
One other important materials factor to
consider is control of the speed of biore-
sorbable processes, bearing in mind the
regeneration speed of biological collagen
and HA. This requirement is based on the
fact that different people (bone density
and age variations) have different injuries
and, thus, need different healing mecha-
nisms. Controlling the speed at which the
new biomaterials work, with the requisite
bioactivity, is an important materials factor
to consider when developing biomaterials
for sports injuries and other orthopaedic
applications.
One option is to employ water soluble
bioglass (also called bioresorbable glass).
1.85
50%
60%
70%
1.9
C
o
l
l
a
g
e
n

v
o
l
u
m
e

(
%
)
Compact bone density (g/cm
3
)
1.95 2
0
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0.5
P
e
r
c
e
n
t
a
g
e

r
e
l
e
a
s
e
d
Time (hour)
1 1.5 2 2.5 3 3.5
Long term release
Short time release
Figure 5: The contribution of collagen by volume varies as a function of bone
density.
Figure 6: Water-soluble bioglass degradation and release of active ingredients
can be precisely controlled by means of formulation design.
(%)
(
M
P
a
)
High speed
Slow speed
Figure 4: Bone deformation is represented by a
typical stress s and strain curve.
EMDT1207 024 24 7/10/12 5:01:40 PM
The first generation of bioglass developed
in the late 1960s by Larry Hench proved
to be both biocompatible and bioactive.
Since then, many types of bioactive glasses
have been developed; indeed, this is still
an important research area even today.
Here the main concerns are the control of
bioresorbable speed at use. New inorganic
controlled release technology (CRT) has
recently been developed at Ceram, which
is based on water soluble glass technology.
Figure 6 is an example of this technol-
ogy that demonstrates the water soluble
bioglass degradation (and, at the same
time, release of the active ingredient) that
can be controlled precisely through for-
mulation design. In reality, water soluble
bioglass of this kind can be made with a
half-shelf life of minutes to months to suit
different needs in medical applications.
Further development of the new inorganic
CRT will make it possible to develop a
series of biomaterial systems that can be
tailored to individual needs for sports
injuries, taking into consideration that
sports injuries need different treatment and
healing processes.
Since 1969, HA has been one of the
most important biomaterials for medi-
cal applications. Increasing the bioactive
properties of HA can speed up the healing
process for sports injuries. A new tech-
nology has been investigated at Ceram
to substitute different elements (in pairs
or greater than two) into the HA crystal
structure (mx-HA). This new technol-
ogy makes it possible, at least, to change
HAs surface charge potential and surface
characteristics. A series of new HA-based
biomaterials with substituted elements in
its crystals, with surface properties and,
therefore, biological properties that are
different from pure HA, have been syn-
thesised. In one example, the mx-HA has
demonstrated greater bioactivity than pure
HA.
8
Taking advantage of the more bioac-
tive mx-HA, it is now possible to formu-
late biomaterials that increase the speed of
HA regeneration as well as collagen and
optimise outcomes for sports injuries and
other medical needs.
In summary, the goal is to develop new
biomaterials for sports injuries and simi-
lar applications in order to help the body
regenerate new healthy tissue. A fundamen-
tal understanding of mechanical properties
and fracture mechanics and the nano and
microstructure of collagen and HA-based
materials is key to new biomaterials devel-
opment. In addition, a combination of
new bioresorbable inorganic CRT, such as
water-soluble bioglass, and biopolymers to
stimulate collagen growth, will be benefi-
cial in helping new HA crystal grow into
the collagen fibre matrix and, thus, accel-
erate the healing of bone-related sports
injuries.
A lot of work remains to be done in
this area, but it is hoped that bone-related
fractures, in the future, will heal more
quickly and more effectively, and help
athletes return to training in record, if not
Olympic, time. 1
References:
1. ASTM E399 Standard Test Method for
Plane-Strain Fracture Toughness of Metallic
Materials.
2. R. Simpson, J.D. Currey, D. Hynd, The Effect
of Strain Rate on the Mechanical Properties of
Human Cortical Bone, J. Biomech. Eng. 130,
1 (2008).
3. A. Ural, et al., The Effect of Strain Rate on
the Mechanical Properties of Human Cortical
Bone, J. Mechanical Behaviour of Biomedical
Materials, 7, 10211032 (2011).
4. C. Burger, et al., Lateral Packing of Mineral
Crystals in Bone Collagen Fibrils, Biophysical
Journal, 95, 4, 19851992 (2008).
5. I. Jager, P. Fratzl, Mineralized Collagen
Fibrils: A Mechanical Model with a
Staggered Arrangement of Mineral Particles,
Biophysical Journal, 79, 4, 17371746, (2000).
6. Ceram materials characterisation results.
7. Xiang Zhang, Advances in Man-Made
Materials for Orthopaedics, OrthoTec, 2, 3
(2011).
8. P. Jackson, B. McCarthy, Advances in
Hydroxyapatite, Med-tech Innovation, 1, 6,
26-28.
Xiang Zhang, PhD, is
Principal Consultant,
Division of Medical Materials and
Devices, Ceram,
Queens Road, Penkhull, Stoke-
on-Trent, Staffordshire ST4 7LQ,
UK | Tel. +44 1782 764 428
enquiries@ceram.com
www.ceram.com/healthcare
Visit www.microlumen.com
to learn more.
One Microlumen Way
Oldsmar, FL 34677 USA
Phone: 813-886-1200
Fax: 813-886-3262
EMDT1207 025 25 7/10/12 5:01:47 PM
MANUFACTURING
T
he ability to produce accurate holes
within tight dimensional tolerances
is an important aspect of medical
device design and manufacture. Numer-
ous methods of hole production exist, with
mechanical drilling, chemical etching and
laser machining among the more widely
used. However, as the dimension of the
hole decreases, the choice of process is more
limited and the interaction of the material
with the hole-forming process becomes
more critical. This article looks at various
hole-drilling methods, and, in particular,
examines the use of laser drilling techniques
to make holes in diameters smaller than 20
m. Issues involving the accurate measure-
ment of small holes and how, as the hole
size decreases, measurement becomes an
increasingly complicated and critical aspect
of process control, are also examined.
Dene small
Traditional methods such as mechani-
cal hole drilling allow for the creation of
features on the order of 50 to 100 m,
which is roughly the diameter of a human
hair. By modern standards, these holes can
no longer be described as small. Refined,
repeatable, high-speed laser processes can
machine holes as small as 1 m in diameter
with specialised configurations, and can
easily drill below the 20-m-diameter mark
in a variety of materials.
Small holes serve a number of purposes
in medical devices. Tiny laser-machined
holes in catheters enable drug delivery. By
carefully tailoring hole density and size, the
infusion of an active drug can be control-
led. As technologies progress and medical
devices become less invasive, it has become
necessary to reduce the size of the features
on these instruments, driving demand for
smaller holes. The challenge lies not only
in the accurate positioning of these features
but in controlling hole dimensions and the
materials being processed.
Small-hole production methods
Mechanical drilling involves the use of a
specially designed drill bit, which rotates in
contact with the workpiece to remove mate-
rial and produce a circular hole. Several fac-
tors make it challenging to drill small holes
using this method. First, the diameter of the
drill bit must be the same size as the hole.
This is difficult to achieve, and the tool is
prone to break during the drilling process.
Ultrahigh cutting speeds also must be used
because of the drills small size, making it
difficult to eliminate vibration during the
machining process. Furthermore, process
repeatability can be short lived as the drill
bit begins to wear. The wear issue also
makes it quite difficult to drill hard materi-
als using this manufacturing process. While
mechanical drilling of holes on a larger
scale is extremely economical for many
materials, it is not necessarily the most
feasible on the micron scale.
Punching is a commonly used method
for the production of holes in thin materi-
als. For this process, a punch and die of
a specific size must be manufactured as a
pair. When the material is located between
the punch and die and pressure is applied,
a hole is produced in the sheet by pressing
out a piece of material, called a blank. This
process can offer high speed, scalability and
repeatability. However, punching may only
be used with certain materials such as met-
als and polymers, and is not suitable for use
with brittle ceramics. Furthermore, punch-
ing holes in sheet material is only possible
if the hole diameter is greater than the
material thickness. Many medical devices
call for metal sheets in thicknesses of 20
m or greater, thus making the punching of
micron-sized holes impossible.
Chemical etching also can be used for
the production of small features. First,
the surface of the workpiece is masked off
using a method such as photolithography.
This involves spin coating a resin onto
the surface of a workpiece, followed by
exposure to UV light through a patterned
projection mask. After development of the
hardened resin, a mask with micron-sized
features will remain, leaving the exposed
parts of the pattern to undergo a chemical
Advances in medical technology require ever-smaller holes in catheters and related devices.
Laser drilling achieves strict size and tolerance requirements in an economically viable process.
David Gillen and David Moore, Blueacre Technology Ltd,
Dundalk, Co Louth, Ireland
Tiny Triumphs: Laser Drilling
Micron-Sized Holes
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EMDT1207 026 26 7/12/12 5:20:25 PM
attack when placed in an etchant. Due to
the complex process, this manufacturing
method is best suited to very thin materials.
Metals are frequently etched this way and
ceramics also can be subjected to the proc-
ess, provided suitable etchants are available.
Distinct advantages of this process are the
fine control, repeatability and scalability;
the technique is limited, however, in terms
of the materials that can be processed and
the flexibility of the manufacturing method.
This technique can produce holes smaller
than 1 m diameter in very thin layers.
Chemical etching can be isotropic in many
materials; therefore, it can be difficult to
have fine control over the cross-sectional
geometry of the hole.
Sandblasting, like chemical etching, can
be used in conjunction with a photomask
to produce features on components. This
process is only suitable for use with brit-
tle materials such as ceramics. While there
are advantages to using this process for
the production of larger holes, it is severely
limited by the diameter of the abrasive
particles used in the sandblast. This method
is used to create holes down to submillim-
eter diameters, but it does not necessarily
achieve the performance required to pro-
duce sufficiently small holes in the medical
devices of today.
Electron beam machining can be used in
a similar manner to laser machining to pro-
duce small holes with fine tolerances, typi-
cally in diameters as small as 25 m. Using
electrostatic lenses, the electron beam is
focused to a small point, where a melt pool
is generated and the material is evaporated
to produce a hole. This process is limited
to metals and some ceramics. Advantages
include the ability to produce high-aspect-
ratio holes (up to 25:1), to drill holes at an
angle to the surface and to achieve a very
high machining rate. This process must take
place in a high vacuum, which may be an
inefficient manufacturing method to include
in a production line.
Electrical discharge machining (EDM)
is widely used in industry for the produc-
tion of small holes. While the process is
restricted to conductive materials, holes
down to a diameter of 5 m can be pro-
duced repeatedly. This process involves
moving a wire electrode towards the work-
piece with fine current control to adjust the
spark between the electrode and workpiece.
The spark is the mechanism by which
material is removed to create the hole. By
precisely controlling the current to the elec-
trode, it is possible to produce holes with
very fine surface finishes, which makes this
process popular for applications such as fuel
injector nozzles. While this manufacturing
method can produce holes with excellent
quality, it is inferior to other processes in
terms of processing speed.
Laser drilling is very common in both the
medical device and electronics industries.
By careful selection of a laser that is right
for a given application, fine micron-sized
features can be produced very economi-
cally. While capital investment may match
what is required for other manufacturing
methods, such as high-accuracy mechani-
cal drilling, lasers offer unparalleled reli-
ability and repeatability in high-speed,
high-volume manufacturing environments.
Somewhat similar in function to the proc-
ess of electron-beam machining, the intense
laser light is focused to a small point, which
creates a local melt-pool where the material
evaporates to produce the hole. Lasers are
available with a continuous or pulsed mode
of operation. Pulsed lasers allow the user
to carefully control the amount of energy
delivered to the workpiece, making it pos-
sible to precisely control a laser drilling
process. Using specially designed optical
setups it is possible to drill down to 1-m
diameters in certain thin materials, while
specific drilling strategies can be employed
to control the hole shape and contour.
The comparative cost of different drill-
ing methods is shown in Figure 1. In gen-
eral, the cost of producing a small hole
rises exponentially as the hole diameter
decreases. Laser is the one process that can
be used to cover a broad range of diameters.
Advantages of laser drilling
Using lasers to drill small holes in medical
devices has many advantages. Not only can
lasers create repeatable, high-aspect-ratio
holes in diameters as small as 1 m, the
Visit www.microlumen.com
to learn more.
One Microlumen Way
Oldsmar, FL 34677 USA
Phone: 813-886-1200
Fax: 813-886-3262
EMDT1207 027 27 7/12/12 5:20:34 PM
MANUFACTURING
noncontact process does not require addi-
tional coolants or lubricants during drilling.
The noncontact nature of laser process-
ing is especially advantageous when
machining very thin materials that are too
flexible or fragile to undergo a contact
machining process. With properly defined
laser drilling parameters, it is possible
to produce holes with a minimised heat-
affected zone, thus eliminating postprocess-
ing requirements to create a clean hole.
The materials to be drilled and the size of
the features required will determine the
most appropriate type of laser. Typically,
high-pulse-repetition rate nanosecond UV
lasers operating at 355 nm are suitable for
drilling most materials, as this particular
wavelength of light is absorbed well by met-
als and polymers. Modern lasers, such as
diode-pumped solid-state systems, require
minimal maintenance and are very cost-
effective to run, as there are virtually no
short-life consumable components or tool-
ing. Laser processing also offers flexibility
in changing process parameters for different
materials of varying thicknesses. Careful
tuning of laser parameters such as power,
pulse repetition frequency and beam speed,
allows the user to control the size and cross-
sectional features of any hole.
Considerations in laser drilling
small holes
As previously stated, one of the main
advantages of using lasers for materials
processing is the possibility to choose
a laser source
that will achieve
optimal results
(Figure 2). Materi-
als absorb differ-
ent wavelengths of
light in different
proportions, and
various applica-
tions require
lasers that oper-
ate in different
modes, such as
pulsed or continu-
ous wave. For very
fine applications,
short-pulsed lasers in the nanosecond
range and below tend to provide optimal
results, because heat buildup during the
machining process is minimised. This, in
turn, provides the possibility to machine
extremely clean features without the need
for postprocessing. Of course, some mate-
rials machine better than others. Poly-
imide and PEEK, for instance, machine
particularly well with UV lasers.
When choosing a pulsed laser source,
one must balance the operational char-
acteristics of the laserpulse frequency,
pulse energy and pulse duration. While
some ultrafast lasers in the pico- and fem-
tosecond domains can machine very clean
features, process time often will increase
because of the lack of heat buildup in the
workpiece, thus affecting the economic
viability of the laser process. For many
industrial processes, nanosecond pulsed
lasers provide the best balance between
capital investment, throughput and fine
machining capabilities.
Wavelength selection is an equally
important decision when designing a laser
processing system. As the wavelength of
the light becomes shorter, the energy of the
light increases. Materials such as polymers
tend to absorb UV light (with a wavelength
below 400 nm) very well because of their
atomic makeup and molecular bonds.
Using very high energy light allows the
user to perform virtual cold machining
of polymers. This occurs when the light
energy of the laser exceeds the potential
of the molecular bonds in the material,
allowing the laser light to break the bonds
without generating significant amounts
of heat in the workpiece. Wavelength
considerations for machining metals are
quite different from those for machining
polymers, as the metallic bonds are nor-
mally overcome through a melt vaporisa-
tion process, meaning that heat must be
introduced into the workpiece. Therefore,
the actual absorption of laser light in
metals is related more closely to the actual
reflectivity of the workpiece to different
wavelengths of light. While metals can be
Figure 1: The cost per hole increases as the hole diameter becomes smaller.
Lasers provide the greatest exibility for manufacturing holes.
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80
0
0.2
0.4
A
r
b
i
t
r
a
r
y

c
o
s
t
Hole diameter (m)
0.6
0.8
1.0
Laser, chemical etch
Laser, EDM
Laser, EDM,
mechanical
Figure 2: This graphic shows the most commonly available laser wavelengths. Wavelengths in the UV range
are absorbed well by most materials, and lasers operating at 355 nm produce excellent drilling results.
Excimer laser
157 nm - 400 nm
Diode-pumped solid-state laser
266 nm to 1 m
Visible range Ultraviolet (UV)
157 nm 350 400 450 500 550 600 650 700 750 1 m 10 m
Infrared (IR)
Near IR Far IR
Polymer machining
Mask projection
Remote processing
Metals and polymers
Metal cutting
Gas-assisted fusion
YAG laser
1 m
CO2 laser
10.6 m
EMDT1207 028 28 7/12/12 5:20:37 PM
machined using wavelengths ranging from
IR (10.6-m CO2 lasers) to lasers operat-
ing in the visible range (532-nm green
lasers), some of the best machining of small
features can be performed in the UV range
(around 355 nm), as reflectivity is reduced
at this wavelength. It is also imperative to
choose a laser that can generate enough
heat to induce melting in the machining
process, such as a nanosecond laser. Hence,
it is necessary to carefully consider the
pulse duration and pulse energy of the laser
source.
When trying to machine micron-sized
features, another consideration affecting
wavelength selection is that the shorter the
wavelength of light, the smaller the lasers
focal spot. Light is limited in focal spot size
to the diffraction limit, which is depend-
ent on the lights wavelength; hence, it is
possible to have a smaller focal spot at 355
nm than at 1064 nm. This enables the user
to concentrate the laser energy on a smaller
area of the workpiece and thus be able to
deliver energy more precisely to machine
smaller and finer features. The size of the
laser beam, its circularity and quality are
also critical considerations when drilling
very small holes, as they all influence the
focal spot size.
The laser drilling strategy should also
be considered. For larger holes, a common
method called trepanning is used. This
involves steering the beam in a spiral using
scanning mirror setups. This method is suit-
able for drilling holes that are larger than
the focal spot of the beam and for cutting
square and other irregularly shaped holes.
When trying to drill holes at or below the
focal spot size of the laser beam, it is neces-
sary to use an alternative strategy called
percussion drilling. This involves keeping
the laser beam stationary, and adjusting
the size and shape of the hole by carefully
controlling the pulse energy, frequency and
number of pulses. Figure 3 illustrates the
various hole geometries that are possible by
controlling the laser drilling strategy.
As holes become smaller, manufactur-
ing costs can increase, depending on the
materials machined and the tolerances
required. Through the correct selection of
lasers, machining strategy and materials,
it is possible to optimise throughput and
minimise the cost of a laser drilling proc-
ess. Current diode-pumped solid state lasers
have an expected minimum operational
lifetime of 15,000 to 20,000 hr between
services, meaning that it is feasible to run
these lasers for a minimum of two to three
years in full production. Because of the
noncontact nature of laser machining, no
consumables are used in the manufacturing
process, and the inherent stability of these
lasers increases repeatability, throughput
and process yield.
Figure 3: The types of hole cross-sections that are feasible to manufacture using laser drilling.
EMDT1207 029 29 7/12/12 5:20:50 PM
MANUFACTURING
Small-hole metrology
Traditional methods of measuring micron-
sized features include high-power optical
microscopy, stylus profilometry and scan-
ning electron microscopy (SEM). While
these are highly powerful characterisation
tools, they are not always suited to an
industrial production environment. High-
power microscopy can present problems on
the production line as the field-of-view is
small, and the tight focal plane can com-
plicate the measurement process. Optical
microscopy is limited in resolution by
the diffraction limit and therefore cannot
typically resolve features below 200 nm.
When used for certain applications, opti-
cal microscopy can provide a wealth of
measurement information with very high
repeatability and a short measurement time.
This measurement technique affords the
benefit of being able to measure in reflec-
tive or transmission modes, making it quite
flexible across a range of materials. Special
setups can be implemented when necessary
to measure features in 3-D using techniques
such as depth-from-focus and stereoscopy.
Stylus profilometry is also used in small-
feature characterisation. Atomic force
microscopy (AFM) tends to offer high
resolutions on the order of nanometers, but
it suffers from slow measurement speed and
limited measurement range. Other stylus
profilometers offer greater measurement
ranges but are limited by the radius of the
stylus tip (normally on the order of a cou-
ple of microns). As the stylus must make
contact with each point on the measured
surface in order to generate a 3-D profile,
measurements can take a significant amount
of extra time compared with other methods.
SEM can often provide the best measure-
ments at the micron and nano scale. Mod-
ern SEMs can offer resolutions down to just
a few nanometers and offer high accuracy
and repeatability. However, this kind of
microscopy is not suited to production
lines as it involves a high vacuum and slow
measurement times; it is normally found in
R&D environments. For high-resolution
measurements, nonconductive materials
usually must be coated with a conductor,
also making the technique less suitable for
manufacturing lines in the medical device
markets.
When measuring small holes, many
considerations must be taken into account.
First, the choice of measurement system
and technique often will depend on the
workpiece materials. Transparent materials
are inherently difficult to characterise using
optical microscopy, for example. In such
cases, special techniques such as differential
interference contrast must be used at greater
expense and complexity than traditional
brightfield microscopy. Measuring holes
in semitransparent and opaque materials
tends to be much simpler using the trans-
mission brightfield technique. However,
this becomes more complicated when the
hole is blind. In certain cases, semitranspar-
ent materials will have an advantage when
measuring a blind hole, as it is still possible
to form an image with good contrast. For
opaque materials, reflective brightfield
microscopy often produces the best results.
Having chosen a suitable technique, the
next consideration is measurement resolu-
tion and uncertainty. In a 2-D measurement
in an optical system, the most important
considerations should include camera
resolution, illumination and distortion of
the image by the optics. Modern micro-
scope optics are optimised to minimise field
distortion and colour errors and are suitable
for high-accuracy measurements. The mini-
mum measurement uncertainty should be at
least half of the minimum design tolerance
of the feature to be measured; thus, the
minimum repeatable measurement of small
holes using optical microscopy is in the
region of 1 m in most instances. For stylus
measurements, it is the tip radius and shape
that will define the systems minimum hole
measurement capabilities.
Finally, the surrounding environment is
an important consideration. Many materi-
als will expand or contract on the order of
10 to 100 nm per Kelvin per meter. Vibra-
tion also is a key concern in a high-accuracy
metrology system. By stabilising the envi-
ronment in which the processes are com-
pleted and measurements are performed,
smaller features can by produced with
increased repeatability and process yield.
Conclusion
Current medtech manufacturing trends are
driving the need to drill smaller holes with
increased repeatability and process yield.
While there are several suitable drilling
methods, such as EDM and mechanical
techniques, lasers outperform them in
many applications. Because it is a non-
contact process, there is less need to post-
process the drilled parts, and there is no
mechanical tooling wear to consider. Lasers
afford the user the possibility to drill holes
smaller than can be achieved using other
techniques (1 m) while maintaining high
throughput and economic viability. The
metrology of small holes poses an interest-
ing challenge, especially when considering
the range of materials that can be laser
drilled. Optical microscopy techniques are
best suited to high-throughput manufac-
turing lines, while other techniques, such
as electron microscopy, provide high-res-
olution measurements that can be used as
complementary techniques, especially in an
R&D environment. 1
David Gillen
is Managing Director and
David Moore
is Senior R&D Engineer at Blueacre Technology Ltd,
Aiken Business Park, Old Coes Road, Dundalk, Co
Louth, Ireland
tel. +353 42 938 6922
e-mail: info@blueacretechnology.com
www.blueacretechnology.com
Lasers afford the possibility to drill holes smaller
than can be achieved using other techniques while
maintaining throughput and economic viability.
EMDT1207 030 30 7/12/12 5:20:56 PM
SHOW PREVIEW: ORTHOTEC EUROPE
As the pace of innovation in the
orthopaedic industry continues
to accelerate, OrthoTec Europe
launches a new platform where
innovators get the opportunity
to showcase emerging ideas to
potential business partners.
Camilla Andersson
W
hen orthopaedic professionals
gather in Zrich, Switzerland,
on 12 and 13 September for
the annual OrthoTec Europe event, they
are joining not only a European trade-
show, but a global orthopaedic commu-
nity. Attracting professionals from more
than 23 countries, the event offers ortho-
paedic manufacturers an opportunity to
learn about new products and research
while networking and meeting potential
business contacts. The specialist nature
of the show fosters a sense of community
among the shows visitors and exhibitors.
OrthoTec Europe is not just a
tradeshow, says Qiaoli Vrinat,
Conference Manager at UBM Canon.
Its a forum for medical device
manufacturers. They come here to get
inspiration. They come here to meet
experts. Its an intensive two-day event
where they can connect with suppliers.
I think its a unique platform.
As in the two previous years, OrthoTec
Europe takes place at the Mvenpick
Hotel Zrich-Regensdorf. Switzerland
is a key centre for the development and
manufacture of orthopaedic products.

Accelerating innovation
More than ever, OrthoTec Europe 2012
will emphasise innovation.
The pace of innovation is
accelerating, says Aurore Domange,
Group Event Manager at UBM Canon.
We have new technologies that allow us
to produce devices quicker and quicker.
OrthoTec Europe is an international
platform that really highlights what is
Investment Hub Debuts at
OrthoTec Europe
Conference Features Insights into Chinese Market
The challenges and opportunities of doing
business in emerging markets will be the
focus of a highly anticipated conference
session at OrthoTec Europe 2012. Partici-
pating on the panel, Zeli Yu, Vice President
of Shanghai Hail Fellow Medical Device
Scientic Technology Co. Ltd, an IVD dis-
tribution company, will discuss strategies
for penetrating the Chinese market.
Drawing on years of experience serv-
ing with a Notied Body and providing
regulatory consulting services related
to US FDA quality systems inspections,
Yu will compare and contrast US FDA
and Chinas SFDA approval processes
and highlight entry strategies for for-
eign companies seeking to establish a
foothold in the lucrative Chinese market.
In addition to best- and worst-case sce-
narios, Yu will address warehouse and
logistics issues, quality control conun-
drums and cultural differences.
A well-known gure in Chinas medical
device industry, Yu is eager to share
his rst-hand experience with Chinese
medical device manufacturers.
Id like to take it one step further
at OrthoTec Europe 2012 by not only
providing advice on regulatory matters,
but by delivering strategic insights,
notes Yu. It will be my great pleasure to
provide some professional suggestions
to foreign medical device manufacturers
on how they can avoid common pitfalls
when entering the Chinese market.
Helen Zhang
EMDT1207 031 31 7/10/12 5:08:07 PM
going on in the industry.
Consistent with the innovation theme,
OrthoTec Europe 2012 will introduce
two new features: a series of informative
workshops and the Investment Hub, a
venue where innovators can present their
ideas to potential investors.
Each 1 -hour workshop is designed
to provide a more detailed look into a
fundamental orthopaedic topic. These
include cleaning validation for surgical
instruments, cleaning and packaging
validation of implants, design and
simulation and additive manufacturing.
Since its launch in 2010, OrthoTec
Europe has been a space for industry
professionals to learn about new
orthopaedic products. The Investment
Hub will complement the exhibition by
providing a place for attendees to learn
about products not yet on the market.
Eighteen new concepts and ideas will be
unveiled to potential investors and business
partners, followed by a networking session.
A steering committee of industry experts
will select the projects participating in
the Investment Hub. The deadline for
submissions is 1 August.
The keys for selection will be the
capacity of the project to provide a marked
improvement over the state of the art. This
can be described in terms of patient benefit,
cost reduction, opening of new markets or
other metrics, but overall well be looking
at things that have a potential to markedly
change the picture, says Yves-Alain
Ratron, Director, Global Research Tornier,
and member of the steering committee.
This meeting intends to offer a large
selection of projects of
interest, in one place
in a very short time,
says Ratron. It also
offers the possibility
to [engage] in direct
discussions with
potential industrial and financial partners.
We feel that all parties involved should
find in this forum new opportunities for
business ventures.
Domange came up with the idea of
the Investment Hub after speaking with
attendees who would ask her where they
could find innovations before they enter
the marketplace.
The aim is to create an environment
where ideas, partnerships and new projects
can emerge, says Domange. You can
have good ideas, but you need to develop
them. The definition of innovation is
a good concept that worked and was
launched on the market. 1
1213 September
Zrich, Switzerland
www.medtechinsider.com/medtec-connection
www.orthoteceu.com
Ihr Spezialist fr Teilereinigung
www.amsonic.com
Amsonic 4100/4400
Lsemittel-Teilereinigungssysteme
(Kohlewasserstoffe und modi-
zierte Alkohole der Klasse A3)
Amsonic AquaJet 21
Spritzreinigungs- und
Trocknungssysteme
Amsonic AquaLine
Ultraschall-Przisionsreinigungssystem
Besuchen Sie uns an der
Zrich-Regensdorf, 12.13.9.2012
Halle 1, Stand 305
Amsonic AG Schweiz
Zrichstrasse 3
CH-2504 Biel/Bienne
Tel.: +41 32 344 35 00
Fax: +41 32 344 35 01
amsonic.ch@amsonic.com
www.masterbond.com
154 Hobart Street, Hackensack, NJ 07601 USA
+1.201.33.883 - mainmasterbond.com
staying
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EP42HT-2ND2Med
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450F
- Paste consistency
Adhesive Resists
Repeated
Sterilization
EMDT1207 032 32 7/10/12 5:08:23 PM
Additive manufacturing
Arcam provides a cost-efficient additive
manufacturing technique for the
production of implants. Its electron beam
melting (EBM) technology is used for
the fabrication of CE-marked and US
FDAcompliant orthopaedic implants.
The technology allows for the single-step
production of solid and porous sections
(trabecular structures). More than 20,000
EBM-manufactured acetabular cups
with trabecular structures for improved
osseointegration have been implanted
to date. EBM is also appropriate for the
production of augments, femoral stems
and spinal cages.
Arcam
Stand 411
Implant testing
Empirical Testing Corp. (ETC), a US-
based company focusing on mechanical
testing of orthopaedic products, is
turning its attention to the global medical
device community with an exhibit
at OrthoTec Europe. ETC performs
testing in accordance with international
test standards and customer-specific
protocols, and is accredited to ISO/
IEC 17025:2005 through the American
Association for Laboratory Accreditation.
In addition to mechanical testing,
ETC offers testing methodology
and protocol generation, device and
package evaluation, validation and
testing, sterilisation and contamination
validation and testing, quality systems
and documentation development and
regulatory submission assistance, among
other resources.
Empirical Testing Corp.
Stand 100
Biomedical textiles
The OEM division of Cousin Biotech
applies expertise in textile-fibre
processing to the development of
devices adapted to specific customer
requirements. The products are
manufactured in a cleanroom.
Biomedical textiles are especially
suitable for orthopaedic applications
because of their flexibility and
adaptability, meaning that the implanted
device helps maintain patient mobility
following the procedure.
The implantable textile is created from
a knitted, braided, woven or nonwoven
structure. The materials come in multi- or
monofilament form and are resorbable or
nonresorbable.
Biomedical textiles can be assembled
with one another or with metal
components, PEEK or silicone by means
of stitching, welding, gluing or splicing
to form the final implantable device. The
technology is chosen depending on the
technical properties of the device.
Cousin Biotech
Stand 205
Precision manufacturing
Valtronic has opened a new building for
orthopaedic and precision mechanical
manufacturing. The company offers
a variety of manufacturing services,
including passivation, anodisation, laser
marking, specialised surface treatments,
laser or electron beam welding, plastic
moulding, packaging and sterilisation.
It also has design capabilities. Examples
of orthopaedic implants produced by
Valtronic include screws, plates, rods,
connectors and caps. Valtronic can provide
a preproduction run of qualifying products.
Valtronic
Stand 211
Implantable components
Paragon Medical is a tier-one turnkey
supplier of products and services for
implantable components, surgical
instrumentation, cases and trays. The
company manufactures a range of
instruments and implantable components,
from anchors and screws to complex
multi-assembly instruments.
Paragon Medicals Orthopaedic
Instrument Global Design Centre
is designed to leverage its existing
capabilities while closing the loop
between development and manufacturing
and enable extensive collaboration
between Paragon engineers and its
customers development teams.
Paragon Medical
Stand 405
Exhibition Highlights
EMDT1207 033 33 7/10/12 5:10:03 PM
The medical device manufacturing
industry will have a new rendez-vous,
when the World Medtech Forum Lucerne
(WMTF) debuts at the Lucerne Exhibi-
tion Centre in Switzerland. Scheduled
for 25 to 27 September 2012, the event
combines an exhibition, conference and
various expert meetings. With the World
Medtech Forum
Lucerne, we have
created a platform
that is completely
dedicated to the
needs of the medi-
cal industry, says
Peter Biedermann,
CEO of the Medical
Cluster and a mem-
ber of the WMTF project development
team. For our very first event this year,
we expect 240 exhibitors, 360 congress
participants and 5000 visitors from
Europe, the Americas and Asia.
According to Project Manager Fabi-
enne Meyerhans, approximately 3000
visitors will come from Switzerland with
the remainder hail-
ing from Germany,
France, Italy, the
United Kingdom,
the United States,
Japan and points
north, south, east
and west. The
event primarily will
offerSwiss medtech
suppliers an opportunity to present new
products to an audience of national and
international manufacturers of medical
devices, says Meyerhans. But some
international organisations and compa-
nies have registered to exhibit, as well.
Part of the attraction, adds Meyerhans,
is the ability to meet some 240 quali-
fied suppliers in a single location. Our
concept fosters an interdisciplinary
exchange among all stakeholders. The
Center of Attention and Swiss Lounge, to
cite two examples, support this idea. The
trade show also features one-on-one
partnering, a Start-up Park and various
workshops, says Meyerhans. An exclu-
sive opening event, Medtech Night, is
also scheduled.
Switzerland Welcomes
Global Medtech Community
to First International Medical
Technology Forum in Lucerne
SHOW PREVIEW: WORLD MEDTECH FORUM LUCERNE
EMDT1207 034 34 7/10/12 5:11:27 PM
SPONSORED CONTENT
HIGH MEDTECH
DENSITY
Switzerland is consid-
ered to have the high-
est density of medical
technology companies
of any country in Europe.
More than 700 Switzerland-
based companies manufacture
medical devices, instruments and
consumables that are exported world-
wide. In recent years, exports of medical
products have reached parity with the
prestigious watch industry, accounting
for approximately 5% of Swiss exports.
According to Biedermann, there are
four top destinations in Switzerland rec-
ognised throughout the world: Geneva,
Interlaken, the Matterhorn and Lucerne.
Since the Matterhorn doesnt seem
to befor obvious reasonsa suitable
location for an event like this, consensus
was reached on Lucerne. It has every-
thing we need to attract global visitors:
beautiful scenery, lakes, mountains,
a superb congress infrastructure, top
accommodations and wonderful leisure
possibilities, he says.
CONFERENCE HIGHLIGHTS MEDTECH
MARKET ENTRY STRATEGIES
Focusing on global market entry strate-
gies, each day of the three-day confer-
ence will highlight a single important
market. Market data and expert infor-
mation
on permit
procedures, refund
mechanisms and gen-
eral legal requirements
will provide attendees
with vital information for
making decisions involv-
ing export projects. During
workshops and individual discussions,
participants will have the opportunity
to meet national experts and potential
sales partners.
Meyerhans says that approximately
400 attendees are
expected at the three-day
conference. The con-
gress is organised by the
export platform Medtech
Switzerland, the strategic
partner for the conference.
Our main responsibility
was to identify interesting
conference topics, draft
a programme, and iden-
tify and contact potential
speakers, says Patrick
Dmmler, CEO of Medtech
Switzerland. Confirmed
speakers from leading
companies and organisa-
tions will provide par-
ticipants with valuable insights into the
current developments and challenges of
the global medtech markets.
WMTF also supports the objectives
of Medtech Switzerland as an export
platform. According to Dmmler, Swiss
medical technology enjoys a first-rate
reputation around the world. He says
that the three-day forum offers Medtech
Switzerland an excellent opportunity to
invite foreign delegations to Switzerland
and connect them with potential cus-
tomers. The world famous old wooden
bridge and Lake Lucerne symbolise the
spirit of the World Medtech Forum: We
want to link medtech knowledge and
people from all over the world in an
inspiring setting, explains Dmmler.
MEDISIAMS AND WMTF JOIN FORCES
An important milestone on the path to
building a successful medtech event was
the integration of the Swiss microtech-
nology supplier trade fair MediSIAMS,
says Meyerhans. It is extremely impor-
tant that as many companies as possible
join forces from the beginning, she
stresses. Especially in economically dif-
ficult times, intensive market cultivation
is important. The World Medtech Forum
Lucerne takes place at the
right time. By combining
the only two Swiss trade
fairs that focus purely
on medtech, multiple
resources can be pooled,
creating a powerful plat-
form where the entire
supplier industry can
present itself to interna-
tional manufacturers.
Event partners include
ETH Zurich, Empa, the
University of Bern, CSEM,
EUResearch and the
Fachhochschule Nord-
westschweiz (University of
Applied Sciences and Arts,
Northwestern Switzerland), ensuring
that science and research centres have a
strong representation. The Federal Com-
mission for Technology and Innovation
(CTI) is also using WMTF as a platform,
and the Precision Cluster is participating
as a supporting partner.
Swiss cantons Lucerne, Aargau and
Solothurn, among others, will organise
shared stands to showcase indigenous
medical device companies. Germany,
Austria and Canada will have similar
pavilions.
For more information and a current
conference programme, go to www.
medtech-forum.ch.
Fabienne Meyerhans, Project
Manager, World Medtech Forum
Lucerne.
EMDT1207 035 35 7/10/12 5:11:43 PM
SHOW PREVIEW: WORLD MEDTECH FORUM LUCERNE
Precision machining
Diener Precision Machining is specialised
in the machining of precision components
for use in medical instruments and
implants. Extensive, validated processes
guarantee that all customer requirements
are met. Titanium, high-alloy steels and
aluminium are processed. Core services
include the turning, milling and drilling
of complex products. Laser marking of
all components is available on request;
two cleanrooms are on site. A large
number of the manufactured products are
exported, mainly within Europe and to
the United States. The firm is certified to
ISO 13485.
Diener Precision Machining AG
Hall 2a, Stand A 105
Power supply
A manufacturer of electronic and
electrical components, Schurter will
present power sockets and power entry
modules with and without power-
line filters for use in a broad range of
medical electrical equipment at the
World Medtech Forum in Lucerne. These
products fulfill the requirements of the
base standard, IEC/UL 60601-1, for
medical electrical systems and generally
can be used in most equipment without
additional testing.
Of special note for medical applications
is Schurters V-Lock cord retainer, a
simple and attractive alternative to
brackets. A notch on the power socket
interlocks with a special latch on the
connector, preventing the cord from being
pulled out of the socket unintentionally.
Schurter AG
Hall 2a, Stand C157
PETG film extrusion
Medipack offers high-quality blister
packaging, packaging services and heat
Exhibition Highlights
WMTF / Medisiams Lucerne
EMDT1207 036 36 7/10/12 5:15:16 PM
provides customer-specific packaging
development, cleaning and assembly;
primary packaging in pouches, blisters
and ampoules under cleanroom
conditions; final packaging and coding;
and sterilisation services and validation.
The firm is part of the Swiss Ivers-Lee
group, which has been providing an array
of packaging services to the healthcare
industry for 65 years.
IL-MedTec Ltd
Hall 2a, Stand D170
Machine tools
A supplier of custom machining products
for value-added medical work pieces,
Willemin-Macodel will showcase
sealing machines to the medical device
industry. To meet increasingly stringent
requirements in terms of cleanliness,
production conditions and traceability of
raw materials, the company has expanded
its core business to include PETG film
extrusion. PETG combines transparency,
sterilisation resistance and thermoforming
and sealing properties.
The companys specialisation in the
use of PETG is expected to improve
product quality, as no foreign particles
are introduced into the system. The most
important elements of the extrusion
process are automated, so that even small,
ultra-high-quality production runs can be
performed to tight tolerances. To protect
the PETG film from contamination, the
process runs under controlled conditions
in a cleanroom. The production unit is
currently in the test phase.
Medipack AG
Hall 2a, Stand A103
Packaging services
IL-MedTec Ltd specialises in the
packaging of medical devices such
as implants and surgical instruments
under cleanroom conditions according
to EN ISO 13485. The company
Sphinx Tools Ltd.
Gewerbestrasse 1
CH-4552 Derendingen
Phone +41 32 671 21 00
Fax +41 32 671 21 11
www.sphinx-tools.ch
Swissmade tools
Your partner in Medical Technology
EMDT1207 037 37 7/10/12 5:15:22 PM
WORLD MEDTECH FORUM LUCERNE
various medical parts fabricated on its
machining centres, including biopsy
forceps and cervical plates. The firm
can also manufacture dental implants,
bridges, hip implants, bone plates and
screws, spinal hooks, surgical forceps
and scissors. In addition to the medical
and dental industries, the machine tool
supplier manufactures micromechanical
components and serves the aviation,
aerospace and moulding industries.
A personalised service, from initial
feasibility studies to support of the
machining centre during its life cycle,
is part of the firms commitment to its
customers.
Willemin-Macodel SA
Hall 2, Medisiams
Research and development
The Swiss Federal Laboratories for
Materials Science and Technology, Empa
has long-standing experience and in-
depth know-how in the area of medical
technologies, particularly in bringing
the latest research results to market by
teaming up with industry partners. The
company is active in the development,
design and production of medical textiles
and implant materials. Properties such as
mechanical value, corrosion resistance,
morphology and in vitro biological
response are characterised and evaluated
in detail.
Empas goal is to enhance the
innovative edge and competitiveness of
the Swiss medtech industry as well as
to improve quality of life for the public
at large. The firm will participate in the
Center of Attention during the World
Medtech Forum in Lucerne, a platform
for an informal and interdisciplinary
exchange between research institutes at
clinics, universities, technical colleges and
the medical technology industry.
Empa
Location: Center of Attention
Cendres+Mtaux SA to Present CAD/CAM Project
Cendres+Mtaux SA will be participating in the Speakers Corner, organised and hosted
by the Swiss Precision Cluster. On each day of the World Medtech Forum, the Speakers
Corner will address a particular topic relevant to medical technology and precision
manufacturing. On Wednesday, 26 September, when trends in the dental market will be
highlighted, Cendres+Mtaux will present its innovative CAD/CAM projectan open,
modular and high-quality system.
Over several decades, Cendres+Mtaux has built up consi derable know-how in the
processing of small parts made from titanium and precious metal alloys. Its dental
division develops, produces and sells precious metal alloys for dental crowns and
bridges as well as attachments for the functional and aesthetic fixturing of dentures.
The firm also manufactures an assortment of endodontic dentistry products.
Cendres+Mtaux
Location: Speakers Corner
CLOSE UP
MPS is your specialist for
Micro Precision Systems AG

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MPS Micro Precision Systems AG

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Contact:
MPS develops and manufactures
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EMDT1207 038 38 7/10/12 5:15:35 PM
Liquid crystal polymers
Dyconex has developed ultra-high-density
liquid crystal polymer (LCP) substrates
for medical implant applications. The
company strengthened its technology
portfolio in late 2011 by acquiring several
state-of-the-art technology assets. By
combining these assets with its existing
expertise in LCP technology, the company
is able to fabricate multilayer designs
with 20-m features. The technology was
initially developed for a customers family
of active implantable bionic devices.
The product line is currently in the early
ramp-up stage.
Dyconex AG, an MST company
Hall 4, Stand B432
Materials testing
The RMS Foundation is an independent
lab specialised in the testing and
investigation of materials and products
for medical applications. Prototypes of
new implants are tested at the firms in-
house lab to evaluate strength, fatigue,
and wear and corrosion resistance. For
the manufacturing sector, RMS performs
quality checks on raw materials and
semifinished products. Equipped with
best-in-class systems, the companys tools
enable structural investigations by means
of light and electron microscopy, analyses
of chemical compositions, static and
dynamic testing of products, functional
tests, surface analysis, proof of cleanliness
and detection of impurities. RMS is
certified to ISO 9001 and select standard
investigations are accredited to ISO/IEC
17025.
RMS Foundation
Hall 2A, Stand A113
Cendres+Mtaux SA
P.O. Box
CH-2501 Biel/Bienne
Phone +41 58 360 20 00
Fax +41 58 360 20 13
www.cmsa.ch/medical
Medical
Cendres+Mtaux has more
than 125 years of experience
in rening, casting and
processing precious metals.
Our core competence lies
in producing high-accuracy
components out of precious
metals and titanium. Biocom-
patible precious metal ne
wires, strips, sheets and bars
as well belong to our wide
range of customized products.
Our wires offer an excellent
radiopacity, are bio compatible
and thus perfectly ap-
plicable for long-term
implantable uses. They
exhibit a completely even
surface and maintain the
tightest tolerances. So if
youre interested in high-
quality, fully biocompatible,
homogenous, radiopaque
precious metal ne wires,
bars or strips your search
stops here.
www.cmsa.ch/medical
+
We create more quality
of life out of engineering
and services.
+
From Idea to Solution.
+
From Semi-nished to nished
products.
+
From Engineering to Packaging.
All from one source, under
one roof.
EMDT1207 039 39 7/10/12 5:15:57 PM
MARKETPLACE: ENGINEERING INSIGHT
Listen to Your Heart
CARDIAC DISEASE is a major cause of
death. Wearable heart monitoring sensors
could become an important tool for cardiac
patients, ensuring continuous monitoring
during daily life. This is essential for an
accurate diagnosis of heart problems and for
life-saving interventions.
Due to this large market potential, com-
panies and research institutes are developing
products and research prototypes of wear-
able heart monitoring sensors. The aim is to
make wearable, easy-to-use and ultralow-
power (ULP) sensor systems with a long
battery lifetime.
One-month lifetime
Imec (Leuven, Belgium; www2.imec.be)
and the Holst Centre (Eindhoven, Nether-
lands; www.holstcentre.com) are develop-
ing technologies for wearable sensor systems. Recently, an ECG
patch research prototype was released that combines a ULP ECG
system-on-chip (SoC) with a Bluetooth Low Energy (BTLE) radio.
The integration of a standardised BTLE
radio is important for a commercial
breakthrough of sensor systems. Newly
released smartphones will include a
BTLE radio, which makes it possible
to communicate with BTLE-enabled
sensor devices.
The innovative design of the new
prototype ensures low power consump-
tion. The ECG patch can compute
beat detection and transmit heart rate
during one month on a 400 mAh Li-Po
battery.
System building blocks
The main components of the ECG patch
demonstrator are a dedicated mixed-signal
ECG SoC (imec) and a commercial BTLE
SoC (Texas Instruments).
The ECG SoC has three main building
blocks. First, the analogue front-end sup-
ports concurrent 3-channel ECG monitoring
with 1-channel impedance measurement
and band-power extraction. The second
component is the 12-bit analogue-to-digital
(ADC) converter. This ADC is capable of
compressing the ECG data by a factor of 5.
This reduces the power consumption related
to data processing and transmission. Third,
a dedicated ultralow-power digital signal
processor (DSP) is used for on-board signal
processing. It uses an SIMD processor archi-
tecture, a hardwired accelerate unit, effective
duty cycling, instruction cache and clock gating scheme. This DSP
performs multichannel ECG processing with additional signal filter-
ing, ECG feature extraction, analysis and motion artifact removal.
Els Parton, imec, Leuven, Belgium; Julien Penders, Holst Centre, Eindhoven, Netherlands
The development of small user-friendly sensors will enable an individualised and preventive approach
to medicine and a delocalisation of care from hospitals to home. Recently, an ECG patch was developed
that demonstrates the strength of combining a dedicated ultralow-power ECG system-on-chip with a
standardised Bluetooth Low Energy technology. It overcomes drawbacks of previous systems regarding
wearability, standardisation and lifetime.
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AFE DSP ADC
Mixed-signal ECG SoC
This ECG prototype combines ultra-efcient
electronics with standard wireless communication
(Bluetooth Low Energy). When streaming heart rate, it
has one-month autonomy on a single battery charge.
The ECG patch demonstrator makes use of a dedicated mixed-signal ECG system-on-chip that consists of an analogue
front-end (AFE), analogue-to-digital converter (ADC) and ultralow-power digital signal processor (DSP).
EMDT1207 040 40 7/10/12 5:17:32 PM
A tri-axial accelerometer is also added to
the system. The accelerometer provides addi-
tional information that can be used to infer
the type or level of activity of the user. The
ultimate goal is a health patch that combines
different relevant sensor measurements and
provides an overall picture of the users
health status.
The BTLE SoC used in the demo is from
Texas Intruments. It retrieves data from the
ECG and accelerometer sensors and sends it
to a BTLE-enabled device such as the newest
smartphones (e.g. iPhone 4S). In addition,
a MicroSD card can be used for data log-
ging on the system. A 3.7 V/400 mAh Li-Po
battery powers the system. The subsystems are connected through
SPI interfaces.
A recongurable ECG chip for different applications
The ECG SoC can be configured for different modes of operation
and different processing needs, providing a versatile platform that
can be used in multiple application domains.
At this time, the SoC implements different modes of operation,
for example data collection and beat detection. For the data collec-
tion mode only the analogue front-end is running. In beat-detec-
tion mode, the QRS complex is detected
using an algorithm based on derivative or
band-power extraction.
In the ECG patch demonstrator two
different operation modes were imple-
mented. In the first mode, beat detection
is performed on the ECG SoC and the
heart rate is transmitted through the
BTLE SoC. Average current consumption
is 280 A at 3.7 V. One month lifetime is
achieved on a 400 mAh Li-Po battery.
In the second mode, the ECG is sam-
pled at 256 Hz and 3D-accelerometer at
100 Hz (each acceleration axis), and the
data is streamed wirelessly using BTLE.
In this mode, power consumption is 5.9
mA at 3.7 V, and an autonomy of 2.5 days is achieved.
ePatch technology
The ECG patch electronics mentioned in this article have been
integrated with an ePatch platform from Delta (Hrsholm, Den-
mark; www.madebydelta.com). The ePatch technology offers
a biocompatible, modular and robust mechanical housing for
integrating the sensor electronics. The resulting ECG patch dem-
onstrator consists of a disposable patch with ECG electrodes and
a cap that contains the electronics and two batteries.
Future work
Researchers from imec and the Holst Centre chose to integrate
Bluetooth Low Energy in the ECG patch demonstrator because
this standardised protocol provides connection to the most
recent smartphones. This is an important asset for both the
user and the doctor, because it allows them to have the data at
their disposal anytime, anywhere. In the future, apps can be
developed both for fitness and health applications tailored to the
needs of the user.
The combination of the BLE radio and the customised ultralow-
power ECG SoC ensures extremely low
power consumption and thus long-term
monitoring without requiring the user to
change batteries.
Further work on the ECG patch con-
centrates on circuits and algorithms for
real-time artifact reduction, arrhythmia
detection and health status monitor-
ing. After this, new functionality will
be added to the patch to turn it into a
complete health patch. In this context
skin temperature, bio-impedance and
ion concentration monitoring will be
explored. Furthermore, an ultralow-
power radio compatible with relevant
standards will be developed to further
reduce power consumption, allowing even longer battery lifetime
and smaller size for the system. Finally, new electronic integra-
tion technologies will lead to conformable systems, significantly
enhancing comfort of use and acceptance for wearable sensors.
The collaboration among companies and research institutes
is essential to realise breakthrough solutions for wearable sen-
sor applications and ensure their successful deployment as health
monitoring products of the future. For this reason, imec and the
Holst Centre work together with many industrial partners in their
research on ULP wearable sensors. 1
Mode 1
(0.28 mA at 3.7 V)
BLE-SoC
67%
BLE-SoC
84%
Power management
27%
Power management
14%
ECG SoC
6%
Accelerometer
1.7%
ECG SoC
0.3%
Mode 2
(5.9 mA at 3.7 V)
The use of standard wireless communication such as BTLE
makes it possible for sensors to send data to smartphones.
Power consumption breakdown of the ECG patch.
EMDT1207 041 41 7/10/12 5:17:45 PM
MARKETPLACE
First Look
A roundup of noteworthy new materials, components and
equipment suited for medical technology applications
Medical and industrial displays get
iPad-inspired makeover
Projective
capacitive
(PCAP)
integrated TFT
displays have
been introduced
by andersDX for
nonconsumer
device makers seeking
to mimic the look and feel of an iPad. The
devices are available with display sizes ranging from 4.3 to 15 in.
and in WQVGA to WXGA resolutions. Requests for MVA and
IPS wide viewing technology can also be accommodated.
An optically bonded black border cover lens provides a
sleek flush finish. Available with single or multitouch options,
the displays have been designed for seamless integration
with existing and new product designs, says the company.
Connections are made through an i2C interface and no
recalibration is required.
The displays are offered with customised, decorated
cover glass or PMMA for enhanced front panel styling and
can include printed logos, cutouts for buttons, speakers,
hardbuttons, rounded edges, and LED illumination.
andersDX
London, UK +44 2073 887 171
www.andersdx.com
Sterilisable polypropylene contributes
to cost savings in medical applications
Heat-stabilised polypropylene (PP) from Quadrant withstands repeated
steam and autoclave sterilisation cycles thanks to its deflection
temperature (HDT) > 149C under 0.455 MPa load (66 psi). Resistant to
cleaning agents, disinfectants and various solvents, the material is suitable
for the fabrication of surgical trays, caddies and instrument components
routinely used in life science applications. Such parts are often difficult to
produce by injection moulding, owing to their complexity and the need
to use high viscosity resin, says Quadrant.
The Proteus LSG HS PP material is
supplied in plate form. The production
process involves a proprietary heat-
treatment phase, which increases HDT,
improves machinability and optimises
dimensional stability. The material is
described as a cost-effective alternative
to polyphenylsulphone (PPSU) in
cases where temperature resistance is
less critical, but resistance to repeated
sterilisation cycles is still needed.
Quadrant LSG stock shapes
are tested and evaluated for
biocompatibility according to ISO 10993. The plates are available in
white and black, and in thicknesses of 25.4, 38.1 and 50.8 mm.
Quadrant Engineering Plastic Products
Lenzburg, Switzerland +41 62 885 8150
www.quadrantplastics.com
Qosina launches one-handed haemostasis
valve y connector
Qosina has introduced a one-handed haemostasis valve y connector that allows independent
manipulation of multiple guidewires. The one-handed control lever action allows for lock and
release with light fingertip pressure for three positions; open, semi-open and closed. A click clearly
identifies the valve position by acoustic and tactile feedback, enabling easy and efficient operation.
The housing is made from polycarbonate and polyoxymethylene, which have high clarity and
temperature resistance. The silicone valve fits 0 to 9 FR guidewires and aids in controlling backflow.
The rotating male luer lock minimises tubing kinks, while the female luer lock sideport provides the
ability to flush out the line or check pressure.
Wire lock adapters work in conjunction with the haemostasis valve for applications involving
multiple guidewires. These adapters feature an integrated lock and release function, which enables
independent wire manipulation by utilising one or more adapters.
Qosina
Edgewood, NY, USA +1 631 242 3000
www.qosina.com
EMDT1207 042 42 7/12/12 5:22:26 PM
Planetary gearheads feature
preloaded ball bearings
A provider of high-precision drives and systems has introduced
a series of planetary gearheads. The GP 26 A gearheads close the
gap that previously existed between the 22- and 32-mm diameter
products in the range of power-optimised gearheads, according to
the company. Particularly significant improvements over the
previous generation are the higher permissible loads.
The following features are responsible for the power increase,
according to the company: the integration of robust, preloaded ball
bearings; optimised gearhead geometry; high permissible motor
speed; and optimised dimensions of the output shaft. This gearhead
is part of a modular system and is available in one-stage to three-
stage versions, with a total of nine different reduction ratios, from
5.2:1 up to 236:1. The maximum continuous torque of the one-
stage version is 0.75 Nm; the three-stage version is 4.5 Nm. The
short-term torques are 1.1 Nm and 6.2 Nm, respectively. Thanks
to the preloaded ball bearings, the tempered, rust-free output shaft
has no axial play.
Within the maxon motor modular system, the new GP 26 A
gearhead can be combined with five different motor types. For the
control functions, various 1- and 4-quadrant controllers, as well as
positioning controllers, are available.
maxon motor
Sachseln, Switzerland +41 41 666 1500
www.maxonmotor.com
TUV 13485 certified quality assurance,
unparalleled design expertise and 30 years
of ultrasonic technology excellence...
it all
comes
down
to this.
INTROTEKS newest innovative design, the miniature air-in-line
bubble sensor, represents next-generation pulse-type ultrasonic
circuitry for todays advanced medical, portable and wearable devices.
The Mini is developed to TUV certication standards to ensure highly
reliable, low cost, non-invasive air detection.
Introteks Mini The worlds
smallest ultrasonic air bubble sensor
For unsurpassed commitment to design excellence,
process integrity and patient safety, specify Introtek
ultrasonic sensors.
150 Executive Drive Edgewood, NY 11717 631-242-5425 introtek.com
EMDT1207 043 43 7/12/12 5:22:42 PM
Spotlight
MARKETPLACE
1 Microfluidics
Axxicon Moulds Eindhoven
provides high-precision mould
manufacturing. The company
produces lab-on-disc systems
in cooperation with diagnostics
and life science companies. Pro-
viding a full range of services,
the company offers design,
prototyping, testing, consulting,
engineering, tool design, mass
production and automation
services.
Axxicon Moulds
Eindhoven B.V.
Eindhoven, Netherlands
+31 49 949 4450
www.axxicon.com
2 Multicomponent
injection moulding
In addition to processing dif-
ferent thermoplastic materials
using multicomponent injec-
tion moulding technology,
Raumedic also offers silicone
moulding. Special expertise
has been developed in combin-
ing both materials. Raumedic
offers multicomponent injection
moulding under cleanroom
conditions compliant with ISO
14644; quality systems are
certified to ISO 13485 and ISO
9001.
Raumedic AG
Helmbrechts, Germany +49 9252 3590
www.raumedic.com
3 Silicone
components
ET Elastomer Technik produces
high-end components from
liquid silicone rubber (LSR),
including breathing masks,
bags, balloons, seals and short-
and long-term implants. Its
cleanroom technology, certified
to EU GMP Class D and ISO
154644-1 (Class 8), enables
the production of complex and
sensitive silicone components
in a sterile environment. The
firm operates its own injection
mould construction unit.
ET Elastomer Technik GmbH
Ellhofen, Germany +49 9732 788 650
www.elastomer-technik.com
4 Liquid silicone
rubber moulding
Liquid silicone rubber (LSR) is
sufficiently flexible to be used
in the moulding of low-volume
single-cavity prototype com-
ponents as well high-volume
fully automated production. An
ISO 13485certified company,
Primasil produces liquid silicone
injection moulded parts and
platinum-cured silicone extru-
sions. Assembly and packag-
ing work is conducted in three
separate areas with ISO Class 7
cleanroom facilities.
Primasil Silicones Ltd
Weobley, UK +44 1544 312 600
www.primasil.com
3
4
2
1
Moulding
EMDT1207 044 44 7/10/12 5:20:25 PM
5 Composite
moulding
Offering new product develop-
ment and contract manufactur-
ing services, Composites Busch
follows good manufacturing
practices and works to US FDA
and ISO 13485 standards. The
companys composite moulding
process is applied to the pro-
duction of a variety of medical
devices used in the orthopaedic,
surgical and dental sectors.
Composites Busch SA
Porrentruy, Switzerland
+41 32 465 7030
www.compositesbusch.ch
6 Silicone fittings
Moulded silicone fittings sup-
plied by NewAge Industries
for medical, laboratory, R&D,
biomedical and pharmaceutical
applications consist of tubing
and moulded tri-clamp ends
that are designed to be all-in-
one parts to reduce end-user
assembly time and improve
cleanliness. The silicone tubing
and fittings are custom moulded
from USP Class VI silicone elas-
tomers. The tubing and fittings
are autoclavable, sterilisable and
reusable.
NewAge Industries Inc.
Southampton, PA, USA +1 215 526 2300
www.newageindustries.com
6
5
32300
Introducer Needle,
Super Sharp Tip
with Protector,
Thin Wall
18 G x 2.75 inch (70 mm)
SS, PP, LDPE
Tip Detail
12135
Saf-T Cube
Needle Holder
with Double Sided
Adhesive
EVA, PP
Phone: +1 (631) 242-3000 Fax: +1 (631) 242-3230
info@qosina.com www.qosina.com
EMDT1207 045 45 7/10/12 5:20:39 PM
MARKETPLACE
In Focus
Connectors for harsh
environment
Fischer Connectors has introduced the
Fischer UltiMate Original Series line
for a broad range of harsh environment
applications. The rugged, compact,
lightweight and sealed connectors and
cable assemblies can withstand severe
environmental, industrial and chemical
conditions. In the medical device arena,
the connector has been used in artificial
heart devices. The main features of the
new UltiMate Original Series include a
rugged, miniature and ultralight design;
extremely robust keying; shock and
vibration resistance; shielding; and
sealing performance rated to IP68/69K.
Four robust mechanical codings allow
easy mating even in the dark and are
designed to prevent misconnection.
The push-pull connector is available
in a range of body styles, sizes and
configurations including multipole
contacts numbering from two to 42. The
compact design makes the connectors
suitable for use with devices that have
restricted space requirements.
Fischer Connectors
St-Prex, Switzerland +41 21 800 9595
www.fischerconnectors.com
Circular plastic connectors
Lemo and its associated Redel brand
offer the new Redel XP connector with
high-density contacts. The connector is
available with up to 22 contacts in an
ergonomic, sculpted shell with thumb
grip. The circular plastic connectors are
especially adapted for medical electronic
and test and measurement applications.
The connectors withstand operating
temperatures between -50 and 170C.
The XP series offers additional fea-
tures such as a recessed latch sleeve
within the connector body to enhance
shock resistance and withstand repeated
sterilisation cycles. The complete connec-
tor, including the contact configuration,
can be assembled from spare parts.
Lemo S.A.
Ecublens, Switzerland +41 21 695 1600
www.lemo.com
Connectors and lead wires
Contract manufacturer Plastics One
offers high-quality, durable connectors
and cable assemblies. The company
manufactures and assembles innovative
devices for patient diagnostics and
monitoring, nerve integrity monitoring
and hearing enhancement; cables for sleep
and respiratory studies are also produced.
The 80,000-sq-ft facility includes an
in-house design department equipped
with 3-D software, a mouldmaking shop
and an injection moulding department.
All of the companys products are
designed in adherence to ISO 9001:2008
requirements, and all operations are
performed at the firms US facility.
Plastics One Inc.
Roanoke, VA, USA +1 540 772 7950
www.plastics1.com
System Combines Optical and
Electrical Signalling in Single Connector
Molex Inc. has introduced the MediSpec Hybrid Circular MT Cable and Receptacle
System, an integrated optical and electrical product that reduces the number of
connectors required in medical equipment and devices. The multifunctional connector
has three configurable MT ferrulecompatible ports for a combination of copper or
fibre media carrying electrical power, low-speed copper signalling, optical data or
video signals.
The MediSpec Hybrid Circular MT system offers a more-streamlined approach to
medical system design and is suitable for a variety of applications including robotic
surgery, neurosurgery, orthopaedic surgery, diagnostic imaging, optical coherence
tomography, guidance/illumination/navigation, interventional energy lasers and pic-
ture archiving and communication systems (PACS).
Molex Deutschland GmbH
Walldorf, Germany +49 6227 309 10
www.molex.com
Connectors and Wires
EMDT1207 046 46 7/12/12 5:23:46 PM
Exhibition and Conference
The International
Exhibition and Conference
of Manufacturing and
Automation Technology,
Materials and Outsourcing for
Medical Device Manufacturers
Based in Ireland
www.medtecireland.com
Sponsored by:
10-11 October 2012 - Radisson Blu Hotel - Galway, Ireland
2
2
6
9
6
_
I
R
_
M
T
1
2
For more information and to register, please visit:
EMDT1207 047A 47A 7/12/12 5:23:53 PM
MARKETPLACE
In Focus
Medical-grade filters
Medical-grade flat fabric filters from
Pneuline Supply are welded into the
housing to prevent the filters from
collapsing. These filters combine various
housing materials with a range of fabric
selections. They can be used for filtering
gases and fluids including numerous
chemicals. The firm offers a combination of
barb fittings for various tubing diameters.
Bodies can be moulded from nylon,
polycarbonate, glass-filled polypropylene
and PVDF materials; and filter materials
include nylon, polyester, polypropylene
and PVDF. The welded filters range in size
from 1 to 250 m in nylon and polyester.
The company also offers a selection of
polypropylene and PDVF filters ranging
from 105 to 250 m.
Pneuline Supply Inc.
Greeley, CO, USA +1 970 506 9670
www.pneulinesupply.com
Microfiltration devices
Microfiltration devices manufactured
by GVS respond to the demands of both
liquid and air filtration in the medical
environment for end-users and OEMs.
The patented technology developed by
GVS in the field of liquid filtration and
the development of modified media ensure
cost-effective, high-precision products that
deliver accurate and stable flow.
The line of IV flow regulators and Easy-
drop, Eurodrop and Crystaldrop products
respond to specific problems, such as the
inconsistent performance of roller clamps.
The GVS IV flow regulator, for example,
ensures a stable flow rate over 24 hours
of infusion, making it suitable for critical
applications. The large channels and tri-
ple labyrinth path prevent clogging, and
downstream use of the companys Speed-
flow IV filter eliminates contaminants.
For air filtration, the firms Air Safety
division provides bespoke design and
manufacturing services along with a range
of proprietary devices.
GVS SpA
Zola Predosa, Italy +39 0 5161 76311
www.gvs.com
Sterilising-grade filtration
Mott Corp. has developed an all-metal
filter media that performs sterilising-grade
filtration to ASTM F838-05. Sterilising-
grade filters are suitable for devices that
require a stronger, more durable and longer
lasting filtration component. They are
biocompatible, impervious to solvents and
compatible with most organic compounds
and complex drug chemistries. Offered in
316L stainless steel and titanium, the filters
can be integrated into implantable devices.
Mott Corp
Farmington, CT, USA +1 860 747 6333
www.mottcorp.com
Silent-Running Cleanroom Filters
Air for Ophthalmic Device Manufacturer
Connect 2 Cleanrooms has delivered a modular cleanroom to German ophthalmic
device manufacturer Morcher. Specialising in intraocular lens implants, Morcher uses
micromanufacturing methods to develop and fabricate implants for cataract surgery.
The company needed a clean air filtration system for its production area to achieve
particle counts in accordance with ISO 14644-1 Class 7. Connect 2 Cleanrooms,
which designs freestanding cleanroom systems with HEPA filtration, installed a
system with built-in fan units in Morcher's facility that achieves 99.99% efficiency at
0.3 m.
The modular cleanrooms HEPA filtration features a combination of low sound,
low wattage and a low profile. Emitting only 51 dBA, the 600 x 1210 mm HEPA
filter fan unit (FFU) is described as one of the quietest FFUs available.
Connect 2 Cleanrooms Ltd
Kirkby Lonsdale, UK +44 1524 274 170
www.connect2cleanrooms.com
Filtration
EMDT1207 048 48 7/10/12 5:24:04 PM
MVENPICK HOTEL ZRICH REGENSDORF, SWITZERLAND
12-13 SEPTEMBER 2012
3
R
D

E
D
I
T
I
O
N
www.orthoteceu.com
THE ANNUAL EUROPEAN ORTHOPAEDIC
DESIGN AND MANUFACTURING
CONFERENCE AND EXHIBITION
A tailored event for orthopaedic product
development leaders
t Driving innovation
t Reducing manufacturing costs
t Accelerating time-to-market
OrthoTec Europe Features:
t Over 80 international suppliers of orthopaedic manufacturing and
technologies
t Two-day high level conference adressing new trends in R&D and
manufacturing, global regulatory updates and new market opportunities
NEW! ORTHOTEC INVESTMENT HUB FOR
ORTHOPAEDIC START-UP
Who is attending?
Leading international SME and OEM managers from orthopaedic
companies involved in:
t Senior Technical and Corporate
Management
t R&D
t Production and Manufacturing
t Product Development Engineering
t Packaging Engineering
t Purchasers / Procurement
t Financial and Legal
Representatives
t Investment
Strategic Partner: MEDTEC
Official Media Partners:
EM1207 049 49 7/13/12 1:28:57 PM
Advertiser Page Advertiser Page
ADVERTISERS INDEX
Fortimedix bv ................................................................................ 7
www.fortimedix.com
Innovative Europe ........................................................................52
www.lcdarms.eu
Interface Catheter Solutions ........................................................ 13
www.interfaceusa.com
Introtek International ..................................................................43
www.introtek.com
Jiuhong Medical Instrument Co. ..................................................... 4
www.jiuhongmed.com
L. Klein SA ..................................................................................29
www.kleinmetals.ch
Machine Solutions ......................................................................... 5
www.machinesolutions.com
Master Bond Inc. ........................................................................32
www.masterbond.com
Medical Extrusion Technologies Inc. ............................................ 15
www.medicalextrusion.com
MicroLumen Inc. .................................................................... 25, 27
www.microlumen.com
MPS AG .......................................................................................38
www.mpsag.com
MS Techniques ............................................................................36
www.ms-techniques.com
Multivac GmbH ............................................................................ 21
www.multivac.com
Plastics One Inc. ........................................................................... 6
www.plastics1.com
Qosina Corp.................................................................................45
www.qosina.com
Riverside Medical Packaging Ltd ...................................... Classified
www.riversidemedical.co.uk
Sphinx Tools Ltd ..........................................................................37
www.sphinx-tools.ch
WL Gore & Associates Inc. ........................................................... 19
www.gore.com
Amsonic ...................................................................................... 32
www.amsonic.com
Applied Plastics Co. ......................................................... Classified
www.appliedplastics.com
Ark-Plas Products Inc. ................................................................... 4
www.ark-plas.com
Atlantic University Alliance ......................................................... 17
www.aua.ie
Azurea .......................................................................................36
www.azurea.ch
B. Braun OEM Division, B. Braun Medical ........................................ 9
www.bbraunoem.com
Carniaflex srl ................................................................................ 6
www.carniaflex.com
Cendres + Mtaux ......................................................................39
www.cmsa.ch/en/Pages/default.aspx
DCA Design International ............................................................... 2
www.dca-design.com
Fort Wayne Metals Research Products Corp. ................................ 11
www.fwmetals.com
CLASSIFIEDS
To advertise in this section please contact
Hermann Jordi, e-mail: hermann.jordi@jordipublipress.ch
tel. +41 32 666 3090 fax +41 32 666 3099
Marketing
25 Edicott St., Norwood, MA 02062
general@appliedplastics.com
www.appliedplastics.com
This index is offered as a service. The Publisher cannot be held
responsible for errors or omissions.
EMDT1207 050 50 7/12/12 5:26:26 PM
The Industrys
Premier Design Awards Program
Presented by:
Transforming HealthcareOne Innovation at a Time
www.MDEAwards.com
Visit our website for complete information.
Platinum sponsor:
Silver sponsor:
Endorsed by:
EMDT1207 051 51 7/12/12 5:26:30 PM
monitors laptops
tablets keyboards
Custom mounting solutions for...
www.LCDarms.com
Innovative has worked with such prestigious healthcare institutions and partners as:
American Red Cross, Astra Zeneca, Beckman Coulter, Carstens, Childrens Hospital Los
Angeles, Fresenius Medical Care, Jefferson University Hospitals, Lilly, Mayo Clinic,
Siemens, Thermo Scientific, Vanderbilt University Medical Center.
2012 Innovative Office Products. US and Intl Patents Pending. Innovative Europe ApS | Copenhagen, Denmark | +45 469.490.79
Let us create a unique mounting
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EMDT1207 052 52 7/12/12 5:26:34 PM

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