FULLTEXT01

An alignment tool
for prosthetic
components
A conceptual development
PAPER WITHIN Product development with specialization in assistive technology

AUTHOR: Robin Johansson
TUTOR: David Rusaw and Melina Ettehad
JÖNKÖPING June 2022
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This exam work has been carried out at the School of Health and Welfare, Jönköping
University, in the subject area product development with a specialization in assistive
technology. The work is a part of the master’s program MASTech. The author takes
full responsibility for opinions, conclusions and findings presented.
Examiner: Marisol Rico Cortez
Supervisors: David Rusaw and Melina Ettehad
Scope: 30 credits (second cycle)
Date: 2022-05-25
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Abstract
Prosthetic alignment is the principle of the position and orientation and of the components in a
lower limb prosthesis to achieve desirable biomechanical characteristics. Poor alignment of
lower limb prostheses is related to decreased balance, knee and hip arthritis, and higher
energy expenditure for the user. Clinicians, the prosthetists, have declared they need better
tools and increased knowledge in how to perform lower limb prosthetic alignments. Therefore,
the aim was to develop a tool concept for clinicians to use in the prosthetic alignment process.
This thesis mapped out most of the variables a clinician must consider in the alignment
process, identified the clinicians needs of an alignment tool, and screened the market for
existing solutions. A systematic approach was applied to develop a conceptual tool from the
gathered information. The needs of the customer were based on interviews with clinicians and
competing products were benchmarked. Two different conceptual tools were developed,
tested with clinicians with promising results, and presented in this thesis. Due to confidentiality
agreements with the cooperating company, the designs and functions of the final concepts
cannot be shown in the report and are therefore covered in the publication.
Keywords: Prosthetics, alignment, malalignment, misalignment, artificial limb, design, product

development.
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Sammanfattning
Protesuppställning är principen av att orientera och positionera komponenterna i en benprotes
för att uppnå önskvärda biomekaniska egenskaper. Undermålig protesuppställning är relaterat
till försämrad balans, knä- och höftartros, samt högre energiförbrukning hos användaren.
Ortopedingenjörer har uttalat att de behöver bättre verktyg och ökad kunskap kring hur man
bäst utför uppställning för benproteser. Uppsatsen ämnade därför att utveckla ett
verktygskoncept för ortopedingenjören att använda i protesuppställningen. Den här uppsatsen
har kartlagt de flesta variabler som en ortopedingenjör behöver överväga i
uppställningsprocessen, identifierat ortopedingenjörers behov i ett uppställningsverktyg, samt
undersökt marknaden för existerande lösningar. Ett systematiskt tillvägagångsätt användes för
att utveckla ett konceptuellt verktyg baserat på den insamlade informationen. Kundens behov
identifierades genom intervjuer med ortopedingenjörer och konkurrerande lösningar
sammanställdes i en konkurrensanalys. Två olika konceptuella verktyg utvecklades, testades
tillsammans med ortopedingenjörer med lovande resultat, samt har presenterats i denna
uppsats. På grund av sekretessavtal med företaget som ingått i samarbetet kunde designen
och funktioner, som ingår i de slutliga koncepten och resultatet, inte visas i denna rapport och
är därmed övertäckta vid publicering.
Nyckelord: Protes, uppställning, inställning, felställning, konstgjord kroppsdel, design,

produktutveckling
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Acknowledgements
Anna Lára Ármansdóttir, Friðrika Björk Þorkelsdóttir and Guðfinna Halldórsdóttir –
Thank you for your valuable support and discussions during my time at Össur.
David Rusaw and Melina Ettehad – Thank you for your input, your support, and insights
during my writing of this thesis.
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Abbreviations and glossary
Abduction movement or angle of a limb away from the midline of the body
Adduction movement or angle of a limb closer to the midline of the body
Anterior a position or movement relating to the front of the body
ASIS anterior superior iliac spine
CAD computer aided design
Contracture a permanent tightening of soft tissue which limits the range of motion
in a joint
CPO certified prosthetist orthotist
Distal indicates a part of the body which is further away from the body centre
Dorsiflexion a movement where the top side of the foot moves closer to the leg.
Extension movement that increases the angle between two body parts
Flexion movement that decreases the angle between two body parts
GRF ground reaction force
IFU instructions for use
Inferior indicates a position or movement further from the head relative to
another position
Plantarflexion a movement where the top side of the foot moves away from the leg.
Posterior a position or movement relating to the back of the body
Proximal indicates a part of the body which is closer to the body centre
SRM socket reaction moment
Superior indicates a position or movement closer to the head relative to another
position
Tilt/angle change in angles between two prosthetic components
Translation/shift change in position between two prosthetic components without
changing angles
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Table of Contents
1 Introduction .................................................................................................................... 9
1.1 Background ............................................................................................................. 9
1.1.1 The Össur company ......................................................................................... 9
1.2 Assigned task and description of problem ............................................................... 9
1.3 Aim and research questions ...................................................................................10
1.4 Delimitations...........................................................................................................11
1.5 Disposition .............................................................................................................11
2 Theoretical background .................................................................................................12
2.1 The prosthesis user ................................................................................................12
2.1.1 Lower limb amputation levels ..........................................................................12
2.2 Alignment ...............................................................................................................13
2.3 Anatomical planes ..................................................................................................13
2.4 The lower limb prosthesis .......................................................................................14
2.4.1 Componentry of a lower limb prosthesis ..........................................................14
2.5 Component cartesian coordinates ..........................................................................18
2.6 Biomechanics .........................................................................................................20
2.7 Alignment techniques .............................................................................................21
2.8 The prosthetist .......................................................................................................22
3 Method and implementation ..........................................................................................23
3.1 Connection between Research Questions and Methods ........................................23
3.2 Framework .............................................................................................................23
3.3 Competitor analysis ................................................................................................25
3.4 Identify customer needs .........................................................................................25
3.4.1 Interview..........................................................................................................25
3.4.2 The identified needs ........................................................................................26
3.5 Generate product concepts ....................................................................................27
3.5.1 Brainstorming ..................................................................................................28
3.5.2 Sketching ........................................................................................................28
3.5.3 Benchmarking .................................................................................................28
3.5.4 CAD ................................................................................................................28
3.5.5 3D-printing ......................................................................................................29
3.6 Select product concepts .........................................................................................29
3.6.1 Pugh Matrix .....................................................................................................29
3.7 Test product concepts ............................................................................................32
3.7.1 Prototypes and rapid prototyping .....................................................................32
3.7.2 User observation .............................................................................................35
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3.8 Validity and reliability ..............................................................................................36
4 Results ..........................................................................................................................38
4.1 Overarching aim .....................................................................................................38
4.1.1 Concept 1........................................................................................................38
4.1.2 Concept 2........................................................................................................38
4.1.3 Complementary software ................................................................................40
4.2 Results RQ1 ...........................................................................................................41
4.3 Results RQ2 ...........................................................................................................42
5 Discussion .....................................................................................................................44
5.1 Method and findings ...............................................................................................44
5.2 Ethics .....................................................................................................................46
5.3 Research questions................................................................................................46
6 Conclusion ....................................................................................................................49
6.1 Future work ............................................................................................................49
6.2 Conclusion .............................................................................................................49
7 References ....................................................................................................................51
8 Appendices ...................................................................................................................56
8.1 Appendix 1: Interview guide ...................................................................................56
8.2 Appendix 2: Benchmarking.....................................................................................57
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1 Introduction
This report is carried out as a master’s thesis within the field of Product Development with a
Specialization in Assistive Technology. The first chapter contains general information about
the background, the company, the assigned problem, the research aims, the delimitations, and
the disposition.
1.1 Background
Prosthetic alignment is a term which refers to the position and orientation of prosthetic
components, both in relation to other prosthetic components and the human anatomy. The
process of alignment is the process of setting up the prosthetic components to achieve certain
biomechanical goals (Zahedi et al., 1986). This process is most often performed by a certified
prosthetist but is still considered a highly subjective process, which may be problematic
(Zahedi et al., 1986). It has been shown that prosthetists themselves report lacking tools and
knowledge to perform the prosthetic alignments (Klute et al., 2009). If a prosthesis is
misaligned, it could result in poor biomechanics and consequences such as knee and hip
arthritis (Gailey et al., 2008; T. Zhang et al., 2019, 2020).
1.1.1 The Össur company

Össur is a large enterprise based in Iceland with over 4000 employees globally. Össur
develops, manufactures, and sells non-invasive orthopaedic devices, i.e., orthotics,
compression products, and prosthetic solutions. The main research and development
department for lower limb prosthetics is located in Reykjavik.
1.2 Assigned task and description of problem

At first contact, during the initial internship which took place before this thesis, it was presented
that the company requested to have better possibilities to document their research and
development of lower limb prosthetic components. As of today, it was described that the
prosthetic alignment was a subjective and undocumented process. This led to the alignment
being a possible confounding factor in the development of new prosthetic components during
the evaluation phase, ultimately slowing down the overall development of lower limb
prosthetics.
A deeper investigation into the literature on lower limb prosthetic alignments revealed that this
is a widely spread problem in the field of lower limb prosthetics. It has been found that
clinicians, researchers, and prosthetic users experience that alignments can be problematic
and an increase in knowledge of alignment and alignment measuring systems were requested
(Klute et al., 2009). Moreover, it has been shown that most studies involving prosthetic
alignment solely rely on a prosthetist’s judgment, or a combination of the prosthetist and
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feedback from the prosthetic user, which is lacking standardization, validation, reliability, and
quantification (D. Boone et al., 2012; Davenport et al., 2017; Geil, 2002; Won et al., 2021;
Zahedi et al., 1986).
It has been suggested there is an acceptable range of alignment, which may be narrower when
walking on more complex surfaces (Sin et al., 2001; Zahedi et al., 1986). Also, it was found in
a review that no obvious optimal alignment could be derived from published articles
(Jonkergouw et al., 2016). Even though no optimal alignment could be derived, research has
revealed that misalignment can have various effects on the prosthetic user: altered
biomechanics (D. A. Boone et al., 2013; Fiedler et al., 2016; Hashimoto et al., 2018; Knight et
al., 2021; Parakova et al., 2007; Schmalz et al., 2002; Yang et al., 1991; T. Zhang et al., 2019,
2020), and gait deviations (Beyaert et al., 2008; Fiedler et al., 2016; Fiedler & Johnson, 2017),
possibly resulting in a high prevalence of knee or hip arthritis (Gailey et al., 2008; T. Zhang et
al., 2019, 2020) and higher energy expenditure (Schmalz et al., 2002).
In the study by Klute et al. (2009), clinicians particularly expressed concern about the alignment
of the components of lower limb prostheses which led the authors to conclude that clinicians
need better alignment tools and more knowledge. As the clinicians are the frontline workers to
perform alignments on all lower limb prosthetic devices, they need to be able to translate
alignment recommendations by the manufacturers and researchers to the devices and its end-
user. Therefore, this thesis aims to develop a tool concept for clinicians to use in the alignment
process of lower limb prosthesis components.
1.3 Aim and research questions

The overarching aim of this thesis is to develop a tool concept for clinicians in the alignment of
the components of lower limb prosthetics. To identify the characteristics of such a tool, it would
be fundamental to understand the needs of the clinicians, which will be the first research
question. This research question will be addressed in the results Section 4.2:
RQ1: What needs are there in an alignment tool from a clinician’s perspective?
In discussions with the Össur staff it was stated that it was common that clinicians had
difficulties implementing alignment recommendations in practice, which is supported by Klute
et al. (2009). However, no recent study was identified that investigated the clinician’s opinion
on alignment implementation, which opens up for the possibility that clinicians are now utilizing
tools in the alignment process that better fulfil their needs. Therefore, a second research
question is formulated, which also will be addressed in the results Section 4.3:
RQ2: What tools do clinicians use and what needs do the tools meet?
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1.4 Delimitations
The project is limited by the 20 course weeks available and therefore limited to the concept
development phase, with multiple developed prototypes in the end. The project is also limited
to high-income countries settings, which makes the identified needs perhaps only applicable
to these settings. Final steps to commercialize the product could be taken by the company if
they decide to do so. Because of the author’s background, it is possible that mechanical
designs can be developed for prototyping, but any electronic or software are likely to be
undeveloped as part of this thesis.
1.5 Disposition
Below is Table 1, which describes the layout of the chapters and their contents for the rest of
the thesis.
Table 1 The content and disposition of this thesis.
Chapter title Content

Theoretical background Explanations of fundamental theories and
background information to facilitate an
understanding for the reader
Method implementation Descriptions of framework, methods, and

tools, as well of descriptions of how these
were implemented. Discussion on validity and
reliability of methodology is found last in this
chapter
Results Presentation of conceptual results and the
answers to the research questions
Discussion Discussion on implementation of methods and

the result, discussion about validity, reliability,
and ethical considerations
Conclusions Conclusions from the thesis and suggestions

for future work.
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2 Theoretical background
In this chapter, fundamental theories and definitions will be described to facilitate an
understanding for the reader. Topics that are described and defined relate to the prosthesis
user, the alignment, the anatomical planes, the prosthesis, the principle of biomechanics in
mobility, current alignment techniques, and the prosthetist’s role in alignment.
2.1 The prosthesis user

The typical prosthesis user is an individual who had an amputation. There are several different
reasons for amputation. The leading cause in developed countries is surgical amputation
resulting from complications of conditions that affect blood circulation, such as vascular
diseases, diabetes, and peripheral arterial disease (Shores, 2021). A limb can be surgically
removed also if an infection or cancer threatens the life of the individual. Amputations are
sometimes the result of traumatic incidents where an extremity is torn away or cut off. Some
individuals using a prosthesis have a congenital amputation, i.e., born with a missing or
incompletely formed extremity (Shores, 2021).
The characteristics of a prosthesis user are as unique as any other human being. The
conditions for using a lower limb prosthesis may therefore differ vastly depending on different
factors, which often must be considered when performing an alignment of a prosthesis. For
instance, lower limb prosthesis users are known to have less muscle strength in their residual
limb compared to their intact limb, which consequentially affects balance (Hewson et al., 2020).
Contractures, i.e., limited range of motion, in the knee joint or hip joint are prevalent after
transtibial and transfemoral amputations and may influence the way a prosthesis should be
aligned (Yoo, 2014). Pain is also a variable in people with lower limb amputations, which the
prosthetist must consider when fitting and aligning a prosthesis (Yoo, 2014).
2.1.1 Lower limb amputation levels

There are several lower limb amputation levels (International Organization for Standardization,
2020). Five common amputation levels were visually described by Hussain et al. (2019) for
lower limb levels: foot amputations, transtibial, knee disarticulation, transfemoral, and hip
disarticulation (Figure 1). Amputation level may affect the outcomes of prosthesis use. A more
proximal amputation level is associated with fewer remaining muscles, muscle insertions,
joints, and, therefore, proves a more challenging task to do alignment and achieve desired
biomechanics (Jaegers et al., 1995).
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Figure 1 From Hussain et al. (2019). Level of amputation for lower limb. [picture].
https://www.researchgate.net/figure/Level-of-amputation-for-lower-limb_fig3_337261018
2.2 Alignment
The alignment process of lower limb prostheses is iterative, involving the experience of a
prosthetist, recommendations from prosthetic component manufacturers, and the feedback
provided by the prosthesis user. (Zahedi et al., 1986). The prosthetists often perform an
alignment in three phases: Bench alignment, static alignment, and dynamic alignment
(Zahedi et al., 1986). During the bench alignment, which is done before the user wears the
prosthesis, the prosthetic components are aligned according to the relevant Instruction For
Use (IFU) and certain characteristics of the prosthesis user. In the static alignment, the
prosthesis user wears the prosthesis, and the alignment of components is adjusted to the
user. The dynamic alignment involves the prosthesis user walking, running, and generally
using the prosthesis. At this stage, the prosthetists perform a gait analysis to adjust the
alignment until to optimize biomechanical characteristics of the gait.
2.3 Anatomical planes

To facilitate communication between professions in clinical work, a common language is
needed. The anatomical planes are commonly referred to in work regarding prosthetic
alignment, both in general and in this thesis. The human body can be sectioned into three
planes: sagittal plane, frontal plane, and transverse plane (Betts et al., 2013) (Figure 2). When
an alignment is performed in the sagittal plane, this means that the perspective is perpendicular
to the sagittal plane.
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Figure 2 Planes of the Body. The three planes commonly used in anatomical and medical imaging are the
sagittal, frontal (or coronal), and transverse plane. [picture] https://openstax.org/books/anatomy-and-
physiology/pages/1-6-anatomical-terminology
2.4 The lower limb prosthesis

The modern lower limb prosthesis consists of multiple parts that are assembled and adjusted,
i.e., aligned, to achieve comfort, safety, and certain biomechanical properties. What parts to
assemble depends on many different factors, including residual limb characteristics, general
physical characteristics, clinical conditions, functional capabilities, motivation and perceived
needs, anticipated activity, environmental conditions, locally available products and services,
and social and economic circumstances (International Organization for Standardization, 2008).
2.4.1 Componentry of a lower limb prosthesis

In Figure 3, two common prosthesis types are shown: a transtibial and a transfemoral/knee
disarticulation prosthesis. The numbers indicate the components as follows: 1 – prosthetic foot,
2 – a connecting pylon, 3 – a knee component, 4 – a connecting adapter/pylon, 5 – a
suspending socket, and 6 – pyramid adapters.
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Figure 3 The transtibial (left) and the transfemoral/knee disarticulation prosthesis (right).
2.4.1.1 Foot components

There are several kinds of prosthetic feet and which one to choose depends on multiple
variables, as described in Section 2.4. Different kind of feet could have different
recommendations for alignment, for instance, there are differences in the IFU’s recommended
alignments between a carbon fibre low-activity foot and a carbon fibre running foot (Figure 4).
Figure 4 The alignment bench alignment recommendations in the Instruction For Use for Össur's Proflex LP align
(left) and Cheetah Xceed and Flexrun (right).
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2.4.1.2 Knee components
A knee component is often installed when the anatomical knee is no longer present. The knee
component allows for knee flexion and assists in walking, running, standing, and sitting. There
are many types of prosthetic knee joints, ranging from very simple to highly technical, which
can be categorized into two groups: single-axis and multiple-axis knee joints (Peke Waihanga
Artifical Limb Service, 2022). Different kinds of knee components have different recommended
alignments, with subtle differences, for the knee to be safe and function as intended. Each
prosthetic component is delivered with an IFU, where recommendations for alignment usually
are presented for the prosthetist to implement (Table 2, Figure 5).
Table 2 The table exemplifies different static alignment recommendations for Össur knees in the sagittal plane
with the use of a load line reference produced with a force plate.
Knee Load line

reference distance Load
point from KPR line on
Össur knees (KPR) (mm) foot
Rheo/Rheo XC -30
MAUCH/MAUCH PLUS Single Centre of -35
OP4/Balance OFM2 knee axis rotation -40
Centre
Locking knee -45
of foot
Total knee 1900/2000/2100 Anterior -30
Multi
PASO/OH7/OH5/OP5/OHP3 knee superior -35
axial
Balance OM8/OFM1 axis -40
Figure 5 Examples of bench alignment recommendations from the Instruction For Use of the Össur Mauch knee
(left), Össur Cheetah knee (middle left), Össur Total knee (middle right), and Ottobock Kenevo knee (right).
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2.4.1.3 Socket types
There are multiple types of socket shapes for both transtibial and transfemoral prostheses
(Paternò et al., 2018) (Figure 6). The prosthetist usually decides what type of socket is suitable
for the prosthesis user and the different variants could influence different outcomes such as
comfort and biomechanics. The differences in socket design add to the complexity when
performing alignment, as it is possible that a certain alignment works better with a certain
socket design.
Figure 6 Modified from Paterno et al. (2018); ICS = Ischial Containment Sockets; PTB = Patellar Tendon Bearing;
SC = Supra Condylar; SCSP = Supra Condylar Supra Patellar; PTK = Patellar Tendon Kegel; KBM = Kondylen-
Bein-Muenster; NSNA = Normal Shape-Normal Alignment; narrow ML = narrow Medio-Lateral; CAT-CAM =
Contoured Adducted Trochanteric-Controlled Alignment Method; MAS = Marlo Anatomical Socket; QUAD =
quadrilateral; VAS = Vacuum Assisted Socket). [picture] https://www.researchgate.net/figure/a-Schematic-
representation-of-the-different-anatomical-positions-typically-used-to_fig3_322667772
2.4.1.4 Adapters
A lower limb prosthesis more often than not include the use of adapters between the rest of
the components. The pyramid adapter is an adapter which allows for alignment adjustments
in two planes. The most basic pyramid adapter consists of a male and a female part (Figure
7). There are screws in the female parts which are adjusted to change the orientation
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between the male and the female component. Other variants of adapters allow for additional
degrees of freedom, for instance rotation or translation of a component (Figure 8).
Figure 7 From College Park. The male and female parts of a pyramid adapter. [picture] https://www.college-
park.com/media/catalog/product/cache/1/image/1200x1200/602f0fa2c1f0d1ba5e241f914e856ff9/e/n/endo-kit-ss-
1200_1.png
Figure 8 From Ottobock. A pyramid adapter with rotational control and translating function. [picture]
https://shop.ottobock.ca/fr/Proth%C3%A8ses/Membre-inf%C3%A9rieur/Adaptateurs-Composants-
structurels/ADAPTATEUR-DE-TRANSLATION/p/4R103
2.5 Component cartesian coordinates

Because of the unique characteristics of each individual’s residual limb, and the many different
types of socket geometries declared in Section 2.4.1.3, it is a challenge to find a common
reference system for the prosthetic sockets. One attempt to define a reference system was
made by Zahedi et al. (1986), where a midline is visualised through the socket and cartesian
co-ordinates can be defined (Figure 9). Two planes are defined in relation to the user’s line of
progression, positioned perpendicular to the midline and 25mm from the distal end and 25mm
from the patella bar (on the transtibial socket) or the lower socket brim (on the transfemoral
socket) (Figure 10). By personal experience it seems that, in clinical practice, this midline is
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often merely imagined by the clinician in the alignment process. In research, Zahedi’s et al.
(1986) article on alignment and principle of defining a socket midline seem to still be often cited
and used, and, to the author’s knowledge, the latest scientific article on that specific matter.
Figure 9 Cartesian co-ordinate system visually defined, and the visualised socket reference planes. (Zahedi et al.
1986)
Figure 10 Socket axis reference system visualizing how a midline would be defined on a transtibial and
transfemoral prosthesis socket. (Zahedi et al 1986)
The other components can also be described with Cartesian coordinates. The components
can be translated along the X (red), Y (green), and Z (blue) axis, and rotated (yellow) around
each axis, giving them a total of 6 degrees of freedom per component (Figure 11). These
translations and rotations are referred to in different ways in clinical practice. For instance,
rotation of the socket around the Z (blue) axis would be spoken of as flexion or extension of
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the socket, but sometimes also as posterior or anterior tilt. If the socket, the knee, or the foot,
would be rotated around their Y (green) axis, this would be referred to as internal or external
rotation of the component. If the foot component would be translated, or shifted, posteriorly of
the socket, this refers to the foot moving along the X (red) axis in the opposite direction of the
body’s progression.
Figure 11 Cartesian coordinates visualized for the individual components in prosthesis setups. Red is the X-axis,
green is the Y-axis, and blue is the Z-axis. The yellow arrows indicate rotation around the X, Y and Z axis.
2.6 Biomechanics
The biomechanics of a prosthesis can be altered as a result from adjustments to the prosthesis
alignment. An illustrative example is seen in Figure 12, where a heel contact is shown in the
sagittal plane perspective. In the left frame, the Ground Reaction Force (GRF) results in a
neutral moment at the hip joint, a flexing moment in the knee joint component, and a
plantarflexion moment in the foot component. In the right frame, the foot component has been
translated anteriorly in relation to the knee joint and socket. Hence, the GRF will be positioned
more anteriorly in the same gait phase, resulting in a flexing moment at the hip, a neutral
moment at the knee joint, and a smaller plantarflexion moment at the foot component. The
GRF acts on joints and components in three dimensions, therefore the alignment would be
relevant to consider in all anatomical planes.
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Figure 12 Example of how biomechanics can change due to alignment changes. In the left illustration, the foot
component is positioned more posteriorly in relation to the knee and socket, than in the right illustration.
2.7 Alignment techniques

There are currently some available technologies and methodologies for performing objective
and quantifiable alignments. Some methods rely on a vertical axis or anatomical landmarks as
references (Ikeda et al., 2012; Lin et al., 2000; Tafti et al., 2020; Zahedi et al., 1986), often
used together with plumb lines or line laser instruments. The approach of these methods is to
define the orientation and position of the components by quantified measurements in relation
to common reference points and lines. In the alignment process, these approaches are
applicable to the bench and static alignment. Some instruments rely on either Socket Reaction
Moments (SRM) (Chen et al., 2016; Hashimoto et al., 2021; Jonkergouw et al., 2019;
Kobayashi et al., 2015) or Ground Reaction Forces (GRF) (Bellmann et al., 2018; Blumentritt,
1997; Chagas et al., 2020; Talaty & Esquenazi, 2013; X. Zhang et al., 2018). Both these
approaches quantifies alignment by measuring the forces that acts on components and joints
to ensure these are suitable for the user and the components. The SRM and GRF approaches
are applicable to the static alignment and dynamic alignment phases. It is also possible to do
prosthetic alignments utilizing motion capture system (Zabala et al., 2020) or radiography
(Mooney et al., 2013).
Each approach has their benefits and drawbacks. For instance, the novelty of line lasers and
vertical axis reference, often used in clinical settings because its utility and availability, may
lack high precision and does not reveal how forces act on the prosthetic user. In contrast,
methods involving instruments to visualize GRF or SRM may have high precision and assists
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in understanding otherwise invisible variables but are currently pricy and sometimes
unavailable (especially in less developed countries). Lastly, motion capture systems and
radiography are high precision approaches as well, if utilized correctly, but are complex and
often unavailable in the prosthetist’s clinical setting. Moreover, the radiography approach may
be target for an ethical discussion, as the alignment process is iterative by nature and often
requires many adjustments to find the most satisfactory alignment, and radiation exposure is
part of the radiographic methodology.
2.8 The prosthetist

The prosthetist is often the clinician who performs and is responsible for the alignment process
of the components in a prosthesis. The clinician needs to consider several factors in the
alignment, such as keeping updated on the latest research regarding alignment,
recommendations from the manufacturers of prosthetic components, and the many variables
surrounding the prosthesis user (Figure 13). The clinicians incorporate all these factors and
apply their own clinical experience to perform the alignment. After a meeting between a
clinician and a patient, the clinician should document and journal the content of that meeting.
The reason for this is traceability and patient safety. As mentioned previously, Klute et al.
(2009) indicated that clinicians lack sufficient tools to perform the alignment, which makes it a
challenge to both perform and document alignment settings.
Figure 13 The prosthetist is the person who performs lower limb prosthesis alignment derived from multiple
different factors.
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3 Method and implementation
The characteristics of this thesis study were of conceptual development nature with the main
aim of developing a tool concept for clinicians to use in the alignment process of lower limb
prosthesis components. In this chapter, the reader can find descriptions of what, why, and
how, methods and tools were implemented in practice throughout the whole development
process. A section discussing the validity and reliability of the implemented methods and tools
can be found at the end of the chapter.
3.1 Connection between Research Questions and Methods

In the table 3 below, the relations between the methods, the tools, and the aims of the thesis
are indicated. Here are the aims and research question:
Main Aim: Develop a tool concept for clinicians to use in the alignment process of lower limb
prosthesis components.
RQ1: What needs are there on an alignment tool from a clinician’s perspective?
Table 3 The table indicates what methods or tools were user to address each aim or research question.
MAIN AIM RQ1 RQ2

FRAMEWORK X
INTERVIEWS X X X
NEEDS IDENTIFICATION X X X
BRAINSTORMING X
SKETCHING X
BENCHMARKING X X
CAD X
3D-PRINTING X
LITERATURE STUDY X
PUGH MATRIX X
USER OBSERVATION X
3.2 Framework
To increase the chance of a successful conceptual outcome for this thesis, a framework was
be used to structure the development process. Employing a formal process for steps such as
idea generation and concept development is one of several key features that distinguish the
25% best performing companies from the rest in terms of sales and profit success (Crawford
23
& Di Benedetto, 2021). For this thesis, the book “Design and development” by Ulrich et al.
(2020) was chosen to inspire the framework of this thesis. This approach was suitable because
it was investigated in the study with the verdict that it has been widely and effectively used in
education as a way to define a development process (Tomiyama et al., 2009). It was defined
as a process that is “concrete and general”, i.e., the category of methods that aims at concrete
methodological descriptions but applies to several types of products. Although Ulrich et al.
(2020) claimed the framework to be universal, the study by Tomiyama et al. (2009) stated one
disadvantage of the method was that it has not been used widely in industry and is possibly
limited to use in mechanical product design, a limitation suitable for this project. In contrast to
the statement by Tomiyama et al. (2009), this framework has been successfully utilized in
previous master’s theses (Stridh & Lindström, 2010; Wikström, 2022) and development work
in assistive technology (Abu-Abdoun et al., 2022). As mentioned in the Delimitations Section,
this thesis will be isolated to the conceptual phase according to Ulrich et al. (2020) (Figure 14).
Figure 14 The concept phase framework, adapted from the framework by Ulrich et al. (2020).
A concept has been defined by Andreasen et al. (2015) as “a proposal for a product’s
composition and issues that is detailed enough to justify it as a good answer to the task and
intention”. Ulrich et al. (2020) defined a concept in a similar way: “a description of the form,
function, and features of a product”, but also added that it would often be accompanied by
technical specifications and justifications in terms of economic analysis and competitor
analysis.
Although the chosen framework was expected to facilitate better outcomes in achieving the
overarching aim of this thesis, it was not to be applied blindly, according to Ulrich et al. (2020).
Certain parts of the framework could therefore be applied and modified to better suit the
circumstances of each specific project, whilst other parts could be omitted if they were out of
the scope. For instance, for this concept development, performing an economic analysis was
omitted as it was not needed to fulfil the aims and research questions.
24
3.3 Competitor analysis
An investigation of literature was conducted to map out currently existing methods and
apparatuses which could be used in an alignment process. Creating an understanding of this
could facilitate development steps such as concept ideation and benchmarking of competitive
products. The literature search was conducted within the Pubmed, Google Scholar, and
Patentscope databases. The data gathered from the search was used to assemble the
benchmarking table, found in Section 3.5.3 and Appendix 2.
3.4 Identify customer needs

In order to find answers to both RQ1 and RQ2, and fulfil the main aim, the needs and voice of
the user would be critical to identify, much like in any new product development project
(Andreasen et al., 2015; Crawford & Di Benedetto, 2021; Ullman, 2010; Ulrich et al., 2020).
The process to identify customer needs is often to first identify who the customer is, then gather
data from the customer, which is interpreted in terms of needs and then organized in a
structured manner. There are both obvious needs and latent, or hidden, needs to identify. The
goal with identifying and defining the customer’s needs is to ensure that the product is focused
on these and that no critical needs are missed or forgotten. Moreover, having a defined set of
needs can facilitate a common goal and understanding of a project within a development team
(Ulrich et al., 2020).
3.4.1 Interview
Several different approaches can be employed to gain information from target groups: paper
or online surveys, individual interviews, focus group interviews, or observing the users in their
operative settings. Interviewing the real users of the product is an effective method to gain
insight in the needs of a product (Crandall, 1998). Although focus group interviews seem to
result in the most expressed needs per session, individual interviews would be the most cost-
effective option (Ulrich et al. 2020), as they require less time and are easier to arrange. The
personal meeting is also superior to surveys or telephone-based meeting because the
interviewer can pick up body language and better identify latent needs through in-depth
questions (Ulrich et al., 2020).
The interviews in the work of this thesis were semi-structured, i.e., an interview guide was
developed to serve as a framework for the interviews, but additional questions or follow-up
questions were allowed to create a more relaxed atmosphere and possibly detect any hidden
needs. The full interview guide can be viewed in Appendix 1. Some examples of questions
from the interview guide are:
• Can you tell me about how you do the alignment of a transtibial and transfemoral
prosthesis?
25
• What is important to you when you do the alignment?
• What would be key features of a new tool, in your eyes?
In this thesis, a total of five interviews were conducted, four via online meeting and one physical
meeting. The clinicians interviewed were active in Canada, Sweden, and Iceland, which gives
a representation of developed settings. The interviews were approximately an hour each. Five
individual interviews would cover 75-80% of all needs in a product (Figure 15) (Griffin &
Hauser, 1993).
Figure 15 Graph from the book by Ulrich et al. (2020).
3.4.2 The identified needs
From the interviews, 38 needs were identified. The 38 needs were arranged in groups in
discussion with colleagues in Össur. These group were based on different properties, such
as functional properties, physical properties, applicability to users, and goals and effects of
use, as seen in Figure 16.
26
••• The device is easy to operate ••• The device is a good investment
••• The device is safe to use ••• The device helps in increasing the overall
•• The device is usable for inexperienced quality of prostheses
•• The device is easy to learn how to use •• The device is affordable to purchase
•• The device is easy to calibrate •• The device saves time during alignment
•• The device is easy to read values from •• The device requires little effort from
•• The device is intuitive to use • The device helps reduce re-visits to clinic
•• The device has a good guide on how to use • The device is backed-up by science
• The device is operable from a distance
• The device is easy to set up in different •••The device helps with documentation of
environments alignment
•• The device helps with journaling of
••• The device applies to unique features of •• The device facilitates communication
patients patient and CPO
••• The device is applicable to above-knee
prostheses •• The device helps finding position and
•• The device is applicable to below-knee orientation of prosthetic components
prostheses ••• The device decreases alignment subjectivity
•• The device helps teach and learn alignment ••• The device ensures that prosthetic
• The device utilizes several approaches to component manuals can be followed
alignment •• The device helps finding position and
• The device applies to other patient groups orientation of socket
•• The device helps finding position and
•• The device is reliable in its function orientation of prosthetic knee joint
••• The device is precise in its measurements •• The device helps finding position and
••• The device is accurate in its measurements orientation of prosthetic foot
••• The device takes up a small area •• The device helps detect prosthetic
•• The device is pretty lightweight malalignments
• The device tolerates some dust • The device helps position socket adapter
• The device helps replicate alignments
Figure 16 The needs identified from the interviews, categorized into groups based on similarities. Each need was
given importance rating, where three dots indicate high importance and one dot indicate less importance. Needs
in bold indicate the start of a new group, followed by the similar needs.
3.5 Generate product concepts

The concept generation process was not a clearly defined single event but was a rather long
process that overlapped other activities, just as Ulrich et al. (2020) described. Different tools
were utilized in the concept generation phase, which are explained in the subchapters to this
chapter.
To facilitate the ideation process, the alignment process was also broken down into several
subproblems to be solved, based on findings from the literature study, for instance, how to
measure a specific degree of freedom for a specific component, or the different alignment
phases which a prosthetist would go through. Moreover, different approaches to assess
alignments were investigated, e.g., the use of Ground Reaction Forces, Socket Reaction
27
Moments, vertical line reference, the use of light or sound for gait analysis, but also scientific
articles on alignment procedures were investigated. In total, 13 refined concepts were
produced during the generation process, which characteristics may not be revealed due to
disclosure agreement reasons.
3.5.1 Brainstorming
A fundamental approach for idea generation was to start each morning with a brainstorming
session, where 5-10 ideas were generated, either as simple sketches or short sentences.
Brainstorming has been described as a process conducted by a team or an individual where
human creativity is used to generate conceptual solutions, and to facilitate an uninhibited
flow of ideas, no judgment should be passed and all ideas should be welcomed (Ulrich et al.,
2020). The identified needs, the benchmarking (Appendix 2), patents, and other unrelated
sources of inspiration were utilized to facilitate the brainstorming sessions.
3.5.2 Sketching
Sketching was used during the brainstorming sessions. The purpose of this was to ideate and
visualize new ideas, refining previous ideas, and to communicate them to the Össur staff and
the thesis supervisors. Sketching has been described as a method of quick freehand drawing
intended to create many models, ideas, designs, and principles, in a fast, rough, and dirty
manner (Andreasen et al., 2015). Sketching can be performed in multiple mediums, such as
2D sketches with pen and paper, or 3D sketches from mediums like clay or 3D printing (Ulrich
et al., 2020). At the end of concept ideation, around 70 simple sketches were produced which
were implemented in 13 more refined conceptual sketches with written descriptions.
3.5.3 Benchmarking
To facilitate ideation, benchmarking was used. The information in the benchmarking (Appendix
2) was a result from the literature study. Benchmarking has been described as the principle of
assembling a spreadsheet with information on competitive products to get a better perception
of the goals of the current product development (Ulrich et al., 2020). In product benchmarking,
variables such as physical properties, such as weight and size, product price, actions and time
needed to perform a task with the product, and other technical specifications.
3.5.4 CAD
Computer-Aided Design (CAD) has been described as a method where software is used to
create 3-dimensional models of a product. The CAD models could quickly be created and
modified to facilitate communication between team members or stakeholders of product
development. (Ulrich et al., 2020). Moreover, the CAD models could be used for analytical
work, e.g., strength or flow simulations. In the ideation process, CAD software was used as a
28
tool to visualize ideas and the 3D-models could also be used to 3D-print real-life models to
facilitate further ideation.
3.5.5 3D-printing
3D printing could be described as an additive manufacturing method which builds up the object
layer by layer, either by extruding material, e.g., plastics, or by solidifying a layer of liquid or
powder with the help of laser or UV light (Ulrich et al., 2020). The method allows for a high
degree of design freedom, e.g., the possibility of creating geometries which are difficult to attain
in traditional manufacturing methods. The results from 3D-printing were physical objects, both
physical functioning and non-functioning, to evaluate shapes or functions, as part of the
ideation process. Both CAD and 3D-printing were also used to create prototypes, which can
be read in Section 3.8.1.
3.6 Select product concepts

As a next step, 13 refined conceptual sketches from the concept generation process, needed
to be filtered down to fewer and stronger concepts. For this reason, Pugh decision matrices
were used in two steps: The first matrix would support discussions on what concepts to include,
combine or exclude. The second matrix would support decision on what concepts would
progress for prototype production.
3.6.1 Pugh Matrix

As developed by Stuart Pugh, the Pugh matrix is a decision matrix tool to support the
conceptual phase in order to effectively narrow down and produce stronger concepts (Ulrich
et al., 2020). There are other alternative tools for this purpose, but the Pugh matrix has been
shown to be the most effective for creative and successful concepting (Frey et al., 2009). The
matrices were constructed so that the concepts were in the columns and the criteria, which the
concepts would be assessed against, were stated in the rows. One concept was selected as
a reference, or datum, to which the other concepts would be compared. If a concept were
better, similar, or worse, than the reference concept, the cell would be marked with (+), (=), or
(-), respectively. The scale could be weighted or have higher resolution, but Pugh himself
advocated an unweighted scale (Frey et al., 2009). The scoring of different concepts facilitated
thought processes and supported decision making, as concepts were decided to be further
improved, combined, or excluded. The criteria used in the Pugh matrixes for this thesis were
derived from both the identified needs of the interviewed clinicians (Section 4.2) and criteria
which often were utilized when doing concept assessment within Össur:
• Project complexity: How complex would the project be if moving forward (Company)
• Prototype price: How expensive it would be to build a functional prototype (Company)
• Prototype build time: How time-consuming would it be to make a prototype (Company)
29
• Price for the customer: Estimation of what the price for end-consumer would be
• Complexity of use for customer: E.g., number of actions to use the product
• Intuitive product: Estimation of how “easy to use” the product would be
• Innovative product: How much does it differ from already existing products?
• Product weight: Estimated product weight
• Product size: Estimated product area size used by the product
• Product portability: How easy is the product to bring along
• Patient perception of tool: Estimation of patient perception of the tool
• Fulfils thesis aim: Does the goal of the product align with the aim of the thesis
• Tool objectiveness: Potential to increase objectiveness of alignment
• Tool reliability: Potential preciseness of the tool, repeated measures
• Documentation/journaling: How well the tool could help with documentation
• Quantification: How well the tool could quantify different alignment parameters
In the first Pugh matrix (Figure 17), concepts with high potential were taken directly to the next
matrix, concepts with medium potential were combined with other concepts in a refinement
process, and concepts with little potential were excluded. Because of the difficulty assessing
some criteria, such as project complexity or project cost, the ratings were unweighted and only
given rough estimations compared to the reference concept, to facilitate discussions. The
ratings were discussed together with colleagues in Össur and the supervisors in the thesis
project.
30
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Co t B
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Project Complexity = + - = + - - - = - - - -
Prototype price = + - - + - - - = - - = -
Prototype time = + - - = - - - = - = - -
Price for customer = + + + + - - - = - = - -
Complexity for customer = + + = - - - - - + = = +
Intuitive product = + + + - - + + - + - + +
Innovative product = - - - + + + + + + = + -
Product Weight = = + + + + - = + - + + -
Product Size = + + + + + + + - - + + -
Product Portability = + + + + + + + - - + = -
Patient perception of tool = - + = = + + = + + = = +
Fulfils thesis aim = = = = = = = = = = = - =
Tool Objectiveness = = + + - + - = = + - - +
Tool Reliability = + = = - + + + = + = - +
Documentation/journaling = - = + - - + - - - - - -
Quantification = - - - - = = - - - - - -
Dynamic alignment N N N Y Y Y Y Y Y N Y N N
Static alignment Y N Y Y N Y Y Y Y Y Y Y Y
Bench alignment Y Y Y Y N N Y N N N N Y N
Net score 0 5 3 2 1 0 0 -2 -3 -3 -3 -4 -5
Rank 5 1 2 3 4 5 5 6 7 7 7 8 9
Continue? C C C C Yes No No No Yes C No No No
Figure 17 First concept screening with a Pugh matrix. C = combine with another concept
The second matrix (Figure 18) contained the evolved concepts from the first matrix but also an
addition in terms of a new idea which needed to be assessed. These were then rated to decide
what concepts to make physical prototypes of. The different criteria assessed were the same
as from the first decision matrix. The results from the second Pugh matrix were discussed with
colleagues in Össur to decide what concepts to make functional prototypes of.
31
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Pugh matrix 2
A
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Project Complexity = + - + + - - -
Prototype price = + - + = - = -
Prototype time = + - = = - - -
Price for customer = + = = = = = =
Complexity for customer = + = - - - = -
Intuitive product = + + - - - - +
Innovative product = - + + + + - +
Product Weight = + = + - = + -
Product Size = + = + - - + -
Product Portability = + = + - - + -
Patient perception of tool = - + = + + + +
Fulfils thesis aim = = = = = = = =
Tool Objectiveness = = + - = + - -
Tool Reliability = = = - = = - -
Documentation/journaling = = + - - + = -
Quantification = - = - - = - -
Dynamic alignment N N N Y Y N Y Y
Static alignment Y Y Y N Y Y Y Y
Bench alignment Y Y Y N N Y Y Y
Net score 0 6 2 0 -2 -3 -3 -8
Rank 3 1 2 3 4 5 5 6
Prototype? Yes Yes Yes Yes No No No
Figure 18 Second concept screening with a Pugh matrix to support decision of prototype making
The results from the second phase of Pugh matrices gave us four concepts to make prototypes
of. The latest concept addition scored very high and qualified as prototype candidate together
with three other concepts. The approaches of the concepts included the use of laser/UV light,
the use of sound, and elementary mechanics.
3.7 Test product concepts

To investigate the four different concepts, in terms of functionality and needs fulfilment, they
had to be designed and realized into physical products.
3.7.1 Prototypes and rapid prototyping

Prototypes are physical models created to evaluate the shape and function of a product, or
sometimes specific details of a product. Prototypes are often made from material with similar
32
properties as the intended final material (Andreasen et al., 2015). The making of a prototype
reduces the risk of costly iterations to production tools, such as injection moulds or sheet metal
tools, by validating a design and detecting defects at an early development stage (Ulrich et al.,
2020). Prototypes were designed with the CAD software Solidworks and, because of the long
manufacturing time in Össur’s mechanical workshop for prototypes, the designs were adapted
to facilitate function and printability for 3D-printing. Descriptions of CAD can be read in Section
3.6.4 and 3D-printing can be read in Section 3.6.5.
The combination of CAD software and 3D-printing enables what is sometimes referred to as
rapid prototyping or quick-build prototypes (Ulrich et al., 2020). Rapid prototyping is the
principle of creating quick models of the product to evaluate the whole product or certain details
or parts. This iterative approach to prototyping was used in this thesis, where several
prototypes could be printed each week, and sometimes each day. Depending on the purpose
of the printed prototype, it was assessed in different ways. For instance, if the design had relief
numbers printed on its surface, it would be assessed for readability in discussion with
colleagues. Or if a mechanical function was assessed, such as a snap fastening, the present
author tested the function himself by assembling the parts. Based on the testing outcomes and
the experience by the author or discussions with experienced mechanical engineers within
Össur, iterations were made quickly.
As the four chosen concepts for prototyping had different approaches in their function, different
solutions were adapted to fit the concepts. When applicable, prefabricated parts were included
in the designs to facilitate a certain function or to save time. For instance, two of the concepts
utilized lasers, why the 3D-printed designs were designed to include battery-powered line laser
units (Figure 19) when the intended final concept likely would include different laser
components.
33
Figure 19 From TableTop-Laser (2022) Battery driven line laser [picture] https://www.tabletop-
laser.com/p/70145168
The intention was that all four concepts from the Pugh matrices would be produced for testing
with clinicians in an observational testing scenario. However, two of the concepts were
excluded during the prototyping phase for reasons that will now be declared.
In a concept which would use sound to facilitate alignment, solutions relating to mechanics of
sound, e.g., musical instruments, were investigated by visiting music stores for inspection of
different musical instruments and discussing with the staff members of the stores. Designs
were made in CAD, 3D-printed, and tested by the author. The purpose was to produce sound
with the prototype, utilizing the mechanical movements of prosthetic feet or prosthetic knees.
The concept was abandoned after several failed prototype attempts and when discussions
with mechanical engineers within Össur did not yield in any new design iterations.
The second abandoned concept intended to use UV-lasers and a screen of material which
glows when activated by UV-light. Further details are not revealed as this concept might be
pursued in future projects by Össur. A functional representative prototype was created and
tested on the author himself. In discussions with a clinician during this test, it was decided that
this concept would be abandoned for this thesis but kept for other future projects. The reason
was that the concept’s function did not fulfil the thesis aim as an alignment tool but rather
another type of tool, based on the clinician’s and the author’s clinical experience.
Two concepts resulted in prototypes which were chosen for structured prototype testing, user
observation, based on discussion with Össur staff members, as these were considered to meet
the thesis’ main aim.
34
3.7.2 User observation
User observation is a method to gather data and assess product designs by letting the targeted
user use the product and communicate their impressions. The data gathered can be used to
make critical decisions and increase the likeliness of successful product launches (Bhuiyan,
2011). Observing the intended user’s interaction with a prototype is perhaps the most
informative and direct approach to gather such data, although other approaches are common
too, for instance, rendering of the products and sending out as surveys to gather impressions
(Ulrich et al., 2020). The user observation can be supplemented with surveys to rank needs
fulfilment (Ulrich et al., 2020).
There were multiple purposes for this testing. First, assessing the concept’s functionality and
accuracy as an alignment tool, based on the impressions by the testers. The purpose was also
to assess if the concepts would address the most important identified needs of the clinicians.
The results from the testing would partly be a foundation to decide which of two concepts to
pursue and how it could be improved to better meet the user’s needs.
Two test users partook in the testing of the two individual concepts, hereafter referred to
concept 1 and concept 2. The participating users either were clinically active or had previously
been clinically active, to match the intended target group. The sample size was limited due to
the availability of clinicians, as the testing was held in-house at Össur, Regardless, the
impressions by the testers would still be useful to facilitate further development decisions.
The test procedure involved the clinician performing measurements on a transfemoral

prosthesis user, after careful ethical considerations which are discussed in Section 5.2. There
were six measurements done (Figure 20): three in the sagittal plane (socket flexion, knee
flexion, and horizontal offset between the trochanter major and knee component centre) and
three in the frontal plane (socket abduction/adduction, knee abduction/adduction, and
horizontal offset between the anatomical landmark anterior superior iliac spine). More
parameters could be added, but given the limited availability of the clinicians, few but highly
relevant measurements were chosen to make the most of the booked time. The parameters
were chosen inspired by the study by Tafti et al. (2020), as the concept’s approaches are
similar to the one in the study.
35
Figure 20 Sketch of how the measurements during user testing were made. The red lines indicate a vertical
reference line, the blue lines indicate the angles of socket and knee components, the green lines indicate the
horizontal offsets between landmarks.
After the measurements, the test users were asked to rank how well they thought the concepts
fulfilled some presented needs. The highest-ranked needs, as defined in the needs analysis
(Section 4.2): Easy to operate, intuitiveness, safe to use, applicability to patients, precision,
good investment, documentation/journaling, increases quality, ensures manual can be
followed, useful for inexperienced CPO’s, and portability. The needs were assessed on a scale
of 1 to 5, where 1 meant “Strongly disagree” and 5 meant “Strongly agree”.
3.8 Validity and reliability

The chosen framework, by Ulrich et al. (2020), had previously been criticised as it was not
extensively used in industrial settings and was perhaps limited to mechanical designs
(Tomiyama et al., 2009). However, this framework was still chosen for this product
development thesis because of the author’s familiarity to it and the fact it has been used
successfully in previous studies (Abu-Abdoun et al., 2022; Stridh & Lindström, 2010; Wikström,
2022), which indicated that the framework could be applied to product development in real
settings. The freedom of the framework to include other tools or omit, for the study, excessive
parts, allowed for creativity and exploration of different solutions, while keeping the project on
track to meet the aims. If the study would be repeated with the same approach and the same
number of users interviewed, it is possible that the result would be similar. If the number of
36
users were more, naturally more needs would have been identified. Due to the nature of the
prototypes, they are unlikely to violate any new need that would show up. If anything, additional
needs would likely just add features to the prototypes.
Because of the current state of these concepts, i.e., the very early development phase without
any intellectual property protection, other clinicians than those working in-house at Össur in
Reykjavik were not included in the user testing. Naturally, this becomes a limitation for the
project as testing with more users would have yielded more feedback for improvement.
Regardless, the early testing gave indications of both concepts meeting the most important
needs, with documented improvement areas.
The fact that some concepts were too complicated to pursue, due to the involved technology,
could mean that some potentially good ideas were scrapped. But then again, the added
complexity of such products would have increased cost for the end-user and would likely not
meet the need of affordability, which is arguably one of the most important needs of clinicians.
37
4 Results
In this chapter, the reader can find the results of the thesis. The main aim and the two research
questions will be addressed separately.
4.1 Overarching aim
Main Aim: Develop a tool concept for clinicians to use in the alignment process of lower limb
prosthesis components.
In the process of developing a concept for a tool for the prosthetist to use in clinical practice,
many concepts could be narrowed down to fewer by excluding and combining concepts. At the
stage of user testing, the users expressed positive feedback on both concepts which is why
both concepts are presented in the results of this thesis.
4.1.1 Concept 1
The first concept is a portable and simple tool implementing simple mechanics to measure
angles and offsets of a lower limb prosthesis. The prototype, seen in Figure 21, contains a total
of 8 parts, including 3D-printed parts, ball-bearing, retractable string, movable markers. The
tool is designed to have an angular sensitivity of 1 degree and a distance measurement
sensitivity of 1 mm. Detailed descriptions of the design are omitted from the published thesis
due to a confidentiality agreement with Össur.
Figure 21 Concept 1: a handheld tool to measure angles and offsets of prosthetic components.
4.1.2 Concept 2
The second concept is a laser-based portable tool to measure angles and offsets of the lower-
limb prosthetic components. The prototype, seen in Figure 22 and Figure 23, contains in total
10 parts, including aluminium profiles, line-lasers, 3D-printed parts, and both analogue and
38
digital measuring units for angles and distances. The tool is designed to have an angular
sensitivity of 0,1 degrees and a distance measuring sensitivity of 1 mm. Detailed descriptions
of the design are omitted from the published thesis due to a confidentiality agreement with
Össur.
Figure 22 Concept 2: A laser-based tool to measure angles and offsets of lower limb prosthetic components.
Figure 23 Concept 2: detailed picture of the green line-laser, the millimetre scale and the digital level tool
Both devices seem to make good impressions on the clinicians during the user testing
sessions. Both clinicians mentioned that concept 2 was perceived as more precise, while
concept 1 seemed to be more applicable to clinical practice. The reason was that concept 1
was small enough to fit in a pocket and therefore “easier to bring along”. Both clinicians said
about concept 1 that it was something they would buy for all their clinicians in their
departments. One of the clinicians said that concept 1 was something he would bring to an
alignment session in general and if he needed to be more precise, he would bring concept 2
instead.
39
During the user testing, the users were asked to reflect on the impressions and rank how well
the prototypes fulfil the needs that with highest importance ranking, as seen in Table 4. The
needs which were ranked with the highest importance were included. The scale was 1 to 5,
where 1 means “Strongly disagree” and 5 means “Strongly agree”. The rankings from the two
users can be viewed in Table 4.
Table 4 Ranking of needs fulfilment for two conceptual tools for prosthetic alignment.
Need Concept 1 Concept 2

Easy to operate 4 3,75
Intuitive 4 4,25
Safe to use 5 4,5
Applicable to TF users 5 5
High precision 4 3,5
Good investment 4,5 5
Facilitate documentation 5 5
Increases quality 4,5 4,75
Useful for new CPO’s 5 4
Applicable to IFU’s 4 4
Portable 5 4,5
Total 50 47,75
When measuring with the tools, a certain standard procedure should be followed to improve
reliability. In the Ottobock 3D L.A.S.A.R. system, there is standardization of feet position, where
both feet should be placed symmetrically on the two force plates. For the two proposed tool
concepts, the standardization would be to ensure the prosthetic foot is placed flat against the
floor during the measurement, in both frontal plane and sagittal plane. The exception would be
if there is a heel height included which then will be taken into consideration. Furthermore, if a
knee component is used, this should be fully extended to ensure no flexion is compromising
the reliability of the measurements.
4.1.3 Complementary software

Both concept 1 and concept 2 seem to be effective tools that could be used to measure
prosthetic alignment variables in the sagittal and frontal planes. However, both concepts could
be stronger if a system for alignment recommendations could be developed in addition to these
products. This system could be an app, or an addition to the journaling system. The taken
measurements can be entered and the prosthetist could get immediate feedback on whether
the values are within a normal value range. The prosthetist could also add information on joint
ranges of motion, residual limb length, muscle strengths, activity level, balance capacity, and
40
other relevant variables. The recommendations from the software could synthesise all the
entered variables and give specific quantified recommendations for prosthetic components and
alignment. The recommendations could be based on a larger set of data, which possibly could
be collected from the clinically active prosthetists, from research, or from the major
manufacturers within prosthetic components.
4.2 Results RQ1
From the interviews conducted, 38 needs could be identified. In discussions with two
colleagues within Össur, the needs were organized and assigned an importance level (Table
5). The scale goes from 1 to 5, where 1 is less important and 5 is most important.
Table 5 The needs on an alignment tool from a clinician’s perspective. The needs are given an importance
ranking on a scale of 1 to 5.
No. Need Imp.

1 Easy to operate 5
2 Safe to use 5
3 Considers unique features of patients 5
4 Applicable to above-knee prostheses 5
5 Precise in its measurements 5
6 Good investment 5
7 Increasing the overall quality of prostheses 5
8 Ensures that prosthetic components manuals can be followed 5
9 Usable for inexperienced CPO's 5
10 Good guide on how to use it 5
11 Documentation of alignment 5
12 Journaling of alignment 5
13 Accurate in its measurements 4
14 Takes up a small area 4
15 Decreases alignment subjectivity 4
16 Easy to learn how to use 4
17 Easy to read values from 4
18 Reliable in its function 4
19 Affordable to purchase 4
20 Finds position and orientation of prosthetic components 4
21 Easy to calibrate 3
22 Intuitive to use 3
23 Applicable to below-knee prostheses 3
24 Helps teach and learn alignment 3
25 Lightweight 3
26 Requires little effort from patients 3
27 Facilitates communication between patient and CPO 3
41
28 Helps detect prosthetic malalignments 3
29 Easy to set up in different environments 3
30 Saves time during alignment 2
31 Utilizes several approaches to alignment 2
32 Tolerates some dust 2
33 Reduces re-visits to clinic 2
34 Backed-up by science 2
35 Replicates alignments 2
36 Operable from a distance 1
37 Applies to other patient groups 1
38 Helps position socket adapter 1
4.3 Results RQ2
Vertical Line Laser
The most used tool among the interviewed clinicians was the vertical line laser. The tool comes
from the construction industry but was found to have applicability in the field of prosthetics and
orthotics as a replacement for a plumb line. The tool projects laser light on the prosthesis in
the form of a constantly vertical line. No tool was used at all times; however, this was the most
prevalent of all mentioned tools and all interviewed clinicians had experience with it. The needs
it seemed to fulfil were primarily affordability, the small and lightweight portable size, the tool
simplicity, the applicability to all amputation levels, and the applicability to IFU’s where a
vertical reference line often is recommended for the alignment process. One clinician only used
the vertical line laser in cases where they had to educate a new CPO, indicating it is useful as
a teaching tool. The clinicians also found the laser tool as intuitive and easy to set up in different
environments.
Ottobock L.A.S.A.R.
Three of the clinicians had some experience with the Ottobock L.A.S.A.R. system and two of
them used it in clinical practice from time to time. This system consists of a force plate where
one or two limbs are positioned, a laser line is then projected onto the body to indicate where
the vertical component of the ground reaction force is. The indicator to use it was when an
alignment on a patient was more challenging than usual. The general perception was that the
tools met the needs of reducing alignment subjectivity and visualizing the load on the limb.
Ottobock 3D L.A.S.A.R.
42
Two clinicians had experience with the Ottobock 3D L.A.S.A.R. system, where of only one of
them had clinical practice experience. The main difference from the old Ottobock L.A.S.A.R. is
that the GRF is visualized in 2 dimensions with the aid of a tablet and augmented reality. An
indicator to use this tool was also when an alignment situation was difficult to interpret. The
needs this tool met were the reduced subjectivity and visualizing of the load on both limbs. The
possibility to photograph the situation seemed to meet the need of documentation and
journaling to some extent. The tool was perceived as accurate in its measurements and
assisted in following the manual of some prosthetic components.
43
5 Discussion
In the discussion chapter, the thesis is discussed regarding the methods, tools, and the
outcomes of the project. A section addressing ethics is included. Each research question is
addressed separately.
5.1 Method and findings

This thesis has presented the work and results from investigating clinicians needs and the
delivery of two tool concepts. It was also recommended to develop a software in addition to
the tools. The intention was to anchor design decisions in the need of the end-user, by doing
interviews and extracting both obvious and latent needs. Individual interviews were chosen, as
literature suggested it being more cost-effective and superior to other alternatives (Ulrich et al.,
2020). Five individual interviews were held in total, which is a possible limitation of the thesis,
as one could argue that more interviews are needed to state with higher confidence that all the
most important needs have been identified. However, the interviewees are from three different
countries which adds to the strength of the sample. One could also argue that the background
of the author, being a CPO himself, may have influenced the needs identification process. On
one hand, it could possibly have limited the author’s ability to “think outside the box”. On the
other hand, it could have facilitated a deeper understanding for the problem at hand, which
possibly facilitated a more efficient needs identification. This is supported by Urban & von
Hippel (1988), who claimed that innovation often comes from lead users, as these have a good
understanding of the needs and therefore can produce effective concepts. Regardless, to
mitigate bias, the author designed the interview guide according to literature’s
recommendations and approached the whole thesis with a neutral mindset. All in all, despite
the relatively low sample of interviewees, the circumstances give the author the confidence to
state that the most important needs have been identified.
In the interviews with the clinicians, it became apparent that most of them did not use any kind
of tool in their day-to-day practice. They would instead rely on eye measurement and the
feedback from patients. This is problematic for two reasons. First, literature has suggested that
relying on the prosthetist’s judgment and patient feedback lacks validity and reliability (D.
Boone et al., 2012; Davenport et al., 2017; Geil, 2002; Won et al., 2021; Zahedi et al., 1986).
Second, the literature on how to conduct interviews with users was designed around questions
regarding their current tools. Hence, it was a confusing task to gather insights into tools when
none were used. Although, all prosthetists had some experience with the line laser tool and
some prosthetists had experience with more advanced tools, which resulted in some insights
regarding those. The now proposed two concepts should be further tested and used in clinical
44
practice and their insights would be valuable insights to identify additional needs and
improvements of the concepts.
During the phase of generating concepts, no limitations were put on what type of technology
could be used to solve the problem of measuring alignment. Different approaches were
investigated, ranging from the use of sound, through mechanical solutions, to the use of light
beams. However, several of the concepts were filtered away or narrowed down due to project
complexity or falling outside of the scope of this thesis. For instance, one concept which
possibly could assist in detecting gait deviations during gait analysis – an area related to
alignment – was excluded as it was discussed among colleagues that it would not contribute
directly to the documentation or measurement the alignment. However, those types of
concepts would be interesting to investigate further in projects with a wider or alternative scope.
Moreover, during the concept selection phase, each concept was discussed with various
colleagues regarding several aspects (see Pugh matrix in Figure 17) to facilitate sensible
decisions on what concepts to pursue. Some concepts were vastly more complex, both
technically and project-management wise, than others and were abandoned due to the
expectation that a certain technology would result in a product with very high cost for the end-
user. There can be some bias during the selection process, where people with “favourite areas”
or outdated insights may have too much influence on the selection (Andreasen et al., 2015). It
is therefore important that a project leader ensures the needs are considered. The concept
selection in this thesis, therefore, relied highly on the identified needs and their importance
ranking, leading to the highly complex concepts being excluded. The two presented concepts
in this thesis rely on simple technology which likely would be a more realistic purchase for the
clinicians. Although, some of the more advanced concepts could possibly result in higher
satisfaction in terms of other needs than, e.g., cost, why it could be fruitful to revise the
concepts in the future if certain technologies become cheaper and easier to apply. For now,
the present author has much confidence that the most promising concepts were selected with
the identified needs as foundation.
Two individual user tests were conducted with the concepts, where each clinician got to test
both concepts doing measurements on a transfemoral prosthesis user. During these tests,
comments, which the users made, were noted. Although the designs of both concepts had
much improvement potential, most of the comments were positive. Both users mentioned that
concept 1 was something they would want to mass produce and send out to every clinician. In
user testing, cognitive biases are almost impossible to completely erase (Natesan et al., 2016),
and it is possible that biases which affect the reliability were present during the user testing in
this thesis. However, interference from the test leader while the users tested the products were
45
kept to a minimum and the questions regarding the needs were asked in a neutral manner, to
mitigate these biases.
5.2 Ethics
One topic of ethical discussion concerns the methodological approaches of different alignment
tools. Of all the mentioned approaches in Section 2.8, the approach of both the concepts are
similar to the one used in a study by Tafti et al. (2020). The study by Tafti et al. claim that their
method, which utilizes anatomical landmark as references for alignment purposes, must be
further tested for validity and reliability. Even though the interviews with clinicians revealed that
the need for evidence-base was less important than many other needs, the resulting concepts
in this thesis should be screened for validity and reliability. This should be addressed in future
work. For ethical reasons, it would be preferable if the tools which are applied to vulnerable
patient groups would be proven effective. Although the radiation dose from radiography usually
is not harmful, one should be aware of the risk associated with such an approach (Mancini &
Ferrandino, 2010). One can argue that the approach of the concepts in this thesis is preferable
compared to the approach of radiography (Mooney et al., 2013), because the avoidance of
radiation. Although, one concept involves the use of lasers, which can possibly be harmful to
eyes which may be an ethical issue. There are lasers classified as harmless which would be
suitable for the purpose of the concept. Regardless, as of today, line-laser tools are commonly
used in clinical practice among prosthetists, so introducing similar products would not pose a
new risk to the field. This was something carefully considered before it was decided to conduct
observational user testing with clinicians and a transfemoral prosthesis user, all of whom works
in-house in the Össur company and volunteered to participate.
5.3 Research questions
The needs identified would account for about 75-80% of all the needs, as five clinicians were
interviewed (see Figure 15). The discussion on small sample size has already been addressed
in Section 5.1, but it is worth to state again that there are likely more needs out there, which
may be investigated in future work. With the current set of needs, the outcomes of the two
concepts seem to meet many of the most important needs, although with some improvement
potential. If there are additional unidentified needs to be revealed, some which may be critical,
the two concepts may need further refinement to meet these. Moreover, one thing to point out
is that the needs identified in this thesis may not be fully relevant in the future. New technology
and products can alter the expectations and needs of the customers. For now, the identified
needs can be considered up to date and a good foundation to further improve and develop
46
alignment tools. Arguably, there seems to be an absence of tools today which fulfils all the
most important needs of clinicians. The two final concepts of this thesis, however, have the
potential to address these needs.
The needs identified did not present many significant surprises. The most important needs
were related to safety, accuracy, affordability, applicability to above-knee prostheses,
documentation, and more, which are somewhat obvious needs to the author. Although, one
surprise was the extent which all clinicians expressed that the tool needed to be a good
investment. If the tool even could be considered for purchasing, it must either be a cheap tool
or a highly effective tool, preferably both. Many of the clinicians expressed that most tools were
heavy investments which rarely could be motivated in the procurements. Today’s clinics in
smaller cities or rural areas handle fewer prosthesis users compared to larger cities. It is known
that practice is an important part if you want to become good at something (Ericsson et al.,
1993). This means it is difficult to become better at performing alignments as a clinician
because of the few available patients. It also means that it is more difficult to motivate the
purchase of expensive alignment equipment, as the cost would be spread on few patients.
This is a paradox, as clinicians that have less possibilities to gather alignment experience are
the ones who need proper alignment tools the most. This highlights the need for affordable
alignment tools even more, or possibly a policy shift in purchasing departments. It is paramount
that clinicians have knowledge or tools to conduct correct alignments as this could ultimately
affect the outcomes and health of the prosthesis user.
Moreover, it was a surprise to the present author that the need for evidence on a tool was
considered less important by most of the clinicians. One clinician expressed it as “Of course,
if it would be backed-up by science, that would be good, but as long as a tool works it is less
important right now”. This can be interpreted in two ways. Either that the lack of good tools
creates a void which must desperately be filled by an alignment tool as soon as possible, or
that the clinicians care less about an evidence-based approach in their work. Given that the
interviewed clinicians seemed to mind scientific evidence in the rest of their practice, and with
the benefit of doubt, the present author believes, based on own judgment and previous
research (Klute et al., 2009), that there is a gap and need for a new alignment tool and
increased alignment knowledge among clinicians.
From the 5 included clinicians, some tools were found to be commonly used in practice: the
vertical line laser tool and both the L.A.S.A.R. systems from Ottobock. From the interviews, it
was apparent that no tool seemed to fulfil all needs from the clinicians, indicating there is a
market need and opportunity. The clinicians who had experience with costly tools such as the
47
L.A.S.A.R. systems did not utilize the tool at all times, but only in situations where the alignment
was trickier than usual, indicating it was not worth the extra work of setting it up, calibrating it,
and using it to align a prosthesis, and document the end-result. For the clinicians who did not
have access to the L.A.S.A.R. systems, their impressions were that the systems could possibly
be useful, but the investment in such a tool was hard to justify with what they thought were
somewhat unclear benefits. Such statements came from interviewees regardless of if they
were financially dependent on Össur, Ottobock or any other organisation.
It has been identified that current tools on the market do not fulfil all the primary needs of
clinicians. Even though loadcells and force plate systems do capture some important
information useful in the alignment process, they are not financially accessible for most
clinicians interviewed.
48
6 Conclusion
In this section, suggestions for future work are mentioned, followed by the final conclusions
of the thesis.
6.1 Future work

There are several paths to investigate if this project is to continue. The likely first step would
be to conduct further user testing and iterations to the prototypes to decide which of concept 1
or 2 to pursue. It is possible that both concepts have potential to reach the market but choosing
one of them to launch first would probably be the best option. Parallel to this, additional
interviews could be useful to ensure that most needs have been identified. Moreover, focus
group testing with currently existing products (Appendix 2) would be beneficial to understand
how these fulfil the needs of the customers.
When one concept is superior to the other, a plan for downstream development could be
beneficial to lay out the potential for the product. Things such as developing a full technical
model and a cost model for the product would be vital as a next step toward launch or project
cancellation. As mentioned in the result, the tools would be even more useful if a system was
developed in addition to the tools. The development of this software is something to
investigate. Future work would also include an investigation into intellectual property to reveal
the possibilities to protect the products and thereby securing profit from a product launch.
Because of the intended purpose is to medically investigate the anatomical position of a

prosthesis user while wearing the prosthesis, both concepts are susceptible to a CE-marking
according to the European Medical Device Regulations (Regulation (EU) 2017/745 of the
European Parliament and of the Council of 5 April 2017 on Medical Devices., 2020). Both
concepts, in their current designs, are most likely in class I of the Medical Device Regulation.
This needs to be investigated for a launch to be possible.
Lastly, future work should include a study to examine the validity and reliability of the presented
concepts, regardless of if the needs identification revealed that the need for evidence-base
was less important than many other needs.
6.2 Conclusion
The aim of this thesis was to develop a tool concept for clinicians in the alignment of the
components of lower limb prosthetics. Five interviews were held with clinicians from three
different countries and needs were identified and extracted from these. The user needs were
the foundation for the rest of the development process. In the results, two tool concepts were
presented as user testing indicated that both met the most important user needs similarly.
Moreover, the interviews reveal what tools clinicians usually use in clinical practice and what
49
needs those meets, with the verdict that current tools do not fulfil all the most important needs
of clinicians. Instead, there are important indications that there is a gap needed to be filled,
especially in smaller cities or rural areas where clinicians handle few prosthesis users. This
thesis reinforces an earlier study’s conclusion that clinicians need access to alignment tools
and alignment knowledge.
50
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8 Appendices
8.1 Appendix 1: Interview guide
No. Question Probes
1 Can you tell me a little about yourself and your work?
2 Can you tell me about how you do the alignment of a Bench, static, dynamic alignment,
transtibial and transfemoral prosthesis? heel height, foot rotation, dorsi-
plantar flex, socket angles,
heights, weight distribution...
3 How long times does an alignment take? Transtibial vs transfemoral
4 How long does this skill take to develop? Learning curve
5 How often do you do alignments?
6 What is important to you when you do the alignment? Time, precision, safety, portability
of tools, recommendations of the
manufacturer, patient’s
preferences, socket fit/comfort,
alignment variables, gait sound
visual gait deviations…
7 What is challenging with doing alignments? Knowing what changes to do vs
How to achieve them
8 In what settings do you do alignments?
9 What tools do you use?
10 What tools have you tried? LASAR Posture/3D, Load-cells,
Line laser, Alignment jig…
11 Do you use any alignment tools on other patients?
12 What else do you rely on during alignment?
13 What do you like with your current tools and method?
14 What do you think could be improved with your current
tools?
15 How do you keep track of adjustments you do? Journaling, documentation…
16 What are your thoughts on replication of an alignment?
17 How often do you have to replicate an alignment?
18 What are your thoughts on recommendations from the Are they useful? What could be
manufacturer to align a prosthesis? better? Are you able to follow
them?
19 What would be key features of a new tool, in your eyes? Price, portability, aesthetics,
weight, size, intuitiveness,
simplicity, innovative,
documentation, journaling,
procurement, evidence-based,
patient-involvement...
20 What are important variables of a tool in the Price, evidence...
procurement processes?
56
8.2 Appendix 2: Benchmarking
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An alignment tool

PAPER WITHIN Product development with specialization in assistive technology

Examiner: Marisol Rico Cortez

Supervisors: David Rusaw and Melina Ettehad

Scope: 30 credits (second cycle)

Keywords: Prosthetics, alignment, malalignment, misalignment, artificial limb, design, product

Nyckelord: Protes, uppställning, inställning, felställning, konstgjord kroppsdel, design,

1.1.1 The Össur company

1.2 Assigned task and description of problem

1.3 Aim and research questions

Chapter title Content

Method implementation Descriptions of framework, methods, and

Discussion Discussion on implementation of methods and

Conclusions Conclusions from the thesis and suggestions

2.1 The prosthesis user

2.1.1 Lower limb amputation levels

2.3 Anatomical planes

2.4 The lower limb prosthesis

2.4.1 Componentry of a lower limb prosthesis

2.4.1.1 Foot components

Knee Load line

2.5 Component cartesian coordinates

2.7 Alignment techniques

2.8 The prosthetist

3.1 Connection between Research Questions and Methods

MAIN AIM RQ1 RQ2

3.4 Identify customer needs

Figure 15 Graph from the book by Ulrich et al. (2020).

3.4.2 The identified needs

3.5 Generate product concepts

3.6 Select product concepts

3.6.1 Pugh Matrix

3.7 Test product concepts

3.7.1 Prototypes and rapid prototyping

The test procedure involved the clinician performing measurements on a transfemoral

3.8 Validity and reliability

4.1 Overarching aim

Need Concept 1 Concept 2

4.1.3 Complementary software

4.2 Results RQ1

No. Need Imp.

4.3 Results RQ2

Vertical Line Laser

5.1 Method and findings

5.3 Research questions

6.1 Future work

Because of the intended purpose is to medically investigate the anatomical position of a

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