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SAMINT-MILI-22042
Master’s Thesis 30 credits
June 2022
The Strategic adoption of Additive manufacturing in the orthopedic industry in Sweden
Louis Bertrand Ndangamira Shema
Master’s Programme in Industrial Management and Innovation
Masterprogram i industriell ledning och innovation
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Abstract
The Strategic Adoption of Additive
Manufacturing in the orthopedic industry in
Sweden
Louis Bertrand Ndangamira Shema
Additive Manufacturing (AM) is another name for rapid prototyping and 3D
printing (3DP), an advanced manufacturing technology that creates 3D
objects. AM's ability to produce complex shapes in industrial production is
one of its chief advantages. AM is spreading to different areas in healthcare
and is being considered a disruptive innovation that is changing
orthopedics. However, integrating AM into daily orthopedic practice remains
a challenging task. This thesis aims to explore clinicians' views on the adoption
of AM implants, surgical guides and accessories as well as investigating which
way do regulations and policies affect the adoption of 3DP in the orthopedic
industry in Sweden. Apart from reviewing existing literature contemplated on
factors that affect the adoption of AM in an industry, in this study, a
qualitative research approach have been used. A semi-structured interview
has been applied to all the seven orthopedic surgeons who participated in the
research. Using a thematic analysis approach, the data have been analyzed to
address the thesis research questions.
According to the thesis findings, AM adoption in the orthopedic sector is
influenced by a number of factors. With the technology, organization, and
environment (TOE framework) there are classified into three main contexts.
The study used the findings along with the TOE model, which embeds the
regulation factor within an environmental context. The findings indicate that
the medical device regulation (MDR) affects the adoption of medical devices
both positively and negatively in the orthopedic industry in Sweden.
Technologically, the dilemma and challenge of adopting AM is influenced by
the lack of resources in the healthcare field which also influence the
organization context. It is the viewpoint of the buyer that orthopedists and
hospitals have when it comes to adoption of AM. This means that the trading
factor expressed in the environment context is another driving factor for AM
adoption. By using the Kraljic model, AM technology has been classified as a
strategic item. The procurement and purchase efforts should focus on
establishing a long-term relationship with a single manufacturing company and
both aiming to combine effort and resources to reduce total costs. In
conclusion, The implementation of AM in orthopedic practice will be possible
as long as all factors are taken into account. In orthopedic practice, AM
should be used to create surgical guides, 3D models for surgical planning, and
custom implants.
Key word: Additive manufacturing, orthopedic, surgeon, framework
Supervisor: Jonas Ålberg Subject reader: Anders Brantnell Examiner: David Sköld SAMINT-MILI-22042 Printed by: Uppsala Universitet
Faculty of Technology Visiting address: Ångströmlaboratoriet Lägerhyddsvägen 1 Postal address: Box 536 751 21 Uppsala Telephone: +46 (0)18 – 471 30 03 Telefax: +46 (0)18 – 471 30 00 Web page: http://www.teknik.uu.se/education/
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Popular science summary
Technological innovation in the health sector is a critical journey, but it is most crucial for
developing quality products for the benefit of not only stakeholder groups but also for patients
and society in general. The use of additive manufacturing (AM) in health care in Sweden is as
well a challenging innovation journey. AM is commonly referred to as 3D printing. This type of
printing is additive because it builds up thin layers of material one by one. Dentistry and
cardiology are examples of major clinical use of AM technology. This project is focused on the
clinical implementation of AM in the orthopedic industry in Sweden. Various stakeholders from
the Swedish healthcare industry are jointly conducting research on AM. Therefore, this research
investigates possible factors that can affect adoption of AM to contribute to the business
implementation of AM in the orthopedic industry in Sweden.
First, the study reviewed the existing literature regarding the adoption factors of AM and as the
purpose was to examine orthopedic surgeons' views on AM adoption in the orthopedic practice,
the research study focused on gathering relevant data and interviews were conducted. Seven
orthopedic surgeons took part in the study. Based on the research conducted, and the analysis of
primary data, the study determined the factors that might affect the adoption of AM and
establishment of 3D printers at the point of care of orthopedic surgeons. From the standpoint of
clinicians, six main themes have been identified as important in this thesis research as the most
influential factors for the adoption of AM in the orthopedic industry. Among these factors are
technology, partnerships, investment, management, application, and regulation. Nevertheless, to
align the research findings with the existing theory, we have grouped the overall factors that
influence the adoption of AM into technological, organizational, and environmental factors,
which are all interconnected.
Even though the technological and organizational aspects highly influence AM adoption in an
orthopedic practice, the environmental aspect is another major aspect that hinders AM adoption.
The regulation factor and the trading factor are included within the environmental context. One
of the important issue addressed in the environment aspect, is regarding limited resources in the
Swedish healthcare. This make the environment context another important driving factor to
consider to successfully adopting AM in the orthopedic industry in order to mitigate all the
hindering factors, clinicians and hospitals are advised to apply a strategic implementation
approach, which is primarily concerned with purchasing and procuring process. The Kraljic
purchasing model has been used to analyses AM in the orthopedic sector. To achieve to adopt
AM in the orthopedic industry in Sweden, clinicians should look for a long term partnership with
a single manufacturer or a research facility as an effective way to reduce the total costs and
effectively manage resources so that AM is quickly adopted in orthopedic practices in Sweden.
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Acknowledgement
Let me begin by thanking my subject reader Anders Brantnell at Uppsala University. My thanks
to Him for the chance he gave me to conduct my research at the competence center for additive
manufacturing in the Life Science, in the sector that emphasizes on business implementation. I
greatly appreciate all the support and help getting in touch with surgeons, as well as the fruitful
discussions and constructive suggestions.
My thanks also go to Jonas Ålberg my supervisor for his endurance and excellent guide during
the thesis process. His support included connecting me with orthopedic surgeons who
participated in the study as well as providing feedback on the report.
My sincere appreciation goes out to all orthopedic surgeons who offered their time to me and
participated in my research; their insights were valuable and crucial to the completion of this
study.
I am grateful to the whole industrial management and innovation department at Uppsala
University for the knowledge provided. I also thank dear colleagues, for interesting discussions
mainly during seminars.
I extend my warmest gratitude to my mother, Mrs. Stephanie Mukantabana and my sister, Marie
Ange Ndangamira Mutoni for providing me financial assistance during the two years I spent
studying in Sweden. Additionally, I would like to thank my friends and family for their
continuous encouragement during my studies and especially during the time I conducted my
thesis.
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Table of contents
Abstract ......................................................................................................................................................... i
Popular science summary ........................................................................................................................... ii
Acknowledgement ...................................................................................................................................... iii
Table of contents ........................................................................................................................................ iv
List of tables............................................................................................................................................... vii
List of figures ............................................................................................................................................ viii
List of abbreviations .................................................................................................................................. ix
1 Introduction ............................................................................................................................................ 1
1.1 Background ..................................................................................................................................... 1
1.1.1 The story of AM ....................................................................................................................... 1
1.1.2 AM in the healthcare ............................................................................................................... 1
1.2 Problem formulation ...................................................................................................................... 2
1.3 Purpose............................................................................................................................................. 3
1.4 Research question ........................................................................................................................... 4
1.5 Delimitation ..................................................................................................................................... 4
2 Literature review .................................................................................................................................. 5
2.1 Orthopedic device industry outlook .............................................................................................. 5
2.2 AM in orthopedic practice ............................................................................................................. 6
2.2.1 AM in surgical planning .......................................................................................................... 8
2.2.2 AM in developing orthopedic implants and guide .............................................................. 10
2.3 Adoption factors of AM in the industrial setting ....................................................................... 11
2.3.1 Technological factors ............................................................................................................. 12
2.3.2 The organization factors ........................................................................................................ 12
2.3.3 The environment factors ....................................................................................................... 13
2.4 Adoption factors of AM in the orthopedic industry .................................................................. 13
2.5 Understanding the Regulatory Requirements ............................................................................ 17
2.5.1 Regulation outline .................................................................................................................. 17
2.5.2 Medical device categories under MDR ................................................................................ 18
2.5.3 Orthopedic medical devices under MDR ............................................................................. 20
2.5.4 Additively manufactured orthopedic devices under MDR ................................................ 20
3 Theory ................................................................................................................................................... 23
v
3.1 The Technology organizational and environmental framework .............................................. 23
3.2 The kraljic matrix framework ..................................................................................................... 25
3.2.1 The overview of the four categories of items in the Kraljic model .................................... 27
3.2.2 The procurement strategy for AM ....................................................................................... 27
4 Methodology ......................................................................................................................................... 29
4.1 Research design ............................................................................................................................. 29
4.1.1 Sampling method.................................................................................................................... 30
4.1.2 Sample size .............................................................................................................................. 32
4.2 Data collection method ................................................................................................................. 32
4.2.1 Semi-structured interview ..................................................................................................... 32
4.2.2 Advantage and Disadvantage of Interview .......................................................................... 34
4.3 Data analysis .................................................................................................................................... 34
4.4 Ethical consideration .................................................................................................................... 35
4.5 Trustworthiness ............................................................................................................................. 36
5 Results and analysis ............................................................................................................................. 38
5.1 Themes emerged from coding ...................................................................................................... 38
5.2 Factors affecting the adoption of AM from the perspective of orthopedic surgeons .............. 40
5.2.1 Technology .............................................................................................................................. 40
5.2.2 Partnerships ............................................................................................................................ 42
5.2.3 Investment .............................................................................................................................. 44
5.2.4 Management ........................................................................................................................... 45
5.2.5 Application .............................................................................................................................. 46
5.2.6 Regulation ............................................................................................................................... 48
5.3 Effect of regulation in the orthopedic industry in Sweden ........................................................ 49
6 Discussion.............................................................................................................................................. 51
6.1 Factors affect the adoption AM in the orthopedics through the TOE framework ................. 51
6.1.1 The technology Context ......................................................................................................... 52
6.1.2 The organization Context ...................................................................................................... 53
6.1.3 The environment Context ...................................................................................................... 54
6.2 The implementation of AM through the kraljic matrix ............................................................ 56
6.2.1 The management approach to apply for AM’s development ............................................. 57
6.2.2 The collaboration approach to apply for AM’s development ............................................ 58
6.2.3 Resource management for AM’s development .................................................................... 59
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6.3 The sustainability implication of AM .......................................................................................... 60
7 Conclusions ........................................................................................................................................... 61
7.1 Limitations ..................................................................................................................................... 62
7.2 Recommendation ........................................................................................................................... 63
References .................................................................................................................................................. 65
Appendix .................................................................................................................................................... 71
Appendix A. Interview guide ............................................................................................................... 71
vii
List of tables
Table 1. AM adoption factors according to Asonova et al. (2017) ............................................... 16
Table 2. Three established regulations on medical devices .......................................................... 18
Table 3. Advantage and disadvantages of the sampling method used. Source: (Bell et al. 2009) 31
Table 4. Interviewee’s information ............................................................................................... 33
Table 5. Advantage and disadvantage of interview. Source: (Bell et al., 2019) ........................... 34
Table 6. Impacts of regulation ...................................................................................................... 50
viii
List of figures
Figure 1, AM in orthopedic expertise. Source: (Pascau et al.,2021) .............................................. 7
Figure 2, Design and manufacturing procedure for AM implant. Source: ( Jindal et al.,2020) ... 10
Figure 3. Classification Medical devices. source: (Strålin, 2022) ............................................... 19
Figure 4. Software classification under MDR. Source: (Mdcg, 2021) ......................................... 22
Figure 5. TOE diagram (adopted from Wang et al.,2019) ............................................................ 24
Figure 6. The kraljic matrix .......................................................................................................... 26
Figure 7.Themes emerged from coding ........................................................................................ 39
Figure 8. AM adoption in TOE framework .................................................................................. 52
Figure 9. AM in The kraljic matrix ............................................................................................... 57
ix
List of abbreviations
3D Three Dimensional
AM Additive Manufacturing
CE Conformité Européenne
CAGR Compound Annual Growth Rate
EU European Union
DOI Diffusion of Innovation
FDA Food and Drug Administration
IoT Internet of Things
R&D Research and Development
MDD Medical Device Directive
MDR Medical Device Regulation
NBs Notified bodies
SLA Stereolithography
TOE Technology, Organization and Environment
WHO World Health Organization
1
1 Introduction
The first section of this chapter briefly discusses the background of Additive manufacturing
(AM) and AM in the Healthcare, followed by the problem formulation, and the section that
addresses the aim of this thesis, research questions formulated, and delimitations. All parts of
this section will be useful in gaining an understanding of AM specifically in the healthcare sector
and will guide our research study leading to a deeper understanding of creative integration of
AM in the Swedish orthopedic industry.
1.1 Background
1.1.1 The story of AM
AM is another name for rapid prototyping and 3D printing (3DP), an advanced manufacturing
technology that creates 3D objects by layering them one on top of another. The method is called
additive because it usually involves building up thin layers of material one by one (Wong et al.,
2012). "Objects are made by fusing or depositing materials such as metal, plastic, powders,
ceramics, liquids, or even living cells, in layers to create a 3D object" (Garg et al., 2018). AM
was first employed in the late 1980s (Pidge et al., 2020). The patent of AM was granted to Chuk
Hull in 1984 under the number US4575330 (Whitaker, 2014). One of the most highlighted
benefits of AM in the industrial production process is its capacity to produce complex shapes
that are not achievable using traditional casting, injection moulding, extrusion, forging and
machining processes and AM eliminates waste from the process significantly compared to the
traditional manufacturing process (Ramola et al., 2019). The use of 3DP has initially been
applied to the aerospace and automotive industries, but has continued into other industrial
sectors, where the medical industry has adopted this technology that has radically changed the
production process (Kurzrock, 2016).
1.1.2 AM in the healthcare
Stereolithography (SLA) was the first 3DP technique available in 1994 and the first used in the
biomedical field (Hoang et al., 2016). SLA is the process of using a computer-controlled laser to
harden a liquid polymer or resin, building a structure layer by layer. As the first 3D printers
could only print hard materials, the technology was first applied to orthopedic Surgery, oral and
maxillofacial Surgery. Currently, every surgical specialty has published applications for 3DP
(Hoang et al., 2016). Currently, AM is used in many clinical fields, including dentistry and in
cardiology (Ramola et al., 2019). A wide range of orthopedic implants and surgical instruments
can also be developed by using technology due to the ability to design, and manufacture,
complex geometries with multiple design features (Zeidler, 2020). Different stakeholders in the
2
Swedish healthcare industry have combined effort in research and development on AM through a
company named Amexci, to develop a new generation of products that utilize AM for a more
sustainable production (Zomaya & Sakr, 2019). As well, OssDsign has been one of the earlier
users of AM for healthcare in Sweden, developing titanium reinforced calcium phosphate
implant "through the manufacturing process involved 3DP of the defect perimeter, moulding,
setting and drying of the implant followed by material analysis” (Bloom et al., 2020). Zeidler
(2020) argues that the use of 3D printers offers a great opportunity to remove many technical and
economic limitations associated with orthopedic implant production. Equipment and powder
costs, for example, significantly influence the business case to change from conventional to AM.
Hence, additive technology is expected to play an increasingly important role in the ongoing
evolution of personalized medical treatment.
1.2 Problem formulation
Within five years there will be an increase in market share within the orthopedic device market,
with a CAGR of approximately 4.9% for the period 2021-2026 (Mordorintelligence, 2021). AM
in Europe expect to hold a market value of 1836.96 million by 2027, at a CAGR of
approximately 27.41% (Market data forecast, 2022). In spite of this, Sweden still records various
adverse events in the orthopedic sector. Approximately 9000 claims are filed in Sweden after
orthopedic surgery each year, and about half are settled with compensation (Öhrn et al., 2012).
By far the most amounts of total claims are attributed to orthopedic surgery, with 28% of all
claims related to orthopedics (Öhrn et al., 2012). However, “It has been said that no surgeon goes
to the operating room planning to fail, but that many surgeons go to the operating room failing to
plan” (Hak et al., 2010). Thus, implementing AM technology would be a strategy to achieve a
better surgical planning, thereby reducing the number of claims. The current expected industry
growth coupled with the difficulties surgeons face in performing a successful operation will
force innovators in the health sector to focus on developing and implementing smart solutions
including the usage of AM in the orthopedic device industry to generate quality products that
assist surgeons in delivering quality surgical outcomes. Currently, AM is spreading to different
areas in healthcare and is considered a disruptive innovation that is causing radical changes in
the orthopedic and traumatology sectors (Pascau et al., 2021). Despite AM's technological
capability, its actual use and clinical implementation are not fully understood. FDA is currently
conducting a study to examine the feasibility of establishing 3D printers at the point of care, in
hospitals and care centers to achieve efficient, agile manufacturing and quick delivery of
implantable and surgical instruments (FDA, 2021). Despite this, the dilemma remains over the
appropriate clinical guidance that both patients and clinicians can follow.
According to different researchers, integrating AM into daily orthopedic practice remains a
challenging task. The current regulatory requirements in Europe and a lack of adequate labor
expertise are raised as factors that prevent the adoption of this technology in the orthopedic
industry (Ashish et al., 2019). According to Migliore (2017), a change in regulation will cause
3
the availability of AM implants and surgical instruments to increase in lead time for market
access due to complying with all the regulations' requirements. Additionally, Singh et al. (2020)
have noted that the biggest challenge with AM adoption and implementation in the orthopedic
industry is complying with all regulatory requirements established in Europe. For stakeholders in
the orthopedic industry, this will present a significant challenge. Starting from hiring experts
who have a clear understanding of the process control and quality assessment of AM (Singh et
al., 2020). Furthermore, Hak et al. (2010) elaborated on the problem of successfully managing
the current resources, it is unfortunate that with limited resources in healthcare, large amounts
are diverted towards compensating unsuccessful operations, this affects clinicians, hospitals,
insurance companies, and regulatory bodies ” (Hak et al., 2010). Researchers and companies
wonder, however, what strategies clinicians can use to achieve widespread adoption of 3DP until
it is established at the point of care while simultaneously managing the resource shortage issue.
Before business implementation, it is imperative to critically investigate all potential threats and
opportunities.
By adopting AM in orthopedic the surgeon would achieve a production model involving in-
house manufacturing just at the point of care, aligned with the current trend of "do it yourself"
(Pascau et al., 2020). In spite of these factors, there are still some factors that affect the make or
buy decision of orthopedic clinicians regarding the orthopedic medical devices. An
understanding of the factors that influence orthopedic surgeons to adopt AM can help to establish
the strategic implementation approach that clinicians and hospitals with a need to use AM in
surgical operations would apply.
1.3 Purpose
Developing procurement and purchasing strategy for clinicians to follow can be a driving force
in the adoption of AM in the Swedish orthopedic sector. According to (Gadde and Håkan, 1994)
the new method of purchasing has gradually changed since the 20th century. Firms and
organizations are taking into consideration their first priority to purchase the cheapest products at
the market, this is a major competitive advantage for them to sustain on the market as a result of
using a cost-effective products (Gadde and Håkan, 1994). As resources are scarce in the
healthcare system, adopting new innovations may be a smart solution in order to use resources
accordingly, which will depend on the strategies designed and models applied in sourcing new
products. “In many companies purchasing is responsible for more than a half of the total costs”
(Gadde and Håkan, 1994). With a concrete example, “In Karolinska University Hospital goods
and services are purchased for more than 20% of the hospital’s €1.2 billion turnover” (Terio,
2010).
It is therefore quite a priority on management's part to incorporate and follow a most efficient
procurement and purchasing strategy in order to minimize the resource used. This isle
simultaneously introduces new modes of operation for the benefit of patients. According to a
4
study conducted on the procurement of medical equipment in Sweden, it is crucial that
procurement is done efficiently and effectively in order to reduce running costs and ensure the
safety of patients (Terio, 2010).
In this degree project, I will analyze the orthopedic industry trend in Sweden with a focus on the
possibility of implementing AM into orthopedic practices specifically at the point of care, in-
house manufacturing. A strategic approach to the clinical implementation of AM will be
explored by mainly taking the orthopedic surgeon's viewpoint into account. I have divided the
aim of this project into two main parts: 1) Exploring clinicians' views on the adoption of AM
implants, surgical guide /instruments, and accessories (in house production or external)
; 2) To explore clinicians' understanding and knowledge of the regulatory requirements in
Sweden for AM implants, in particular when produced in house
1.4 Research question
1. What factors may influence the adoption of AM and the establishment of 3D printers in
orthopedic practice from the perspective of the Swedish orthopedic surgeons?
2. In which way do regulations and policies affect the adoption of 3DP at the point of care in the
orthopedic industry in Sweden?
1.5 Delimitation
The scope of this thesis will be to examine factors that influence the adoption of AM in the
orthopedic industry as well as the impact of regulatory changes on the adoption of AM. This
study has been conducted using a qualitative method (Bell et al., 2019). The significant factors
affecting the adoption of AM products will be examined through a combination of the adoption
theory known as TOE, and a strategic adoption and implementation approach identified through
the Kraljic model will guide the procurement and purchasing strategies for AM products.
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2 Literature review
This chapter consists of an overview of different studies that have been conducted and
scrutinized on the clinical application of AM in the orthopedic sector. Additionally, it
incorporates the regulation’s perspective on AM implants and surgical instruments specifically in
the orthopedic device industry.
To provide a proper understanding of the clinical implementation of AM in the orthopedic
industry, a need of gaining an insight into the orthopedic industry structure is needed. Thus, this
chapter is divided into 4 main parts, Orthopedic device industry outlook, AM in orthopedic
practice, the third part of this chapter discusses 3DP adoption factors from the perspective of
different researchers, and last part discusses regulation framework, and requirements for using
AM in the orthopedic industry in Sweden.
2.1 Orthopedic device industry outlook
According to the world health organization, the term medical devices covers “An article,
instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness
or disease, or for detecting, measuring, restoring, correcting or modifying the structure or
function of the body for some health purpose.” (Who, 2003). In the orthopedic medical device
market, there are mainly Spine orthopedic devices, Skull orthopedic devices, Hip orthopedic
devices, Joint reconstruction, Knee orthopedic devices, and Trauma Fixation devices. In the
global orthopedic annual report, the joint replacement and spine product segments possessed the
highest market share for orthopedic products (Marketdataforecast, 2022). According to a report,
the orthopedic medical device market in 2020 was valued at USD 39,585 million. The market is
forecast to grow at a CAGR of approximately 4.9% from 2021 to 2026 (Mordorintelligence,
2021). The expected increase in life expectancy and the increase of older population will play an
important role in fueling the market increase of orthopedic medical devices (OssDsign, 2020).
Due to the Covid Pandemic restrictions and their impacts, the global orthopedic device market
declined by 5.6 billion from the year 2019 to 2020 (Evers, 2021). This substantial market
decrease was caused mainly by a suspension of both private and public transport to mitigate the
spread of the virus in many countries around the world. The bun and the reduction of the
movement of people have directly reduced the number of global accidents which mostly affected
the shrink of the market size in the global orthopedic device industry (Evers, 2021).
It is most important to draw special attention to the Covid pandemic’s impacts on the clinical
sourcing operations, or overall on the supply chain activities in the orthopedic devices industry.
From a clinical management perspective, which represents the downstream portion of the supply
chain, it used to be quite challenging to successfully coordinate and execute the supply chain
activities, especially when it came to procurement of orthopedic medical devices. In the sample
of 181 Orthopedic specialists, 86 percent reported that in their daily clinical practice, they have
experienced one of the following issues, “being exposed to material failure, low effective of
6
medical device, implants which do not meet patients need, delay provision of implants and
surgical instruments and accessories, purchasing error including wrong material planning, low
quality of instruments and many more’’ (Lingg et al., 2017). Achieving to better coordinate the
supply chain network, the clinician’s management department needs to consider many aspects
including understanding first the design and manufacturing process, and by additionally,
grasping ISO standards and regulation’s perspective which suppliers need to fulfil as well to
achieve providing a safe and quality product to the end-user (Lingg et al., 2017).
Apart from the above-highlighted factors from the clinician’s perspective that continue to act as a
threat in sourcing orthopedic medical devices, currently, many challenges are emerging in the
upstream portion of the supply chain represented by the external manufacturer (Zamborsky et
al., 2019) note that orthopedic device manufacturers face many threats such as the lack of
production capacity, mainly pertaining to the difficulties in designing all the necessary shapes
through conventional manufacturing. With this traditional approach, there is a longer lead time,
fewer experienced people able to use AM technology, higher production costs for medical
devices due to new regulatory requirements, and the highest level of competition among firms
that rely heavily on research and development, leading to a higher investment. These and many
more threats are being experienced by manufacturing firms within the orthopedic industry.
According to (Evers, 2021), currently, there are three key innovation trends in orthopedic
industry. The first highlighted trend is regarding the adoption of enabling technology. Secondary,
multiple companies collaborating to foster innovation success and thirdly, another trend is the
shift from not only performing all surgical operations at the hospitals rather to the outpatient
applying and use ambulatory surgery centers (ASCs) to increase patient satisfaction. ASCs
setting, “is a modern healthcare facility that is currently trending due to remarkable clinical and
economic advantages to both patients and physicians” (Badlani, 2019).
By reflecting on these trends, the adoption of enabling technology in orthopedics involves
developing high quality implants. In orthopedic surgery, the quality of the implants plays an
important role in efficiently improving patients' outcomes. The research highlights that the use of
smart implants in orthopedic does not only help in therapeutical benefits but also has a role in the
diagnosis process (Ledet et al., 2018). Besides the Internet of Things (IoT) features, Smart
implants in orthopedic, it also concerns with the physical parameters of implants developed such
as the force, pressure, and strain of the product which basically depend on the material used in
the manufacturing process (Ledet et al., 2018). Working with this advanced technology will
simultaneously lead to a flexible business model hence increasing the firm’s economic growth.
2.2 AM in orthopedic practice
In the orthopedic industry, integrating AM into the production of implants and surgical
instruments aligns with the trends that (Evers, 2021) highlighted. AM technology is a strategic
way of developing bone implants. According to (Wong et al., 2017) it has been more than a
7
decade since the application of AM technology started to be used in the medical industry. In
1994, SLA was the first 3DP technique available and the first used in the biomedical field
(Hoang et al., 2016). Orthopedic surgery, craniomaxillofacial surgery, and cardiothoracic surgery
have been early adopters of using this advanced manufacturing approach because the first 3D
printers could only print with hard materials (Hoang et al., 2016). The orthopedic sectors hold
the biggest market share in using AM technology compared to other clinical sectors. In 2016 it
retained 44% of all AM applications in the global healthcare system (Asanova et al., 2017).
Moreover, the forecast still predicts that the orthopedic industry will hold the highest market
share in the future.
According to the report published by Market data forecast (2022), the use of 3DP in the
European market for medical devices is currently estimated at 547.11 million in 2022. The
forecast predict a high market growth within five years to come with a market value of 1836.96
million by 2027, at a CAGR of approximately 27.41% (Market data forecast, 2022). The ten first
mover country in the EU to adopt AM within the healthcare includes The United Kingdom,
France, Spain, Germany, Italy, Russia, Sweden, Denmark, Switzerland and Netherlands (Market
data forecast, 2022). Considering the research study conducted in Spain, Pascau et al. (2021)
have presented the statistics of orthopedic expertise with the adoption of AM.
The figure below represents the annual distribution of AM products by area of expertise
Figure 1. AM in orthopedic expertise. Source: (Pascau et al., 2021)
8
When it comes to the orthopedic sector, the variety in injury and complexity in surgery are major
factors driving innovation forward in this sector. Several trauma surgeries resulting in vast bone
loss and deformities, pelvic surgeries, and joint revision surgeries place a great deal of stress on
orthopedic surgeons (Wong et al., 2017). The above figure also can shows that trauma surgery
from 2019, holds the biggest share of an orthopedic area which AM mostly assist surgeons. The
difficulties in treating patients who used to be characterized by specific and distinct issues are the
ones that are pushing innovators and researchers to highly consider this sector, thus leading them
to develop and learn how advanced technology can come to assist orthopedists. Starting by
highlighting the development of advanced medical imaging such as computed tomography (CT),
magnetic resonance image (MRI). The adoption of this imaging technology in the orthopedic
sector has currently played an important and significant role in the diagnosis and allows surgeons
to understand every patient’s issue (Wong et al., 2017). Moreover, the good quality of 3-D
models depends on the imaging quality provided by CT, MRI, or other imaging data sources.
The use of AM is classified into two major applications within the orthopedic surgical practice.
Firstly by industrial application and secondary by everyday practice which means in clinical use
(Mulford et al., 2016). According to (Mulford et al., 2016) clinical applications of 3DP are
mainly used in education or surgical planning. Surgical planning “involves a preoperative
method of pre-visualizing a surgical intervention, to predefine the surgical steps and any bone
segment repositioning in the context of the outcome”. (Dockery, 2015)
Since its application in the orthopedic industry, the major drawback that makes AM reluctant in
experiencing the quick adoption in every day’s clinical application was due to the high expensive
price of the 3D printer machine. However, currently, there is an increasing trend in the use of
3DP in clinical applications due to the cost reduction of 3D printers and the availability of free
software (Mulford et al., 2016).
Next, I will focus on AM application’s fields, starting with AM in surgical planning, followed by
the application of AM for custom implants and guides
2.2.1 AM in surgical planning
As of right now, 3DP has been most commonly used for surgical planning in orthopedic clinical
practice. Currently AM in orthopedics is being used as an educational tool in providing
instructions to patients and in training surgeons (Wixted et al., 2021). This approach has helped
to high extent orthopedists to understand injury’s complexity, and it allows them to respond in a
short time before a patient can have other complications (Zamborsky et al., 2019). Similarly Hak
et al. (2016) also highlight the importance of surgical planning to assist orthopedists in
understanding and mitigating possible problems in advance which might arise and affect the
treatment and the diagnosis process. The AM technology provides a 3D physical model, which
surgeons can utilize before performing any surgical operation on the patient. The 3D physical
models developed by 3D printers are mostly efficient and with higher accuracy than the images
9
provided by CT and MRI (Hurson et al., 2007). Using a 3D printed model before conducting a
surgical operation is the best strategy to critically understand a patient’s issue and to achieve a
successful surgery outcome. Through a follow-up conducted on the 12 cases undergoing a
fractured acetabulum, the researcher has highlighted that the 3D physical model has assisted the
surgeons to better understand the patient's issue prior to surgery and to respond to the complexity
of the fracture (Hurson et al., 2007). Thus, the 3D physical model allows the development of a
highly efficient medical device that meets the needs of the human body accurately.
Generally, surgical planning is a preoperative planning conducted with an aim of increasing the
surgical operation’s outcome (Hak et al., 2016). According to Hak et al. (2016), there are 3 main
sessions of preoperative planning. Successful surgical planning involves designing the overall
outcome, developing gradual surgical tactics, and allocating all needed operation logistics. CT
and MRI applications have currently emerged and assist the surgeon to understand patient’s
anatomy hence improving the operation outcome. However, for example in trauma cases due to
the wide differences in cases “ the displacement and the angulation of distinct patient fracture
fragment is mostly unique and critical to analyze as the two-dimensional imaging and three
dimensional imaging configuration don’t easily permit an accurate reconstruction of the enact
bone” (Hak et al., 2016). It is vital to emphasize that preoperative planning is not critical only in
trauma; all surgical plans require detailed, highly accurate planning, which creates good
communication among all members of the operative team (Hak et al., 2016).
According to Mulford et al. (2016), 3DP is gaining popularity in orthopedic surgery and is most
commonly used in surgical planning during different surgical procedures. “The cases vary from
complex fracture patterns to revision arthroplasty surgery” (Mulford et al., 2016). In similar
fashion to Hak et al. (2016), currently 3DP is used mainly for complex trauma cases in which the
models aid surgeons in selecting the most appropriate surgical approach (Mulford et al., 2016).
As example 3D models are being used for understanding challenging pelvic. Furthermore,
According to Mulford et al. (2016) the use of 3D printed models has assisted with the
management of complex spine scoliosis, coalitions of the foot and Perthes and Blounts disease.
Additionally, 3D technology has also been used in cases where complex osteotomies of the
lower and upper limbs have been performed (Mulford et al., 2016). Alternatively, 3DP is used to
create surgical guides, these are patient specific instruments that include disposable cutting
blocks fabricated based on the patient's anatomy using 3DP technologies and never used again
(Mulford et al., 2016). Despite the technology capability, there are still barriers to the fast
adoption of 3DP in the pre-operational planning process, such as cost and a lack of expertise
among employees (Mulford et al., 2016).
10
2.2.2 AM in developing orthopedic implants and guide
Another important clinical application of 3DP technology in orthopedic is to manufacture
implants and surgical accessories. In the article titled, three-dimensional printing in orthopedic
surgery, current applications, and future developments, (Wixted et al., 2021) mentioned how AM
in orthopedic has radically changed the design theory and manufacturing process due to how it
lead to easy prototyping and efficiency in exploiting production materials. The process is in line
with lean manufacturing principles. AM is a just-in-time approach, a relevant production process
strategy to eliminate waste. “AM in orthopedics is an advanced technology that will come to
respond to the issue of the use of resources within the health care sector” (Wixted et al., 2021).
The technology will allow shifting from conventional manufacturing which is used to produce
both implants and surgical instruments by relying on the forecasted market, which leads to mass
production and results in storing large inventories (Wixted et al., 2021).
The Figure below briefly presents the design and manufacturing procedure for AM implant
Figure 2. Design and manufacturing procedure for AM implant. Source: ( Jindal et al.,2020)
11
AM in the orthopedic industry will rather switch to an on-demand manufacturing approach
(Wixted et al., 2021). AM contributes to the reduction of part’s cost at a maximum amount of 80-
90% in comparison to the conventional manufacturing approach (Zamborsky et al., 2019).
Moreover, the technology is capable to deliver complex shapes, unlike the conventional
approach. It allows responding to every patient’s injury by producing customized implants and
manufacturing surgical instruments and accessories based on the orthopedist and patients’ need.
Currently, conventional manufacturing also known as the traditional manufacturing approach
cannot be used to develop custom-made implant and surgical instruments (Graichen et al., 2007).
The 3D printed (3DP) bone highly resists fracturing more than normal bone. “The 3DP bone is
22 times stronger than normal bone” (Zamborsky et al., 2019). This advanced manufacturing
reduces the time patients used to spend at healthcare centers waiting for proper diagnosis. On the
other hand, some claims that AM still delays specifically the overall printing process, during the
case conducted by Bloom et al. (2020) after the design approval, it has taken 23 days to get a
cranioplasty implant. Thus analyzing the factors that may influence the development of AM
would lead to the spread of AM in the orthopedic sector
2.3 Adoption factors of AM in the industrial setting
Generally, there are fewer studies that discuss the factors that influence the adoption of 3DP
(Yeh et al., 2018). Through contemplating on the factors influencing 3DP implementation,
Mellor et al. (2014) identified six factors as the most common factors to consider in fostering
3DP adoption. It includes external forces, organizational factors, technological factors, strategic
factors, operational factors, and supply chain factors (Mellor et al., 2014). The organization
business model, however, plays an essential role toward a successful adoption of a rapid
manufacturing process as analyzed by Muita et al. (2015), by looking at the factors affecting the
adoption of new rapid manufacturing processes. Business models play an important role in
hindering or facilitating the transition from one way of working toward adopting new ways (
Muita et al., 2015). Similarly to Muita et al. (2015), Wang et al. (2019) found that "3DP
implementation is influenced by the external environment in which business firms are located"
(Wang et al., 2019). Additionally, Ukobitz (2021) published a review regarding factors that may
influence the adoption of AM in an industry. Unlike the others, for them, the technological factor
dominates all other factors in influencing AM adoption.
Ukobitz (2021) in his report addressed three broader contexts in which he classified factors
affecting AM adoption, namely technology context, organizational context, and environmental
context. Yeh et al. (2018) on the other hand, state that the factors influencing the adoption of
AM may be divided into four dimensions: the technological, the organizational, the
environmental, and the cost-related dimensions. Almost a similar approach was taken by Yeh et
al. (2018) in addressing the factors that may influence AM adoption as Ukobitz (2021). They
only differ in their views on the cost factor. Yeh et al. (2019) discuss the cost as the fourth factor
12
which affects the adoption of AM, however, from the perspective of Ukobitz (2021), the cost is
embedded in the technology context. She claims that investment costs for 3DP activities become
a burden to firms, investment costs for AM are associated with the high acquisition cost, the
increase in maintenance cost, and labor cost (Ukobitz, 2021).
Regarding the cost dimension, "Cost is also another crucial aspect for understanding the success
of 3DP" (Yeh et al., 2018). Yeh et al. (2018) describe the cost as including the fixed cost, which
includes the investment in hardware, software, appropriate production space, and the variable
cost, which include the usage cost, maintenance, and labor costs.
Although Ukobitz (2021) and Yeh et al. (2018) discuss different factors that influence AM
adoption, there are many similarities between their perspectives. The following part elaborates
on the adoption factors through the three main contexts.
2.3.1 Technological factors
It includes both the internal and external effects of the new technological innovation (Yeh et al.,
2018). The complexity of the technology embedded with 3DP and the software skills required to
run and implement AM makes it possible for firms and organizations that apply advanced
technological products to easily implement AM technology (Yeh et al., 2018). According to
Ukobitz (2021), the technological factor plays the largest role in driving the adoption of AM.
With regard to traditional manufacturing, the reduced lead time that AM brings is a major driver
factor and a competitive advantage to be adopted by different industrial sectors, as it is a
technology that will accelerate the time to market (Ukobitz, 2021). One other aspect that the
researcher noted that aligns with the sustainability goals of AM is that through AM a zero waste
model is introduced (Ukobitz, 2021). On the other hand, factors such as developing user-friendly
software, which can be easily grasped and can also offer flexibility in the design, can also
motivate companies to implement 3DP (Ukobitz, 2021). Furthermore, according to him, it is
important to consider the printer size as an important factor that can impact the adoption of AM
(Ukobitz, 2021). From a technological standpoint, there are many factors driving the adoption of
AM, but simultaneously there are some which could hinder it from Ukobitz (2021) perspective.
2.3.2 The organization factors
Organizational factors play a major role in the adoption of AM within an organization (Yeh et
al., 2019). In relation to AM adoption (Ukobitz, 2021), mention the organization factor as the
second most relevant factor. This involves both the role and support of senior managers and
different organizational conditions such as the availability of resources including the financial or
technological resources (Yeh et al., 2018). A company's management has a significant role to
play in adopting 3DP since they are the ones who make all of the decisions (Yeh et al., 2018). In
addition to top management responsibility, a dynamic organizational culture can also contribute
13
to adoption (Ukobitz, 2021). From the different research and study published in the context of
adoption, they have mostly focused on the willingness of the organization to adopt 3DP
(Ukobitz, 2021). Yeh et al. (2018) also refer to it as organizational readiness. Organizational
willingness and readiness to adopt 3DP can be determined based on the human resources within
the organization or the organizational structure's capacity and capability to develop and train the
current skilled workforce (Ukobitz, 2021).
2.3.3 The environment factors
“Environmental factors introduced within this research field are categorized into competitive
pressure, expectations from market trends, trading partners, and government support”. (Yeh et
al., 2018). The semi-systematic review conducted by Ukobitz (2021) found that the environment
context was attributed the lowest quotes compared to the other two factors that affect the
adoption of AM. Yet, despite the limited amount of literature that addresses environmental
factors in the adoption of 3DP, she asserts that this context has the greatest impact on adoption
(Ukobitz, 2021). According to the researcher, the market and type of industry are the major
factors that drive the competition, which is able to foster innovation and ensure the adoption of
new technologies (Ukobitz, 2021). This environment context also acknowledges the government
and regulation support as major factors forcing new trends to penetrate the market (Ukobitz,
2021). A government incentive program encourages firms and companies to adopt 3DP. The
market trends impact managers' decision making regarding which technology they should invest
in, whereas the trade partnership also affects adoption, “a trading partner spreads the technology
to purchasers through its machine vendors. Next, purchasers continue to spread the technology to
their own trading partners”, (Mellor et al., 2014).
However, in addition to the factors that influence the use of 3DP that are merged into three main
factors, Ukobitz (2021) have also addressed some other interesting factors, such as, the trend
among publications of research in time, where since 2013, when researchers started to raise the
awareness of AM, firms and organizations have started to show interest in the 3DP technology
(Ukobitz, 2021).
In the next section, I will discuss the adoption factors specifically in the orthopedic industry as
reported by Asonova et al. (2017).
2.4 Adoption factors of AM in the orthopedic industry
Additionally, Asanova et al. (2017) has also addressed the factors that affect the adoption of AM
specifically in orthopedics sector. There are some similarity within the issue addressed by
Asanova et al. (2017) and the above addressed researchers. However, I have paid attention to his
publication, because the factors that he addresses align with the adoption of AM in the
orthopedic sector. According to Asanova et al. (2017) the adoption factors can be divided into 3
14
major dimensions. Value-added activities associated with AM technology, the role of supply
chain activities in the development of technology, and the key actors involved in all activities to
adopt AM. Asanova et al. (2017) suggestions can provide access to AM implants, surgical
instruments, and accessories within the orthopedic device industry.
Table 1 below highlights the factors that can influence the adoption of AM in the orthopedic
sector elaborated as three major dimensions according to Asanova et al. (2017).
Dimensions Activities Description
Value-adding R&D Most important in gathering
extensive knowledge and
understanding the
implementation feasibility
Design The technology’s
competitive advantage, by
the use of different software
that allows the translation of
the medical data and images
into a 3D virtual design
Policy Government support is
needed to redesign policy in
line with the use of AM in
orthopedics. Both in-house
or external manufacturing
Partnership Among academia,
entrepreneurs, Government
institutions, clinicians etc.
Services Manufacturing capacity of
3D printed medical devices
either in-house or external
15
Table 1. (Continued)
Dimensions
Activities
Description
Supply chain Input and Upstream
coordination
In terms of gathering patient
data and sourcing needed
material
Product development and
manufacturing
With the use of a 3D
scanner, software
development, and 3D printer
Product generation Implantable medical device
or external medical device,
Surgical instruments and
accessories
Distribution facilities The process can either be in-
house manufacturing or with
a near external manufacturer
Application Orthopedics: either at
hospitals, sports centers,
Downstream benefit End-user -Patient and
orthopedists
16
Table 1. (Continued)
Dimensions Activities Description
Actors Contributing in knowledge-
gathering
Such as Research centers,
Knowledge and technology
holders
Testing and demonstration
facilities
For example laboratories
and industries boost
technology development
Help to train skilled labors Educational institutions,
Universities or vocations
and training centers
Support regulatory
framework
Standards and patents
organizations
Generating demand Hospitals, Health care
centers
Human resource
development
Managers, Designers,
Manufacturers, Operators.
Ensuring an affordable
medical device for the
patients.
Health insurance providers
Redesign policy and
procedures
National government
Table 1. AM adoption factors according to Asonova et al. (2017)
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2.5 Understanding the Regulatory Requirements
2.5.1 Regulation outline
The European Commission in the study conducted in 2016 titled, “Identifying current and future
application areas, existing industrial value chains and missing competencies in the EU, in the
area of AM”, classify medical devices possible to adopt AM into five categories. Models for
preoperative planning; Tools, instruments, and parts for medical devices; Inert implants; Medical
aids, supportive guides, splints, and prostheses and Bio manufacturing (Duchêne et al., 2016).
Accordingly, the goal of this regulation's perspective part is to consider the legal implications
related to the development of an orthopedic medical device using AM. In May 2017 the new
regulation guideline on medical devices has been introduced in Europe, where it has replaced the
Medical Device Directive ( MDD) 93/42/EEC and the Active Implantable Medical Device
Directive (AIMMD) 90/385/EEC hence come into being a new European Medical Device
Regulation (MDR). Before MDR come into force medical devices manufacturers have been
given a period of 3 years as a transition period.
From May 2020 the established MDR was supposed to be considered and harmonized standards
have to be met (Asanova et al., 2017). However, due to the Covid pandemic’s effect, there has
been a schedule change. In April 2020 the European Commission and the European Parliament
have extended the implementation due date to May 2021 (Europarl, 2020). The MDR has been
introduced to upgrade both Active Implantable Medical Device Directive (AIMMD) and
Medical Device Directive (MDD) (Migliore, 2017). Generally, during this modification, the term
medical devices have been expanded and incorporated other products which do not have a
straight medical intention such as disinfection and sterilization products, implanted devices used
for esthetic and cosmetics, and many more modifications (Migliore, 2017). Simultaneously,
medical devices have been reclassified into different categories depending on their level of risks,
and the roles of notifying bodies “the core organization of the regulatory system in the EU” have
been adjusted and improved (Migliore, 2017).
The table below presents the difference in the three established regulations concerned with the
production of medical devices. Currently, EU medical device manufacturers must comply with
MDR.
18
# AIMDD MDD MDR
Full form Active Implantable
Medical Device
Directive
Medical Device
Directive
Medical Device
Regulation
Legislation Directive
90/385/EEC
Directive
93/42/EEC
Regulation (EU)
2017/745
Year of
introduction
June 1990 June 1993 May 2017
Scope
“It included devices
that inserted into the
patient’s body and
supposed to remain
in the body after the
operation”
“It included devices
either used alone or
in combination
with software”
mainly devices
developed by the
manufacturer
to be utilized, “on a
human being
mainly for
diagnosis,
prevention,
monitoring and
treating the
diseases or injury.”
“The definition of
medical devices
broadened, thus
include other product
not intended for
medical purpose”. The
change in software
classification etc.
Scope of MDR is
wider compared to
MDD
Table 2. Three established regulations on medical devices
2.5.2 Medical device categories under MDR
To understand what applies in the case of producing or developing orthopedic implants and
surgical instruments under EU new regulation on medical devices, an overview of how devices
are classified is needed. Medical device manufacturers aiming to launch their products on the EU
market need to comply with the new regulation and are required to check the class assigned to
the products they are developing (Strålin, 2022). Medical devices are classified into four classes
19
mostly depending on the degree of risk toward a patient’s health (Chai, 2000). Because of the
change in regulation with stricter rules, the class of many orthopedic devices has changed in
MDR (Strålin , 2022). On the other hand, the conformity assessment to be fulfilled just depends
on which class the device in question belongs to, and is done before launching the product on the
EU market (Chai, 2000).
Figure 3. Classification Medical devices. source: (Strålin, 2022)
As a general rule, only manufacturers can perform conformity assessment on products with very
low risk, medical devices that belong in Class I. With class I products, manufacturers can
perform a self-certificate via a written assessment that complies with MDR requirements
(Strålin, 2022). In other remaining classes the notified bodies must get involved before receiving
CE mark approval to be allowed to enter the EU market. “NBs are the core roles in this system
who evaluate the safety and reliability of devices, then certificate the CE marking on the
qualified devices for the later market in the whole EU.” (Strålin, 2022). Every medical device
product in class IIa, class IIb and class III must be approved by notified bodies that fulfill all
essential requirements before entering the EU market (Strålin, 2022).
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2.5.3 Orthopedic medical devices under MDR
With the new MDR, all orthopedic implants are classified as high risks devices (Shohat, 2019).
Class III devices are taken as products with high risks. Manufacturers must comply with special
requirements that fall under the class III category including providing clinical data that prove
implant’s safety (Shohat, 2019). It was noted that during the implementation of MDR, the new
regulations will not only affect the clinical evaluation of the new product expected to enter the
EU market but also those that are already on the market must get inspected and fulfill all
requirements aligned with MDR. In the post-market clinical follow-up, the devices that will fail
in re-evaluation will be banned on the EU market (Shohat, 2019).
Disregard the implant’s application either is designed to be used for trauma, hips, joint
replacement, the MDR considers all orthopedic implants as devices with high risk. Thus before
entering the EU market, medical devices in class IIb and class III must get approval and hold the
Conformité Européenne (CE) mark. Moreover, there will be a continuous assessment, post-
market clinical follow-up (PMCF) for ensuring medical device safety after entering the EU
market, manufacturers need to carry out PMCFs. Alternatively, the Notified Body is responsible
to conduct post-market surveillance (Fennema et al., 2019). For medical devices in class III, the
notified body must get involved within the design and the production process (Fennema et al.,
2019).
Regarding orthopedic surgical instruments according to the new MDR, reusable surgical
instruments are classified in Class I (Mdc, 2019). These are instruments used in surgical
operations either for cutting, drilling, sawing, clamping, or with another similar plan of action
which after being used they can be cleaned, disinfected, and sterilized. On the other hand,
Invasive devices designed to only be used for a single operation are in Class IIa (Mdc, 2019).
However, the MDR legislation has stricter requirements for reusable surgical instruments despite
being classified in class I. All surgical instruments classified in class IIa or class IIb are subjected
to the conformity assessment with the involvement of the notified body, they must bear a CE
mark to be sold on the EU market. In the case of assessing class I surgical instruments, the
notified body participation should only emphasize the aspect of cleaning, maintenance, and other
aspects that are related to instructions for use (Mdc, 2019).
2.5.4 Additively manufactured orthopedic devices under MDR
Currently, in Europe the clinical application of AM is mainly conducted in in-house laboratories
full or partially owned by clinicians (Tel et al., 2021). However, some hospital centers on the
other hand remain in collaboration with external manufacturers regarding the production of AM
21
implants for a specific patient’s need (Tel et al., 2021). With the implementation of MDR, both
point of care 3DP labs currently emerging in different hospitals and AM external manufacturers
will be affected while complying with the new regulation’s requirements (Carl et al., 2021).
Previously they were no clear standards with a well-defined regulatory framework to comply
with when producing medical devices with AM. The article by Singh et al. (2020), adds that
regardless of which manufacturing approach is used, either by conventional or AM technology,
implantable orthopedic devices fall under the risk category III and IIb of the MDR. On the other
hand with the new MDR, AM applied on the custom-made devices are subject to a simplified
pre-market approval process (Carl et al., 2021).
Regarding custom-made devices (Singh et al., 2020) also underlined that manufacturers should
conduct self-assessment themselves. Manufacturers must follow and comply with Annex XIII of
the MDR when performing self-assessment (Europa, 2017). However, by producing class III
implantable customized devices, notified body involvement is obligatory (Singh et al., 2020).
From the manufacturer's perspective, criticism remains on the definition provided by MDR on
the term customer-made medical device. In the second article of the MDR, the term custom-
made is defined as,
“any device specifically made in accordance with a written prescription of any person authorized by national
law by virtue of that person's professional qualifications which gives, under that person's responsibility,
specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their
individual conditions and needs. “Mass-produced devices which need to be adapted to meet the specific
requirements of any professional user and devices which are mass-produced by means of industrial
manufacturing processes in accordance with the written prescriptions of any authorized persons are not
considered custom-made” (Carl et al., 2021).
From the above definition, medical devices that are adapted and transformed into the patient-
matched according to every patient’s individual issue are not considered as custom made medical
devices. Until today, those devices must be classified according to the general MDR medical
devices classification, thus manufacturers need to obey and meet all requirements depending on
the class the medical device being produced is subjected to. Generally, orthopedic manufacturers
have to comply with the orthopedic implants and orthopedic surgical instruments requirements
under MDR legislation. Moreover, additively manufactured medical devices have a special case
as they mostly rely on software in their production process. Thus, external manufacturers and
point-of-care 3DP labs must use medically certified software (Carl et al., 2021). Software
intended to be used for medical purposes falls under MDR as well according to the MDR second
article (Europa, 2017). New regulations have considered the software’s effect on a patient's life
and hence divide them into classes depending on their capacity and function in the diagnosis as it
has been illustrate in figure 4.
22
The figure bellow is the illustration of Software under MDR
Figure 4. Software classification under MDR. Source: (Mdcg, 2021)
The next chapter will elaborate on the theory that underlies this study
23
3 Theory
The purpose of this chapter is to present the theoretical framework that will be used in this study,
and its motivation for selecting the chosen models. The chapter is divided into two parts. In the
first part, the TOE framework is discussed, while the Kraljic matrix model is discussed in the
second part
3.1 The Technology organizational and environmental framework
Technology-organization-environment model (TOE) is a model developed by Tornatkz and
Fleischer (1990). According to Gutirrez et al. (2015), TOE is mainly used for the analysis of
adoption of new technologies within an organization. In the same way, by analyzing the many
adoption theories for the adoption of 3DP in an organization, researchers have identified TOE to
be relevant and one of the most relevant and widely applied theories to study the adoption of AM
in organizations (Ukobitz, 2021). It is also possible to apply other adoption models to this study
in order to have a better understanding of AM in the orthopedic industry, such as the diffusion of
innovation theory (DOI) developed by Rodgers (1983). Ukobtiz (2021) asserts that the TOE
theory has some similarities to the DOI theory; however the major difference is that TOE
considers the context of the environment as well. The TOE framework was selected for this
study because, in addition to taking into consideration the technology and organization context, it
would be interesting to analyze relevant external factors that might be addressed from the
designed research questions. In this study I will also reflect on how the environment context
could affect and influence the adoption of AM in the Swedish orthopedic industry.
Below is the illustration of the TOE framework
24
Figure 5. TOE diagram (adopted from Wang et al., 2019)
The TOE framework is built on the three main contexts that Tornatkz and Fleischer (1990)
identify as the most important influencing factors for firms and organizations to adopt and
implement new technology innovations. The aim of TOE “ is to examine the influence of a
firm’s context on technology adoption” (Ukobtiz, 2021). In this framework, the dependent
variable is the technological innovation decision, while the drivers are divided into technological
context, organizational context, and environmental context (Ukobtiz, 2021). According Ukobtiz
(2021), the environment context contemplates on different external factors such as the
competition, governments, partners and trading.
Adoption theories, however, have some drawbacks. Focusing on the TOE framework, “ TOE is
too generic” (Gangwar et al., 2014). In light of this, I have selected to integrate another theory to
elucidate how clinicians can adopt AM in orthopedic practice. In addition to the adoption
theory, this study also uses the Kraljic matrix framework. The second theory can be used to
reflect on the adoption and implementation of AM in the orthopedic industry based on the factors
addressed that can influence the spread of AM. In addition, as the environmental context reflects
on the trading factor and as clinicians play buyer perspectives in adopting AM, the second model
will focus on the procurement and purchasing strategy based on the product class in the matrix.
25
3.2 The kraljic matrix framework
Kraljic has published an article named purchasing has become supply management published in
Harvard business review in 1983; in the same article he introduced the purchasing model
(Kraljic, 1983). Because clinicians and hospitals will have the buyer's perspective in adoption of
AM in the orthopedic sector, this is the reason I wish to apply this framework to this study. The
framework has been mostly used in professional purchasing, in many scenarios purchasing
strategies have been decided in the kraljic matrix and many academicians’ researchers have
conducted further research with the aim of investigating on the evidence of this model (Caniels
et al., 2005). Specifically in the healthcare, because of the complexity of purchasing medicines,
and managing suppliers in health sector, it has been suggested by different researchers that the
Kraljic purchasing model can be a useful tool that central hospitals can use when procuring and
purchasing medicines (Arantes et al., 2022). The framework is based on the two factors, the
strategic importance, mainly termed profit impact and the supply risk. In the Kraljic model, these
two factors determine supply and buy strategies. The matrix is composed with four different
categories, the strategic items, bottleneck items, leverage items and the non-critical items
(Kraljic, 1983). By using the highlighted two factors, the firm or organization use a certain’
product criteria in the matrix and analyze which categories it falls in, thus understanding which
strategy is most appropriate to introduce to strengthen the company's business development.
The figure below is the illustration of the kraljic matrix
26
Figure 6. The kraljic matrix
The profit impacts
This is plotted on the y-axis of the matrix, the profit impact of certain item or product can be
represented in terms of percentage of total purchase cost, volume purchased, impact on the
quality of the product on business development and growth etc. (Kraljic, 1983).
The supply risks
This is plotted on the x-axis of the matrix, and it represent various aspect but most importantly
reflect on the possibility of substitutes, competitive demand, storage risks, the number of
suppliers available and make or buy opportunities (Kraljic, 1983)
To analyze and classify AM's technology within the Kraljic matrix; it is important to understand
the category of items in the matrix
27
3.2.1 The overview of the four categories of items in the Kraljic model
1. Strategic items
They are items that are dominant in the company, and so important due to their high economic
impact, as well as the risk associated with them. With a product that falls in the strategic item
categories, the strategic approach that company should apply should emphasize maximum
collaboration with the supplier, focusing on a single supplier, accurate need analysis, centralized
purchasing, and monitoring long-term relationship (Kraljic, 1983).
2. Bottleneck items
Items with high supply risk, but minimal economic impact, fall into the second category. Items
that fall within the Bottleneck category should be managed by seeking new suppliers, ensuring
volumes despite price increases, and focusing on local purchase or central coordination (Kraljic,
1983).
3. Leverage items
The leverage items are products with high economic impacts but sourced from low-risk markets.
For these products, the company should collaborate with multiple suppliers, focus on price
negotiation, perform mid-term needs analysis, mix spot contracts, and rely mostly on
decentralized coordination (Kraljic, 1983).
4. Non-critical items
The last category of products comprises products with a low economic impact on the company
and low supply risk associated with sourcing them. To reduce administrative burden and
maximize efficiency in the procurement process of these products, it is essential to optimize
order volumes, standardize supplies, analyze short-term needs, and implement a decentralized
purchasing coordination process (Kraljic, 1983).
3.2.2 The procurement strategy for AM
Gadde and Håkan (1994) highlighted three strategic dilemma that firms and organizations need
to reconsider that basically shape the purchasing strategy from which the firm should undertake,
those three dimensions are, Make or buy , Supply-base structure and customer-supplier
relationship (Gadde and Håkan, 1994). The first issue that most organization faces is regarding
either to buy or introduce an in-house production system (Gadde and Håkan, 1994). The second
strategy tackles the issue of the number of suppliers from which a firm need to cooperate with,
28
when it comes to sourcing a certain product and it reflect as well on linking the whole supplier
network activities, this has been named supply-base structure. Additionally, the third issue is
regarding the customer-supplier relationship to be applied. When it comes to B2B, Business
relationship is very important. “The wealth embedded in relationships is now more important
than the capital contained in the land, factories, buildings, goods and even bank accounts
consume a lot of resources for every firm development.”(Bagdoniene et al., 2009). However on
the other hand not all relationship are important to the firms economic growth and development,
thus an organizations and firms need to decide whether the purchasing strategic approach will be
a just in time exchange or either rely in a close relationship which might turn into partnerships or
alliances. However, for this decision to be effective for the firm and organization must be based
on the product/ item or services going to be exchanged between both the buyer and seller.
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4 Methodology
This section discusses in detail the method used in this study. The section is divided into five
phases which include the research design, data collection method, data analysis, ethical
consideration, and limitations of the study.
4.1 Research design
In this study, I will use a qualitative research approach. Through qualitative research, we can
gain a deeper understanding of the process. Bell et al. (2019), argues that a qualitative research
method involves starting the research with a general research question, which guides the
researcher throughout the entire research process. Even if you formulate well-crafted research
questions, that doesn't mean your research is going to be of good value, but poorly developed
research questions can certainly cause troubles that affect the whole study (Agee, 2008). It is
important to note that in qualitative research, “The research questions are stated with varying
degrees of explicitness” (Bell et al., 2019). This means that a question needs to be formulated in
such a way that its corresponding answer will be comprehensively and clearly explained. Besides
the fact that qualitative research is concerned with words rather than numbers, it also highlights
other important details such as how it incorporates an epistemological perspective. Epistemology
“stresses the understanding of the social world through an examination of the interpretation of
that world by its participants” (Bell et al., 2019). Thus, I haven’t choose to use quantitative
research approach, as his purpose is not to test a certain hypothesis or theory rather this research
aims to gather a deep understanding of the orthopedic surgeons’ perspective regarding the
adoption of AM in the orthopedic industry by simultaneously addressing the impacts of the new
regulatory requirement on the development of AM in orthopedic sector.
A research study should include a design, a framework for collecting the data, as well as an
analysis of the data (Bell et al., 2019). Bell et al. (2019) highlighted five different research
design, experimental design, cross-sectional design, longitudinal design, case study design and
comparative design. By carrying out this study, a cross sectional design approach is used in order
to reach the project goal. A cross sectional design “is research design which aim to collect data
from many different individuals at single point in time” (Bell et al., 2019). The aim is to access
orthopedic clinicians insight on their perspective on the adoption of AM in the orthopedic
practice, thus different orthopedic surgeons within different orthopedic sector were approached
within a specific timeframe. The main reason of selecting the cross-section design align with the
this project aim and additionally it was a strategy to increase the number of sample size of the
participants who can contribute in this research study which also has a specific time frame of
collecting data. Despite the orthopedic sector a surgeon belongs to, every surgeon’s insight
would contribute toward reaching the project goal.
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4.1.1 Sampling method
Researchers can apply the sampling principle in qualitative research to different levels. The
qualitative process involves choosing an appropriate site, as explained by Bell et al. (2019). The
purpose with a specific geographic location is to investigate and clarify the detail of interaction
with its environmental context (Stake, 1995). Thus, with this study, Sweden has been chosen as
the site to assess the clinical implementation of AM within the orthopedic industry. This is
become I can reach orthopedic surgeon in Sweden and also this is due to the willingness of
stakeholders, especially clinicians to adopt and use this new technological approach. Considering
Sweden as a site, a researcher intends to analyze stakeholder / clinicians perceptions towards the
adoption of AM in the Swedish orthopedic industry by simultaneously exploring how regulations
and policies may influence the adoption of AM in the orthopedic industry in Sweden.
In contrast with a quantitative researcher who generally emphasizes applying probability
sampling, a qualitative researcher will choose samples based on specific criteria rather than
applying a random sampling method. It is pertinent to highlight that only non-probability
sampling methods are used in qualitative research. However, according to Bell et al. (2019), the
selected sample mostly depends on the research question that a researcher has designed. The
main reason behind this is that qualitative researchers usually try to reach out to relevant
participants who can contribute to their research study with a deep understanding of the study
phenomenon to ensure that their investigation reaches an elaborated and in-depth understanding
of the phenomenon (Gill, 2020). However, different sampling techniques might be used in
qualitative research depending on the aim of the research and its matching research question. It
can also depend on the type and complexity of the study, the availability of target participants,
etc. According to Gill (2020), different sampling techniques can be used by qualitative
researchers to investigate their research.
A non-probability sampling method will be used in this qualitative study, a researcher aims to
apply multiple sampling techniques while targeting important participants who can take part in
this research. Generally, in conducting this research study I have applied the purposive sampling
method. According to Bell et al. (2019), purposive sampling is a method mainly applied
depending on the research goal thus targeting key relevant participants with a deep
understanding of your research study. As this study has specific aims, purposive sampling will be
employed first to reach relevant stakeholders in the orthopedic industry, it aims to include
orthopedic surgeons’' opinions on the adoption of AM in orthopedic practice. On the other hand,
snowball sampling has been used in this study. It is a mainly applied sampling method in
qualitative research. A snowball sampling “is a sampling technique in which the researcher
sample initially a small group of people relevant to research questions, and these sampled
participants propose other participants who have had the experience or characteristics relevant to
the research.”(Bell et al., 2019). Another sampling technique involves in this research study is
convenient sampling also known as volunteer sampling (Gill, 2020). With the time constraints
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issue, while conducting a research study, a researcher can apply this method to incorporate
available participants and those who have a willingness to participate in the research study, these
participants must also have much insight into the research study.
The table 3 below elaborates the advantage and disadvantages of the sampling method used in
this research study
Sampling method Pros Cons
Purposive sampling: also
known as selective
sampling, targeting
participants based on the
research question
participant have an
understanding on the
research study
Participant highly
contribute on the
research
It may take time
to find targeted
participant
Snowball sampling
technique: participants are
reached through the contact
of first selected people
Cost-efficient as in
most time it can be the
easiest way of reaching
participant
Time efficient
it can sometimes
do not add on
anything new on
data as referral
may provide
people with same
perspective
Convenient sampling
technique: Also known as
volunteer sampling.
targeting available
participant
Collaborative
participant
Not difficult to conduct
Time-efficient
Affordable / not
expensive
It may affect the
increase of
irrelevant data
mostly when
participants have
no clear
understanding of
the study
Table 3. Advantage and disadvantages of the sampling method used. Source: (Bell et al. 2009)
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4.1.2 Sample size
A total of seven orthopedic surgeons in Sweden participated in this study. .According to Bell et
al. (2019), the main challenge that qualitative researchers experience while conducting their
research is highly related to the sample size needed to approve that the collected data can be
considered enough and relevant to the research study. There is no defined number of participants
involved in qualitative research. In qualitative research, different researchers use a different
number of participants. In contrast to quantitative research design with the aim of generalization,
qualitative research mainly focuses on the quality of the data that aligns with the research
question rather than relying on the sample size. Qualitative research aims to make an in-depth
understanding of the phenomenon, in most cases during the data collection, qualitative
researchers often are challenged with do not achieve reaching all participants as planned before
in the research proposal (Gill, 2020). In qualitative research, it is recommended and advised for
researchers to stop incorporating other new participants in the study once they have reached what
is known as data saturation (Bell et al., 2019). Reaching data saturation means no new data, this
happens when new participant’s data are tending to relate to other collected data, which results
in no new identified codes and themes. With the seven participants I can easily access saturation
in my data. Vasileiou et al. (2018) report that qualitative researchers usually make use of
different sample sizes during the data collection phase to achieve data saturation.
4.2 Data collection method
Qualitative research uses several methods to collect data that differ from each other (Bell et al.,
2019). Thus, when selecting a data collection method for the research study, a researcher should
explain their decision regarding the reason for choosing one method over another. Bell et al.
(2019) underline that interviews are the most useful method researchers apply while conducting
qualitative research. Even those who choose another method like participant observation or
ethnography often end up conducting interviews with research participants (Bell et al. 2019).
Bell et al. (2019) provided two types of interviews mostly used in qualitative research. An
interview can be either an unstructured interview or a semi-structured interview. An unstructured
interview is typically tending to be like a normal conversation, an interviewee is freely when
answering the interview questions, the interviewer also usually follow-up with a question
depending on the answer given by an interviewee. On the other hand, by using a semi-structured
interview, a researcher prepares in advance the list of questions to be covered in the interview
process. This is known as an interview guide. However, an interviewer has the flexibility of
coming up with other questions as well depending on things said by an interviewee, in both cases
the similarity is the flexibility during the interview process (Bell et al., 2019).
4.2.1 Semi-structured interview
Semi-structured interviews were conducted with each of the seven participants for this thesis.
Different interview questions related to AM and MDR for medical devices are included in the
33
interview guide (given in Appendix A). Based on the aim of this thesis study regarding
investigating the stakeholders’ view on the adoption of AM in the orthopedic industry, this study
can benefit from a semi-structured interview since interviewees will be asked similar questions
to address relevant codes in the analysis process. A sample interview guide with similar
questions for all participants will assist in generating synergies between answers. The interview
questions could be diverted depending on the interviewee's responses. With semi-structured
interviews, there can be a better opportunity to cover the issue and the interviewee has an
opportunity to elaborate on their perspective on the topic, thus capturing what they think about
the topic (Bell et al., 2019).
The table 4 below provides an overview of the interviewees and their current
function/organization
Nr Orthopedic specialty Gender Hospital Experience Experience
with AM
1 Trauma surgeon M Hospital C > 10 years Yes
2 Spinal surgeon F Hospital A >20 years Yes
3 Hand surgeon M Hospital B < 5 years Yes
4 Trauma surgeon M Hospital C > 10 years Yes
5 Trauma surgeon M Hospital C >15 years Yes
6 Trauma surgeon M Hospital C >15 years Yes
7 Spinal surgeon M Hospital C >20 years Yes
Table 4. Interviewee’s information
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4.2.2 Advantage and Disadvantage of Interview
Conducting interview is one method of collecting data. According to Bell et al. (2019) with
interview a researcher can have an opportunity to ask follow-up up questions. However, there are
also some drawbacks associated with using interview.
Advantages and disadvantages of applying interview as a methodological approach in collecting
data in qualitative research are summarized in the table below
Advantages Disadvantages
Flexibility in answering
Possible to ask follow-up questions
In-depth information is covered
Time-consuming
Difficult to transcribe
Losing data in the analysis process
Difficulty to determine dependability
Table 5. Advantage and disadvantage of interview. Source: (Bell et al., 2019)
4.3 Data analysis
Different researchers consider the data analysis phase of qualitative research to be the most
challenging and difficult part, according to Nowell et al. (2017). The complexity of analyzing
qualitative data may be caused by the vast amount of data retrieved during data collection (Bell
et al., 2019). The data collected from the research participants was analyzed using a thematic
analysis approach in this thesis project. Thematic analysis is “ a method for identifying,
analyzing, organizing, describing and reporting themes found within a data set”(Nowell et al.,
2017). Thematic analysis is the most useful approach in qualitative research (Bell et al., 2019).
Despite the flexibility of the thematic analysis, where a researcher can present themes in several
different ways, on the other hand, it may result in inconsistency and a lack of coherence in the
development of themes from the research data (Nowell et al., 2017). According to Braun and
Clarke (2016), a researcher should only attempt to use one and easily understandable structure to
present his analysis using a table, templates, etc. Thematic analysis is based on finding themes
throughout the coding process. to identify relevant themes emerging from transcribed data,
researchers should emphasize five recommendations (Bell et al., 2019).
.
35
● Repetitions
● Indigenous typologies or categories
● Metaphors and analogies:
● Transitions
● Similarities and differences
I have analyzed qualitative data by applying inductive thematic analysis, which means
identifying codes and themes that emerged from the entire collected data (Bell et al., 2019). After
interviewing each participant, I conducted a transcript of the interview. It is recommended that
the researcher read through the transcript to get an understanding of the collected data. By
highlighting key important content, the researcher may be able to identify possible coding that
seems relevant to addressing the research question (s). In the coding process, I focused on
repeating data and similarities. Therefore, I developed sub-themes from the coding obtained, and
then I addressed the main themes by merging the codes or by redefining and renaming them in a
manner that can help me address my research questions. As soon as I had the relevant themes for
the study, I proceeded to the next step, where the comparison of empirical data with theory
retrieved from existing literature was required (Braun and Clarke, n.d.).
4.4 Ethical consideration
When conducting research, ethics is essential since it gives researchers a set of guidelines and
principles to follow (Saunders et al., 2019). There is a different importance of ethical concerns in
research, according to Bell et al. (2019). Having ethical guidelines helps researchers to recognize
ethical issues as barriers they need to overcome in order to successfully carry out their research,
in addition to mitigating any risks that might arise in advance (Bell et al., 2019). In addition, Bell
et al. (2019) discuss the need to have ethical principles before conducting a research study. In
this study, I have also taken into account a number of ethical concerns, including:
● Notifying participants that their data will be used in the master's thesis
● Obtaining the consent of interview participants by letting them know in advance that the
interview will be recorded
● Informing study participants that their data could be published in scientific articles
● Providing information that participants can opt out of the data collection at any time
● Assuring anonymity in the thesis report for participants and their organizations
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4.5 Trustworthiness
The overall purpose of conducting this qualitative research with the described chosen
methodological approach is to examine trustworthiness. This involves determining the
credibility, transferability, dependability, and confirmability of the collected data. Bell et al.
(2019) claim that evaluating qualitative research should be quite different from evaluating
quantitative research. They both must, however, provide quality data. Regarding qualitative
research, trustworthiness is a term used in research, and it is based on four main criteria:
1. Credibility
Based on Guba and Lincoln (1994), the credibility of qualitative studies can be split into two
categories. The first is regarding conducting the study in a such way that increase the finds
believability. Bell et al. (2019) address the need of triangulation. This means that a study should
aim to integrate different methods, so that the findings are relevant. During this study, I have
used a variety of methods to collect data, starting with a review of existing literature that has
examined the research question for my thesis. Furthermore, I conducted interviews with different
participants who worked for different hospitals, which enhances the credibility of the findings. A
second method is to present the credibility of the research to external readers. This approach has
not been applied extensively due to time constraints, however insight provided by the subject
reader and supervisor has contributed to reducing the possibility of bias occurring when no other
person examines the study result.
2. Transferability
This refers to the extent to which findings can be transferred to other settings, a concept that is
known as external validity in quantitative research and describes the criteria with respect to
generalizability of findings (Bell et al., 2019). It is generally not feasible to generalize qualitative
research findings to other settings. In spite of this, the research design used a cross-sectional
design, which included participants from various organizational settings, which helps minimize
the risk of biased findings.
3. Confirmability
A confirmability standard is concerned with ensuring that the data addressed in a report comes
from participant insights and that the interpretation of published data did not result from the
researcher's imagination or his own thoughts (Bell et al., 2019). For the purpose of increasing the
level of confirmability in this study, all interview transcripts were stored; thus, all interviews
have been recorded, and this might prove that data provided was from the participants'
perspective.
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4. Dependability
In Bell et al. (2019), dependability can be understood as the degree of similarity between
answers. It is a measure of the stability of retrieved data over a period of time, regardless of
conditions. Developing the interview guide, which consisted of questions relevant to the study
and aligned with the research questions of my thesis, had been the first step in reaching the
dependability of my findings. In this study, I have asked the same question to participants and
have stopped collecting more data until I have reached saturation. Data saturation means that no
new information is being provided by respondents, and it can occur when their answers typically
resemble one another.
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5 Results and analysis
The empirical findings from the interview conducted will be presented in this chapter. The main
themes emerging from the coding will be used to answer the research questions of this thesis
project. The first part will consist of the identification of relevant sub-themes that emerged from
the data, and together with the identified main themes are presented in a table. In the second part,
I will explore and deeply describe the main factors that influence the adoption of 3DP in the
orthopedic industry in Sweden based on the main themes identified. Since regulation is one of
the major relevant dilemmas to contend with, the third part of this chapter outlines the impact of
regulation on the adoption of AM in the orthopedics industry in Sweden in order to address the
second research question.
5.1 Themes emerged from coding
The sub-themes derived from the coding process are presented in the figure 7. However, in the
report, I have only discussed the sub-theme that is deemed important and interesting based on the
number of times respondents have mentioned them. Throughout the thesis, I have focused on
sub-themes that are based on their frequency, the adoption factors that were raised by the
majority of participants are further discussed in the sub-themes, and I utilize few sub-themes in
every main theme created not only for the report space issue but rather from how useful there are
in addressing the research questions of this thesis.
Below there are the six main themes presented in the figure, as well as their corresponding sub-
themes.
39
Figure 7.Themes emerged from coding
40
5.2 Factors affecting the adoption of AM from the perspective of orthopedic surgeons
5.2.1 Technology
Printing time
In terms of technology constraints, there is a most highlighted factor that contributes to the delay
in the adoption of AM in the orthopedic market. This is concerned with the printing time.
According to (Surgeon 1) there is a need to: “providing 3DP that is easy to use and do not need
someone’s full-time work only with the 3d printer [...]”. In similar fashion, considering (surgeon
2) experience in using AM in orthopedic practice, the issue with the use of AM is that:
“ you get a 3D model within a couple of days, if the process was like another printer, for
example, quick as the way we print paper, it can be easy to play with, we would use it more
[...]”.
Many surgeons have addressed the printing time issue, as it has been expressed also by (Surgeon
4) “while doing complex pelvic you can need a week or two weeks to get done with the printing,
I need to get done tomorrow morning [...]”. As it has been highlighted by many Surgeons, the
printing time plays a significant role in preventing orthopedists from adopting 3DP in clinical
practice and specifically in-house manufacturing because they need to be able to respond quickly
to their patients' issues. However, the orthopedists involved in this research project expect that in
the future 3DP will be commonly used in orthopedic surgery practice as they expect technology
to continue to advance and for its performance to improve. According to all surgeons, AM is a
growing field in orthopedics. In their view, AM in orthopedics will be a reality and totally
implemented in many orthopedic clinical operations. As it has been mentioned by this surgeon:
“I hope many surgeries will use 3DP more than they do today [...]” (Surgeon 3). The majority
have a positive attitude toward technological development in the future. As expressed by this
surgeon “I think we will have them in-house, we can plan our operation for the next day, come
back have a 3D printed product [...]” (Surgeon 6). In addition to the difficulties related to
technical performance, it is important to highlight that AM is not appropriate for all surgical
operations; few surgeries require the use of AM, this is also another major factor influencing
orthopedists' reluctance to use AM in their daily operational practices. From (Surgeon 4)
perspective “Most of the patients we can use traditional plates and screws but for some complex
and specific cases we cannot fix them traditionally”. From his experience He only uses AM for:
“Difficult complex fractures, to get an idea of how it looks before I do the operations [...]”
(Surgeon 4). Moreover, another surgeon expressed “I think AM will be reserved for special cases
[...]” (Surgeon 1).
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The implications of this are that AM is currently used in mainly complex and specific cases, if
the technological improvement is not pursued towards the production of user-friendly 3D
printers and software, these factors will keep hindering the interest of orthopedists in introducing
AM in the daily practice towards spreading the use of AM to other markets segments apart from
complex cases, which would reduce market potential since complex cases are rare.
Research and development
Despite current emerging trends in 3DP in clinical settings in the health sector, most notably in
the orthopedic sector, there is still a journey to take before AM can efficiently be introduced in
the orthopedic sector in Sweden. A focus on research can be a helpful strategy to gather
information because research is concerned with increasing understanding. (Surgeon 1) has
expressed: “it is still difficult to translate things from the laboratory setting to actual use in
clinical practice [...]”. All possible limitations that align with 3D printed products must get
identified and the problem must be addressed by research so that it cannot continue to stymie the
adoption and use of AM. (Surgeon 2) with expertise in spinal surgery has highlighted a further
requirement as (Surgeon 1) who reported that there is still some uncertainty in promoting 3DP
adoption in the orthopedic practice as well. And he suggests synergies in research as a way to
practically understand the context of AM technology considering the biological factors:
“Understanding technology with biology together is where we struggle, sometimes we fix the
bone perfectly but we destroy everything around including the muscles it doesn’t make
sense”(Surgeon 2).
(Surgeon 2) highlighted an important point to consider when working with the business
implementation of AM technology in the orthopedic sector, “Through a continuous research we
have to be better at understanding the combination of metal, implant, and biology” (Surgeon 2).
In addition to the uncertainty related to unpredictable biological factors, which are an additional
source of uncertainty from different surgeon's point of view, there are still other threats from
which with the different research projects appropriate solutions can be developed, In order to
have AM flourish in the future within the orthopedic practice, according to (Surgeon 4):
“We need to do it as many research project as possible, apply for money and show that there is a
benefit for us, for staff and for the patients.”
(Surgeon 4) elaborated that in different further research studies, surgeons, technicians, and
managers could provide case studies, which could prove the technological abilities and thus be
used as an application for aids and funds to make the technological implementation successful in
the health sector. A research synergy between several sectors can significantly assist in
determining an AM's possibilities, feasibility, and the progress of its development within the
health industry.
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Skills and competence
Despite its advanced technical capabilities, AM is still challenging for orthopedists to use from
the perspective of the first adopters of this new technology. They reflect on different
technological difficulties concerning both software and hardware performance. As expressed by
this surgeon “What we will need from people in the basic science field, is technical support,
providing 3DP that is easy to use” (Surgeon 1) said. Many orthopedists experience technological
challenges when developing 3D printed models for surgical planning or when creating surgical
guides to be used during the operation. In regards to AM software and hardware performance,
one Surgeon stated that:
“We as doctors, we need to learn how to use this machine. And I think there are not user
friendly, and sometimes you get so annoyed when it doesn’t work properly”. (Surgeon 2).
In addition to the difficulties with accessing advanced software, it is also for orthopedists
challenging to grasp how to use existing software. They usually spend a lot of time planning the
surgery to ensure a successful outcome. From surgeon 2's perspective, finding some other time to
learn how to use software is challenging. Although there may be a will to adopt AM in
orthopedics, the time constraints limit the quick progress. The majority of Surgeons reported
software difficulties as an obstacle to the rapid adoption of AM in orthopedists. For example,
according to some surgeons “there is a quiet learning curve to the actual software, it’s not
impossible to learn it anyway but it takes some time” Moreover, (Surgeon 1) also mention that:
“If it was easy to use like using a word processor, easy to use software, we can do more and
apply it at a high rate of pre-operative planning”.
5.2.2 Partnerships
Academic collaboration
One of the major factors that will largely influence the uptake of AM in orthopedics is to
strengthen partnerships among different stakeholders including clinicians, academics,
manufactures, government and private sectors, and others who can collaborate and help to make
it possible for AM to be implemented in orthopedics successfully. Most of the respondents in this
study have experience with AM in the field of orthopedics, however, what is interesting to note
is that many of them do not currently have in-house 3DP facilities in their hospitals. They have
however experienced and benefited from utilizing AM in collaboration with a university, where
this technology has helped surgeons perform operations with a more satisfactory outcome.
As expressed by (Surgeon 4) “I don’t know any hospital in Sweden which actually have their
own 3D, I think they work with commercial services to get 3D printed products. But usually, it’s
with collaboration with the university”.
43
The results of this research demonstrate how many surgeons are the beneficiary of the
collaboration of hospitals with other different stakeholders especially universities are essential
and will play an important role in the implementation of AM in orthopedic practice, as it can be
noticed from (surgeon 5) statement, “now I am lucky I can get the 3D printed model while using
the university’s 3D printer just I need to cross the road and get access to the printing system”
There are numerous ongoing research projects in universities on AM technology. There are also
several people with an interest in AM technology, who may be able to contribute to the research
and investigate the proper use of AM in various fields of technology
Nonetheless, not every hospital can rely on academic collaboration. As mentioned by this
surgeon “We have hospitals in Sweden that aren't university hospitals. I don't expect private
clinics to collaborate with universities, as I don't think it's easily feasible to do so [...].”(Surgeon
7). A successful implementation of AM in healthcare in general is crucial since it should result in
a high quality outcome, and, to accomplish this, it shouldn't be a solo endeavor that one hospital
or independent clinician can undertake alone. In addition to academic collaboration, the use of
the organizational network and business relationships can be necessary for adopting AM
Networking and Business relationship
From their experiences on using AM in orthopedic practice, all respondents stressed the
importance of a network as it contributes to the overall development of the industry in general
and allows the whole industry to achieve big goals together. Most surgeons use AM as a result of
a good relationship with their partners and relying on their network for access to technology.
Many surgeons have used AM established in universities as well as 3DP found in various
research centers. As mentioned by (Surgeon 5)
“I have some experience from the newly started printing unit AM hub; they have helped me a
few times to print bone pieces”.
With respect to using 3DP for the production of implants for specific complex issues, this
becomes more challenging. Although many surgeons have used 3D printed implants, they have
done so in partnership with manufacturers. As it have been described by this surgeon,
“It was in collaboration with a Belgium company, that we have made a 3D developed implants
which comes with its guide” (Surgeon 4). Moreover surgeon 1 as well addressed a need of
collaborating with a manufacturing company when it concern with developing 3D implants as a
factor that influence the adoption of AM “When it comes to actual implants, you have to have a
manufacturing company with you, who have experience in producing orthopedic implants [...]
(Surgeon 1).
Not only 3D printed implants require collaboration with manufacturing companies, clinicians
also collaborate with manufacturers in developing 3D printed models, implants and surgical
44
guide as well, as it has been pointed by (surgeon 3) “ regarding surgical instruments an external
manufacturer involves and they are the one to comply with laws [...] ”.The need for business
relationships and partnerships with relevant stakeholders is partly due to the need for expertise in
using AM technology, but there are also regulations to adhere to, which also require attention
and resources.
5.2.3 Investment
Expensive technology
Based on the research, the most critical factor impeding the use of AM in many orthopedic
practices is the cost of the product and its associated price. Unlike some healthcare systems, the
Swedish healthcare system is structured in a way that all patients are treated equally. As outlined
by most of the respondents, the acute scarcity of resources within the Swedish healthcare system
makes it quite difficult and challenging to easily adopt any new innovative technology. New
advanced technologies, in most cases, require a price premium to make them easily accessible in
the opinion of many respondents. “We need money in order to get access to AM [...]” (Surgeon
4). In much the same way as surgeon 4, surgeon 3 mentioned that “cost plays the biggest role
despite thinking that AM is better than the other approach, AM is currently not accessible, it’s
quite expensive [...]”. 3D printed models, guides, or implants are therefore expensive.
Alternative solutions, however, can mitigate the cost issues. In the opinion of many surgeons,
people are always concerned about the price of new technological trends
“When we talk about new technology, we directly reflect on the price. If the price is too high,
who should pay and will it be worth it? [...]”(surgeon 3).
Furthermore, (surgeon 3) suggests that "the cheaper the technology gets, the more people will try
it". Due to this, the competitive advantages for AM to penetrate in the orthopedic industry need
to be focused on the cost and price aspects, where neither the clinicians nor the patients should
be burdened with the high cost and high price when using AM as opposed to other existing
technology. It’s challenging to structure the cost reduction on new technology in the market as
there are huge investments needed within the R&D. But for the long run success in adopting AM
in every orthopedist practice, different surgeons have argued that the availability and increase in
funds and investments in healthcare, especially in AM related project, it will positively influence
the reduction of price and solve the cost issue in accessing AM in clinical practice which will
therefore stimulate the use of 3D printed products in many orthopedics clinical activities.
Resource scarcity
Orthopedic clinicians are mostly affected by the high price of 3DP machines and expensive
software. Due to the high cost of using this technology in comparison to other possible methods,
they label it the most important factor which will hinder clinicians from adopting 3DP, especially
45
if they wish to apply an in-house production approach. Clinicians claim that the Swedish health
sector has a scarcity of resources. “ Currently, resources available in the healthcare sector are
limited For example, Sweden has the lowest number of hospital beds per capita in the entire
European Union, so we must carefully consider how to spend our money [...]” (surgeon 1).
If AM technology continues to be so expensive, it will be too difficult to navigate the market
quite easily. Unless there is a reduction in the cost of 3D printers with easy access to affordable
software, it will not be possible. Additionally, as described by many surgeons, implementing AM
inside hospitals will affect the current working structure in place, which will necessitate new
facilities, a space for 3D printers where they can be set up, which also requires huge investment.
"We need some room to set up the 3D printers facility [...]." (surgeon 4). There is huge
investment needed in order for 3DP to be efficiently embedded within the daily orthopedic
clinical setting. From perspective of many surgeons the dream for the future is to see AM
technology in-house assisting surgeons in conducting a successful operation, as mentioned by the
surgeon
“To achieve to implement the use AM in the Swedish orthopedic sector the capital is needed to
be invested in buying 3D printers, buying updated software’s, constructing AM hub, build AM
rooms at hospital [...]”. (Surgeon 3)
5.2.4 Management
Orthopedist surgeon’s work structure
The role of management and organization structure plays an important role regarding the
adoption of new technology in the orthopedic industry in Sweden. The majority of hospital
follows a decentralized approach when it comes to sourcing items needed by surgeons to perform
a certain surgical operation. The majority of respondents have replied that the surgeon or at the
department level they hold all responsibility in deciding which approach to use either AM
technology or its substitutes. Additionally, surgeons are sometimes the one to be in contact with
manufacturing companies when they want to source 3D developed implants, guide or 3D
developed model. Participated surgeons have similarities regarding the procurement of implants
and other surgical accessories as described (by surgeon 1) “Usually, we decide which approach
to use on the unit level [...]” similarly as (surgeon 1), surgeon 2 also expressed,
“I make decisions for my patients, I see them in the clinic, I look at their problems and I decide
whether we can use traditional implants or whether I need 3D scan and a printer.
The fact that the majority of surgeons have responsibility on purchasing strategy and fully decide
a method to apply is most important to the implementers. Following how the industry is shaped
surgeons decisions and awareness may totally influence the adoption of AM technology, and
once surgeon understand the benefit of AM there can’t be other additional external forces
46
preventing them to experience AM in the orthopedic practice apart from the price obstacle.
New work breakdown structure
“Because your focus is to do the surgery and prepare for that , and if on the other side you are a
printing machine operator. I think it’s wrong and it will not work like that [...]” (surgeon 2).
All participated respondents agree on the point of the need of restructuring the activities and
responsibilities. Having expert personnel with corresponding skills related to the activity
assigned to conduct will be an approach to be applied to easily spread the use of AM in Swedish
hospitals. AM technology will work with embedding lean manufacturing system where
orthopedic department will be made with people from various skills in different aspects,
surgeons, engineers, operators, designers etc. “there are norms that need to change if 3DP is
going to be installed in-house, just there will be a need for the clinic to start hiring engineers”
[...]” (Surgeon 3). AM is one way of adopting lean manufacturing in the health sector, as it align
with the reduction of waste, it should also tackle the lean and agile framework toward structuring
the work activities to efficiently be adopted in the health sector. From this orthopedist point of
view there will be a need of cross-sectional teams in clinical settings to allowing the better use of
AM for increasing the better outcome for the safety of the patients. Moreover, all clinicians wish
to have 3DP in house as it will secure patients data when information is only kept in hospitals.
As expressed by this surgeon
“It is better if a bone can be printed within the hospital area so that we all embrace the same level
of security” (Surgeon 5).
The introduction of 3DP at the point of care will radically change the work structure and that is
the responsibility of the management team to structure activities in a such way that there will a
smooth flow of information and on time to achieve to deliver a quality product for the safety of
patients. Developing a new value chain in advance will affect the proper implementation of AM
in the orthopedic industry.
5.2.5 Application
AM’s substitutes
The main threat that hinders the quick adoption of AM within the orthopedic practice is the
presence of many potential substitutes which surgeons can use and successfully perform the
surgical operation, These include the conventional manufacturing for developing implants and
guide and the capability of CTs and MRI imaging used in surgical planning, as described by
(surgeon 3) “Often with the use of CT navigation picture, we achieve to understand and be
accurate, because without MRI and CT you can’t get even a model”. All surgeons have
highlighted different approach that they use currently and which they plan to continue to use
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once AM continues to remain expensive and inaccessible. Firstly a general aspect to point out is
that AM is not an effective approach to use for every surgical approach as mentioned by
(surgeon 4),
“For most of the patients we can use traditional plates and screws but for some complex and
specific cases we cannot fix it with traditional instrument and implants”
This align with (surgeon 5) point of view “It’s not needed to use 3DP in every operation, I don’t
think so since two human beings almost are looking the same inside when it comes to the surface
of the bone.” this alternative of continuously relying on the conventional manufacturing and the
CTs scan capability in delivering clear and understandable images to be used for surgical
planning affect the willingness of surgeons in the adoption of AM. Currently, with 3D images
on the screen orthopedist achieve to understand patients issue without the need of proceeding to
printing models. All these reduce the market potential and application of AM in the orthopedic
practice.
One reason that delays the implementation of AM is based on current demand and accessibility.
As stated by this surgeon, "3D printing is not easily accessible, there is still a low demand for
custom implants and the technology is not appropriate for routine cases" (Surgeon 4). While
many surgeons have discussed this stumbling block, when it comes to implementation
possibility, all surgeons have stated that it is totally feasible to implement AM in the orthopedic
practice, and adoption is expected to increase, as stated by this surgeon, "I expect AM to be more
frequently used than it is now, I believe it will be used more like CT scanning and MRI"
(Surgeon 6). In regard to the claim of the availability issue with strong substitutes of AM
product, rationally it might be a contradictory argument how the clinical community expects a
successful implementation of in the future. Possibly this is due to the convenience sampling
used, which can lead to identical insight into the positive attitudes regarding the future of AM in
the orthopedic sector in Sweden.
AM’s potential
It is true that there are many substitutes to AM. Additionally, many of them hold a competitive
advantage in terms of cost-effectiveness, for example implants made by conventional
manufacturing are cheaper than implants made by AM. However, it is also important to note that
AM is also taken as “another tool in the toolbox” from (surgeon 3) perspective. This point of
view with an analogy term can be describe in the way that classifieds AM as an important tool to
be used, a surgeon wanted to mean an add on value of AM technology within the orthopedic
practice. “There is quite high demand for surgical instruments, we use AM for many cases while
developing guides [...]” (surgeon 3). Additionally another surgeon mentioned,
“We typically apply AM when we want a custom made implants and in critical issue during
surgical planning [...] Surgeon 1.
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The trend of AM in the orthopedic practice increases thanks to the capability of AM in assisting
orthopedist surgeons in both the planning phase and in developing of accessories for surgical
operation, known as surgical guide and in producing custom implants. Within this research, the
findings shows that all orthopedists participated in this study have an experience with using AM
in the orthopedic practice. Many surgeons have used AM to develop models to be used in
surgical planning or either in producing surgical guide, instruments used by surgeons during the
operation and some of surgeons have also used 3D printed implants when operating patients with
a specific issue during critical cases. Additionally, the application of AM in orthopedics align
with the sustainable development goal, as stated by (Surgeon 6) by using 3D printing at the point
of care, it will be possible to recycle the materials used to develop models for surgical planning.
5.2.6 Regulation
Adaptation
According to the collected data and analysis conducted, the majority of surgeons have a basic
knowledge of new MDR. As expressed by this surgeon
“We follow all the rules , However I don’t know actual rules to comply with when developing
3D models, I am not well informed enough on the new MDR [...] ” (Surgeon 3).
With this concern, majority of orthopedic surgeon have reflected on the difficulties stakeholders
in the orthopedic industry will count to face in adapting to the change in regulation. As expressed
by this surgeon “Some regulations have changed how we do things now. Currently, each screw
has to be parked individually and it has affected allocating needed material in the operation [...]”
(Surgeon 2). As describe by many surgeons the limited knowledge on all the regulation
requirements when producing medical devices is because with the conventional manufacturing
approach, manufactures were the one to comply with regulation. As mentioned by this surgeon:
“Manufacturing companies have more experience with regulatory procedure, CE marking
procedures and complying with all the MDR regulations” (Surgeon 1).
However, with the current trending manufacturing approach that rely on AM, clinicians as well
will need to have broad insight on the regulation as 3DP can also be used in-house. The majority
of respondents have highlighted that with the novel MDR, it would be difficult from a regulatory
point of view and impossible to navigate under tight regulation. As it has been expressed by this
surgeon “ if there come more regulations it will hinder the introduction of 3DP in the clinical
setting [...]” (Surgeon 4). Despite raising the difficulties to adapt on the new MDR, it is
important to note that all surgeons Believes that regulation do not only act as constraint. As
mentioned by the majority, (surgeon 6) also has addressed that “With no accurate regulation, the
business may easily corrupt where many companies move in and start to make fake products”.
This is an interesting point to consider which provide a response regarding in which way
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regulation affect the adoption of AM. Through orthopedic surgeons perspective it is in both in
positive and negative way new MDR affect the orthopedic industry in Sweden
5.3 Effect of regulation in the orthopedic industry in Sweden
.“Oftentimes regulations are here to help us but they may be hindering us more than helping”
(Surgeon 2). With a similar negative perspective, Surgeon 7 expressed “it is almost impossible to
navigate under the novel MDR; it will delays the introduction of new products [...]”
Moreover, surgeon 7 like some other surgeons, have claimed that currently at their hospital, they
have hired personnel for regulation related responsibilities. AM's entry into the orthopedic
sector will be determined and influenced by a number of factors, including regulation. Majority
of surgeons have mention that with tight regulation, there will be no freedom to operate, which
will result in no new products, delaying of products to market as much bureaucracy consume
time. However, Clinical practitioners do not only take regulation as a threat, but the majority
have both view, negative and positive view toward the regulation’s perspective as it have been
summarized in table 6. They acknowledge its importance in shaping the orthopedic industry. As
expressed by this surgeon “It is also important to consider that regulation, help to limit fake
products in healthcare” (Surgeon 3). Many have highlighted also the positive impact of having
clear regulation such as fostering competition, and reducing patient uncertainty when it comes to
a new product.
“I don’t think regulation will be a problem, it’s an opportunity for reaching quality [...] ”
(Surgeon 6).
The presence of regulation is not viewed from the orthopedic surgeon's perspective as a threat,
but also as a possibility to practitioners who strive to achieve quality care.
The table six, below briefly address the way regulation affect the orthopedic industry in Sweden
from the perspective of the orthopedic surgeons
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Negative impacts Positive impacts
Hinders innovation Shaping the industry
Need hiring experts Consider patients safety
Time consuming Bunning fake products
Raise conflict of interest Structure the market
Consume resources Reduce patients uncertainty
Table 6. Impacts of regulation
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6 Discussion
There are two main parts to this chapter. Both part’s aim is to integrate the findings with the
selected theoretical framework and analyze how the highlighted factors can be strategically
implemented to achieve a rapid adoption of AM in the orthopedic sector. By putting together the
existing literature with empirical findings, the first part of this chapter discusses the factors that
influence the adoption of AM, while simultaneously exploring the impact of regulation on the
adoption of AM with the help of the TOE framework. This first section provides answers to all
of the research questions of the thesis. A second part of the paper discusses how to implement
AM in the orthopedic industry using the Kraljic matrix analysis.
6.1 Factors affect the adoption AM in the orthopedics through the TOE framework
The technological innovation product is the adoption of AM in the orthopedic sector. As a result
of my first research question, the factors that influence the adoption of AM in orthopedic
practices can primarily be categorized as technology factors and organizational factors. Although
from the reviewed literature and within the results addressed, there are also other external factors
that are highly significant and seem to affect the adoption of AM (Yeh et al., 2018). Addressing
these external factors is also part of my second question for my thesis. I will discuss the way that
regulations affect the adoption from the perspective of orthopedic surgeons while considering
what the literature has to say about the matter. However, it is important to note that the
regulation is not the only external factor that influences adoption. In the TOE framework, the
environment factor covers all the external factors that influence the adoption of AM (Ukobitz,
2021).
.
The following figure summarizes the outcomes of the factors associated with AM adoption based
on the TOE framework
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Figure 8. AM adoption in TOE framework
6.1.1 The technology Context
According to Zamborsky et al. (2019), technology is an important factor that influences the
adoption of AM in the orthopedic industry. In my opinion, technology can both positively and
negatively influence adoption. In terms of the positive perspective, 3DP's ability to develop
complex shapes within a shorter lead time compared to conventional manufacturing will
encourage many orthopedic surgeons to choose AM in the orthopedic sector (Ukobitz, 2021).
The orthopedic surgeon frequently has to deal with complex bone issues, so an advanced method
for helping surgeons to better understand their patients' problems will likely gain a high market
share. The majority of the reviewed literature emphasizes that the reduction in overall lead times
is an important factor of AM adoption (Zamborsky et al., 2019). On the other hand, through the
findings that formed the theme 1, there is a sub-theme formulated concerning printing time.
Apparently, orthopedic surgeons find that the printing process for AM takes a great deal of time
as well. Compared to conventional manufacturing methods, the overall time product takes to
reach the market is too long for the conventional approach. However, AM printing process also
delays from clinicians' expectations. Similarly, Bloom, (2020) emphasizes the printing time that
AM requires as a hindering factor to its adoption. Additionally, other factors, such as software
complexity and operating 3DP printers, there are also limitations related to the size of printers
that have been identified from existing literature and from the thesis research finding as well.
Additionally, it is important to point out that AM advanced technology requires advanced skills
and competence to run and use AM products; these aspects have been acknowledged throughout
53
reviewed literature including Yeh et al. (2018) and Ukobitz (2021), and they are in line with the
point of view of the majority of participants as explained in Theme 1.
Moreover, the adoption of AM is primarily influenced by the investment required. The hospital
needs to invest a certain amount of capital to adopt AM in the orthopedic practice. Yeh et al.
(2018) have noted that the costs can be classified into a number of sections. There are fixed costs
for hardware, 3D printers, and software (Yeh et al., 2018). Reflecting back on the threat of the
size of AM hardware, these will likely increase fixed costs as the machine will need a special
room where it can easily stand. As for the need for a new space for the AM machine, most
surgeons have raised the same issue in Theme 4. The adoption of new technology in orthopedics
will also directly affect variable costs. According to Ukobitz (2021), especially regarding the
adoption of AM, the variable costs will increase both in terms of maintenance and labor. This is
because the adoption of AM will require a new skilled force that are experts in dealing with the
design process and engineers that know how to use 3D printers. Despite several technological
factors that may be considered to be hindering AM adoption, it is important to point out that
through literature and opinions of many surgeons, there are also some technological factors that
can be considered to be driving factors. Firstly, we can take advantage of AM's ability to produce
complex shapes with the shortest possible lead time (Zambrosky et al., 2019). Also, R&D is
playing an important role in raising awareness of the AM technology since 2013 (Ukobitz,
2021). R&D plays an important role in adding value to AM technology (Asonava et al., 2017).
Additionally, surgeons believe that through a continuous R&D in AM, the major technical
dilemma will be mitigated, where with synergy in research engineers can come up with relevant
technical solutions, and managers can help coordinate the research for obtaining funding, and
therefore obtaining the needed investment to adopt AM.
6.1.2 The organization Context
Additionally to the factors that must be converged in the technical aspects that affect the
adoption of AM in orthopedics, Using the TOE framework, there are also many other factors,
both retrieved from the literature and as well as from the findings which can be classified in the
common category, this is what Tornatkz and Fleischer (1990) describe as the organization factor.
The organization structure is the first aspect highlighted in Theme 3. From the perspective of
surgeons, the orthopedic department needs to be restructured to achieve AM in the orthopedic
practice. (Ukobitz, 2021) refers to the need for dynamic organizational culture. The researcher
does not elaborate on what he means by dynamic culture, but generally, a dynamic organization
is built on flat structures where the decision making is decentralized rather than on hierarchies.
Theme 3 describes how orthopedic surgeons have total control over the treatment methods they
will use for a certain patient's issue. Despite a decentralized approach in which departments hold
the responsibility of deciding whether to use AM or not, when it comes to purchasing AM
products, managers are involved.
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Yeh et al. (2018) indicates that top management’s role is crucial to implementing new
technologies, which is exactly what is happening when adopting AM in the orthopedic practice.
The level of responsibility stakeholder can have in adopting AM in the orthopedic sector can be
challenging from one perspective, since the surgeon is responsible for selecting the approach to
use, whereas on the other hand, top managers should be involved when it comes to procurement
and purchasing due to the high cost of the AM product. Therefore, it can be a bit difficult to
determine who holds the main responsibility when it comes to adopting AM in orthopedics. A
surgeon may be hesitant to adopt AM due to the outlined technical factors, which can require
advanced skills, but on the other hand, surgeons may be willing to adopt it and a lack of top-
management support may also hinder the adoption of AM. The organization's willingness to
adopt AM is another important factor mentioned by Ukbotiz (2021). It is imperative to spread the
willingness to adopt AM to both clinicians and managers within the orthopedic sector. Asanova
et al. (2017) assert that the willingness to use AM in the orthopedic will spur the need to hire
more professionals such as engineers. In addition, Ukbotiz, (2021) and Yeh et al. (2018) agree
that new skilled labor is needed. In this regard, these researchers point of view align with the
theme 3. To achieve the adoption of AM in orthopedics, A sub-theme of the new work
breakdown structure calls for rescinding the activities and forming cross sectional teams
comprised of people with various expertise so that the discussion on using AM will be at a unit
level, where surgeon, engineer, legal expert, and purchasing personnel will be able to discuss and
divide assignment to make sure AM is implemented.
6.1.3 The environment Context
The impact of regulation on the adoption of AM
The second question revolves around the question of how regulations affect 3DP adoption in the
orthopedic industry. Ukobitz (2021) identifies regulation as one of the main external factors
affecting AM adoption embedded in the environmental context. Based on the research
conducted, it was found that a majority of clinicians are unaware of the new MDR guidelines for
firms and organizations that intend to develop orthopedic medical devices. The reasons for this
are understandable given the fact that the current rules were established in May 2017 and, due to
the Covid pandemic, European states have been slow to implement the new MDR (Asanova et
al., 2017). Compliance with the new MDR began last year, which is why clinicians may not be
well informed about this brand new EU regulation. As theme 6 addresses, from the clinician's
perspective, it will be challenging for stakeholders in the orthopedic industry to adapt to all of
the regulations and policies. As per the collected data, this is due to the necessity of CE marking
and the involvement of NB in the assessment of many orthopedic medical devices (Fennema et
al., 2019). Although, Theme 6 suggests that there are feasible ways to adopt AM while
developing models and guides since there are no strict regulations to follow. In producing guide
a self-assessment is enough without the involvement of NB (Singh et al., 2020). Although it is
55
my opinion that regulations may become a burden to deal with when developing class IIb and
class III devices since in addition to the assessment in the pre-market with the involvement of
notified bodies, regarding class III category, there must be a follow-up in the post-market to
ensure medical device safety (Fennema et al., 2019). Besides the changes in regulations that
raise new challenges, the legal aspect is considered to be a major external factor when adopting
AM (Yeh et al., 2018). With regard to theme 6, clinicians also view regulation in a positive light
regarding its ability to shape the industry. In this sense, I can argue that the regulations are not
introduced to hinder innovation and adoption of new technologies in the orthopedic industry, but
rather to emphasize patient safety so that a better and more quality product can be produced.
AM substitutes and role of partnership
Another environmental factor important to note as a factor that affects the adoption of AM in
orthopedic practice relates to its substitute's capability. It is true that CT scans assist surgeons;
however, AM can do a lot more in the way of building models, guides, and implants (Hurson et
al., 2007). Ukobtiz (2021) highlight competition as a major factor affecting adoption. The AM
product has strong substitutes, namely CT and MRI scans, which are currently dominating the
market. Similarly, theme 5, discusses how many surgeons rely on the CT scan to understand
patient issues. Thus despite AM's potential to deliver 3D models, it is not always the case that a
model assists the surgeon. In high probability, every surgeon can mention that the current trend
of AM, with a very expensive price tag, will not easily penetrate the market, while there are other
potential approaches that may assist surgeons in understanding the patient's issue.
Therefore, the role of partnership as a driving force in the adoption and acceptance of AM in
orthopedics has been pointed out as another important environment factor that can enhance its
adoption. According to Asanova et al. (2017), government, academic institutions, and
entrepreneurs will drive the adoption of AM in orthopedics. In the context of the external
context, Ukobitz (2020) also emphasize that partnerships in order to achieve the adoption of AM
are vital. This is in line with what has been addressed in the review of literature. As part of
theme 2, the AM approach can also be applied to clinical settings by collaborating with
universities. Moreover, most surgeons who want to develop 3D models rely on the research
collaboration. By collaborating with universities and research centers, not only can a company
access 3DP, but combined efforts can result in the ability to acquire sufficient resources to assist
with the adoption of AM. On the other hand, when it comes to custom-implants, surgeons
collaborate with manufacturers (Theme 6). The surgeons take the buyer's perspective when
sourcing AM products. Hence, through a well-structured partnership, AM can be quickly
adopted. Trading is another factor that influences AM adoption (Ukobtiz,2020). Therefore, from
the buyer's perspective, surgeons should employ well-structured purchasing strategies to deal
with the trading factor while simultaneously managing resources.
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The next discussion will focus into the strategy of trading that surgeons and hospitals can use to
strengthen the environment factor and thereby enable adoption of AM in the orthopedic industry,
instead of hindering it. We will use the kraljic framework to guide the discussion.
6.2 The implementation of AM through the kraljic matrix
The kraljic matrix helps to design purchasing strategy for products that the organization procures
(Gadde and Håkan, 1994). Using the Kraljic matrix, the adoption factors can be discussed and
thus a strategic implementation of AM in the orthopedic industry can be developed. A kraljic
matrix framework can help clinicians understand the procurement and purchasing strategies they
can employ to support the implementation and the use of AM in their everyday work. Figure 7,
of the Kraljic matrix, presented in the theory section, allows for a deeper analysis of the main
factors that can influence the adoption of AM in the orthodontic industry, including the
technology factor, the organization factor and as well as the environment factor. In Order to
analyze AM technology in the Kraljic matrix, two of the guiding factors, profit impact and risk,
will be represented with certain variables that align with what Kraljic has suggested in order to
derive a particular category of the product (Kraljic, 1983). Thus, the adoption factors in the
kraljic matrix can help us to identify the AM's product category. To classify AM's technology in
the kraljic matrix, I will utilize two factors, which would be plotted on the graph. According to
Kraljic, profit can be represented by the technology impact on business development. Y-axis
represents technology factor's impact, which is high according to Ukobitz, (2021). On the other
hand, X-axis represents mainly the risk. When AM is adopted, there is a regulation risk
associated with it. Therefore, the X-axis can represent the environment factor. According to Yeh
et al. (2018) external factors are major factors that affect 3DP adoption.
The results show that, by taking into account the high technological factor that affects business
development and the high environment risk associated with adopting AM technology for
orthopedic practice, AM technology falls under the strategic item categories in the Kraljic model.
The figure below address AM’s product as a strategic item in the kraljic matrix
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Figure 9. AM in The kraljic matrix
Through combining AM technology with the kraljic framework, AM's product is viewed as a
strategic item. According to Kraljic (1983), a strategic item is a product with a high profit impact
and a high risk associated with its accessibility (Kraljic, 1983). There are various approaches that
an organization may employ to market a product of this type, according to Kraljic (1983).
6.2.1 The management approach to apply for AM’s development
Using the kraljic matrix approach, AM's orthopedic products are strategic items. To achieve a
more effective management approach, a centralized structure is a good approach (Kraljic, 1983).
To implement AM effectively in orthopedic practice, hospitals should implement a centralized
structure. Simultaneously Yeh et al. (2018), mentioned the need of a dynamic organization
culture with what concern with the organization context. Thus, Using a centralized management
approach, the work breakdown can be restructured which align with the Theme 2 that address the
need of restructuring the organization. As part of restructuring the activities, new personnel in
the orthopedic department will be introduced and different tasks will be accomplished. Thus,
the orthopedic department management can be restructured and rely on a cross-section team
composed of experts in different activities, where in addition to orthopedist surgeons, it may
include software engineers, designers, machine operators, procurement personnel, and legal
personnel.
58
The results of this study align with Asanova et al. (2017), where, when reflecting on the factors
that may drive adoption of AM in the orthopedic industry, many researchers suggested there is
an ecosystem of different actors that will drive adoption.
In the surgeon's opinion, he or she has complete responsibility in planning and executing the
surgical operation, adding on 3DP activities and acting as an operator is also challenging. In
addition, many surgeons suggest that for AM to spread in the orthopedic industry, new personnel
assigned for other activities, such as operating machines, and compliance with regulations can
stimulate its adoption. Within the retrieved data, addressed in Theme 3, surgeons are also the
ones who cooperate and coordinate the relationship with academic institutions and
manufacturers. I see the current management technique, where all activities are done by
orthopedic surgeons, as hampering the adoption of AM in the orthopedic industry as it is difficult
and challenging for clinicians to coordinate all activity alone, especially at the early stages of
AM technology with new regulations associated with developing medical products.
6.2.2 The collaboration approach to apply for AM’s development
Regardless of whether AM is established in-house, or whether the manufacturer outsources the
technology or the 3D-developed products, the need for collaboration between clinicians and
manufacturers is an important driving force in the development of AM in orthopedics. This is
similar to the environment context that addressed the partnership as the crucial factor in the
adoption of 3DP (Ukobitz, 2021). Moreover, in theme 2, it has been mentioned by many
orthopedic surgeons that academic collaboration and business relationships are important for
achieving successful implementation of AM, either internally or externally. Nevertheless, with
strategic items, it is recommended to cooperate only with one supplier (Kraljic, 1983). strategic
items are a critical products that requires so much coordination with a supplier, thus
collaborating with a single supplier, it helps to manage the relationship appropriately, so as to
reach long-term partnership targeting the reduction of total costs including production cost,
transportation cost, R&D cost (Kraljic, 1983). The current approach clinicians used in sourcing
conventionally manufactured orthopedic implants, where they worked with different
manufactures via tendering, it must change for the implementation of AM in orthopedic practice.
In the opinion of (surgeon 3), the hospital's collaboration with different manufacturing
companies allows them to obtain quality products. Yet the price of the product plays a
significant role in the choice of product from which they will buy. It is important to note that
AM-developed products will require collaboration with a single supplier or research hub. The
surgeons who have experience with 3D-developed implants have done so with a collaboration of
a single manufacturing company or AM research center. In this study, all surgeons who took part
had experience with AM. Even so, most surgeons have mentioned that their hospital does not
have 3D printers, but by collaborating with a university or an AM research center, they've been
able to plan surgical operations and develop 3-dimensional models.
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It is interesting to see how the approach used by surgeons when sourcing AM orthopedic
products aligns with kraljic recommendations of coordination strategies organizations can use
when developing strategic items. .
6.2.3 Resource management for AM’s development
The most factors in hindering the adoption of AM and other new innovation in the healthcare is
the resource scarcity, which different healthcare practitioners address as a major issue faced in
the health sector industry as it is has been addressed within the reviewed literature. According to
Zamborsky et al. (2019 ), fewer people are able to use AM technology due to higher price for
3D developed devices. Moreover Yeh et al. (2018) pin point the investment cost as major factor
that affect 3DP adoption. In similar fashion with the research findings in theme 4, all surgeons
claims AM to be extremely expensive, they highlighted that the production cost is expensive and
there is needs of additional huge investment for production facility of AM especially to apply in
house manufacturing such as buying 3D printers, building rooms for AM technology.as
addressed in theme 4, It is challenging to understand how AM will be efficiently implemented
in-house at the point of care with the scarcity of resource in the Swedish healthcare. Unlike the
current applied approach while sourcing traditionally manufactured orthopedic devices,
regarding adopting and the use of AM’s products, clinicians must not only target the price
reduction. The strategy need to change depending on the product classification (Kraljic, 1983).
A close relationship between clinicians with a single manufacturing company will not only
tackle the exchange of good and services. According to Kraljic (1983) regarding sourcing a
strategic items an organization should apply close business relationship with a single supplier.
The reason for this relationship is to target to reduce the total purchasing cost together in
cooperation and for the benefit of every stakeholder in the industry. Unlike aiming for the
product price reduction, the total purchasing cost should be targeted for AM to be adopted in the
orthopedic industry in Sweden. According to Gadde and Håkan (1994), a close business
relationship targets the reduction of total purchasing cost. The price is a small part of the total
purchasing cost. The total purchasing cost involves, the production facility, storage cost, capital
costs, relationship handling costs, administrative costs, development costs. (Gadde and Håkan,
1994). Through a close business relationship, stakeholders in the healthcare can effectively
achieve to implement AM in the Swedish orthopedic industry. The issue raised of the price of
AM ‘products, the need of production capacity, the capital for investment can be well mitigated
through partnership between a hospital and a manufacturers or an AM research academic hub.
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6.3 The sustainability implication of AM
For AM to be a sustaining technology for the future it must align with the global sustainability
goals. AM complies with the current trend of a circular economy work process which includes
the concepts of Reduce, Reuse, Recycle, embedded within the implementation of AM in the
orthopedic practice. As mentioned by Wixted et al. (2021) using AM in orthopedic practice is a
strategy to eliminate waste, a just-in-time approach align with lean manufacturing process. In
addition, from a surgeon's point of view, an in-house manufacturing operation will allow
clinicians to recycle materials while planning for several surgical operations. The use of AM
relies on an on-demand manufacturing process, as opposed to conventional manufacturing,
which primarily produces based on the forecasted market (Wixted et al., 2021). Relying on the
forecasted market led to mass production and excessive use of resources. Through the use of
AM, it is possible to apply an on-demand manufacturing approach, where the production of
products varies based on the patients need, which reduces the use of resources, combining it with
recycling the material used to create models for surgical planning, will thereby improve the
environment sustainability of the orthopedic industry.
The research on AM shows that it aims to provide better quality for the patient safety in terms of
its social sustainability. In this study, we addressed the current major issue faced by surgeons in
the orthopedic sector in Sweden, as per Öhrn et al. (2012); there are many complaints after the
surgical operation has been conducted. Patients are not always satisfied with the outcome of
surgical operations and, when the number of unsatisfied patients continues to rise, it may create a
conflict between society and the healthcare system, most especially orthopedic clinicians. With
AM's technological potential, applying AM in orthopedic practice would benefit both patients as
well as clinicians through the fine planning of the surgical operation leading to a better outcome
and thereby contributing to social sustainability. Although there are criticisms regarding the
enormous cost embedded with adopting AM in orthopedic practice, both from the literature
review and from surgeon insights, these criticisms highlight the issue of high price which
negatively impacts the ability of the technology to align with the economic sustainability.
However, throughout the continuous research process, AM will be implemented in the
orthopedic industry in Sweden and come to achieve environmental, social and economic
sustainability.
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7 Conclusions
The conclusion is the final chapter of the thesis. The first part of the conclusion outlines the
assessment of overall outcomes of the thesis study on the implementation of 3DP in the
orthopedic industry in Sweden, and it begins by addressing the two research questions of this
study and then moves on to contemplate the strategic adoption approach. In the second part, I
will cover the limitations found during this research project, and in the third part, I will provide
recommendations for future research.
To conclude this research study by addressing the first thesis research question about the factors
that influence the adoption of AM in orthopedics within Sweden, all possible factors have been
classified into 3 major categories. Among these are the technological factors, basically focusing
on the product itself; the organizational factors, which are focusing on how the resources are
managed; and the environmental factors, which focus on the external interaction. In response to
the second research question of the study, which was to investigate in what way regulation acts
upon the adoption of AM at the point of care, this regulatory factor acts in both positive and
negative ways. The new MDR regulations are important for shaping the medical device sector,
and they help reach quality products for patient safety by excluding actors who develop fake
products and make the industry a niche for companies and organizations striving for quality.
However, it is difficult to adapt to new regulations and, in most cases, it reduces innovation and
research. Regulation is an important factor that affects the adoption of AM and can be embedded
within the environment factor. In addition, it is important to note that the three main factors
suggested are interconnected.
Thus, with the known factors and a clear strategy for adopting AM in the orthopedic industry, the
implementation of AM in the orthopedic industry should be focused on developing 3D models
for surgical planning, manufacturing guides, and building custom implants. According to the
Swedish orthopedic industry, these are the three most common applications of AM. These
conclusions were drawn based on the data and findings reviewed and presented in this thesis.
The most significant function of AM is to assist orthopedic surgeons with surgical planning by
creating models to guide the development of a better understanding of injury and to make it
easier for patients to understand the fracture and the treatment process.
Due to the factors that are addressed pertinently that keeps hindering the adoption of AM. By
considering both internal and external factors, the thesis outcome has elaborated a strategic
adoption and strategic procurement and purchasing approach for clinicians and other
stakeholders in the orthopedic sector. Due to the new regulations that apply to the medical device
industry, in the case of developing 3D models and guides, it is recommended that in-house
manufacturing is used. For developing custom implants, clinicians could work with an external
manufacturer. There are currently no regulations restricting the use of AM in the development of
62
3D models, though some may fall under class I products, in which case it is possible to conduct
self-assessment without the involvement of notified bodies. Furthermore, because of the skills
needed to create custom implants and the need to comply with regulatory requirements, sourcing
implants would be a strategic path to adopting AM. The goal is to achieve a quick adoption, in
which clinicians can utilize AM at an early stage in orthopedics and benefit from learning how to
take advantage of the use of 3D printers so that in the future when AM is totally embedded in
hospitals, they will be equipped to print medical devices.
In light of the three main adoption factors addressed through the use of the TOE framework,
restructuring the orthopedic organization work flow will be fundamental in mitigating many
possible threats from both the technology and the environment factors. Therefore, by responding
to all potential factors that may hinder the adoption of AM in the orthopedic industry in Sweden
through the increasing of the positive technological, organizational, and environmental factors,
orthopedic clinicians will achieve the key goal of strategically adopting AM in the industry. The
recommended strategic approach will positively impact the environment because partnering with
a manufacturer and a research center will allow clinicians to learn about 3DP so they can
implement their own "Do it yourself" manufacturing in the future. Kraljic recommendation
outlines a feasible method for overcoming the uncertainties of AM technology innovation today,
and as time passes the technology will be developed and the regulatory environment will become
more friendly, leading to an effective use of AM in the orthopedic industry in Sweden.
7.1 Limitations
The first limitation of this thesis project is the research methodology used. Findings can't be
generalized using qualitative research methodology. However, as I have obtained the data
saturation findings could be applicable to other orthopedic surgeon in Sweden. However, I have
only talked to surgeons who use AM. The findings might differ if I talked to non-adopters.
Only surgeons with experience in using 3DP in orthopedic practice took part in this study. All
respondents have been early adopters of 3D printing as a new technology in orthopedic practice.
The convenience sampling approach led to only include participants who were available and
willing to give contributions to this study, and most wished to participate just because they are
enthusiastic about using 3D printing in orthopedic. This might affect the biased results mostly
when it comes to the future application of AM in orthopedics; they all expect a successful
implementation. We can learn a lot by listening to the perspectives of surgeons who have no
prior experience with the AM and understand whether there are any similarities or differences
that can help us draw relevant conclusions about how AM should be incorporated into the
orthopedic industry in Sweden
63
It is difficult to find scientific articles related to the adoption of AM in orthopedics, and getting
access to some existing literature which is mainly concerned with the AM market share in
healthcare is difficult because many reports are quite expensive
Using the interview as a data collection method it helps to gain a deeper understanding of the
topic, however, other methods can also be applied, such as participant observation, for example
to understand theme 1 and theme 5 mostly regarding the time for printing, the use of AM, and
the current threat of CT and MRI images, interacting with the user can help to get an overview of
the orthopedic department surgery activities.
Time constraints limit the possibility of maximizing the quality of the findings. Firstly, it has
affected the sample size used in this study. I attempted to reach as many participants as possible.
In addition, finding an orthopedic surgeon and setting up an interview have also been
challenging and complex as you depend on their availability. Furthermore, The Thematic
analysis approach is time consuming and there is huge probability of losing relevant and useful
data, which eventually affects the discussion process.
Regarding the orthopedic surgeons' knowledge on the regulation requirements, it appears that the
requirements are new and most have basic knowledge of the new regulation; this may have
limited the finding on where the new MDR could hinder the adoption of AM.
It is interesting to have reached participants who have experience using 3DP in orthopedics;
these participants can provide insights into the factors affecting AM based on their experience.
However, some participants have only used AM once, so their answers may be biased.
7.2 Recommendation
Suggestion for further research:
It would be interesting to include other stakeholders, such as regulatory agencies. Future
research could raise the understanding of regulation bodies to better understand regulation's
perspective, Recent literature on the regulation has mostly focused on raising awareness of the
new regulation, so it would be interesting to speak with them about it, and how hospitals and
manufacturers are responding to the new requirements.
A future study could also look into how manufacturers, especially orthopedic medical device
manufacturers, could be integrated into the study to help understand all factors influencing
adoption. It should include both those who have experience with AM and those who do not use
AM. This thesis mainly focuses on the buyer's perspective. Understanding the supplier's
perspective as well as their experience in producing implants would be beneficial. Furthermore,
they are the ones who are mainly in compliance with the MDR, so they can easily address its
impact
64
Additionally, using other types of research methodologies as well as other methods of data
collection can also increase the quality of the findings. In this study, quantitative research may be
relevant and useful in generalizing the findings. Furthermore, the survey can be conducted
quickly compared to waiting for a surgeon to become available for an interview.
65
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Appendix
Appendix A. Interview guide
Note: Firstly, I will introduce myself and describe my research project titled “ The strategic
implementation of additive manufacturing in the orthopedic industry in Sweden”. A master's
thesis within the competence center in Additive Manufacturing for the Life Sciences.
The introductory questions
Could you give me a short presentation of you and your current position?
How many years have you had this position?
What is your educational background?
Could you describe your daily work shortly?
Additive manufacturing adoption / Interview questions
1. What is your experience with Additive manufacturing in orthopedic practice?
2. What are the benefits of using Additive manufacturing in orthopedics?
3. In what way Additive manufacturing is used at your workplace?
4. Who is involved in making decisions regarding the adoption of new technology such as
additive manufacturing in your workplace?
5. What hinders the adoption of Additive manufacturing in orthopedic practice from your
perspective?
6. What is needed to increase the adoption of Additive manufacturing in orthopedics?
7. Are there any other ways that Additive manufacturing can be effectively employed in
orthopedic practice?
- Can you name a few things where you consider there could be clinical benefits from
using Additive manufacturing?
- In addition to being used in implant development or surgical planning, are there any
other orthopedic practices with which Additive manufacturing can assist surgeons?
8. In which orthopedic specialty areas do you believe Additive manufacturing can be
useful?
9. What is your point of view on the trend of shifting From the conventional manufacturing
approach to the use of Additive manufacturing in producing orthopedic medical devices?
10. Which way do regulations and policies affect the adoption of 3D printers in hospitals?
11. Are you aware of any hospitals in Sweden having their own 3D printers?
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- What hospitals?
- Do those hospitals have dedicated personnel responsible for complying with
regulations?
- What do you think about having 3D printers at hospitals?
- What is your concern about the regulatory requirements that lay upon the hospitals if
they decide to produce implants in-house?
12. It seems feasible to apply Additive manufacturing primarily to patient-specific implants,
As in the case of other implants, conventional production methods are more effective,
and more recommended. How will this affect orthopedic practice?
13. In some studies, researchers have suggested that Additive manufacturing may not be a
good choice in emergency situations due to the design and manufacturing time 3D
printers take. What is your opinion of that issue?
14. Could you highlight any other example of innovation trends being adopted in orthopedics
currently?
15. Considering your experience in the orthopedic industry, what do you expect for the
application of Additive manufacturing in the future?
16. Is there someone else who I should talk to who could have knowledge about the issues
we have talked to both at your hospital and at other hospitals?
