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1 t 3D-PRINTED MEDICAL DEVICES Report on promising KETs-based products nr. 6
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t
3D-PRINTED MEDICAL DEVICES
Report on promising KETs-based products nr. 6
nr. X
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The views expressed in this report, as well as the information included in it, do not necessarily reflect the opinion or position of the European Commission.
3D-PRINTED MEDICAL DEVICES
Report on promising KETs-based product nr. 6
KETs Observatory Phase II Contract nr. EASME/COSME/2015/026
Authors: Sabina Asanova (CARSA), Johannes Conrads (CARSA), Thibaud Lalanne (CARSA), Leyre Azcona (CARSA); in cooperation with Kristina Dervojeda (PwC)
Coordination: EUROPEAN COMMISSION, Executive Agency for Small and Medium-sized Enterprises (EASME), Department A – COSME, H2020 SME and EMFF, Unit A1 – COSME; DG for Internal Market, Industry, Entrepreneurship and SMEs, Unit F.3 - KETs, Digital Manufacturing and Interoperability
European Union, August 2017.
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Executive summary ...................................................................................................... 4
1. Introduction ............................................................................................................... 6
1.1 Background ........................................................................................................ 6
1.2 Objectives of this report ...................................................................................... 6
1.3 Target audience .................................................................................................. 7
2. Key product facts ...................................................................................................... 8
2.1 Introduction to the product ................................................................................... 8
2.2 Relevance to grand societal challenges .............................................................. 9
2.3 Market potential ................................................................................................. 10
2.4 Importance for the EU competitiveness ............................................................. 10
3. Value chain analysis ............................................................................................... 12
3.1 Value chain structure ......................................................................................... 12
3.2 Key players ....................................................................................................... 14
3.3 Key constraints .................................................................................................. 17
4. Analysis of the EU competitive positioning ............................................................. 19
4.1 Strengths and potential of the EU regions ......................................................... 19
4.2 Key risks and challenges ................................................................................... 21
4.3 Opportunities for the EU regions ....................................................................... 22
5. Policy implications................................................................................................... 24
5.1 Measures with immediate focus ........................................................................ 24
5.2 Measures with longer-term focus ....................................................................... 25
Annex A: List of interviewees ...................................................................................... 27
Acknowledgments ....................................................................................................... 27
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Executive summary
The current report aims to provide stakeholders with an analytical base helping to
strengthen cross-regional cooperation mechanisms to boost the deployment of Key
Enabling Technologies in Europe. The report specifically aims to highlight the value
chain structure, key players and constraints for the domain of 3D-printed internal and
external medical devices in Europe. It also addresses the key strengths and potential of
the EU regions, as well as promising business opportunities and key risks and
challenges. Finally, the report elaborates on specific policy recommendations with both
immediate focus and longer-term orientation.
3D printing technology in medical devices unlocks unprecedented possibilities to fully
customise a device to the dimensions and the needs of the patient. It has the ability to
improve medical care while reducing the healthcare costs and time patients need to
spend under direct care. In addition, the shift to on-demand manufacturing allows the
use of fewer resources, raw materials and energy. Although large-scale manufacturing
has not yet fully unfolded in Europe, the prospects are positive, forecasting a strong
position on the global market. The orthopaedical sector is expected to remain the most
beneficial in the next decade, with a high increase in demand for service providers.
The value chain for 3D-printed medical devices is complex comprising multiple actors
from different sectors (namely, software, 3D printer developers, metal and plastic
industries, as well as, hospitals). This requires a clear coordination between different
professionals. The value chain can still be considered as emerging, underlining the
need of further cooperation and alignment with different production and supporting
activities. Actors involved in the value chain range from SMEs to larger companies,
acting in some cases as one-stop-shop. The main constraints identified are the
absence of large scale manufacturing, the lack of information about upstream and
downstream processes, the impact these processes have on the final product, and the
mechanisms to assure the necessary quality control processes.
Europe has all the necessary assets and key players to take on large production
volumes, including strong and stable R&D environment, highly-specialised companies,
and availability of the educational institutions and pool of required skills. The domain,
however, exhibits a rather low demand from end-users and hospitals. Moreover, there
is hardly any synchronisation between new medical solutions and the current
healthcare system. These key bottlenecks should be addressed in order to fully exploit
the opportunities and to compete against other frontrunners such as Japan, South
Korea, China and the United States. The latter became the leader in the production of
3D-printed medical devices on the global market in 2016.
There is a need to strengthen cross-regional cooperation, giving special attention to the
complementarities between different stakeholders, for example to create a network of
demonstrators including research centres, service providers and hospitals. In addition,
the smooth transition towards the new Medical Device Regulation should be ensured
by accordingly informing and assisting the manufacturers. Europe could benefit greatly
from harmonising its various certification and standard systems. This would not only
advance the general acceptance of relevant health and safety provisions, but would
Introduction
5
also foster large-scale manufacturing of AM medical devices. From a long-term
perspective, there is a need to assess the overall impact of 3D-printed medical devices
in order to shape a broader understanding on the benefits these devices will have on
social security and the healthcare system as a whole.
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1. Introduction
The current report has been developed in the context of the second phase of the KETs
Observatory initiative. The KETs Observatory represents an online monitoring tool that
aims to provide quantitative and qualitative information on the deployment of Key
Enabling Technologies1 (hereafter “KETs”) both within the EU-28 and in comparison,
with other world regions. Specifically, the KETs Observatory represents a practical tool
for the elaboration and implementation of Smart Specialisation Strategies in the EU
regions.
1.1 Background
A key challenge for the EU competitiveness policy is to enable European industry to
move to the higher end of the value chain and position itself on a competitive path that
rests on more innovative and complex products. For many KETs, this implies a focus
on more integrated technologies with the potential of connecting several KETs.
To this end, one of the key tasks of the KETs Observatory implies identifying and
describing “promising KETs-based products” and their value chains, and
recommending specific policy actions to help the EU industry stay ahead of global
competition. Promising KETs-based products here can be defined as emerging or fast-
growing KETs-based products with a strong potential to enhance manufacturing
capacities in Europe. Such products correspond to KETs areas where Europe has the
potential to maintain or establish global industrial leadership - leading to significant
impacts in terms of growth and jobs.
1.2 Objectives of this report
In the context of the second phase of the KETs Observatory, in total, 12 promising
KETs-based products have been selected for an in-depth analysis of their value chain,
the associated EU competitive position and the corresponding policy implications. The
selection of the topics stems from a bottom-up approach based on active engagement
of regional, national and EU stakeholders through the S3 Platform for Industrial
Modernisation2.
This report presents the results of the abovementioned in-depth analysis for one of the
selected top-priority topics, namely 3D-printed medical devices. The analysis is
based on desk-research and in-depth interviews with key stakeholders. The report
aims to provide relevant stakeholders with an analytical base helping to establish or
strengthen cross-regional cooperation mechanisms to boost the deployment of KETs in
Europe.
1 Namely Nanotechnology, Micro-/Nanoelectronics, Photonics, Industrial Biotechnology, Advanced Materials and Advanced Manufacturing Technologies 2 http://s3platform.jrc.ec.europa.eu/industrial-modernisation
Introduction
7
1.3 Target audience
The report aims to provide key market insights for 3D-printed medical devices and
identify key directions for action in order to maintain or build Europe’s competitive
position on the global market. The report specifically targets the EU, national and
regional policy makers and business stakeholders who are currently involved in or
consider engaging in cross-regional cooperation mechanisms. The report may also be
relevant for other key stakeholder groups including academia, as well as different
support structures such as cluster organisations, industry associations and funding
providers.
8
2. Key product facts
In the current section, we provide a brief introduction to 3D-printed medical devices.
We also elaborate on the market potential and the importance of this product for the
EU’s competitiveness.
2.1 Introduction to the product
Additive manufacturing (AM) or 3D printing is a technology that builds parts by adding
material layer upon layer using computerised 3D solid models3. The main difference
from the traditional manufacturing processes is that the final shape is created by
adding materials instead of cutting out a shape from a larger stock4. While additive 3D-
printing processes are not new, in the last years, the new technology is experiencing a
true boost, promising to substantially impact the healthcare sector.
This case study aims to shed light on the potential of additive manufacturing in internal
and external 3D-printed medical devices in Europe. The European Commission defines
medical device as “any instrument, apparatus, appliance, software, material or other
article, whether used alone or in combination, including the software intended by its
manufacturer to be used specifically for diagnostic and/or therapeutic purposes and
necessary for its proper application”5.
The European Commission´s study on identifying existing 3D printing industrial value
chains in the EU (2016)6 categorises medical devices into the five following categories:
(1) Models for preoperative planning; (2) Tools, instruments and parts for medical
devices; (3) Inert implants7; (4) Medical aids, supportive guides, splints and prostheses;
(5) Bio manufacturing. The industrial value chains and future prospects of the first three
categories were discussed in the above-mentioned study. The focus of this case will
attempt to investigate 3-D printing technology in the fourth category: external
and internal medical devices used for the purposes of rehabilitation, neurology,
sport/performance (hereinafter referred to as “medical devices”). The medical
segment for these devices is orthopaedics. Examples include orthosis, prosthesis,
exoskeleton, insole, brace, sockets, metal plates, pins, rods, wires and screws8,
endoprosthesis and others9.
3 Gausemeier J., Echterhoff N. (2013) Thinking ahead the future of Additive Manufacturing- Innovation Road mapping of Required Advancement, Direct Manufacturing Research Center (DMRC) 4 Huang S., Liu P. & Mokasdar A. (2013) Additive Manufacturing and its societal impact: a literature review Retrieved from: https://link.springer.com/article/10.1007%2Fs00170-012-4558-5?LI=true 5 For a complete definition, please refer to http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_1_3_rev_3-12_2009_en.pdf 6 European Commission (2016) Report on 3D-printing carried out by IDEA Consult, VTT, AIT and CECIMO, Padilla & Wastyn: Current and future application areas, existing industrial value chains and missing competences in the EU., in the area of additive manufacturing. Retrieved from: http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=8937 7 Note: The analysis of the future prospects and value chains of (1) Models for preoperative planning; (2) Tools, instruments and parts for medical devices; and (3) Inert implants was presented in the EC study. 8 Retrieved from http://emag.medicalexpo.com/new-innovations-driving-the-orthopedic-device-market/ 9 European Commission (2016) Report on 3D-printing carried out by IDEA Consult, VTT, AIT and CECIMO, Padilla & Wastyn: Current and future application areas, existing industrial value chains and missing competences in the EU, in the area of additive manufacturing. Retrieved from: http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=8937
Key product facts
9
3D-printed medical devices offer numerous advantages when comparing them with
their traditional counterparts, ensuring unprecedented customisation to patients.
Additive manufacturing technology enables the production of complex structures,
allowing medical devices to match the needs of the human body accurately10.
Additionally, high resolutions - reaching resolutions below 10 microns11 over shapes
larger than 1 cm – increase the compatibility of medical devices with biological body
parts. Furthermore, the digitisation of manufacturing allows to manipulate data easily
while errors in the production process can be identified and eradicated at initial stage12.
Undoubtedly, 3D printing of medical devices bears an enormous potential to
substantially change the experience and performance of the patient. Prosthesis is a
good example of how the application of 3D technology can make a difference.
Additively manufactured prostheses are cheaper in price and can be produced in a
shorter time span. Additional benefits include the possibility to personalise the
prosthesis and make it visually more appealing, thanks to adapted colours, patterns
and even tattoos13.
2.2 Relevance to grand societal challenges
Health, demographic change and wellbeing
AM of medical devices offers the possibility to fully customise a device to the
dimensions and the needs of the patient in contrast with the one-size-fits-all approach
applicable until very recently14. Customised products have the ability to improve
medical care while reducing healthcare costs, since patients will spend less time in
longer or additional surgeries15 or filing for malpractice lawsuits.16 In addition, the lower
cost is ensured by options such as the stretching and expanding of a medical device,
especially relevant for growing children17.
With governments scrutinising their healthcare spending and rapid technological
advancement, home healthcare is expected to gain more importance in the near future
as patients are expected to spend less time under direct care18. Taking into account an
aging population in Europe and growing life expectancy, AM medical devices are
expected to grow in demand as they have the potential to reduce direct care cost and
time19. Personalised devices and crosscutting activities between different technologies
10 Retrieved from: https://www.mdtmag.com/news/2017/03/medical-3d-printing-current-state-viable-materials 11 1 micron = 0.001 mm 12 Gausemeier, J. (2011) Thinking ahead the Future of Additive Manufacturing – Analysis of Promising Industries. Retrieved from https://dmrc.uni-paderborn.de/fileadmin/dmrc/06_Downloads/01_Studies/DMRC_Study_Part_1.pdf 13 Dodziuk H. (2016) Applications of 3D printing in healthcare. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5071603/ 14 Huang S., Liu P. & Mokasdar A. (2013) Additive Manufacturing and its societal impact: a literature review Retrieved from: https://link.springer.com/article/10.1007%2Fs00170-012-4558-5?LI=true 15 For example, titanium Fast-Forward Bone Tether Plate allows less-invasive foot surgery and already got a clearance from Food and Drug Administration in the U.S.A. Retrieved from: http://www.medshape.com/news-events/96-medshape-announces-fda-clearance-of-new-3d-printed-titanium-bone-tether-plate-that-preserves-bone-anatomy.html 16 Smart Tech White Paper Revolutionizing Healthcare: How 3D printing is creating new business opportunities (2015) Retrieved from: https://www.smartechpublishing.com/images/uploads/general/Final_Medical_White_Paper.pdf 17 Dodziuk H. (2016) Applications of 3D printing in healthcare. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5071603/ 18 Lopez NM, Ponce S., Piccinini D., Perez E. and Roberti M. (2016) From Hospital to Home Care: Creating a Domotic Environment for Elderly and Disabled People. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/27187540 19 How 3D printing is transforming medical device innovation. Retrieved from: https://edisonnationmedical.com/how-3d-printing-is-transforming-medical-device-innovation/
Key product facts
10
– such as embedded sensors in 3D-printed medical devices should allow remote
medical examination of patients and consequently older and/or disabled people to stay
longer home20.
Resource efficiency and raw materials
AM of medical devices should bring a change to the manufacturing supply chain,
moving from large production of standard devices to on-demand manufacturing. This
should allow for savings in resources, raw materials and energy while bringing the final
product cheaper and faster to the consumers21.
2.3 Market potential
The total market for 3D printed medical devices is expected to grow substantially taking
into consideration the solutions it offers to the geriatric population22. In addition, a
growing number of accidents caused by modernisation and fast-paced machines in
combination with the frequent occurrence of chronic diseases are also likely to boost
the market for 3D printed solutions in medical devices23.
By 2026, the overall market for all 3D-printed medical devices is expected to reach
1469.4 million USD24. At the moment, plastic is the most used material for AM in the
medical devices, accounting for up to 2/3 of the total revenue. In the next decades, the
application of biomaterial inks is forecasted to grow substantially, reaching up to 20% in
total market share by 2026. In terms of 3D-printed technologies, the market potential
for inkjet and polyjet is likely to peak in the next 9 to 10 years25.
In the near future, orthopaedics will keep its position as the most profitable segment in
healthcare for additive manufacturing, estimated to account for 44% of all 3D printing
revenues at the moment and with approximately 500 million in revenue in 201626. The
biggest growth in AM in orthopaedics will be in the ´service segment´. In other words,
growth in demand for 3D-printed medical devices will mean higher demand for
manufacturing and engineering services, as the production of both standard and
tailored medical devices is expected to favour the outsourcing of manufacturing27.
2.4 Importance for the EU competitiveness
In 2012, Europe was reported to have a leading position on the medical devices
market, followed by North America28. The latter overtook European market in 2016,
accounting for over 40% of the global market share in the same year29. These numbers
20 Based on project that was led by Curtin University. The researchers embedded sensors in low-cost rehabilitation equipment during 3D printing. Retrieved from https://3dprint.com/53152/sensors-in-casts-3d-printing/ 21 Huang S., Liu P. & Mokasdar A. (2013) Additive Manufacturing and its societal impact: a literature review Retrieved from: https://link.springer.com/article/10.1007%2Fs00170-012-4558-5?LI=true 22 Retrieved from: http://www.futuremarketinsights.com/reports/3d-Printed-medical-devices-market 23 Retrieved from: http://www.futuremarketinsights.com/reports/3d-Printed-medical-devices-market 24 1241.35 million at current exchange rate (02/08/2017) 25 Retrieved from: http://www.futuremarketinsights.com/reports/3d-Printed-medical-devices-market 26Use of additive manufacturing for orthopedic implants generates nearly $500m in revenue opportunities in 2016. Retrieved http://www.tctmagazine.com/3D-printing-news/additive-manufacturing-orthopedic-implants-500m-2016/ 27 Ibid. 28 Retrieved from: http://www.marketsandmarkets.com/Market-Reports/additive-manufacturing-medical-devices-market-843.html 29 Retrieved from: http://www.futuremarketinsights.com/reports/3d-Printed-medical-devices-market
Key product facts
11
however correspond to the overall share for medical devices in all categories, rather
than exclusively for the medical devices discussed under this study.
The European industry for medical devices is an important employer in the region. In
2010, 25.000 companies employed 575.000 people in the European Union. 95% of
those companies were registered as Small and Medium-sized Enterprises (SMEs)30. In
addition, the number of applications in medical technology for patents at the European
Patent Office (EPO) is higher than for any other sector in Europe and amounting to a
total of 11.124 filed patents in 201431 and 12 263 in 2016, 41% of which come from
European countries32.
In the field of 3D-printed medical devices, Europe has competitive advantages in R&D,
prototyping, as well as in technology and product development with some game-
changing companies founded and based in Europe.
30 Medical Devices and Safety: Importance of Medical Devices Sector. Retrieved from: http://emanet.org/medical-devices-and-safety/ 31 Ibid. 32 Data retrieved from 2016 EPO Annual Report available from: https://www.epo.org/about-us/annual-reports-statistics/annual-report/2016.html
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3. Value chain analysis
The current section addresses the value chain structure of 3D-printed medical devices
and its constraints. It further sheds light on the main players in the field. The value
chain for 3D-printed medical devices is a hybrid value chain, bringing together actors
from different sectors – ranging from software and 3D printer developers to metal and
plastic industries, as well as, hospitals. The value chain of AM’s internal and external
medical devices is particularly intricate for two main reasons: (1) Critical production
aspects; and (2) the multitude of professionals and instruments involved, e.g. medical
practitioners, bioengineers, radiologists, designers, legal representatives and health
insurance33.
Europe has an emerging value chain for 3D-printed devices, that should be further
developed and synchronised by accelerating the supply chain and setting up cross-
regional partnerships working on networks of demonstrators. In addition, enabling
actors could support the development of the value chain by providing training and
capacity building activities.
3.1 Value chain structure
Figure 3-1 illustrates the reconstructed value chain for 3D-printed internal and external
medical devices, represented in three dimensions: (1) value-adding activities; (2)
supply chain; and (3) enablers.
FIGURE 3-1: Value chain model for 3D-printed external and internal medical devices
Value-adding activities
The first dimension represents six interrelated and complementary value-adding
activities. Design does not only include tailoring devices to the human anatomy, but
33 Based on interview data
Value chain analysis
13
also considers the taste and esthetical preferences of the patients. The promotion of
the advantages 3D-printed medical devices brings to the population and the economy -
with proactive policy support for governments on different levels - were identified as a
further value-adding activity. Additionally, cross-regional and international partnerships
bringing key players together are among actions to be considered, with a particular
focus on setting up joint demonstrators. All activities presented under this dimension
should be seen as interlaced activities with multiple feedback cycles that feed and
advance R&D, design and production of the 3D-printed medical devices.
Supply chain
The supply chain segment illustrates the necessary steps needed to ensure product
delivery to the end-users. As personalisation is the most game-changing feature34 for
this KETs-enabled product, the specific data of the patient – including body scan /body
part shape, habits, environment, physical status and restriction, as well as personal
expectations - is a key input. All these factors must be understood and matched with
possible or available clinical and biomechanical solutions35. Materials are the second
layers of input. These are mostly materials such as bio inks, new forms of plastics,
including biodegradable and high-temperature polymers (PEKK, PEEK and Nylon 6.6,
Nylon 6, etc.) and metals (stainless steel, cobalt chrome and Ti6AlV4 and Ti6AlV4 ELI,
pure titanium, etc.)36;37.
The product development and manufacturing result in external and internal medical
devices by means of a complicated process. In this process, software and 3D scanners
are used to allow data processing such as detailed 3D imaging and the virtual design of
a medical device. The virtual design model is typically subject to the surgeon´s or
orthopaedist´s approval. Once the model is ready, the actual process of additive
manufacturing can commence involving the use of various technologies ranging from
powder bed printing by laser (SLM, lasercusing) or electron beam (EBM) systems to
pneumatic/hydraulic extrusion and selective laser sintering38;39. 3D-printed medical
devices undergo a quality control before they are possibly sterilised, packaged and
delivered to the distributors such as hospitals, orthopaedic vendors, rehabilitation and
sport centres and finally placed or implanted into the patient´s body. The quality control
includes post-printing processes, namely validation, testing and verification. While the
supply chain is illustrated in a linear way, it is important to see it as a series of actions
that include a lot of feedback, testing and validation at each step of the chain with
quality assurance as an important aspect.
Enablers
34 Banks J. Adding value in additive manufacturing: Researchers in the United Kingdom and Europe look to 3D printing for customization. IEEE Pulse. 2013;4(6):22–26 35 Based on interview data 36 Titanium Coating on PEEK spine implants. Retrieved from: http://www.orchid-ortho.com/orchid-blog/titanium-coating-on-peek-spine-implants 37 Based on interview data; 3D printing in orthopedics: a bright future ahead. Retrieved from: http://blog.peekmed.com/3d-printing-in-orthopedics-bright-future-ahead/ 38 Medical 3D Printing: The Current State of Viable Materials Retrieved from: https://www.mdtmag.com/news/2017/03/medical-3d-printing-current-state-viable-materials 39 Note: the abovementioned technologies and materials are not exhaustive and serve illustrative purposes
Value chain analysis
14
The third segment represents actors that are needed to enable and/or support the
entire ecosystem. These bodies support, feed and boost the supply chain. Knowledge
and technology holders such as universities, clusters, laboratories and research
centres ensure technology and knowledge development, transfer and capacity building.
Educational institutions such as vocational and educational training centres as well as
universities have an important role in training the skilled workforce. Standards and
patents organisations support a regulatory framework, while health insurance providers
ensure that the devices and required medical services are affordable for the patients.
3.2 Key players
The following actors were identified for the European value chain on AM internal and
external medical devices:
Research and development centres: these organisations are responsible for
developing materials, software and hardware along with the technologies that
are applied in the 3D printing process of medical devices. These centres also
offer testing and prototyping facilities and services. In some cases, bringing
together and matchmaking relevant key players and business partners along
the value chain fall under activities of the centres.
Medical practitioners, hospitals, patients: this group triggers the demand
and plays a crucial role in the evolution of the value chain. Practitioners that
work with the investigated medical devices are in most of the cases surgeons
and orthopaedists. The interviewed stakeholders reported that there is still little
awareness and eagerness among these key players to opt for 3D-printed
solutions.
There are also scenarios for the future where hospitals could take up a role of
manufacturers and suppliers of medical devices to the patients. While it is hard
to assess this possibility for the near future, the general acceptance is that
additive manufacturing in the hospitals is a highly complex process and the
scenario of 3D printing hospitals should be examined in meticulous details
before it is allowed40.
Software developers: software allows the translation of the medical data and
images into 3D virtual design. Medical imaging uses various software such as
Orthanc, Mimics and OsiriX. Open source software packages are also
available, e.g. 3DSlicer, MicroDicom and InVesalius.
Europe includes some of the global leaders in medical imaging such as AGFA
Healthcare and Aquilab41.
Hardware developers: 3D printer and 3D scanner developers are needed to
translate data into virtual and eventually into 3D-printed medical device. CT and
MRI-scanners are the most used 3D scanners. OECD data shows that there
are big differences in the availability of scanners between EU Member States.
40 http://flandersbio.be/en/what-we-do/flandersbio-member-events/2017/may/hospital-3d-printing-conference-save-the-date/ 41 Analysis on the medical image analysis software. Retrieved from: http://www.marketsandmarkets.com/Market-Reports/medical-image-analysis-software-market-846.html?gclid=CjwKCAjwk4vMBRAgEiwA4ftLszfohm2dZ5vh9EjkoVDaudpXfMDAf80EzBcpUMMHvA8YDoQnjcT-VxoCzlkQAvD_BwE
Value chain analysis
15
Germany had 30 MRI-scanners per one million inhabitants in 2015 while for the
same number of population there were only 3 in Hungary. For CT-scanners,
Denmark, Germany and Latvia had between 35 and 37 scanners per one
million inhabitants, whereas Hungary again showed the lowest number with 8
available machines only42. Two of the largest providers of 3D-scanners are the
European Siemens and Phillips43. One of the most mentioned examples is the
special-purpose 3D printer of the Belgian company Materialise44.
Material suppliers: new and more sustainable materials are continuously
populating the availability list for AM medical devices. Companies such as
Arcam and EOS provide large amounts of metals. Together with Stratasys,
EOS is also a supplier of plastic materials45.
Manufacturers or service providers: Manufacturers of 3D printed medical
devices have to operate in a strict regulatory framework when it comes to health
care. But their importance can be hardly overestimated. While the idea of on-
site direct manufacturing is being explored, the interviewed stakeholders
express strong doubts that hospitals will engage in direct service supply to
citizens any time soon. There are numerous obstacles to prevent this scenario
in the near future, starting from complex processes, to necessary skills to
operate the machines as well as the required reorganisation of hospitals. The
production could be further outsourced to specialised manufacturers. The
growing demand could require more production services, thereby generating
increasing revenues to additive manufacturing of the orthopaedics sector46.
The table below presents a number of illustrative names of the different key players
that are active in Europe. Some of the listed private entities – mostly large companies –
have headquarters outside of the EU; nevertheless, these companies are also included
due to their active presence in the development of the value chain for AM medical
devices in Europe. This list should by no means be considered exhaustive.
TABLE 3-1: Mapping of key players47
R&D centres Clusters, associations, FoF projects
Educational institutions
Material suppliers
Hardware developers
Software developers
Service providers
Istituto
Ortopedico
Rizzoli (IT)
KU Leuven
Research &
Development
RegMed –
Flanders Smart
Hub (BE)
Matikem (FR)
Istituto
Ortopedico
Rizzoli
KU Leuven
(BE)
Materialise
(BE)
AIM (SE)
Altran (DE)
Materialise
(BE)
AGFA
Healthcare
(BE)
Materialise
(BE)
AGFA
Healthcare
(BE)
Materialise
(BE)
Ortho Baltic (LT)
Siemens
42 Retrieved from: https://data.oecd.org/healtheqt/computed-tomography-ct-scanners.htm#indicator-chart; https://data.oecd.org/healtheqt/magnetic-resonance-imaging-mri-units.htm#indicator-chart 43 Retrieved from: https://info.blockimaging.com/top-mri-manufacturers-compared-choosing-the-best-for-your-needs 44 A look inside Materialise, the Belgian company 3D printing its way into the future of everything. Retrieved from: http://tech.eu/features/63/a-look-inside-materialise-belgian-3d-printing-pioneer/ 45 European Commission (2016) Report on 3D-printing: Current and future application areas, existing industrial value chains and missing competences in the EU. Retrieved from: http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=8937 46 Use of additive manufacturing for orthopedic implants generates nearly $500m in revenue opportunities in 2016. Retrieved http://www.tctmagazine.com/3D-printing-news/additive-manufacturing-orthopedic-implants-500m-2016/ 47 The list of organisations presented in this table should not be considered exhaustive. It is rather an illustrative representation of organisations currently active in the value chain of 3D-printed medical devices in Europe
Value chain analysis
16
R&D centres Clusters, associations, FoF projects
Educational institutions
Material suppliers
Hardware developers
Software developers
Service providers
(BE)
DMRC –
Paderborn
University
Leuven Inc.
(BE)
Bio-
Incubator
(BE)
AITIIP (ES)
TNO (NL)
Technalia
(ES)
Eurecat (ES)
Prodintec
(ES)
Imdea (ES)
CETIM (FR)
CEA (FR)
CTTC (FR)
IMR (IRL)
TWI (UK)
Coventry
University
(UK)
TUKE (SK)
Flam3D (BE)
Berenschot
(NL)
3D Makers
Zone (NL)
AD Global (ES-
UK)
Symbionica
(Europe)
Addfactor
(Europe)
Borealis
(Europe)
Hi-Micro
(Europe)
Kraken
(Europe)
Mansys
(Europe)
Technology
Cluster AM
(NL)
Antleron (BE)
Padeborn
University
(DE)
Free
University of
Brussels
(VUB) (BE)
VIB (BE)
Eindhoven
University
(NL)
Utrecht
University
(NL)
Maastricht
University
(NL)
UMC Utrecht
(NL)
Leiden
University (NL
Universidad
Carlos III de
Madrid (ES)
EOS (DE)
Arcam (SE)
KMWE (NL)
LCV (BE)
Linde (FR)
MBN (IT)
Stratasys
(Israel)
Lima
Corporate
(IT)
Suprapolix
(NL)
GE
Healthcare
(US)
Cerhum SA
(BE)
Zimmer
Biomet
(US)
Stryker
(US)
DePuy
Synthes
(BE)
Ottobock
(NL)
Altran (DE)
Siemens
(NL)
Phillips (NL)
Fucco
Design (PL)
Lima
Corporate
(IT)
3D
Systems48
(BE-US)
Phoenix
Innovation
(DE)
EOS (DE)
GE
Healthcare
(US)
Mercuris
(DE)
Fit AM
(group)
DWS (IT)
Envisiontec
(DE)
Solido (ISR)
Stryker (US)
DePuy
Synthes (BE)
Ottobock
(NL)
Aquilab (FR)
Ortho Baltic
(LT)
EOS (DE)
3D
Systems49
(BE-US)
AIM (SE)
Triditive (ES)
Altran (DE)
Siemens
(NL)
ESI Group
(France)
Lima
Corporate
(IT)
Phoenix
Innovation
(DE)
GE
Healthcare
(US)
Stryker (US)
DePuy
Synthes (BE)
Ottobock
(NL)
(NL)
Phillips (NL)
3D
Systems50
(BE-US)
Peackock
Medical
group (UK)
Fucco
Design (PL)
Lima
Corporate
(IT)
Phoenix
Innovation
(DE)
D´Appolonia
(IT)
EOS (DE)
AIM (SE)
GE
Healthcare
(US)
Mercuris
(DE)
Fit AM
(group)
Zimmer
Biomet (US)
Stryker (US)
DePuy
Synthes (BE)
Ottobock
(NL)
Some companies in the medical sector act as a one-stop-shop, providing services
along the entire supply chain, possessing all the necessary materials, machinery and
software to produce and distribute the end product51.
48 3D Systems acquired Layerwise in 2014 49 3D Systems acquired Layerwise in 2014 Ibid. 50 https://www.3dsystems.com
Value chain analysis
17
3.3 Key constraints
The following constraints were identified and should be taken into consideration in the
development of the value chain.
Need for connection between value chain players
3D manufacturing of medical devices involves many critical aspects, since it concerns
patients´ treatment. That makes the value chain for the AM medical devices particularly
complex, requiring the involvement of actors from different backgrounds. All key
players needed for the development of the European value chain can be found in
Europe. Coordination and cooperation are lacking among the different actors of the
value chain. In addition, the use of different procedures and interfaces in 3D printing
hinders collaboration. Moreover, when it comes to medical devices, manufacturers
should have a better understanding of the upstream and downstream processes and
the impact these processes have on the final device. The US Food and Drug
Administration (FDA) firmly emphasises this significance in its new draft guidance for
medical device manufacturers52.
Currently, the activities in Europe are often running in parallel and in competition rather
than in cooperation. While in some cases, attempts of pan-European collaboration
were made, the level of understanding and cooperation achieved remain rather
modest.
Product development driven predominantly by technological advancements
At the initial stages of 3D printing, technology was considered to be more appealing
and profitable in the sectors of industrial manufacturing such as automotive, aerospace
and electronics. Recently, the medical sector has gained uttermost interest among
manufacturers giving the industry a substantial technology push. The result is that new
technologies are explored and new materials are used.
What is missing is an interest from hospitals and patients due to a lack of
synchronisation between new medical solutions and the current healthcare system
(e.g. social security system is not aligned). 3D-printing in medical devices could unlock
an unprecedented feature of customisation and personalisation of the solutions. In
order to ensure that the personal preferences and actual needs are taken into
consideration, there is a need for a more effective integration of hospitals and actual
end-users. In this way, manufacturers and developers will be able to comply with the
preferences in performance, design and aesthetics of the medical devices.
51 https://www.3dsystems.com/ 52Draft guidance for medical device manufacturers. Retrieved from: http://www.raps.org/Regulatory-Focus/News/2016/05/09/24901/FDA-Issues-Long-Awaited-3D-Printing-Guidance-for-Medical-Devices/
Value chain analysis
18
Absence of large-scale manufacturing
The value chain for 3D-printed medical devices in Asia is gaining momentum due to
efforts of the government in promoting the technological possibilities of orthopaedics.
The consulted stakeholders believe that more efforts should also be invested in Europe
to boost the supply chain that is currently slow in the uptake of these solutions. Despite
the fact that Europe possesses all the necessary supply chain actors, more activities in
each of the stages would be beneficial for large-scale manufacturing53.
Quality control processes
An efficient and innovative value chain in 3D-printed medical devices requires well-
elaborated quality control processes. As noted earlier, AM’s intricate relationship with
the well-being of patients including the solutions it offers to the aging population, makes
quality assurance a necessity with each step tested and validated carefully. The
question is how that can be implemented for every single 3D-printed medical device.
Before embarking on large-scale manufacturing, the European value chain should
foresee effective mechanisms to assure the necessary quality control processes.
Increasing importance for cybersecurity in AM medical devices: computer viruses
and malware can negatively affect patient´s treatment and privacy54. Cybersecurity
issues should be taken into consideration in the production processes as it is harder to
ensure this once the product is already on the market.
53 Growth of medical 3D printing in Asia. Retrieved from: https://www.medtechintelligence.com/feature_article/growth-medical-3-d-printing-asia 54 FDA emphasizes sharing, collaboration in medical device cybersecurity. Retrieved from: http://www.raps.org/Regulatory-Focus/News/2016/01/20/23937/FDA-Emphasizes-Sharing-Collaboration-in-Medical-Device-Cybersecurity/
19
4. Analysis of the EU competitive positioning
The following section analyses the positioning of the EU regions with regard to 3D-
printed medical devices. It elaborates on the potential of the EU regions and estimates
the main bottlenecks and opportunities.
Europe fulfils all the necessary requirements needed for the development of a firm
value chain, where the production process can be covered exclusively by European
companies. Europe is reported to be particularly strong in research, as well as, in
prototyping and the development of 3D-printed medical devices.
4.1 Strengths and potential of the EU regions
In this sub-section, a short analysis is presented of the current and future position of
the EU with regard to AM’s external and internal medical devices, key competitive
advantages of Europe, as well as regions that have the potential to be in the lead.
Current and future prospects for the EU in the field of 3D-printed medical devices
Europe can be seen as one of the most important players in the field of 3D-printing in
medical devices. It is expected that Europe will retain its second position, doubling its
growth in production by 202555. All interviewed stakeholders stressed that Europe has
the necessary key players, knowledge and technology to keep up at global level.
Taking into consideration the expected growth in production, a positive impact on the
competitiveness of European SMEs and employment could be envisaged. The success
factor for the future will however depend on the pace with which the key players of the
value chain will interact with the enablers.
In general terms, the U.S. is reported to be the EU’s main competitor, owed largely to
its highly advanced infrastructure and R&D. Meanwhile, Japan and Korea belong to the
fiercest Asian challengers. Other Asian countries like China and India are also gaining
momentum - driven by their high number of ageing population as well as growing need
for advanced healthcare, due to increases in the population’s disposable income56.
Consulted stakeholders stress an efficient approach that is present in some of the
Asian countries. While Europe´s 3D manufacturing of medical devices is mostly
technologically driven, the approach in Asia is more overarching attempting to develop
other important factors along the value chain without waiting for the product to be
completely ready. Asia is investing considerably in educational and awareness efforts,
initiated by industry players and government and targeting physicians and patients57. In
parallel, the authorities engage in developing policies, scaling up investments,
trainings, strategic partnerships and mergers, aimed at boosting market shares58.
55 3D Printing Medical Devices Market Size is Projected to be Around $9.8 Billion by 2025 - Market Research Globe. Retrieved from: http://www.prnewswire.com/news-releases/3d-printing-medical-devices-market-size-is-projected-to-be-around-98-billion-by-2025---market-research-globe-631045783.html 56 3D Printing Medical Devices Market Size is Projected to be Around $9.8 Billion by 2025 - Market Research Globe. Retrieved from: http://www.prnewswire.com/news-releases/3d-printing-medical-devices-market-size-is-projected-to-be-around-98-billion-by-2025---market-research-globe-631045783.html 57 Based on interview data. 58 Growth of medical 3D printing in Asia. Retrieved from: https://www.medtechintelligence.com/feature_article/growth-
medical-3-d-printing-asia/
Analysis of the EU competitive positioning
20
Although, it is hard to predict the precise developments in the future, stakeholders are
confident that Europe will continue to play an important role in the large-scale
manufacturing of 3D-printed devices. These expectations are backed up by market
research suggesting that Europe will double its production by 2025-203059.
Key competitive advantages of Europe
Europe has the appropriate ecosystem and framework conditions in place conducive to
research, innovation and product development. The following key competitive
advantages were identified60:
Strong and stable R&D environment with top-notch research in healthcare-
related additive manufacturing;
Proximity and access to a wide variety of relevant experts and value chain
actors;
Companies (hardware and software designers, as well relevant service
providers) with a leading role world-wide;
Excellent reputation for knowledge and quality;
Availability of the educational institutions to provide relevant training for skills
development;
Pool of required skills;
Single market, removing the barriers to work and to trade under one regulatory
framework;
Potentially more elaborated EU database on medical devices (EUDAMED) and
device identification system based on a unique device identifier (UDI) that will
give access to a large number of data on the medical devices available in
Europe. While the current EUDAMED database only acts as a central repository
for information exchange between National Competent Authorities and the
Commission and it is neither comprehensive nor publicly accessible, the future
EUDAMED will include a living picture of the lifecycle of all products that are
being offered on the EU market, with large part of its information being publicly
available61.
Regions that could be in the lead
Stakeholders report that the value chain activities are currently the strongest in
Western Europe. Regions in the UK, Germany, the Netherlands, Italy and Belgium
were indicated to be the most active in 3D printing of medical devices.
The Vanguard Initiative Pilot Project on High Performance through 3D-printing has
included 3D printing for healthcare. It is a pan-European initiative that aims to create a
network of industry-led demonstrators including hospitals, research centres, scientists,
orthopaedics vendors as well as 3D printing service providers.
59 Retrieved from: http://www.futuremarketinsights.com/reports/3d-Printed-medical-devices-market 60 Based on interview data 61 New EU rules to ensure safety of medical devices. Retrieved http://europa.eu/rapid/press-release_MEMO-17-848_en.htm
Analysis of the EU competitive positioning
21
At the national level, clusters such as 3D Makers Zone (The Netherlands), Propoplst
(Italy) as well as Flam3D and RegMed (Flanders) were identified62. These clusters offer
various activities from pure research to one-stop-shop models for B2B solutions in 3D
printing.
Flanders in Belgium is perhaps the most prominent example with almost 20 years of
experience in additive manufacturing. The distinctive feature of this region is that it
succeeded in creating an entire ecosystem that supports and fosters development of
the value chain. Solid knowledge and technologies are supported by quality experts,
regulatory framework, regional funding and most importantly by the companies that are
already performing on the market. In other words, the businesses offer a great support,
by engaging and bringing the academic and research achievements to the market in a
form of a ready-to-sell product63. RegMed is the latest initiative to create an entire value
chain, ensuring a well-balanced and complementary composition with the presence of
businesses to guarantee the uptake of the product to the market64.
4.2 Key risks and challenges
The potential risks and challenges for the regional stakeholders include:
Lack of pan-European approach toward the development of the value chain
and lack of alignment between EU, national and regional policies. The example
of the Vanguard Initiative is reported to be a successful attempt for the creation
of a cross-regional cooperation. However, a number of stakeholders pointed out
that the Vanguard Initiative Pilot Project is lacking a contractual and financial
framework – allowing it to eliminate hesitation to share knowledge and
technologies among its members.
Transition towards new medical devices regulation: In the traditional
manufacturing processes, the same product is reproduced infinitely, making
one regulatory framework sufficient. In the new setting, new challenges arise as
every product that is manufactured has its own unique features. To define a
regulatory framework with unprecedented challenges with regard to device
characterisation, validation and verification is a daunting task65. The European
Union has put considerable efforts in developing a new regulatory framework:
The New European Medical Devices Regulation (MDR) was adopted in
2017, serving to replace the Medical Device Directive (MDD) and the
Active Implantable Medical Device Directive (AIMMD), taking into
account major developments of the recent years66. A transition period of
three years - until 2020 - is given to the manufacturers, while some key
derogations are however foreseen. MDR imposes stricter safety and
performance requirements in prescription, while introducing a number of
new classification rules for software and devices incorporating
62 https://www.clustercollaboration.eu/cluster-list 63 Based on interview data. 64 http://www.flanderssmarthub.be/projecten/regmed-platform 65 6 things you need to do to prepare for the new EU medical devices regulation. Retrieved from: http://www.raps.org/Regulatory-Focus/RAPS-Latest/2017/06/15/27916/6-Things-You-Need-to-Do-to-Prepare-for-the-New-EU-Medical-Devices-Regulation/ 66 http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#new_regulations
Analysis of the EU competitive positioning
22
nanomaterials. Taking on board recent development and aspirations for
´3D-Printed Nanotechnology´ and the role of nanotechnology in 3D
printing materials, manufacturers would need to be informed
accordingly.
The success of the smooth transition will depend on the ability to guide the
process into a new direction. Undoubtedly, a lot of information and guidance will
have to be passed on to manufacturers with a clear message to start the
transition on time and perform the analysis of the 3D printed devices to be
brought on the market67.
Harmonising application of relevant rules and technical specifications for
these products all over Europe: currently, application of relevant rules might
diverge from one Member State to another. Moreover, health and safety
standards are diverse for manufacturers to demonstrate compliance of their
products in the view of certification. This can have a negative impact on AM
production of medical devices in Europe68 and European competitiveness.
Finding a balance between potency, outcome and safety: due to the strict
quality regulations, the objectives of functionality of the device for the patient
might get faded.
Lack of synchronisation between new medical solutions and the current
healthcare system: the update of the 3D-printed medical devices will inevitably
raise questions on how medical insurance companies will act. Currently, there
is hardly an understanding of the long-term impact that the new developments
will create.
4.3 Opportunities for the EU regions
3D-printed medical devices bring opportunities and solutions to Europe’s regions
helping to address the demographic and health challenges Europe is facing.
Furthermore, these solutions create employment and boost the competitiveness of
European SMEs. However, to fully benefit from AM’s potential, there is a strong need
to build cross-regional partnerships and create a balanced value chain with compatible,
complementary and shared activities. This value chain will help businesses to ensure
that the product overcomes the valley of death and is uptake by the end users This can
be achieved by developing jointly demonstration use cases which will help companies
prove the effectiveness and benefits of the devices, as well as, decreasing the costs of
the devices. Setting-up a clear framework for cross-regional cooperation will help to
eliminate final concerns about data and IP sharing.
Furthermore, there is a need for more awareness among physicians, doctors and
patients on the advantages of AM manufactured devices, backed up by the adapted
healthcare system.
67 6 things you need to do to prepare for the new EU medical devices regulation. Retrieved from: http://www.raps.org/Regulatory-Focus/RAPS-Latest/2017/06/15/27916/6-Things-You-Need-to-Do-to-Prepare-for-the-New-EU-Medical-Devices-Regulation/ 68 FoFAM Industrial and regional valorisation of FoF Manufacturing Projects. Retrieved from: http://am-motion.eu/images/Final_FoFAM_roadmap.pdf
Analysis of the EU competitive positioning
23
More partnerships combined with awareness raising should enable the acceleration of
large-scale manufacturing. This will keep Europe as one of the frontrunners in the
production of the 3D printed medical devices – activity in which Europe´s performance
is recognised to outstanding and deserves to develop rapidly.
24
5. Policy implications
The current section aims to present specific policy recommendation on what needs to
be done in order to strengthen the EU competitive position regarding this product in the
coming years, and specifically on how to enable European industry to move to the
higher end of the value chain. We elaborate on measures with both the immediate and
long-term focus.
5.1 Measures with immediate focus
The following measures with immediate focus have been identified:
Need for fostering cross-regional collaboration and value chain
complementarities: consulted stakeholders affirmed on multiple occasions
that Europe possesses all the necessary knowhow, technologies, materials as
well as manufacturers and medical institutions to succeed. Therefore, there is a
need to optimise the value chain in an effective, non-competitive way with an
important role for enablers. Cross-sectoral and cross-regional cooperation
should be seen as a possible solution.
o RegMed is a smart hub in Flanders that could serve as an example of
cooperation among different companies, but also the R&D community
and enablers such as regional government, standard developers,
marketing companies, hospitals, etc69. While this initiative has a regional
orientation, and expanding collaboration with the neighbouring Dutch
regions, there is a need to have similar actions on the EU scale.
o The Vanguard Initiative70 pilot project / Smart Specialisation Strategy
Partnership71 are good examples of ongoing cross-regional cooperation,
but could possibly use a more contractual framework and specific
funding for cross-regional projects and joint demonstrators. This may
increase the willingness to share sensitive data and to do more shared
research among member organisations72.
Ensuring smooth transition to new regulation: the new Medical Device
Regulation (MDR) aims at boosting innovation and competitiveness of the
medical sector while strengthening the EU’s position in the global arena. Being
a timely document, the MDR takes into consideration the new technological and
cross-technological developments. While a general transition period of three
years is given to manufacturers, a lot of additional work should be performed in
order to fully comply with MDR. To ensure a smooth transition, medical device
manufacturers should receive information and guidance on the required steps.
An important role can be played by the intermediaries such as associations of
economic operators, patients and healthcare professionals.
69 Based on interview data; Retrieved from: http://www.flanderssmarthub.be/projecten/regmed-platform 70 Retrieved from: http://www.s3vanguardinitiative.eu/cooperations/high-performance-production-through-3d-printing 71 Retrieved from: http://s3platform.jrc.ec.europa.eu/ 72 Based on interview data
Policy implications
25
o The EU has recently been active in organising gatherings for
professionals73. This should be further maintained and expanded.
During these events physicians are given the opportunity to learn about
new solutions and to see demonstrations. This could serve as one
model of awareness raising.
Harmonisation of application of the rules and the common technical
specifications in Europe will foster the large-scaling manufacturing of the
AM medical devices. The MDR is expected to facilitate this harmonisation.
This stresses once more the importance of the smooth transition and
integration of the new regulation at Member States´ level.
Providing better guidance for companies operating in this sector: FDA
has recently released a draft with guidance for 3D printed medical devices,
providing the producers with FDA´s understanding about the technical
considerations, characterisation and validation of AM manufactured devices.
The interviewed stakeholders have often referred to FDA guidance as the
most recent and clarifying one. Taking stock of the recent medical regulation
and the need for better guidance, one possible solution could be to base
European guidance on already existing FDA guidance74. The guidance should
include the EU´s thinking on the quality control, functionality and cybersecurity
measures in the production stages.
5.2 Measures with longer-term focus
Need to assess the overall impact of 3D-printed medical devices on the
healthcare system: there is a need for a broader understanding and impact
assessment of the transformation 3D-printed medical devices will bring to the
current social security and healthcare systems. It should evaluate a long-term
impact in terms of costs and savings for the future. Taking into consideration
substantial benefits for patients, there is a need to assess solutions for
reimbursement, health insurance´s intervention among other questions that will
arise due to the further penetration of the 3D medical devices into standard
healthcare75.
Providing support for the development of large-scale manufacturing: in
order to engage more businesses and to accelerate the overall uptake of the
supply chain, more pilot projects and demonstration use cases are needed.
This can be achieved by setting up more cross-regional partnerships. In
addition to that, expanding the number of shared testing facilities could be
beneficial, allowing the companies to experiment, test and apply technologies
without a need of uncertain investments. Nevertheless, support to R&D
activities should continue in order to overcome technical limitations.
73 Stakeholders indicate that Europe appears to be recently active in organising high number of exhibitions, symposia, conference and initiatives with the associations and scientific communities73 Example: 3D printing European Conference held in Brussels in May 2016 74 Based on interview data; Retrieved from: https://www.futuremedicine.com/doi/pdfplus/10.2217/rme.15.52 75 Note: In 2016, UK took a similar approach “to explore the assessment and appraisal of regenerative medicines and cell therapy”. The assessment could serve as an example. Retrieved from: https://www.nice.org.uk/media/default/about/what-we-do/science%20policy%20and%20research/regenerative-medicine-study-march-2016.pdf
Policy implications
26
Need to raise awareness on the benefits of 3D-printed medical devices: to
speed up the process for large-scale manufacturing, there is a need for more
demand from physicians and hospitals. Being the intermediaries, physicians
and other relevant healthcare stakeholders should be better informed and
aware of existing good practices and demonstration cases of already produced
devices.
27
Annex A: List of interviewees
Table A-1: Overview of the interviewed stakeholders
Nr Name Position Organisation Country Stakeholder type
1 Jan Schrooten Managing director Co-founder
Antleron RegMed
Belgium SME Cluster
2 Pierre Padilla Senior Consultant IDEA Consult Belgium Company
3 Christian- Friedrich Lindemann
Managing Director Manufacturing Research Center
Paderborn University Germany University
4 Britta Schramm Chief Engineer Paderborn University Germany University
5 Alberto Leardini Technical director Movement-analysis-laboratory
Istituto Ortopedico Rizzoli Vanguard Initiative
Italy Research Centre Cross-Regional partnership
6 Alessio Giuliani R&D Manager - Medical devices,Project Coordinator Symbionica (H2020 project)
Sintea Plustek Italy SME
Acknowledgments
We would like to express our gratitude to Jan Schrooten, Pierre Padilla, Christian-
Friedrich Lindemann, Britta Schramm, Alberto Leardini, Alessio Giuliani, for their fruitful
insights and expert opinions essential for drafting this case study report.
