3D -PRINTED MEDICAL DEVICES

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
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.
1.3 Target audience .................................................................................................. 7
2.1 Introduction to the product ................................................................................... 8
2.2 Relevance to grand societal challenges .............................................................. 9
2.3 Market potential ................................................................................................. 10
3. Value chain analysis ............................................................................................... 12
3.1 Value chain structure ......................................................................................... 12
3.2 Key players ....................................................................................................... 14
3.3 Key constraints .................................................................................................. 17
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
Acknowledgments ....................................................................................................... 27
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.
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.
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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.
Key product facts
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.
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
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– 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
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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
Value chain analysis
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The third segment represents actors that are needed to enable and/or support the
entire ecosystem.…