The future of Health Care

Potential, impacts and models of 3D

printing in the Health Care sector
Contents

Deloitte’s Health Care Med Tech Community 3

3D printing in Health Care 5

3D printing application models in the Health Care sector 7

3D printing in the world 9

3D printing in Italian Health Care 13

3D printing Industry Foresight 17

Conclusions 27
 The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

Deloitte’s Health Care

Med Tech Community

In 2017 Deloitte gave life to the Health Care Med
Tech Community, the first community dedicated
to disruptive technologies and open oriented to
health care and life sciences companies, scientific
associations, disruptive technology experts,
in-house companies, purchasing centers, health
care agencies, the research community, start-ups,
venture capital companies, business incubators and
accelerators, third sector.
In fact, 3D printing has been present in many
economic sectors for some time and it has always
been one of the main areas of application in
healthcare of great extent: the first example of 3D
printing in the health sector goes back to the first
half of the eighties of the last century. At that time,
Chuck Hall made an eye wash cup using stereo
lithography (a method to produce solid objects from
successive hardened layers of liquid polymer).

Innovation in Health Care is the topic on which During its first year of activity, the Community
the Community is focused. Orienting the health dedicated itself to 3D printing to explore some
ecosystem towards innovation means laying the aspects: the employment models, state of the art
foundations for a transformation of the entire and worldwide diffusion, the presence in the Italian
sector, where the value is generated by the healthcare sector, the possible developments and
involvement of all stakeholders with their different barriers to overcome to bring this technology from a
points of view, perspectives and roles. Today, niche dimension to the mainstream.
more than in the past, disruptive technologies
The work of the Community has been developed
can represent the pivot of the transformation and
with the contribution of an Advisory Board
the innovation of operating models in the clinical,
representing the main stakeholders of the health
welfare, organizational and managerial fields. 3D
eco-system: hospitals, life sciences companies,
printing, augmented reality, Internet of Things
scientific associations and supply chain players.
(IoT), Big Data are just some of the technologies
currently available on the market and ready to use,
which create development and enable new ways of
interactions in the ecosystem, making it accessible
to new subjects and attractive for new investments.

The Med Tech Community format, although aware

of the natural interactions and influences among the
different disruptive technologies, aims to focus on
one technology at a time. As a starting point, in the
first year of life, the Advisory Board has decided to
start from the oldest of the innovative technologies:
3D printing.

3
Figure 1 - The Advisory Board members of the Health Care Med Tech Community

Stefano Marchese Commercial Director

Smith&Nephew
Gianluca Ruffi Strategic Marketing and Market Access Director

Medtronic Guido Beccagutti Value, Access & Policy Director

Nicolò Pestelli Programme Director at Area Vasta Sud Est Toscana

ESTAR
Stefano Vezzosi Director of Informatics and Health Technologies

Intercent-ER Alessandra Boni Director

Coordinator, Office of International Relations and the Promotion of

Meyer Pediatric Hospital Kathleen McGreevy
Innovation

Fabio Galbusera Head of the Laboratory of Mechanics of Biological Structures

Istituto Ortopedico Galeazzi
Gloria Casaroli Research Engineer

Director, Research Center in Health Economics & Health Care

LIUC Università Cattaneo Davide Croce
Management

Innogest Claudio Giuliano Partner

PLS Educational Luigi Cammi Managing Director

 The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

3D printing in Health Care

Some analysts’ forecasts for 2018 suggest a global 3D printing is a production mode,
market growth to $12 billion, an increase of about
20% over the previous year1. In 2018, over 50% also called additive manufacturing,
of the market will be located in the United States which allows the fabrication of objects
and Europe with a turnover of $7.6 billions. Other
(component parts, semi-finished
estimates predict that the turnover will reach $20
billion by 2021 with a 20.5% compound annual or finished products) through the
growth rate, on a five-year basis, from 2017 to aggregation of successive layers of
20212. These data clearly show the dynamic growth
of 3D printing, which is emerging as a widespread
material that are added to each other. 2
technology in various market sectors.
A significant share of worldwide turnover in the 3D
printing industry has always been generated in the
medical field. In 2012, according to a study by Deloitte
University, 16.4% of 3D printing business in the US was In recent years, 3D printing applications have become
generated by the healthcare sector. Analysts forecasts increasingly more common. The 3D printing technology
that in 2018 the 3D printing worldwide turnover related has already made it possible to print surgical
to healthcare will reach $ 1.3 billion1. instruments such as hemostats, forceps, scalpel
handles, etc.3 In the next years, a quantitative increase
Different applications in the medical field support
in the established applications is expected, but also
this growth. To date, the most significant applications
the development of new applications in even more
refer to the production of different types of devices in
ambitious areas.
the dental, orthopedic and acoustic fields. However,
even the most innovative areas such as the 3D Ultimately, 3D printing technology has the potential
printing of tissues, organs and bones show important to deeply modify the healthcare’s delivery and
growth rates and begin to spread significantly (56.6% organization models in different areas of clinical
compound annual growth rate, on a five-year basis, specialization.
from 2017 to 20211).

1. 3D printing spending is about $ 12 billion in 2018, 3DPrinting.com

2. ASTM International, Standard terminology for additive manufacturing technologies, designation F2792 − 12a, 2013, p. 2
3. The Major Milestones Of 3D Printing In The Medical Industry, 3DPrintersBay.com
5
 The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

3D printing application
models in the
Health Care sector
Based on some Deloitte University The integrated reading of these two Path I: stasis
research highlights on additive dimensions generates four possible
In this model 3D printing is used
manufacturing, 3D printing contributes models of 3D printing application in the
to generate efficiency rather than
to the health sector transformation health sector, as can be seen in Figure
innovation. Organizations (predominantly
by acting on two different dimensions: 2, and it allows us to develop an organic
medical device manufacturers) consider
product innovation and process and coherent approach to the analysis
3D as the acceleration technology of
innovation, the latter with particular of the opportunities of 3D printing
some processes. The most frequent
reference to traditional supply chain ("3D Printing Health Care Industry
case of using this model is related to
activities. Framework").
the use of 3D printing for the rapid
prototyping of medical devices that are
then produced on a large scale with the
Figure 2 – 3D Printing Health Care Industry Framework traditional technologies.
High product change Example
+ In early 2018, the Marchesini Group
Path III: Path IV: business
product evolution model evolution Company from Bologna, a leading
packaging manufacturer in the
Companies benefit from Companies create a new business
leveraging the 3D printing model through 3D printing pharmaceutical sector, inaugurated a
economies of scope to (e.g. bioprinting, custom new structure dedicated to 3D printing
achieve greater levels of production of implantable technology, which is, according to the
performance or innovate prostheses)
company, "one of the main declension
High supply chain change

their products (e.g. 3D printing

No supply chain change

for more precise and less of the Industry 4.0 paradigm"4. The new
invasive surgical operations) structure will be equipped with several 3D
printers, along with new systems that will
- + be working operating 24 hours a day to
quickly print prototypes for components
Path I: stasis Path II: supply chain
evolution that will then be produced through
traditional manufacturing processes. This
Companies do not look for Companies benefit from
radical changes either in the leveraging the economies of new 3D printing facility by Marchesini
supply chain or in the products. scale offered by 3D printing Group will allow customers to monitor
This type of companies use in terms of supply chain error management, machine wear and
the 3D technology to streamline (e.g. on-site production of
processes (e.g. prototyping) production planning, besides controlling
surgical equipment)
costs.
-
No product change

4. Marchesini Group Increases Focus on Industry 4.0 by Acquiring Vision System Company and Opening 3D Printing Facility, 3DPrint.com
7
The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector
Path II: supply chain evolution
This model can be summarized with
the "manufacturing at point of use"
paradigm. Organizations benefit by
producing goods for healthcare use
through 3D printing at the place of use
or immediately nearby. Medical devices’
manufacturers, but also hospitals, could
have considerable advantages from the
application of this model. The former
could reduce production costs, product
delivery time, streamlining distribution
and logistic processes. End users could
decide to create their own hubs (or to
resort to private hubs) for 3D printing
inside the hospital, or for a group of
hospitals, and dedicate themselves to
producing some devices "on their own".
Example
The London-based company 3D
LifePrints has launched a project
to create "innovation hubs" on 3D
printing in four National Health Service
(NHS) hospitals and has recently
invested £ 500,000 to expand its 3D
printing center network and recruit
biomedical engineers and specialized 3D
technicians. The company incorporated
four "innovation hubs" on 3D printing:
three in Liverpool and one in Oxford.
Each innovation hub is a place where
doctors, surgeons, companies and
technicians can collaborate and find
new solutions for clinical and assistance
problems starting to produce medical
devices with a "manufacturing at point-
of-use" approach. 5
5. 3D Lifeprints Secures £500,000 Investment To Rapidly Expand, 3DLifePrints.com
6. Five Children Receive Ear Implants Made From Their Own Cells, Thanks to 3D Printed Molds and Scaffolds, 3DPrint.com
7. Chemical MP3 Player Can 3D Print Pharmaceuticals On-Demand from Digital Code, 3DPrint.com
8
Path III: product evolution
This model is driven by the possibility of
using 3D printing to create innovative
products and improve the quality of
medical performance, which is going
to affect the generated outcome. This
is the case, now quite frequent, of the
reproduction of organs and anatomical
parts for the preparation of surgical
interventions of particular complexity
concerning, for example, the removal
of tumor masses. In other cases, it
went so far as to realize scaffolds for
cell cultivation aimed at reconstructing
anatomical parts.
Example
At the National Tissue Engineering
Research Center of China, a team of
scientists has released a new study
describing the use of 3D printing in
an ear reconstruction surgery for five
children (between 6 and 9 years old) with
unilateral microtia. The extraordinary
nature of this event consists in having
reconstructed, thanks to 3D printing,
the anatomical parts directly using the
children’s cells. Researchers first took
detailed CT scans of each patient’s
healthy ear, and used a 3D design
software to mirror the images and
convert them into a 3D printable mold.
Next, cartilage-producing chondrocyte
cells were derived from each patient’s
malformed ear tissue, seeded onto the
scaffold molds, and cultured for three
months. When the cultured cartilage
framework had finished growing into
the shape of the patient’s ear, plastic
surgeons implanted the engineered
ear implants and performed ear
reconstruction surgery. 6
Path IV: business model
evolution
This model is the most disruptive,
because it combines process innovation.
It also allows to change the supply chain
structure and innovate products and the
health services offered to patients. This
is an example of a “mass customization
at point of use”, or mass customization
in which it is possible to produce
customized products (eg: implantable
prostheses) near the place of use.
The application of this model deeply
modifies the business models and allows
new ones to emerge, with potentially
relevant effects for all the supply chain
stakeholders.
Example
A research team from the University of
Glasgow used 3D printing technology
to synthesize any compound to
produce pharmaceuticals. This new
mode of production is a key step
for the digitization of chemical and
pharmaceutical manufacturing as it
could allow the production of “on-
demand” and customized drugs, based
on the needs and the clinical picture of
individual patients. 7
 The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

3D printing in the world

The Health Care Med Tech Community analyzed and then we ranked the 218 successful cases within
over 1,000 experiences from all over the world the 3D Printing Health Care Industry Framework.
regarding innovations in the use of 3D printing
The Figure 3 shows a graphical representation about
for Health Care, selecting the most significant 218
the origin of the successful experiences, reporting
cases. In particular, all the experiences that focused
the corresponding numbers for each country.
on mere prototyping (Path I: stasis) were excluded,

Figure 3 - Map of the most relevant news from the world

1 1 4
1
3 7
9 1
10
4
3
3

28

103 2

2 2

1 1

2
1
2

8 3 1 1

1 2 11

9
The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

Figure 4 - International trends in 3D printing use From the analysis of these experiences,
High product change we have identified some international
+
trends in the use of 3D printing,
Path III: Path IV: business model highlighted in Figure 4. In particular, most
product evolution evolution
of the experiences are included in Path
III and IV of the Industry Framework:

41% 51% product evolution (41%) and business

High supply chain change

No supply chain change

model evolution (51%).

- + Analyzing the trends for each country,

we highlight a leading role of the United
States (Figure 5), which shows 103

8% successful cases, 54 of which refer to

the "Path IV: business model evolution".
Even Europe and its Member States are
Path I: stasis Path II: supply chain moving in the same direction.
evolution
-
No product change

Figure 5 - Focus on trends for each country

110
103
100 Legend

90 Business
Product
model
evolution
evolution
80

70
Supply
Stasis chain
60 evolution

50

40

30
28
23
20

10 10 9 8 7
10
4 4 3 3 3 3
0

Other

10
 The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector
Starting from the database, we have selected 10 particularly significant cases, as reported in Figure 6.
Figure 6 - The 10 most successful international cases selected by Deloitte
San Draw Medical Introduces New
Accuracy with 3D Printed Suture
Simulator.
Materialise Expands DePuy Synthes
Partnership to Design New 3D Printed
Surgical Guides.
EIT 3D Printed Cellular Titanium Spinal
Implants Receive FDA Clearance.
RegenHU and Wako Automation
Promoting Drug Discovery and 3D
Bioprinting in the US.
A 3D Printer Can Print Pharmaceuticals
On-demand from Digital Code in
Glasgow.
At the Italian level, the experiences of the M3datek startup and the Meyer Pediatric Hospital deserve a special attention
because of their innovativeness degree.
Wrap, the 3D Printed Plaster that Halves
Healing Times8
M3datek, a start-up of the University of
Parma, in 2015 created WRAP (Wound
Repair Active Print), a plaster able to
halve the healing time thanks to the use of
3D printing. The plaster, designed for the
treatment of diabetes and bed sores, is made
of chitosan (a natural polymer that is found,
for example, in the exoskeleton of many
invertebrates) and it is produced with the
support of a 3D printer. In particular, the 3D
structure allows patients to obtain different
benefits compared to traditional medicines:
WRAP fits to wounds of varying size and
depth, it can be applied to sores in different
stages of advancement. Moreover, the healing
process is accelerated compared to the
products already on the market: the healing
times are halved, going from 15 to 7 weeks.
8. Wrap, the 3D Printed Plaster that Halves Healing Times, ParmAteneo.it
9. T3Ddy Laboratory is born at the Meyer Pediatric Hospital, Meyer Pediatric Hospital Institutional Website
Quebec: New Research Center for 3D
Printing Solutions.
Wrap, the 3D Printer Plaster that Halves
Healing Times.
QMUL Researchers Use 3D Printing and
Self-Assembly Technologies to Create
Constructs Using Cells and Molecules.
Five Children Receive Ear Implants Made
from Their own Cells, thanks to 3D Printed
Molds and Scaffolds.
T3Ddy Laboratory is Born at the Meyer
Pediatric Hospital.
T3ddy Laboratory is born at the Meyer Pediatric
Hospital9
3D printing enters Meyer’s clinical practice with T3Ddy,
the joint laboratory established with the University of
Florence. T3Ddy applies 3D printing in an innovative way
for a series of highly advanced uses: from the creation
of three-dimensional models to improve the surgical
approach, to the realization of tailor-made plaster casts
for the limbs, in addition to the wide use in simulation in
pediatrics for the operators training. Some pilot projects
are particularly relevant, such as: the development of new
medical devices for the treatment of malformations of the
rib cage; the reconstruction of anatomical parts for the
planning and execution of the most complex interventions
(eg. a tumor from the cranial base has recently been
successfully removed without touching the brain of a
16-year-old patient, thanks to a careful pre-operative
planning). This also brings children closer to science and
technology. By introducing 3D technologies into the clinical
practice, T3Ddy lays the foundation for the standardization
of the procedures for the construction of personalized
medical devices.
11
 The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

3D printing in
Italian Health Care

To understand the state of the art on Figure 7 - Survey respondents

the diffusion of 3D printing within the
Italian healthcare sector, we conducted
a survey of the main stakeholders of the
48% Hospitals

health ecosystem: hospitals, life sciences

companies, supply chain players,
scientific associations. The survey,
sent to a hundred individuals, saw the
collaboration of 50 participants, divided
into four targets as shown in Figure 7.

The survey dealt with 7 areas of 22% Scientific associations

analysis divided into 3 clusters:

16%
1. Awareness of the potential to be
exploited. Life sciences companies

2. Actions to be taken to develop

sustainable adoption models.
14% Supply chain players

3. Barriers to overcome for large-scale

applications.

The survey showed that its respondents

see significant opportunities in 3D
technology that, of course, differ
according to the perspectives of different
stakeholders.

13
The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

Figure 8 - Opportunities for hospitals The hospitals recognize great potential

in different fields and, in particular, in the
Reconfiguration of the relationship with
medical devices suppliers
personalization of treatments (i.e. tailor-
made prostheses) and in the creation
Creation of print centers
in the single hospital of public hubs at regional or supra-
Creation of public hubs at regional company level.
and/or wide area level

Creation of private hubs

Innovation of diagnostic and

surgical techniques

Real-time printing of medical devices

(implantable and non-implantable)

Personalization of treatments

Reduction of costs for the purchase/

logistics management of medical devices

0% 2% 4% 6% 8% 10% 12% 14% 16% 18%

Figure 9 - Opportunities for supply chain players The personalization of treatments is one
of the greatest capabilities of 3D printing
also for supply chain players, along with
Creation of private hubs
the reconfiguration of the relationship
Creation on public hubs at regional with medical devices suppliers from a
and/or wide area level
product-based logic to a service one.
Possibility to produce medical
devices independently
Reconfiguration of the relationship with
medical device providers, from a product
logic to a service approach or a generated
value sharing for the patient
Real-time printing

Personalization of treatments

Innovation of diagnostic and

surgical techniques

0% 5% 10% 15% 20% 25% 30%

Figure 10 - Opportunities for life sciences companies In addition to the personalization of

Reconfiguration of the relationship
with Regions and Hospitals
Market entry of new
unconventional competitors
Possibility to offer increasingly personalized
and patient-oriented services
0%
services for the patients, life sciences
companies also envision the possibility of
reconfiguring the relationship between
Regions and the Health Authorities,
adopting a service-oriented approach
rather than a product-oriented one.
They also foresee some possible
threats coming from the entry of new
non-conventional players into their core
5% 10% 15% 20% 25% 30% 35% market.

14
 The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

All respondents, in addition to the
potential, also report the presence of
some barriers that limit a large-scale
spread of 3D printing.
Figure 11 - The barriers to the diffusion of 3D in the healthcare system
Degree of agreement per target
Life sciences Scientific Supply chain
Hospitals companies associations players

The main obstacles can be found in the

lack of regulation, especially since the 43% Lack of regulation on the 3D printing
production process

subject is not included in the Medical

Devices Regulation (EU) 2017/745, and
in the technology adoption, both in
terms of knowledge about printers and
materials available for printing, as well as
in terms of internal skills to be developed
and amount of investments to be
undertaken.
24%
Lack of knowledge and skills on the
use of technology and the related
organizational models
Uncertainty about the amount of
24% investments in technology required
by the company and the related
economic return

The large-scale adoption of 3D printing

9% Maturity of technology (performance
of printers and materials available)

is characterized by the combination of

“high potential/ high barriers”. If, on the High Moderate Low

one hand, there is a strong awareness

of the potential of this technology, on
the other hand the missed mainstream
diffusion of 3D technology is attributed
to the presence of many regulatory and
technical obstacles that have prevented
its exponential growth.

15

3D printing
Industry Foresight
Methodology
The survey identified the two main
drivers in the technological and
regulatory dynamics on which the
evolution of 3D printing in the health
sector will depend.
To imagine the possible future scenarios
for 3D printing in healthcare, two
possible trends were analyzed for
each driver: the optimistic one and the
pessimistic one.
From the analysis of possible
combinations, four different scenarios
about the future of 3D printing have
been articulated, within a 5 and 10 year
time-span.
These scenarios, with their
corresponding impacts on the main
stakeholders in the eco-system
(healthcare providers, patients,
life sciences companies, scientific
associations, purchasing groups
and supply chain players), have been
discussed with the Advisory Board
members.
The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector
Figure 12 - The Industry Foresight methodology applied to 3D printing
1. Driver
The starting point is represented
by the main drivers emerging from
the eco-system survey: regulation
and technology.
2. Trend
For each driver, we have identified
some possible future trends by
imagining two visions: one optimistic
(+) and one pessimistic (-).
3. Scenarios
Based on the identified trends, we
hypothesized four possible scenarios
which are the result of the convergence
of the visions of the two drivers.
4. Impacts
These scenarios have been declined
on the individual stakeholders of the
health ecosystem to understand the
possible impacts.
17
The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

Trends: the dynamics of technology and the regulatory system

Figure 13 - Possible trends in the future evolution of 3D printing technology

+ The new R&D research and investments in the 3D printing sector will lead to developments
and innovations along two directions: on the one hand, the availability of biocompatible
materials with high performance properties will increase (e.g. mechanical properties - rigidity
and elasticity); on the other hand, more performing and multi-material printers will be
developed in line with the timing of health providers. Therefore, the technology providers will
begin to produce printers that will be more technically performable in order to quickly create
objects that can be customized with respect to the patient's clinical picture, as well as generic
objects (orthopedic tools) or drugs. All these factors will lead to a market structure characterized
by the presence of vendors that will make 3D printing competitive, economically and
Technology

qualitatively, compared to traditional methods of medical device production. This will

entail the possible entrance of new players within the life sciences and medical device sector
and will impact the entire supply chain (e.g. the creation of local hubs for sorting and supply of
materials), also giving access to the self-production of medical devices.

The technology will evolve, but not quickly and – anyway - not to the point of allowing
significant technological leaps. In particular, we will not invest much in the search for
biocompatible materials aimed at the production of implantable prostheses. From a technical
point of view, printers will not be upgraded, significantly limiting the possibility of realizing
- realistic devices in a short time. In particular, high productivity printers will not establish
themselves on biocompatible materials and the multi-materiality will be limited.

Figure 14 - Possible trends in the future evolution of regulation on medical devices printed in 3D

In the perspective of giving a new impetus in regulatory terms, the Food and Drug Administration
+ (FDA) will continue to set standards for the production process of the 3D printed devices and
will end up defining a regulatory framework where some aspects are clearly defined, such as the
design of the devices, the functionality-based product testing system, the duration and the quality
system requirements. The European institutions will also start moving in the same direction. The
new European Regulation for medical devices will be integrated with specific standards for 3D
printed devices. The evolution of regulation will also concern 3D printed drugs and the materials
Regulation

used for printing. Thanks to this regulation, the production of 3D printed products will increase
not only in quantitative terms, but also in terms of diversification of the usage areas, with a strong
expansion of the potential market.

The institutions at international level will limit themselves to set production standards only
for some sectors, introducing limits to the production chain. There will be no major progress,
and what today is not regulated because of its limits and regulatory gaps will continue not being

-
so also in the future, especially in Europe. The absence of a clear and structured regulation of
the production of 3D printed devices will continue to limit the mainstream applications of this
technology.

18
 The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector
The four future scenarios of 3D printing
From the conjoint/combined analysis of the future trends, it is possible to identify four
possible scenarios about 3D printing in health sector.
Scenario 1: Underground
This scenario will be characterized by a
regulatory framework that at global
level will continue to favor the use
of materials and technologies for 3D
printing. The intensity of this regulatory
dynamic, especially in the European
Union and its Member States, however,
will have an incremental nature and a
limited impact.
The European Medical Device
Regulation 2017/745, entered into force
on 25 May 2017 and exclusively applied
from 26 May 2020, will not significantly
integrate the 3D printing sector in the
implementing acts.
The EU will deal with 3D printing in
a residual manner with regard to
specific cases, leaving the primacy in
this regulatory framework to FDA
(Food and Drug Administration), which
in 2017 was the first global regulatory
authority to publish a guideline
on 3D printing of medical devices
("Technical considerations for additive
manufactured medical devices").
The technologies and materials for 3D
printing will grow exponentially in the
coming years. However, with specific
* Statement issued in a personal capacity and not representing the company to which it belongs.
- -
reference to the medical sector, in the
European market such technologies
could be unavailable, unusable or too
expensive, with regard to the possible
uses deriving from the configuration of
the regulatory context and the lack of
adoption models, investment capacity
and competent professional figures in
the hospitals.
The absence of significant uses in a
market like Europe could influence the
availability of new materials and new 3D
printing technologies for the medical
sector on a global scale.
"It seems to me very likely that the use of
3D printing for education and preparation
of complex surgical procedures will
establish itself over the next few years." *
Fabio Galbusera,
Head of the Laboratory of Mechanics of Biological Structures at
IRCSS Istituto Ortopedico Galeazzi
19
The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector
Scenario 2: Regulatory Driven niche
This scenario will be characterized by
a regulatory framework, which will
make possible the maximum level of
use of materials and technologies for 3D
printing.
At regulatory level, the FDA will make
3D printing one of the first areas
of interest, if not the first one, by
exponentially increasing its interventions
in this field. The European Union will
move in the same direction, adopting
a regulatory framework where it will
be possible to print many types of
devices (even directly in hospitals or
in pharmacies), including those of an
implantable type as well as a large
number of drugs.
In the coming years, the technologies
and materials for 3D printing will grow
exponentially, but the applications
in the healthcare sector will not
grow proportionally. Consequently,
the diffusion of 3D printing will be
lower than that recorded by other
sectors in which it will become
mainstream. This will mainly occur
20
+ -
due to resistance factors and internal
barriers to health systems. In particular,
there may be problems related to the
availability of financial resources deriving
from the growing pressure that the
demographic dynamics are putting
on many western health systems; the
difficulty of defining and activating
3DP-based operational models on a
large-scale for organizational reasons;
an insufficient availability of skills and
specialized professional figures within
the hospitals. Moreover, in the public
sector, some procurement models that
are not effective in acquiring innovative
solutions could further slow down big
projects. In this scenario manufacturers
and hospitals will use 3D printing with a
“by default” logic, but they will do so only
in specific areas of proven effectiveness
and efficiency, depending on their overall
readiness and profitability. In other
words, several niches focused on the
use of 3D printing will come up in those
clinical contexts that currently prove to
be the readiest or most promising in
adopting this technology.
 The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

Scenario 3: Technology Driven niche

- +

This scenario, which is the opposite of inability of operators to adopt 3D printing

the previous one, will be characterized
by a technological structure in
continuous evolution, pushing the
health eco-system stakeholders towards
an ever-increasing use of 3D printing,
also through the development of
adequate organizational models and
skills.
The technologies and materials will
lead to significant developments in
all fields of 3D printing application.
The availability of biocompatible
materials with high performance
properties will increase (e.g. mechanical
properties: rigidity and elasticity); and
faster and multi-material printers
will be developed, in line with the timing
of healthcare providers. The costs of
technology will decrease, and will make
3D printing ever more accessible and
available.
The regulatory framework, however,
will not have a similar development
since it will have the same dynamics
already described in the underground
scenario. The epilogue of this scenario
is similar to the previous one, because
the result will be a niche market that,
however, will not be determined by the
technologies, but rather by the inability
of doing so in a greater number of areas
and with greater regulatory certainty. In
other words, some niches of 3d printing
use will consolidate in the clinical areas
that are already common today. They will
be based on the consolidation of the “by
default” logic through applications and
processes already available and, in some
cases, established.
"Probably the 3D printer will increase in-
home usage, but I do not think it will be
used for health purposes. For example,
the production of first-aid devices would
require materials and sterilization that
could lead to a substantial increase in
costs, thereby disadvantaging the in-
home production." *
Gloria Casaroli,
Research Engineer at Istituto Ortopedico Galeazzi

* Statement issued in a personal capacity and not representing the company to which it belongs.
21
The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

Scenario 4: Mainstream

+ +

The last scenario is the most disruptive. healthcare sector. A regulatory framework
In this possible future, technological and will be available, defining the production
regulatory dynamics will push many fields standards, the design of the devices
of application of this technology towards and the quality requirements for the
models of 3D printing “by default”, where creation of medical devices, drugs and
3D printing for the production of drugs, artificial organs, with all the 3D printing
devices and health materials becomes techniques.
an ordinary model. As such, it also
radically changes the business models
of both those providing health care as
well as those providing services to such
providers.

In the coming years, technologies and

materials for 3D printing will reach
exponential developments that are not
fully predictable today. 3D printing will
become mainstream, spreading in every
hospital, and there will be specialized
technicians operating in many facilities.
The 3D printing will significantly favor
the diffusion of a customized medicine,
thanks to the possibility of a fast and
precise printing.
Even the most complex applications such
as transplants with artificial 3D-printed
organs will be possible and will bring a
significant contribution to the cure of
many diseases, also putting an end to
unpleasant and ethically unacceptable
exploitations.
All of this will be possible also because
of the regulatory framework that will
favor the use of 3D printing in all its
applications. The European Union and
its Member States will also firmly push
the application of 3D printing in the
"In the medium term, thanks to the
lowering of costs, many of the big players
will move from the current "subtractive
technology" to the "additive" 3D printing
technology. The possibility of relocating
production, of course, will drastically
change the way of conceiving the supply
chain. The relocated production will
become a real commercial offer, where
the company will sell the plant of a
printing center for the hospital, instead
of the single piece (prosthesis), with
the exploitation of some proprietary
patents (design) of plants, and the
associated services including labor for its
functioning." *
Gianluca Ruffi,
Strategic Marketing Director at Smith & Nephew

* Dichiarazione rilasciata a titolo personale e non in rappresentanza dell’azienda di appartenenza.

22
 The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

Impacts on health stakeholders

The identified scenarios were articulated on the individual stakeholders of the health eco-system (healthcare providers, patients,
life sciences companies, scientific associations, purchasing centers and supply chain players) to understand their possible
impacts. For each of them, the Advisory Board of the Health Care Med Tech Community contributed in identifying the relative
probability of occurrence in a period between 5 and 10 years. The impacts in the various scenarios are shown below.

Figure 15 - The underground scenario and the Advisory Board’s opinion

- - Probability of occurrence

Somewhat
Stakeholder Impact Unlikely Very likely
likely

Health care techniques and processes will not evolve significantly, 3D

printing will continue to be used in limited areas and will become mainstream
especially as a technique of education and preparation of complex 5 ye a r s
Healthcare surgical interventions. The promises and potential that characterize 3D
providers printing will not be fully understood, such as, for example, the production

10 ye a r s
and use by default of organs produced with biocompatible materials or the
setting up of 3D printing centers near the operating theaters for printing of
customized prostheses.

Patients will partially benefit from 3D printing. Indirectly, 3D printing will

improve, for example through the reproduction of organs for the preparation 5 ye a r s
of interventions, the outcome of a large number of surgical procedures.
Patients
However, the use of 3D printing on processes that actively involve the patient,
for example to produce customized prostheses at a distance or to print drugs
and / or devices at home, will be possible, but limited to circumscribed cases. 10 ye a r s
3D technology will continue to be used for prototyping purposes
and will only be fully utilized in areas with clear regulation. The large
5 ye a r s
Life sciences
pharmaceutical and medical device companies will not have the advantage of
companies

10 ye a r s
significantly modifying their methods of production and distribution of medical
devices (both high cost, implantable and high volume treatments).

5 ye a r s
Scientific associations and the research world will not consider 3D
printing a key topic in defining clinical studies, guidelines and protocols. A
Scientific limited number of Health Technology Assessment (HTA) studies will be linked
associations to 3D printing in an explicit way in order to grasp links between the technology
and the resulting outcome. The scientific community will not significantly push
the adoption of these technologies into its protocols and recommendations.
10 ye a r s

5 ye a r s
3D printing will not represent a significant expense item for public
aggregators and will continue to be purchased by individual hospitals. The
creation of regional press centers (for example for prosthetics) will not be
Supply chain
feasible on a large scale for regulatory reasons and consequent cost / benefit
ratio. 3D printing will not significantly change the acquisition, logistics and
distribution models of medical devices in health authorities. 10 ye a r s

23
The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

Figure 16 - The Regulatory Driven niche and the Advisory Board’s opinion

+ - Probability of occurrence

Somewhat
Stakeholder Impact Unlikely Very likely
likely

Some health care techniques and processes will evolve significantly and
3D printing will establish itself as a reference mode (3DP by default), even
within limited areas and will definitively establish itself as a standard for
5 ye a r s
Healthcare education activities and preparation of complex surgical interventions.
providers Only some of the promises and potential that characterize 3D printing

10 ye a r s
will be captured, due to the limited interest of the suppliers of technologies
and materials to develop in a generalized way all the application opportunities
deriving from the opening of the regulatory framework.

Some patients will benefit significantly from 3D printing, depending

on the niches in which it will become a standard. For these patients, the
development of techniques based on the use of 3D could lead (depending
on the attractiveness of the reference area) to different types of benefits and
5 ye a r s
improve the outcome of the care received and the experience of using the
Patients
service, thanks to factors such as: the availability of tailor-made prostheses, the
reduction of waiting lists in relation to even serious and chronic diseases (e.g. a
dialysis patient waiting for transplantation), the possibility of obtaining services
at a distance (e.g. of a custom prosthesis in rapid time by a remote scan) or -
10 ye a r s
on the contrary - in hospital in real time.

5 ye a r s
3D technology will continue to be used for prototyping and fully exploited
only in areas where it is economically convenient. The large pharmaceutical
Life sciences and medical device companies will start for some products in their portfolio to
companies convert production processes and marketing mix into welfare processes that
involve the use of 3DP. New competitors, global and local, coming from non-
conventional sectors could emerge in the market. 10 ye a r s

5 ye a r s
In the definition of clinical studies, guidelines and protocols, the scientific
societies and the research world will begin to consider the 3DP in a
Scientific good number of studies of Health Technology Assessment (HTA), but they
associations will not always have satisfactory outcomes. The scientific community will
significantly push the adoption of these technologies within its protocols and
recommendations only in some areas. 10 ye a r s
3D printing will be a more relevant item of expenditure for public
aggregators. However, it will continue to be purchased by individual
hospitals. Centralized tenders at regional and / or national level are not 5 ye a r s
envisaged. At an embryonic level, some hospitals could start in-house printing
Supply chain
of medical devices and evaluate the possibility of rationalizing the supply chain

10 ye a r s
in relation to some products, trying to limit the use of supplies in deposit
account/evaluation which historically represent something critical within
healthcare organizations.

24
 The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

Figure 17 - The Technology Driven niche and the Advisory Board’s opinion

- + Probability of occurrence

Somewhat
Stakeholder Impact Unlikely Very likely
likely

Healthcare Providers will have greater access to technology thanks to lower

costs, but the use of implantable devices printed in 3D on patients will be
limited to some types, excluding devices that require stringent regulation 5 ye a r s
(e.g. prostheses, artificial organs printed with the bioprinting techniques).
Healthcare
Although there will be technological means for the creation of Printing
providers
Centers near the operating theaters, these will not be realized on a large

10 ye a r s
scale due to the slow development of regulation in this area. 3D printing will
become mainstream as a technique of education and preparation of
complex surgical procedures.

3D printing will allow the production of customized prostheses on a large

5 ye a r s
scale (both at high cost - implantable and at high volumes - treatments), but
there will be limits to the diffusion of bioprinting. The use of 3D printing for
the preparation of surgical procedures will benefit patients by improving
Patients the outcome of numerous surgical procedures. The lower costs of the
technology will allow the purchase of printers even to patients themselves,
who will begin to produce, directly in-home, both health items that do not
require stringent regulation (e.g. pills holders, first aid kit, etc.), and non-health 10 ye a r s
objects in common use (e.g. household utensils, fashion accessories, etc.).

The commercialization of many products will still be curbed (e.g.

bioprinting) and will continue to use 3D technology for the purpose of
prototyping the device, thus becoming a consolidated practice in the
5 ye a r s
Life sciences production process; however, the main players on the market will not be
companies encouraged to move towards mass production due to the lack of production

10 ye a r s
standards. The new companies, on the other hand, will derive the
flexibility from this technology that itself allows, and will make it their core
business, thanks also to the lower costs related to the technology readiness.

The Scientific Associations will make 3D printing central in numerous

studies of Health Technology Assessment (HTA). The scientific community
will try to give voice to the main stakeholders that gravitate around the 3D
5 ye a r s
Scientific
technology carrying out activities related to research and innovation,
associations
promoting training courses to develop and consolidate the skills necessary
for the use of technology and inserting it into its own protocols and
recommendations.
10 ye a r s

5 ye a r s
Despite the best cost / benefit ratio for 3D printing and the availability of
technological resources, the creation of regional print centers will not yet
be fully feasible on a large scale for regulatory reasons. Individual hospitals
Supply chain
will continue privately to equip themselves with 3D printers for printing models
that will be used for education and simulation or some implantable, but
without resorting to the bioprinting technique.
10 ye a r s

25
The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

Figure 18 - The Mainstream scenario and the Advisory Board’s opinion

+ + Probability of occurrence

Somewhat
Stakeholder Impact Unlikely Very likely
likely

Healthcare Providers will realize in-home and in short time surgical devices
and, for this reason, they will have to acquire the necessary technology and
skills. The advent of bioprinting will allow on patients the use of implantable
5 ye a r s
Healthcare
devices printed in 3D and will lead to advances in surgical techniques and
providers
the reduction of waiting lists (e.g. waiting lists for organ transplants). They
will also benefit in terms of reduced costs for the purchase and / or logistics
management of medical devices.
10 ye a r s
The possibility of creating highly customized prostheses will allow shorter
recovery times and better biocompatibility compared to prostheses made
with traditional techniques. The perceived quality of health care received will 5 ye a r s
increase, thanks, for example, to the reduction of waiting lists that will allow
Patients
the needs of the patients to be satisfied more quickly. 3D printing will also be

10 ye a r s
accessible to the individual, thanks to its diffusion and the lower costs, which
will be able to realize in-home some objects (e.g. pencil cases, first aid kits,
etc.).

The development of 3D printing will lead to more investments in the

sector, and even the main market players will be encouraged to introduce
this technique for large-scale production. New skills will be introduced in 5 ye a r s
Life sciences companies. The presence of high performance printers from a technical
companies point of view (speed and precision), will allow the consolidation of mass

10 ye a r s
customization, the production of customizable objects in large volumes. There
will be a reconfiguration of the relationship with the Regions and the health
structures.

Universities and Scientific Associations will be involved in redesigning

university courses to develop technical skills in the 3D sector. The scientific
5 ye a r s
Scientific
associations will define new guidelines for the use of technology and will be
associations

10 ye a r s
promoters of training courses for health personnel to develop and consolidate
the necessary skills to use this technology.

5 ye a r s
Thanks to the benefits introduced by 3D printing and its diffusion, there will
be a substantial change in procurement strategies and, therefore, in the
structure of tender specifications, in a service and / or performance based
Supply chain
logic. The creation of public hubs for 3D printing at the regional level will be
promoted. These hubs will modify the supply chain making 3D printed devices
available in less time and with greater ease at the point of use. 10 ye a r s

26
 Il futuro dell'Health Care | Potenzialità, impatti e modelli del 3D printing in ambito sanitario

Conclusions

3D printing has been a reality in the health sector
for many years, at worldwide level as well as in
Italy. Until now, the regulatory framework and the
technological evolution have not allowed such a way
of production to be applied on a large scale.
In fact, the applications of 3D printing are still
of interest to the media. They are newsworthy.
This means that, for many years, this technology
has been limited to a niche, which has involved a
relatively small number of hospitals in a structural
manner and with a limited scope of applications. In
many cases, it remained in an experimental phase.
During the last few years, we have witnessed
several changes. From a regulatory perspective, in
the United States, the FDA has started focusing on
3D printing more and more. Speaking of available
technologies, printers and materials have greatly
evolved.
In the coming years, this process dealing with the
regulation of 3D printing and the technological
evolution of printers and materials will continue and
intensify.
At the European level, with regard to the
implementation path of the new Regulation for
medical devices, it is desirable to recover a vision and
a perspective on the 3D printing sector that have not
been considered in the original legislative text.
In fact, with regard to the different European
healthcare systems and, thus the Italian one, a great
deal of the 3D printing evolution and development
depends on the regulatory context at the European
Community level.
Although the awareness of the relevant 3D printing
potential seems to be high, among the Advisory
Board members and the survey respondents,
the ability of defining adoption paths and models
for these technologies reveals some points of
uncertainty. Some examples: the ways of developing
the necessary competences for the use of 3D
printing inside the hospitals; the organizational
models enabling the creation of hubs at a supra-
enterprise level; the size and type of investments;
the ways of reconfiguring the relationships between
health companies and suppliers, especially in the
medical device sector.
In this regard, the evolution to mainstream 3D
printing is not just a matter of market regulation,
which is in any case a prerequisite (as some
successful Italian cases demonstrate), but certainly
not a sufficient one. On the contrary, it implies
the development of a shared and engaged call-
to-action among all the actors in the ecosystem
of our national health service, so as to define:
an agenda about the priorities to deal with; the
evaluation models based on the HTA method for the
applications of 3D printing that are able to support
the investment programs and decisions; the
capabilities to be developed or acquired in order to
use these new techniques with the corresponding
development paths; the organizational models and
ways of reconfiguring the relationship between
health companies and traditional or emergent
suppliers.

In this respect, the potential envisioned by the

different stakeholders for our national healthcare
service would actually be considerable both in
terms of impact on the patients as well as of process
innovation and cost reduction.

27
 The future of Health Care | Potential, impacts and models of 3D printing in the Health Care sector

Bibliography

1. 3D printing spending is about $12 billion in 2018, 3DPrinting.com

2. ASTM International, Standard terminology for additive manufacturing technologies, designation F2792 −
12a, 2013, p. 2

3. The Major Milestones Of 3D printing In The Medical Industry, 3DPrintersBay.com

4. Marchesini Group Increases Focus on Industry 4.0 by Acquiring Vision System Company and Opening 3D
printing Facility, 3DPrint.com

5. 3D Lifeprints Secures £500,000 Investment To Rapidly Expand, 3DLifePrints.com

6. Five Children Receive Ear Implants Made From Their Own Cells, Thanks to 3D Printed Molds and
Scaffolds, 3DPrint.com

7. Chemical MP3 Player Can 3D Print Pharmaceuticals On-Demand from Digital Code, 3DPrint.com

8. Wrap, the 3D Printed Plaster that Halves Healing Times, ParmAteneo.it

9. T3Ddy Laboratory is born at the Meyer Pediatric Hospital, Meyer Pediatric Hospital Institutional Website

29
Authors
Davide Lipodio
LSHC Innovation
Industry Representative
dlipodio@deloitte.it

Veronica Colombi
Senior Consultant
vcolombi@deloitte.it

Giacomo D'Alessandro
Analyst
gidalessandro@deloitte.it

Verdiana Carini
Analyst
vcarini@deloitte.it

Contacts
Valeria Brambilla
LSHC Industry Leader
vbrambilla@deloitte.it

Guido Borsani
PS Industry Leader
guborsani@deloitte.it
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Graphic Department - Italy | SG.043.18C ENG