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

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

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

Contents

3

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

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.

Innovation in Health Care is the topic on which the Community is focused. Orienting the health ecosystem towards innovation means laying the foundations for a transformation of the entire sector, where the value is generated by the involvement of all stakeholders with their different points of view, perspectives and roles. Today, more than in the past, disruptive technologies can represent the pivot of the transformation and the innovation of operating models in the clinical, welfare, organizational and managerial fields. 3D printing, augmented reality, Internet of Things (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.

Deloitte’s Health Care Med Tech Community

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).

During its first year of activity, the Community dedicated itself to 3D printing to explore some aspects: the employment models, state of the art and worldwide diffusion, the presence in the Italian healthcare sector, the possible developments and barriers to overcome to bring this technology from a niche dimension to the mainstream.

The work of the Community has been developed with the contribution of an Advisory Board representing the main stakeholders of the health eco-system: hospitals, life sciences companies, scientific associations and supply chain players.

Smith&NephewStefano MarcheseGianluca Ruffi

Commercial DirectorStrategic Marketing and Market Access Director

Medtronic Guido Beccagutti Value, Access & Policy Director

ESTARNicolò PestelliStefano Vezzosi

Programme Director at Area Vasta Sud Est Toscana Director of Informatics and Health Technologies

Intercent-ER Alessandra Boni Director

Meyer Pediatric Hospital Kathleen McGreevyCoordinator, Office of International Relations and the Promotion of Innovation

Istituto Ortopedico GaleazziFabio GalbuseraGloria Casaroli

Head of the Laboratory of Mechanics of Biological StructuresResearch Engineer

LIUC Università Cattaneo Davide CroceDirector, Research Center in Health Economics & Health Care Management

Innogest Claudio Giuliano Partner

PLS Educational Luigi Cammi Managing Director

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

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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 market growth to $12 billion, an increase of about 20% over the previous year1. In 2018, over 50% of the market will be located in the United States and Europe with a turnover of $7.6 billions. Other estimates predict that the turnover will reach $20 billion by 2021 with a 20.5% compound annual growth rate, on a five-year basis, from 2017 to 20212. These data clearly show the dynamic growth of 3D printing, which is emerging as a widespread 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 generated by the healthcare sector. Analysts forecasts that in 2018 the 3D printing worldwide turnover related to healthcare will reach $ 1.3 billion1.

Different applications in the medical field support this growth. To date, the most significant applications refer to the production of different types of devices in the dental, orthopedic and acoustic fields. However, even the most innovative areas such as the 3D printing of tissues, organs and bones show important growth rates and begin to spread significantly (56.6% compound annual growth rate, on a five-year basis, from 2017 to 20211).

1. 3D printing spending is about $ 12 billion in 2018, 3DPrinting.com2. ASTM International, Standard terminology for additive manufacturing technologies, designation F2792 − 12a, 2013, p. 23. The Major Milestones Of 3D Printing In The Medical Industry, 3DPrintersBay.com

In recent years, 3D printing applications have become increasingly more common. The 3D printing technology has already made it possible to print surgical instruments such as hemostats, forceps, scalpel handles, etc.3 In the next years, a quantitative increase in the established applications is expected, but also the development of new applications in even more ambitious areas.

Ultimately, 3D printing technology has the potential to deeply modify the healthcare’s delivery and organization models in different areas of clinical specialization.

3D printing is a production mode, also called additive manufacturing, which allows the fabrication of objects (component parts, semi-finished or finished products) through the aggregation of successive layers of material that are added to each other. 2

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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 research highlights on additive manufacturing, 3D printing contributes to the health sector transformation by acting on two different dimensions: product innovation and process innovation, the latter with particular reference to traditional supply chain activities.

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

Figure 2 – 3D Printing Health Care Industry Framework

The integrated reading of these two dimensions generates four possible models of 3D printing application in the health sector, as can be seen in Figure 2, and it allows us to develop an organic and coherent approach to the analysis of the opportunities of 3D printing ("3D Printing Health Care Industry Framework").

Path I: stasis

In this model 3D printing is used to generate efficiency rather than innovation. Organizations (predominantly medical device manufacturers) consider 3D as the acceleration technology of some processes. The most frequent case of using this model is related to the use of 3D printing for the rapid prototyping of medical devices that are then produced on a large scale with the traditional technologies.

Example

In early 2018, the Marchesini Group Company from Bologna, a leading packaging manufacturer in the pharmaceutical sector, inaugurated a new structure dedicated to 3D printing technology, which is, according to the company, "one of the main declension of the Industry 4.0 paradigm"4. The new 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 that will then be produced through traditional manufacturing processes. This new 3D printing facility by Marchesini Group will allow customers to monitor error management, machine wear and production planning, besides controlling costs.

Companies benefit from leveraging the 3D printing

economies of scope to achieve greater levels of performance or innovate

their products (e.g. 3D printing for more precise and less

invasive surgical operations)

Companies create a new business model through 3D printing

(e.g. bioprinting, custom production of implantable

prostheses)

Companies do not look for radical changes either in the

supply chain or in the products. This type of companies use

the 3D technology to streamline processes (e.g. prototyping)

Companies benefit from leveraging the economies of scale offered by 3D printing

in terms of supply chain (e.g. on-site production of

surgical equipment)

Path IV: business model evolution

Path III:product evolution

Path II: supply chainevolution

Path I: stasis

High product change

No product change

High supply chain changeN

o su

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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

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

5. 3D Lifeprints Secures £500,000 Investment To Rapidly Expand, 3DLifePrints.com6. Five Children Receive Ear Implants Made From Their Own Cells, Thanks to 3D Printed Molds and Scaffolds, 3DPrint.com7. Chemical MP3 Player Can 3D Print Pharmaceuticals On-Demand from Digital Code, 3DPrint.com

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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 over 1,000 experiences from all over the world regarding innovations in the use of 3D printing for Health Care, selecting the most significant 218 cases. In particular, all the experiences that focused on mere prototyping (Path I: stasis) were excluded,

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

and then we ranked the 218 successful cases within the 3D Printing Health Care Industry Framework.

The Figure 3 shows a graphical representation about the origin of the successful experiences, reporting the corresponding numbers for each country.

103

3

7

10

28

9

8 3

4

1

2 11

2

2 2

1

2

1

1

1

2

1

1

1

3

1

1

3

4

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

From the analysis of these experiences, we have identified some international trends in the use of 3D printing, highlighted in Figure 4. In particular, most of the experiences are included in Path III and IV of the Industry Framework: product evolution (41%) and business model evolution (51%).

Analyzing the trends for each country, we highlight a leading role of the United States (Figure 5), which shows 103 successful cases, 54 of which refer to the "Path IV: business model evolution". Even Europe and its Member States are moving in the same direction.

Figure 4 - International trends in 3D printing use

Figure 5 - Focus on trends for each country

Path IV: business modelevolution

Path III: product evolution

Path II: supply chainevolution

Path I: stasis

51%

8%

41%

High product change

No product change

High supply chain changeN

o su

pply

cha

in c

hang

e

+

-

+-

0

10

20

30

40

50

60

70

80

90

100

110

Other

103

28

10 10 9 8 74 4 3 3 3 3

23

Legend

Productevolution

Businessmodel

evolution

StasisSupply chain

evolution

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

Figure 6 - The 10 most successful international cases selected by Deloitte

Starting from the database, we have selected 10 particularly significant cases, as reported in Figure 6.

8. Wrap, the 3D Printed Plaster that Halves Healing Times, ParmAteneo.it9. T3Ddy Laboratory is born at the Meyer Pediatric Hospital, Meyer Pediatric Hospital Institutional Website

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.

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.

At the Italian level, the experiences of the M3datek startup and the Meyer Pediatric Hospital deserve a special attention because of their innovativeness degree.

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.

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.

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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 the diffusion of 3D printing within the Italian healthcare sector, we conducted a survey of the main stakeholders of the 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 analysis divided into 3 clusters:

1. Awareness of the potential to be exploited.

2. Actions to be taken to develop sustainable adoption models.

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.

Figure 7 - Survey respondents

Hospitals

Life sciences companies

Supply chain players

Scientific associations

14%16%

22%

48%

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

The hospitals recognize great potential in different fields and, in particular, in the personalization of treatments (i.e. tailor-made prostheses) and in the creation of public hubs at regional or supra-company level.

Figure 8 - Opportunities for hospitals

Figure 9 - Opportunities for supply chain players

Figure 10 - Opportunities for life sciences companies

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

Reduction of costs for the purchase/logistics management of medical devices

Personalization of treatments

Real-time printing of medical devices(implantable and non-implantable)

Innovation of diagnostic andsurgical techniques

Creation of private hubs

Creation of public hubs at regional and/or wide area level

Creation of print centers in the single hospital

Reconfiguration of the relationship withmedical devices suppliers

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

Creation of private hubs

Creation on public hubs at regionaland/or wide area level

Possibility to produce medicaldevices 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% 35%

Possibility to offer increasingly personalizedand patient-oriented services

Market entry of new unconventional competitors

Reconfiguration of the relationshipwith Regions and Hospitals

The personalization of treatments is one of the greatest capabilities of 3D printing also for supply chain players, along with the reconfiguration of the relationship with medical devices suppliers from a product-based logic to a service one.

In addition to the personalization of 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 market.

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

Figure 11 - The barriers to the diffusion of 3D in the healthcare systemAll respondents, in addition to the potential, also report the presence of some barriers that limit a large-scale spread of 3D printing.

The main obstacles can be found in the lack of regulation, especially since the 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.

The large-scale adoption of 3D printing is characterized by the combination of “high potential/ high barriers”. If, on the 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.

Lack of regulation on the 3D printing production process

Lack of knowledge and skills on the use of technology and the related organizational models

Uncertainty about the amount ofinvestments in technology required by the company and the related economic return

Maturity of technology (performance of printers and materials available)

Degree of agreement per target

High Moderate Low

Supply chainplayers

Life sciencescompanies

ScientificassociationsHospitals

43%

24%

24%

9%

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

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.

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.

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

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 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.

Tech

nolo

gy

+

-

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 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.

Regu

lati

on

+

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

Scenario 1: Underground

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.

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

- -

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.

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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

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.

+ -

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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 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

inability of operators to adopt 3D printing 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.

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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. In this possible future, technological and regulatory dynamics will push many fields of application of this technology towards models of 3D printing “by default”, where 3D printing for the production of drugs, devices and health materials becomes 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

healthcare sector. A regulatory framework will be available, defining the production standards, the design of the devices and the quality requirements for the creation of medical devices, drugs and artificial organs, with all the 3D printing techniques.

"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.

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

5 years

5 years

5 years

5 years

5 years

10 years

10 years

10 years

10 years

10 years

Probability of occurrence

Stakeholder Impact UnlikelySomewhat

likelyVery likely

Healthcare providers

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 surgical interventions. The promises and potential that characterize 3D printing will not be fully understood, such as, for example, the production 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

Patients will partially benefit from 3D printing. Indirectly, 3D printing will improve, for example through the reproduction of organs for the preparation of interventions, the outcome of a large number of surgical procedures. 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.

Life sciences companies

3D technology will continue to be used for prototyping purposes and will only be fully utilized in areas with clear regulation. The large pharmaceutical and medical device companies will not have the advantage of significantly modifying their methods of production and distribution of medical devices (both high cost, implantable and high volume treatments).

Scientific associations

Scientific associations and the research world will not consider 3D printing a key topic in defining clinical studies, guidelines and protocols. A limited number of Health Technology Assessment (HTA) studies will be linked 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.

Supply chain

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 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.

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.

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

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

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

5 years

5 years

5 years

5 years

5 years

10 years

10 years

10 years

10 years

10 years

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

Probability of occurrence

Stakeholder Impact UnlikelySomewhat

likelyVery likely

Healthcare providers

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 education activities and preparation of complex surgical interventions. Only some of the promises and potential that characterize 3D printing 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.

Patients

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 improve the outcome of the care received and the experience of using the 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 - on the contrary - in hospital in real time.

Life sciences companies

3D technology will continue to be used for prototyping and fully exploited only in areas where it is economically convenient. The large pharmaceutical and medical device companies will start for some products in their portfolio to 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.

Scientific associations

In the definition of clinical studies, guidelines and protocols, the scientific societies and the research world will begin to consider the 3DP in a good number of studies of Health Technology Assessment (HTA), but they 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.

Supply chain

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 envisaged. At an embryonic level, some hospitals could start in-house printing of medical devices and evaluate the possibility of rationalizing the supply chain in relation to some products, trying to limit the use of supplies in deposit account/evaluation which historically represent something critical within healthcare organizations.

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

5 years

5 years

5 years

5 years

5 years

10 years

10 years

10 years

10 years

10 years

Probability of occurrence

Stakeholder Impact UnlikelySomewhat

likelyVery likely

Healthcare providers

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 (e.g. prostheses, artificial organs printed with the bioprinting techniques). Although there will be technological means for the creation of Printing Centers near the operating theaters, these will not be realized on a large 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.

Patients

3D printing will allow the production of customized prostheses on a large 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 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 objects in common use (e.g. household utensils, fashion accessories, etc.).

Life sciences companies

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 production process; however, the main players on the market will not be encouraged to move towards mass production due to the lack of production 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.

Scientific associations

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 technology carrying out activities related to research and innovation, promoting training courses to develop and consolidate the skills necessary for the use of technology and inserting it into its own protocols and recommendations.

Supply chain

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 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.

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

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

5 years

5 years

5 years

5 years

5 years

10 years

10 years

10 years

10 years

10 years

Probability of occurrence

Stakeholder Impact UnlikelySomewhat

likelyVery likely

Healthcare providers

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 devices printed in 3D and will lead to advances in surgical techniques and 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.

Patients

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 increase, thanks, for example, to the reduction of waiting lists that will allow the needs of the patients to be satisfied more quickly. 3D printing will also be 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.).

Life sciences companies

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 companies. The presence of high performance printers from a technical point of view (speed and precision), will allow the consolidation of mass customization, the production of customizable objects in large volumes. There will be a reconfiguration of the relationship with the Regions and the health structures.

Scientific associations

Universities and Scientific Associations will be involved in redesigning university courses to develop technical skills in the 3D sector. The scientific associations will define new guidelines for the use of technology and will be promoters of training courses for health personnel to develop and consolidate the necessary skills to use this technology.

Supply chain

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 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.

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

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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.

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.

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

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.

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

Bibliography

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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 3Dprinting 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 andScaffolds, 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

Authors

ContactsValeria BrambillaLSHC Industry [email protected]

Guido BorsaniPS Industry [email protected]

Davide LipodioLSHC Innovation Industry [email protected]

Veronica ColombiSenior [email protected]

Giacomo D'[email protected]

Verdiana [email protected]

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