医工連携事業化推進事業

Policy of the Ministry of Economy, Tradeand Industry on medical device industry

November 2017
Medical/Welfare Device Industry Office, Commercial
affairs/service group,
Ministry of Economy, Trade and Industry

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医工連携事業化推進事業

Classification of medical devices(1) Diagnostic devices(3) Other(2) Therapeutic devices
Catheter

Dental materials/unit

PET, PET-CT system

Prosthesis
Cardiacpacemaker

Endoscope (videoscope)

Massager for homeuse

Injector

MRI

Ultrasonography

Cardiopulmonary bypasssystem (roller pump,oxygenator)
Contact lens

X-ray film,Thermometer,Manometer,
ECG, etc.

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Surgical glove2

医工連携事業化推進事業

Trends in the medical device market in Japan The size of the medical device market in Japan has increased since 2004 and moved beyond 2 trillion yen. In 2014, it was about
2.8 trillion yen, and the market size was the largest compared to the past.
 Medical expenses in Japan were 40.1 trillion yen in FY 2013, of which the medical device market accounted for approximately
7%.
Unit: billion yen

Market size of medical devices in Japan and changes in growth rate over the previous year

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

Domestic market [bil yen]
Growth rate over theprevious year

Source: Pharmaceutical Industry Production Statistics by the Ministry of Health, Labour and Welfare
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医工連携事業化推進事業

Structure of the medical device market in JapanOf the medical device market (approx. 2.8 trillion yen), in terms of value, therapeutic devices (catheter, pacemaker, etc.) anddiagnostic devices (endoscope, CT, MRI, etc.) accounted for 55% and 22%, respectively. Generally, the growth rate of therapeutic
devices is higher and the market size is also larger. On the other hand, the percentage of imports was higher for therapeuticdevices.
Diagnostic devices
Unit:
Market size: 611.3 billion yen (22%)
billion yen Average growth rate: -0.65％

Therapeutic devices
Market size: 1,498.7 billion (55%)
Average growth rate: 3.88％

Other devices
Market size: 637.8 billion yen (23%)
Average growth rate: 0.93％

Market size(2015)

Dentalmaterials

Medical devices forhome use

Dental devices

Hygienematerials andproducts(62.7%)

Ophthalmologicalinstruments andrelated products(36.5%)

Steel equipment

Clinical equipment
and supplies(57.2%)

Therapeutic/surgicaldevices

Related device andtool for diagnostic Xray equipment(37.2%)(45.2%)(75.9%)(71.0%)(80.7%)(25.3%)(37.9%)(34.3%)(74.8%)* Domestic market size＝domestic production value＋import value－export value

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Average growth rate
(2006-2015)

Operatingequipment andsupplies

In vitro clinical testdevices(38.4%)

Artificial internalorgan apparatuses
and assist devices

Bioinstrumentation/m
onitoring systems

Diagnostic imaging
systems

Share ofimports
as of 2015 (46.0%)

Unit: ％

Source: Pharmaceutical Industry Production Statistics by Ministry of Health, Labour and Welfare4

医工連携事業化推進事業

Global trends in the medical device market
 Because of the aging of society and the expansion of international demand by emerging countries, the global market for
medical devices has been expanding (as of 2014, it was approx. 40 trillion yen, the largest ever).
 Both exports and imports in Japan are increasing (approx. 8% increase in exports and 4% increase in imports in comparison with theprevious year).
Unit: billion dollars

グローバル市場の動向
Global Market Trend

Transition of import and export of medical devices

OthersAsia(excludingJapan)
Japan○ As for export and import value, as of 2015, imports exceeded approx. 800
billion yen.
(Export value: 622.6 billion yen－import value: 1,424.9 billion yen)
Unit: billion yen
ExportImport

Trade balance(including reverse import)

EuropeU.S.A

Source: World Medical Market Forecasts to 2019
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Source: Statistics of Production by Pharmaceutical Industry by Ministry of Health, Labour and Welfare

5医工連携事業化推進事業

Global trends in the medical device market


While certain international competitiveness is maintained in the field of diagnostic devices, international competitiveness is weak in the field oftherapeutic devices.

Foreign/Japanese world share for major medical devices (global market size in 2014)
MRIs
Ultrasound imaging devices
Flexible endoscopes
Foreign
外資系
Japanese
日系

2.0%

Diagnostic
device%

1.1%

0.9%

118.1
billion yen

Japanese
日系

24.0

European
欧州系

American
米国系

European

欧州系

31.9

32.1%

554.6
billion
yen
51.1

欧州系

European米国系
American%Foreign
外資系

Japanese
日系

76.0

98.0%

466%
billion yen

24.9

Foreign
外資系

American
米国系

%

68.1

36.1%

%

%

Radiotherapy devices

Vascular stents

Prostheses

Japanese
日系

日系Japanese

日系Japanese

2.6%

1.2%

0.0%

Therapeutic
deviceEuropean
欧州系

European
欧州系

European
欧州系

24.0

1.4%

15.1

% 487.8billion yen

米国系
American

640.9
billion yen%

1,405.9billion yen
American
米国系

American
米国系

73.3
Foreign
外資系%

Foreign
外資系

97.4

98.8%

%

84.9

97.4%

Foreign
外資系%

100.0%

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6 in FY 2015 (NEDO) (March, 2016)(Source) Collection of Information on Positions of Japanese Companies in the International Competition

Overallimage of the policy on the medical device industry promoted by the
医工連携事業化推進事業
Ministry of Economy, Trade and Industry
Market development,
design/concept design

Development/clinical trial
Production/service supply

Sales
Marketing●Development of world-leading medical devices
・Industry, academia, and the government collaborate to promote development of advanced
diagnostic/therapeutic systems (Medical device/system R&D project to realize future medical care:approx. requested amount in FY 2018 is 4.8 billion yen)・ Establishment of evaluation indicators and development guidelines that contribute tofacilitation of development/review●Medical device development through medical-engineering collaboration
・Promotion of collaboration between companies and universities with manufacturing technology
and medical institutions, for device development and practical application to meet the needs inmedical practice(Commercialization Promotion Project for Medical-engineering Collaboration: approx. requested
amount in FY 2018 is 3.45 billion yen)

●Improvement of business environment
・Scheme to extract clinical needs
・Preparation and popularization of a guidebook on thesupply of materials for medical devices
・Acceleration of international standardization for overseas
expansion●Acquisition of overseas market
・Integral development of medical devices and services(Promotion of medical technology and service base)(Support system in cooperation with MEJ, JICA, etc.)●Support by the Support Network for Medical Device Development
・Provides uninterrupted support according to the development stage as "accompanying consultation“
・Provides one-stop support for discovery of the needs in medical practice and commercialization (licensing, intellectual property, sales
channel development, financing) etc. through all-out mobilization of development agencies
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医工連携事業化推進事業

What is the Commercialization Promotion Project for Medical-Engineering
Collaboration?
Business to support the development of medical devices that respond to the needs of medical practices using
manufacturing technologies from small and medium-size enterprises[Development business] (Since 2010）
Commercialization Promotion Project for Medical-engineering Collaboration (Medicalengineering Collaboration Project) Approx. requested amount in FY 2018: 3.45 billion yen
 Annual maximum amount: 80 million yen/up to three years inprinciple Auxiliary business (2/3) (enforced by AMED)[Software support business (= Support Network for Medical DeviceDevelopment)] (Since October, 2014)(1) Accompanying consultation(2) Product evaluation service(3) Idea box (Scheme to extract medical needs)
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医工連携事業化推進事業

Overhead view of adoption for Medical-Engineering Collaboration Project*：Corrected in FY 2010 – adopted in FY 2016
(analysis of 149 cases * in total)

Adopted challenges to class III and IV therapeutic devices*Since there are cases where multiple products are included in one case,the total breakdown does not match the number of cases.
Information on overseas
Information on domestic products
products[Breakdown]

Field

Case numberClass I

1. Surgical support
robots/systems

2

2. Artificial tissue/organs

24

3. Minimally invasive
therapy
4. Imaging (diagnosticimaging)
5. Medical devices forhome use

36

Class IIClass III

Class
Non-medical
unknown/non- Medical device
devicemedical device

Class IV

1

1

2

115

6

1

19

7

12

10

10

1

20

1238

12

1

11

1

124

8

3

191

6. Other medical devices

53

1821

1312386

7. Non-medical devices

8Total1476183350422425

59914*Excluding two cases for which the answer was provided collectively with different case numbers(Note) Since the projects adopted multiple times are summarized, the total number of adopted cases and the total of the table (147 cases) do
not agree.
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Product launch data on the Medical-Engineering Collaboration Project
59 products/approx. 3.3
billion yen (October, 2017)

1,500

3,324
Domestic and overseas sales(million yen)

3,500

3,000
1,143

1,000

Domestic and overseascumulative sales (million yen)
901

2,500

2,181
811

2,000

1,370
500

Japan
(Medical devices)
31 products
Class I
14 products
Class II
11 products
Class III
3 products
Class IV
3 products(Non-medical devices) 20 products
51 products

468468Overseas
5 products (19 products)

1,000

3 products
8 products (22 products)*When a device is sold in different countries/regions, it is counted as multiple products.

0– FY 2013

FY 2014

FY 20151,5005000FY 2016

(Note) The sales of launched products (actual results) completed by FY 2016 are tabulated. For business assignment projects not covered by thesurvey in FY 2017 and projects not yet answered in FY 2017, the results of the survey in FY 2016 (up to FY 2017 results) are included in thetotal as sales.
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10Source: Prepared based on the follow-up survey in FY 2016 and FY 2017.

医工連携事業化推進事業

Significance of the Medical-engineering Collaboration ProjectIn the era when the country's medical device demonstration project was focused on R&D derived fromseeds utilizing advanced technologies from large enterprises, a demonstration project aimed atcommercialization was started in FY 2010, giving importance to medical device development to meet theneeds of medical practices utilizing manufacturing technologies from small and medium-sized enterprises.

Development
derived from seeds

Development derived
from needs

State-of-the-art
technologies of large
enterprises

Manufacturing
technologies of small andmedium enterprises

R&B

Commercialization

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医工連携事業化推進事業

Conditions for public recruitment to promote commercialization
Acceleration of commercialization through community building⇒medical institutions (needs) + small and medium enterprises withmanufacturing technologies (technologies) + manufacturing and sales
company (sales)
Community
Small and medium
Must enterprises with
manufacturing
technologies

Must
Manufacturing and sales

University/research
instituteMust

Applicationcompany*Scheduled acquisition during theproject period is also possible

Medicalinstitutions

Sales

・ Pharmaceuticals and Medical Devices Agency(PMDA)・ Food and Drug Administration(FDA)
・ Third party certification organizations, etc.

Approval,certification

Wholesalecompany
agencyCustomer(domestic, overseas)

For commercialization, [manufacturing and sales companies] are required inaddition to [medical institution] + [small and medium enterprises]
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Features of Medical-Engineering Collaboration Project (⇒accompanying consultation)
Acceleration of commercialization not only by development financesupport but also by accompanying expert consultation
Accompanying consultation(Continuous support by specialized consultants from theinitial stage of development to commercialization)

Marketing/financestrategy

Regulation
correspondence
Production/intellectual
property strategy
Business/overseas strategy

Sales/marketing

Manufacturing/
service supply system

Development/
testing

Market exploration
Concept designLaunch[Category of accompanying consultation]
1. Business strategy/concept design
2. Clinical needs
3. R&D
4. Clinical trials
5. QMS system establishment
6. Approval application
7. Intellectual property strategy
8. Financing
9. Sales strategy
10. Overseas expansion
11. Insurance reimbursement

In order to accelerate commercialization, it is important to provide
consultation in all sectors, including approval application, intellectualproperty, insurance reimbursement from the beginning of business
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Spin-out of software support business[Business contents of the Support Network for Medical Device Development ](1) Accompanying consultation
 Provides expert advice on the entire commercialization process of medical devices from business strategy/concept
design to pharmaceutical affairs/intellectual property/sales strategy etc.
 Advice to a question "What to do (What)" such as identification of issues is free of charge in principle. About "How tosolve the issue (How)“, paid experts and support services are introduced.

(2) Product evaluation service A service that multiple medical staff in the specialized field evaluate in-house medical devices.
 Started for a fee in FY 2017.

(3) Idea box (scheme to extract medical needs)
 Gathers needs of medical practices, and published the needs assessed and examined by experts from the viewpoint of
universality/importance on the website. Membership registration is required for use. Free of charge.

Created a service that anyone can use
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医工連携事業化推進事業

Typical examples of failures are also analyzed
1. Development of medical devices not meeting market needs
2. Development of medical devices for which business is not established[Source] Guidebook for medical device commercialization through medicalengineering collaboration (March 2015 edition)

Creation of case study materials based on case studies(Example) Case 1: A case where the product was made in a technology-driven manner but it did not sell because
it did not match the needs in medical practiceCase 2: A case where development was promoted under the leadership of a doctor without
verification of whether the needs are general

Clarifying failure patterns and making themknown to everyone⇒To obtain case study materials⇒contact medic@mri.co.jp
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