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Copyright (C) MEDIC 医工連携事業化推進事業

医工連携事業化推進事業

Policy of the Ministry of Economy, Trade and Industry on medical device industry

November 2017

Medical/Welfare Device Industry Office, Commercial affairs/service group,

Ministry of Economy, Trade and Industry



Classification of medical devices

(2) Therapeutic devices(1) Diagnostic devices (3) Other

PET, PET-CT system

MRI

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

Endoscope (videoscope)

UltrasonographyCardiopulmonary bypass system (roller pump, oxygenator)

Cardiac pacemaker

Prosthesis

Injector

Dental materials/unit

Massager for home use

Surgical glove

Contact lens

Catheter

2

http://www.med.shimadzu.co.jp/products/pet/03.html



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%.

3Source: Pharmaceutical Industry Production Statistics by the Ministry of Health, Labour and Welfare

Market size of medical devices in Japan and changes in growth rate over the previous yearUnit: billion yen

Domestic market [bil yen]

Growth rate over the

previous year

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015



Structure of the medical device market in Japan

Source: Pharmaceutical Industry Production Statistics by Ministry of Health, Labour and Welfare* Domestic market size＝domestic production value＋import value－export value

In vitro

clinical test

devices

Of the medical device market (approx. 2.8 trillion yen), in terms of value, therapeutic devices (catheter, pacemaker, etc.) and diagnostic 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.

4

Diagnostic devicesMarket size: 611.3 billion yen (22%)Average growth rate: -0.65％

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

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

Diagn

ostic im

aging

systems

Bio

-in

strum

entatio

n/m

on

itorin

g systems

Re

lated d

evice and

to

ol fo

r diagn

ostic X

-ray eq

uip

men

t

Clin

ical equ

ipm

ent

and

sup

plies

Artificial in

ternal

organ

app

aratuses

and

assist devices

Op

erating

equ

ipm

ent an

d

sup

plies

Therap

eutic/su

rgical d

evices

Steel eq

uip

men

t

Op

hth

almo

logical

instru

men

ts and

related

pro

du

cts

Med

ical devices fo

r h

om

e use

Den

tal m

aterials

Den

tal devices

Hygien

e m

aterials and

p

rod

ucts

(46.0%) (37.2%)(38.4%) (57.2%) (36.5%) (62.7%) (45.2%) (75.9%) (71.0%) (80.7%) (25.3%) (37.9%) (34.3%) (74.8%)

Share of imports

as of 2015

Unit: billion yen

Unit: ％

Market size Average growth rate(2006-2015)(2015)



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 the previous year).

グローバル市場の動向 Transition of import and export of medical devices

○ 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)

5

Unit: billion dollars Global Market Trend

Asia

(excluding

Japan)

Others

Japan

Europe

U.S.A

Export Import

(including reverse import)

Trade balance

Unit: billion yen

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



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 of

therapeutic devices.

6

Foreign/Japanese world share for major medical devices (global market size in 2014)

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

米国系

36.1

%

欧州系

32.1

%

日系

31.9

%

外資系

68.1

%

米国系

0.9%

欧州系

1.1%

日系

98.0

%

外資系

2.0%

米国系

73.3

%

欧州系

24.0

%

日系

2.6%

外資系

97.4

%

米国系

84.9

%

欧州系

15.1

%

日系

0.0%

外資系

100.0

%

Vascular stents Prostheses

Flexible endoscopes

Radiotherapy devices

MRIs

米国系

97.4

%

欧州系

1.4%

日系

1.2%

外資系

98.8

%

Diagn

ostic

device

The

rapeu

tic d

evice

466

billion yen

118.1

billion yen

640.9

billion yen

487.8

billion yen1,405.9

billion yen

米国系

24.9

%

欧州系

51.1

%

日系

24.0

%

外資系

76.0

%

Ultrasound imaging devices

554.6

billion yen

Japanese

Japanese

European

JapaneseJapaneseJapanese

Foreign

Foreign

Foreign

ForeignForeignForeign

Japanese

European

European

EuropeanEuropeanEuropean

American

American

American

AmericanAmericanAmerican


医工連携事業化推進事業Overall image of the policy on the medical device industry promoted by the Ministry of Economy, Trade and Industry

●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 to facilitation 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 in medical practice

(Commercialization Promotion Project for Medical-engineering Collaboration: approx. requested amount in FY 2018 is 3.45 billion yen)

●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

●Improvement of business environment・Scheme to extract clinical needs・Preparation and popularization of a guidebook on the supply 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.)

Market development,design/concept design

Development/clinical trialProduction/service supply

SalesMarketing

7



8

Commercialization Promotion Project for Medical-engineering Collaboration (Medical-engineering Collaboration Project)

[Development business] (Since 2010）

Approx. requested amount in FY 2018: 3.45 billion yen

Annual maximum amount: 80 million yen/up to three years in principle

Auxiliary business (2/3) (enforced by AMED)

[Software support business (= Support Network for Medical Device Development)] (Since October, 2014)

(1) Accompanying consultation

(3) Idea box (Scheme to extract medical needs)

(2) Product evaluation service

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



9

[Breakdown]*Since there are cases where multiple products are included in one case,

the total breakdown does not match the number of cases.

Information on domestic productsInformation on overseas

products

Field Case number Class I Class II Class III Class IVClass

unknown/non-medical device

Medical deviceNon-medical

device

1. Surgical support robots/systems 2 1 1 2

2. Artificial tissue/organs 24 1 15 6 1 19 13. Minimally invasive therapy 36 7 12 10 10 1 20

4. Imaging (diagnostic imaging) 12 3 8 1 2 1 11 1

5. Medical devices for home use 12 4 8 3 1 9 1

6. Other medical devices 53 18 21 13 6 12 38 6

7. Non-medical devices 8 8 5

Total 147 33 50 42 24 25 99 14*Excluding two cases for which the answer was provided collectively with different case numbers

Overhead view of adoption for Medical-Engineering Collaboration Project

(analysis of 149 cases * in total)

(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.

*：Corrected in FY 2010 – adopted in FY 2016

Adopted challenges to class III and IV therapeutic devices



10

468

901 811

1,143

468

1,370

2,181

3,324

0

500

1,000

1,500

2,000

2,500

3,000

3,500

0

500

1,000

1,500

– FY 2013 FY 2014 FY 2015 FY 2016

Domestic and overseas sales(million yen)

Domestic and overseascumulative sales (million yen)

Product launch data on the Medical-Engineering Collaboration Project

Source: Prepared based on the follow-up survey in FY 2016 and FY 2017.

(Note) The sales of launched products (actual results) completed by FY 2016 are tabulated. For business assignment projects not covered by the survey 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 the total as sales.

59 products/approx. 3.3 billion yen (October, 2017)

Japan Overseas(Medical devices) 31 products 5 products (19 products)

Class I 14 productsClass II 11 productsClass III 3 productsClass IV 3 products

(Non-medical devices) 20 products 3 products51 products 8 products (22 products)

*When a device is sold in different countries/regions, it is counted as multiple products.



11

Significance of the Medical-engineering Collaboration Project

In the era when the country's medical device demonstration project was focused on R&D derived from seeds utilizing advanced technologies from large enterprises, a demonstration project aimed at commercialization was started in FY 2010, giving importance to medical device development to meet the needs of medical practices utilizing manufacturing technologies from small and medium-sized enterprises.

Development derived from seeds

R&B

Development derived from needs

Commercialization

State-of-the-art technologies of large

enterprises

Manufacturing technologies of small and

medium enterprises



12

Conditions for public recruitment to promote commercialization

CommunitySmall and medium

enterprises with manufacturing technologies

Medical institutions

Must

Must

Must

Application

・ Pharmaceuticals and Medical Devices Agency (PMDA)・ Food and Drug Administration(FDA)

・ Third party certification organizations, etc.

Approval, certification

Customer(domestic, overseas)

Wholesale company agency

University/research institute

Manufacturing and sales

company

*Scheduled acquisition during the

project period is also possible

Sales

For commercialization, [manufacturing and sales companies] are required in addition to [medical institution] + [small and medium enterprises]

Acceleration of commercialization through community building⇒medical institutions (needs) + small and medium enterprises with

manufacturing technologies (technologies) + manufacturing and sales company (sales)



13

Features of Medical-Engineering Collaboration Project (⇒accompanying consultation)

[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

Market explorationConcept design

Development/testing

Manufacturing/ service supply system

Sales/marketing

Business/overseas strategy

Production/intellectual property strategy

Regulation correspondence

Marketing/finance strategy

Accompanying consultation

Launch(Continuous support by specialized consultants from the

initial stage of development to commercialization)

In order to accelerate commercialization, it is important to provide consultation in all sectors, including approval application, intellectual property, insurance reimbursement from the beginning of business

Acceleration of commercialization not only by development finance support but also by accompanying expert consultation



14

Spin-out of software support business

(1) Accompanying consultation

(3) Idea box (scheme to extract medical needs)

(2) Product evaluation service

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.

[Business contents of the Support Network for Medical Device Development ]

Created a service that anyone can use

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 to solve the issue (How)“, paid experts and support services are introduced.

A service that multiple medical staff in the specialized field evaluate in-house medical devices. Started for a fee in FY 2017.



15

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

Clarifying failure patterns and making them known to everyone

[Source] Guidebook for medical device commercialization through medical-engineering 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

⇒To obtain case study materials⇒contact [email protected]

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