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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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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[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
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
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.
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
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
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
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)
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
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
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
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.
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
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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]