Development Environment for medical
devices in Japan and the United States:Impact on current activities and the roles ofclinical engineering (CE)

June 11 | 8:00-9:00
Hiroki Igeta, MSc, BEng, CCE 1) 2)
Aso Iizuka Hospital 1)
Japan Association for Clinical Engineers (JACE) 2)© 2017 Association for the Advancement of Medical Instrumentation www.aami.org

Agenda・ Introduction of clinical engineer system in Japan・ Recent movement of medical device development in Japan・ Intellectual properties and medical professions
・ JACE Medical-Academia-Industrial Collaboration Committee

The author has no conflict of interest to disclose concerning the presentation.

Introduction of Clinical Engineer
System in Japan

Clinical Engineers : Japan・ Clinical Engineer License System
Established in 1987
National License・ Education
4 years education in universityor
3 years education at a polytechnic college

The Facts
Operating Equipment in the Clinical Environment
•••
•
•
•
••
•
•

40%

Respiratory therapy
Perfusion (HEART-LUNG machine)
Dialysis (Dialysis equipment)
Operative treatment (Surgical equipment)
Intensive care units
Cardiac catheterization
Hyperbaric oxygen therapy
Other treatment (defibrillators)
Pacemakers
Implantable cardioverter defibrillators (including CRT-D)

Service Delivery Management

20%

Patient Safety

20%

Healthcare Technology Management (HTM)

20%

Our Clinical Fields(a case of Aso Iizuka Hospital)

HTM

Haemodialysis

Operation RoomPerfusion

Intensive Care

Endoscopy

Cardiac Catheter(intervention)

Hyperbaric Oxygen Therapy

Operation AssistanceCapsule Endoscopy(Interpretation)

Pacemaker Clinic

Staff Education

Recent Movement of Medical
Device Development in Japan

Japanese Medical Device Market
US (17)

USGermany (4)

Japan
27%

39%

Germany

1%France

2%

China

20%
8%
3%Italy

10%UKCanada

3% 4% 4%

OthersMarket Size of Medical Device

Japan (3)21%Netherland (1)

2%

51%

France (1)2%4%Ireland (1)3%

Switzerland (1)10%UK (1)Sweden (1)4%Other Manufacturers

Market Share of Top 30 Device Manufacturers

espicom "Medistat Worldwide Medical Market Forecasts to 2017"

Rodman Media "TOP 30 MEDICAL DEVICE MANUFACTURERS (by FY12 revenue)"

Japanese Market Size of Medical Device and the Import Rate

Domestic Market(billion JPY)

Import Rate(%)

Therapeutic

1256.451

Diagnostic

612.6

28

Total

2386.044

MHLW “Annual Report on Statistic of Pharmaceutical Industry”

Japanese Trade Balance of Medical Devices
billion JPY
1000

500

import
475

530

490

480

453

exportbalance

0-500
500
-602

-600

-578-698

1000
-1000
1075
1500
1000
-1500

20091055
20101058
201111882012-7701300
2013

Japanese Trade Balance of Medical Devices
Data from: MHLW “Annual Report on Statistic of Pharmaceutical Industry”

Recent Movement
Japanese government issued New Growth Strategy“Japan Revitalization Strategy - Japan is Back -“The policy is a mix of the “three arrows” for reviving
the Japanese economy:(1) Aggressive monetary policy(2) Flexible fiscal policy(3) A growth strategy that encourages private sector investment
From: The office of the Prime Minister of Japanbillion JPY≧65y/o20-64y/o0-19y/o60,00050,00040,00030,00020,00010,00002015

2020

2025

2030

2035

2040

Estimating Future Medical Expense in Japan
Data from “Japan Medical Association Research Institute”

Barriers of Device Development
Strict regulatory and time consuming approval process

Difficulty of fundraising

Seeds or academic oriented development

Lack of human resources in project management

The Situation is Changing
Strict regulatory and time consuming approval process
Central and local governments are implementing variety of aggressive
measures and taking strong actions

Difficulty of fundraising
Variety of public subsidies
Increasing public and private financing institutions

Seeds or academic oriented development
Some movement of shifting to needs oriented development

Lack of human resources in project management
Education courses in some universities
e.g. Biodesign course in three universities

Medical-Engineering Collaboration
Needs, Ideas

Industry

Hospital

Manufacturer
Small Enterprise
DealerPhysician
Nurse
Technician
Admin

Local government

R&D
Academia(university)

AMED
NEDO
PMDA
JAAME
etc.

R&D

AMED : Japan Agency for Medical Research and Development
NEDO : New Energy and Industrial Technology Development Organization
PMDA : Pharmaceuticals and Medical Devices Agency
JAAME: Japan Association for the Advancement of Medical Equipment

・ Poor evaluation of needs and ideas (clinical perspective)・ Lost in translation between the industry and clinical fieldExpected Roles of Clinical Engineers
in Device Development
・ Evaluation of needs and ideas
・ Translation between industry and the medical field・ Promotion of the activities

・ Gathering information and summarization

Intellectual Properties
and Medical Professions

Intellectual Properties
・ Patent (Patented invention)
・ Utility Model・ Design・ Trademark
Not many medical professions including physicians
and CEs are involved in medical device development
especially with IP strategies.

Cultural Background・医は仁術 i-wa-jinjyutsu
Medicine is benevolent act or humanitarian profession.

・ Japanese Medical Law
Notwithstanding the provisions of the preceding paragraph,the permission set forth in paragraph (1) may be refused toa person who wishes to establish a hospital, clinic orbirthing center for profit.
Article 7-4 of the Medical Care Act (Act No. 205 of 1948)

MedicineMoneyOther Factors
・ Most of hospitals, clinics don’t have any rules,

regulations or policies concerning IP.
(except university hospitals, national centres, etc.)

・ Medical professions serving for public institutes

may not be allowed to receive extra income(side job prohibition rule )Article 103 of the National Public Service Act (Act No. 120 of 1947)
Article 38 of the Local Public Service Act (Act No. 261 of 1950) etc.

Need to establish rules or policies concerning IP

Other Factors
・ Medical staff are busy especially physicians.
(The average Japanese physician’s work week : 63.3-70.6 hours)
No. ofDr/1000

No. ofNs/1000

No. ofbeds/1000

Japan

2.3

10.5

13.3

US

2.5

11.2

2.9

length of
hospital
Stay (days)*1

No. of
Dr/100beds(estimated)

No. ofNs/100beds(estimated)

17.2

17.3

78.9

6.1

86.2

386.2
*1 general ward only

Data from: OECD “Health-Statistics 2015”

・ Poor environment of medical device development

for medical professions. (e.g. consultation, agent)
JACE supports to improve the environment(2012)

JACE Medical-Academia-Industrial
Collaboration Committee(established in 2016)

Roles of the Committee
1) To promote medical device development
based on clinical needs
2) To support our members in device development
3) To expand CEs’ fields and opportunities

Activities of the Committee
1) To promote medical device development
based on clinical needs
・ Idea posting system on the web site of JACE・ Needs/idea evaluation service by committee
members and observers.

Activities of the Committee
2) To support our members in device
development
・ Introducing CEs’ needs and ideas
at medical-industrial matching events.

・ Introducing needs and ideas by CEs
at exhibitions, expos, trade shows

Activities of the Committee
3) To expand CEs’ fields and opportunities
・ Medical device development could be a new field to use
CEs’ engineering skills and their medical knowledge.
million140120kilo＜65y/o50,0001,800≧65y/o40,0001,600

100

30,000

80

1,400

60

40

20,000

1,200

10,000

20
1,000

0

Number of Clinical Engineers

Data from the Ministry of Health, Labour and Welfare

2025

2023

2021

2019

2017

2015

2013

2011

2009

2007

2005

2025

Number of Beds

2020

2015

2010

2005

2000

Data from “Bureau of Statistics of the Ministry ofInternal Affairs and Communications”

1995

Population Trends of Japan

1990

2035
2030
2025
202020152010
2005
2000
1995
1990
1985
1980
1975
1970
1965
1960
1955
1950

0

Conclusion
Majority of Japanese clinical engineers work in active medical fields

Japanese government encourages and promotes medical device
development under the new growth strategy.
Not many medical professions are involved in medical device
development especially with IP strategies.
Clinical engineers are expected to play their roles in medical device
development especially in medical-engineering collaboration.
JACE established the “Medical-Academic-Industrial Collaboration
Committee” to support the members in medical device development.

Thank you for your attentionSheep-Rin

Hiroki Igeta
Aso Iizuka Hospital

higetah2@aih-net.com