Roles of Clinical Engineers
in Medical Device Development
June 5 | 10:00-11:00
Hiroki Igeta, MSc, BEng, CCE 1) 3)
Jun Yoshioka, M.P.A.S, CCE 2) 3)
ASO Iizuka Hospital 1)
Yamagata University Hospital 2)
Japan Association for Clinical Engineers (JACE) 3)© 2016 Association for the Advancement of Medical Instrumentation www.aami.org

Agenda・ Clinical engineer system in Japan・ Recent movement of medical device development in Japan・ Expected roles of CEs in medical device development
・ Introduction of a case of ASO Iizuka Hospital as an example

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%

Japan Association for Clinical Engineers(JACE)
JACE was established under the approval of the Ministry of Health,
Labor, and Welfare (MHLW) in March 2002.
The objective of JACE is to contribute to the promotion and development of
the nation’s medical care and welfare through the raise of professional ethics ofCEs, enhancement of their professional knowledge and skills, andimprovement of reliability of equipment-based medical care and welfare,including life-support systems.

35,000 licensed Clinical Engineers in Japan
15,000 of them are the members of JACE

Social Mission of CE

Japanese Medical Device Market

Market Size of Medical Device
espicom "Medistat Worldwide Medical Market Forecasts to 2017"Market Share of Top 30 Device Manufacturers
Rodman Media "TOP 30 MEDICAL DEVICE MANUFACTURERS (by FY12 revenue)"

Japanese Market Size of Medical Device and the Import RateMHLW “Annual Report on Statistic of Pharmaceutical Industry”

Japanese Trade Balance of Medical Devices

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 -“in 2013
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 Japan

Three Action Plans of“Japan Revitalization Strategy”“Japan Revitalization Strategy” sets three action plans detailing concrete
initiatives for the realization of growth:

From: The office of the Prime Minister of Japan(http://japan.kantei.go.jp/96_abe/documents/2013/1200485_7321.html)

Market Size

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

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

Government Policies
in Medical Device Industry(Ministry of Economy, Trade and Industry)

Device development through medical-engineering collaboration
Promoting new entrants from outside industry or start-up companies
Promoting device development based on clinical needs
Most advanced medical device development
Promoting advanced medical technologies by “industry-governmentacademia” collaboration
Business environment improvement to meet regulatory system
Capturing medical device market abroad

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

・ Poor evaluation of needs and ideas (clinical perspective)・ Lost in translation between the industry and clinical fieldWhy Clinical Engineer?
• Specialized in medical devices
HTM
Safety Education for staff and patientsEngineering knowledge• Working in the clinical fieldRespiratory 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)

Medical knowledge

Close relationshipwith physicians,
nurses, other medicalprofessions.

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

JACE and Prefectural Association for CE
Introducing needs and ideas by clinical engineers at exhibitions,
expos, trade shows
Introducing needs and ideas at medical-engineering collaboration
matching events

http://www.hospital-expo.jp/

http://www.medtecjapan.com/

JACE and Prefectural Association for CE
What are the advantages for hospitals? CE?
IP?
Need to establish a continuing mechanism.

JACE is considering to establish a new board or commission
for medical innovation and medical-industrial collaboration.

Case of ASO Iizuka Hospital
Establishment :Hospital Division :Beds :
Wards :
Staff:

August 1918
Community Health Care Support Center
1116 beds
32 wards
Physician
298
Nurse
1103
Technician
533(Clinical Engineer65)
Administrator, etc.
517
Total

2451

Clinical Department: 39
Internal Medicine, Hepatic Medicine, Gastrointestinal Medicine, Respiratory Medicine,
Endocrine & Diabetic Medicine, Blood Medicine, Primary Care Medicine, Psychosomatic Internal Medicine,Collagen Diseases &Rheumatism Medicine, Radiology, Psychiatry, Pediatrics, Nephrology, Cardiology,
S u r g e r y, D i g e s t i v e O r g a n S u r g e r y, R e s p i r a t o r y O r g a n S u r g e r y, P e d i a t r i c S u r g e r y, O r t h o p e d i c s ,Dermatology, Plastic Surgery, Urology, Obstetrics & Gynecology, Ophthalmology, Otorhinolaryngology,
Neurosurgery, Neurology, Cardiovascular Surgery, Dentistry & Oral Surgery, KANPO medicine, Anesthesia,
Rehabilitation, Pathology, Emergency Section, etc.

a case of ASO Iizuka Hospital

Roles of Clinical Engineers in AIH
Apheresis Center

Operation RoomPerfusion
Endoscopy Center

Cardiac Cath. Lab

ICU

Hemodialysis
Center

Dept. of Clinical Engineering
ME Center(management and maintenance)

HBOT

NICU

Cardiac Rhythm Management(Pacemaker, ICD, CRT)

Kaita Hospital(Group Hospital)
Innovation Promotion Officea case of ASO Iizuka Hospital

Innovation Promotion Office・ Needs and Ideas Management
・ Intellectual Property Management
・ Education
・ Medical Engineering Partnership(Local government, university and AIH)

・ Coordination with Partner Institutes

Staff
Physician1

Clinical Engineer3

Administrator3

a case of ASO Iizuka Hospital

What can we do as a hospital?
Needs Finding

Idea

Needs Evaluation

Prototyping

Idea Generation

Animal Test

Idea Assessment

Preclinical Test

IP Survey

Clinical Trial

Patenting

Regulatory

Idea Identifying

Into the Market

Advantages as a hospital

Could be possible
as a hospitala case of ASO Iizuka HospitalIndustry-Government-Academia Collaboration

Medical-Engineering Collaboration

Industry

Conclusion
Majority of Japanese clinical engineers work in active medical fields
Japanese government encourages and promotes medical device
development under the new growth strategy.
Industry-government-academia collaboration and medical-engineeringcollaboration are promoted and are now practiced in many areas.
Clinical engineers are expected to play their roles in medical device
development especially in medical-engineering collaboration.
• Needs and ideas collection and evaluation• Interpreter between the industry and clinical field• Promotion using the networks though the organizations

Thank you for your attention

Sheep-Rin

Hiroki Igeta
ASO Iizuka Hospital

higetah2@aih-net.com