1. Roles of Clinical Engineers in Medical Device Development at Hospital
Hiroki IGETA 1), 2)
1) Aso Iizuka Hospital,
2) Japan Association for Clinical Engineers
Fourth WHO Global Forum on Medical Devices

2. Disclosure The presenter declares no conflict of
interest with the materials provided.

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

4. Hyperbaric Oxygen Therapy
Clinical Engineer
Japanese Clinical Engineers are not only working for the management and maintenance of medical devices, but also for operating them especially life support machines such as heart-lung machines, respirators, haemodialysis machines, hyperbaric oxygen therapy,
cardiac pacemakers, etc..
Hemodialysis
Heart-Lung Machine
Intensive Care
Operation Room
Endoscopy
Arrhythmia Therapy
Hyperbaric Oxygen Therapy

5. Aso Iizuka Hospital

6. Aso Iizuka Hospital Establishment : Hospital Division :
Number of Beds :
Number of Wards :
Number of Staff :
Clinical Departments :
1918
Community Health Care Support Center
1048 (General : 978 Psychiatry 70) 31
Physicians 　 312
Nurses 　 1065
Technicians
(Clinical Engineers )
Others 　
Total 　2384 42
Hepatology, Respiratory Medicine, Respiratory Oncology, Psychosomatic Medicine, Endocrinology Diabetes & Metabolism Medicine, Gastroenterology, Hematology, General Internal Medicine, Rheumatology, Palliative Care, Radiology, Radiation Oncology, Psychiatry, Pediatrics, Nephrology & Hypertension, Cardiology, Surgery, Orthopedic Surgery, Dermatology, Urology, Obstetrics & Gynecology, Ophthalmology, Ear Nose & Throat, Pediatric Surgery, Neurosurgery, Dentistry & Oral Surgery, General Thoracic Surgery, Thoracic Surgical Oncology, Cardiovascular Surgery, Neurology, Kampo Medicine, Emergency Medicine, Critical Care Medicine, Traumatotherapy, Plastic & Reconstructive Surgery, Physical Medicine & Rehabilitation, Anesthesiology, Surgical Pathology & Cytology, Clinical Oncology

7. Example of Our Clinical Fields
HTM
Haemodialysis
Operation Room
Operation Assistance
Perfusion
Intensive Care
Cardiac Catheter (intervention)
Hyperbaric Oxygen Therapy
Capsule Endoscopy (Interpretation)
Pacemaker Clinic
Endoscopy
Staff Education

8. Dept. of Clinical Engineering Innovation Promotion Office
Roles of Clinical Engineering at AIH
Apheresis Centre
Operation Room
Perfusion
Endoscopy Centre
Cardiac Cath. Lab
Dept. of Clinical Engineering
ME Centre
(HTM)
HBOT
ICU
Hemodialysis
Centere
NICU
Cardiac Rhythm Management (Pacemaker, ICD, CRT)
Kaita Hospital
(Group Hospital)
Innovation Promotion Office

9. Innovation Promotion Office (IPO)
・ Device Development
　　1) Device development or modification based on AIH
clinical needs and ideas
　　　　　・ in house
　　　　　・ ordering to manufacturers
　　　　　・ joint development with manufacturers
　　2) Referral cases
・ To support acquiring IP for hospital staff
・ Prototyping, making simple devices
・ Needs survey entrusted by manufacturers
・ Device assessment entrusted by manufacturers
Staff : 1 Physician, 2 Clinical Engineers, 2 Administrators

10. AIH IPO Workshop A base of AIH Innovation activities
Socialization
AIH IPO Workshop
FIIの考え方をも参考に、AIHでも院内に工房を設け、ここを職員のイノベーション活動のプラットフォームとしている。
A base of AIH Innovation activities
(platform for needs and ideas excavation)

11. Database (Combined management)
Excavation of Needs and Ideas
Ideas and Needs Posting System
(can post from any of AIH intranet working PCs）
Other Sources
Clinical sites
Incidents
TQM
Parties, Drinking-out
Direct visits to IPO
Database (Combined management)

12. Searching marketed devices
Needs and Ideas Collection and Evaluation
Posting Site
Direct Visits
Interview
Observation
Needs Evaluation
Searching marketed devices
Prototyping

13. Commercialization through Collaboration
Searching partner manufacturers
Prototyping
Patenting
Clinical Tests
commercialization
Joint application agreement, Royalty contract
Joint Research Agreement, Joint Development Agreement
NDA

14. Clinical immersion programme in Iizuka region
　iizuka medicolabo
medicolabo : medical＋collaboration＋laboratory
Clinical immersion programme in Iizuka region
The fellows can access and observe our clinical fields during the program. It will help them to understand practical clinical sites and also to find “unmet needs”.
<Target>
Manufacturers
Researchers
Students etc.

15. iizuka medicolabo Expanding Our Innovation Activities in Iizuka Region
A joint program of 3 hospitals in Iizuka City
Organiser : IPO of Aso Iizuka Hospital

16. Acute Hospital with Advanced Emergency Medical Centre
　iizuka medicolabo
No. of Beds
1,048
General 978
Psychiatric　70
250
General 50
Community Care 50
Rehabilitation 50
198
General 108
Community Care 26
Rehabilitation 44
Palliative Care 20
No. of Dept. 42 15 16
No. of Staff
2,345
354
241
Features
Acute Hospital with Advanced Emergency Medical Centre
Acute Care
Post Acute Care
Palliative Care
Advanced DM Treatment

17. iizuka medicolabo THE YOMIURI SHIMBUN Opens hospital’s clinical sites
“Collaboration” for medical device development
Opens hospital’s clinical sites
for medical device development

18. meeting the clinical needs
To benefit patients
To promote the quality of medicine
To produce new devices
meeting the clinical needs
Improve the brand of Aso Iizuka Hospital
and its magnetism
Provide our patients with high-quality
medical care services through innovation

19. Innovation Activities of Japan Association for Clinical Engineers JACE Medical-Academia-Industrial Collaboration Committee (established in 2016)

20. 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.

21. Activities of the Committee
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

22. Activities of the Committee
To expand CEs’ fields and opportunities
　 ・ Medical device development could be a new field to use
CEs’ engineering skills and their medical knowledge.
Population Trends of Japan
Number of Beds
Number of Clinical Engineers
Data from “Bureau of Statistics of the Ministry of
Internal Affairs and Communications”
Data from the Ministry of Health, Labour and Welfare

23. Conclusion
Majority of Japanese clinical engineers work in active medical fields.
Clinical engineers can play their roles in medical device development using CEs’ engineering skills and their medical knowledge gained through experience in practical clinical fields.