Roles of Clinical Engineers in Medical Device Development at Hospital

1. Roles of Clinical Engineers in Medical Device Development at Hospital Hiroki IGETA1), 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 • NationalLicense • ・ Education • 4 years education in university • or • 3 years education at apolytechnic college

4. Clinical Engineer Japanese Clinical Engineers are notonlyworking 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 Intensive Care Heart-Lung Machine Operation Room Endoscopy Arrhythmia Therapy Hyperbaric Oxygen Therapy

5. AsoIizuka Hospital

6. AsoIizuka 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 524 (Clinical Engineers 62) Others 493 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 Operation Assistance Operation Room HTM Haemodialysis Perfusion Cardiac Catheter (intervention) Intensive Care Hyperbaric Oxygen Therapy Capsule Endoscopy(Interpretation) Pacemaker Clinic Staff Education Endoscopy

8. Roles of Clinical Engineering at AIH Apheresis Centre Hemodialysis Centere Endoscopy Centre Cardiac Cath. Lab Dept. of Clinical Engineering ME Centre (HTM) HBOT Operation Room Perfusion ICU NICU Kaita Hospital (Group Hospital) Cardiac Rhythm Management(Pacemaker, ICD, CRT) 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 ・ joint development with manufacturers ・ To support acquiring IP for hospital staff ・ Prototyping, making simple devices ・ Needs survey entrusted by manufacturers ・ Device assessment entrusted by manufacturers Staff : 1Physician, 2 Clinical Engineers, 2 Administrators

10. Socialization AIH IPO Workshop A base of AIH Innovation activities (platform for needs and ideas excavation)

11. 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. Needs and Ideas Collection and Evaluation

13. Commercialization through Collaboration commercialization Joint application agreement, Royalty contract Joint Research Agreement, Joint Development Agreement NDA

14. 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. iizuka medicolabo

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

18. 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 Activitiesof Japan Association for Clinical EngineersJACE Medical-Academia-Industrial Collaboration Committee(established in 2016)

20. Activities of the Committee 1) To promote medical device development based on clinical needs ・Ideaposting 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. Number of Beds Population Trends of Japan Number of Clinical Engineers Data from “Bureau of Statistics of the Ministry of Internal Affairs and Communications” Data from the Ministry of Health, Labourand 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.