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

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

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

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

Aso Iizuka Hospital

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 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

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

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

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

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)

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)

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

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

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.

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

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

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

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

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

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 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 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

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.