From Professor Kiyokazu Nakajima, MD, PhD, FACS
Research and Development of Minimally Invasive Medical Devices by Industry-Academia-Government Collaboration
At research and development (R&D) of medical devices, it is indispensable to have a substantial collaboration of clinicians who can extract and send out the problems and/or unmet needs encounter in their clinical practice, manufacturing companies and sales company with the ability to solve the problems/needs and bring the products into the world and other experts in intellectual property or medical device regulations. It is inefficient to launch a team each time we start a new R&D, the know-hows we obtained would not accumulate. R&D platform or R&D complex is thus required to function sustainably.
In 2008, we started as a small research group called “ENGINE” within the Department of Gastroenterological Surgery at The University of Osaka for the purpose of pursuing innovative R&D of medical devices for minimally invasive diagnosis and treatment. ENGINE stands for Endeavour for Next Generation of INterventional Endoscopy; it represents our strong intention to pioneer the next generation of ultra-minimally invasive therapeutic field through R&D of medical devices. Although it was a small industry-academia collaboration project of only 6 companies to start with, we adapted the epochal “open innovation” community system and performed many challenging R&Ds in medical devices. Four years later, in 2012, our group grew up as Department of Next Generation Endoscopic Intervention at Osaka University with 10 companies participating. Supported by more doctors and more companies, our department is now functioning as a unique R&D “platform” with over 20 companies and over 50 supporting clinicians on and off Osaka University.
Our department sent out 20 medical devices so far and made incomparable achievements as a medical device R&D consortium lead by academia. Among these achievements include some nationwide top selling products used in operating rooms and endoscope suites. We hold our position as joint research group and share our research results and have applied for over 150 joint patents. In order not to complete R&D of medical devices as just manufacturing, we also have a mission to work on education in human resource development and scientific activities as part of important duty of being a department of University.
Hope you come back to find our latest work!
Kiyokazu Nakajima, MD, PhD, FACS
Professor
Department of Next Generation Endoscopic Intervention (Project ENGINE)
Graduate School of Medicine, The University of Osaka, Osaka, Japan
Department of Gastroenterological Surgery, Graduate School of Medicine, The University of Osaka, Osaka, Japan
- 1992
- M.D., Osaka University Medical School
- 1999
- Ph.D., Osaka University Graduate School of Medicine
- 2001
- Postdoctoral Associate in Surgery, Department of Surgery,
Weill Medical College of Cornell University, New York, NY, USA - 2004
- Chief, Section of Colon and Rectal Surgery, Osaka Rosai Hospital
- 2006
- Assistant Professor of Surgery, Department of Surgery, Osaka University Graduate School of Medicine
- 2010
- Lecturer, Osaka University Medical School
- 2012
- Associate Professor, Department of Surgery, Osaka University Graduate School of Medicine
- 2012
- Professor, Department of Next Generation Endoscopic Intervention, Osaka University Graduate School of Medicine
Professional Organizations and Societies
- Japan Surgical Society (Board Certified Surgeon, Board Certified Supervisory Surgeon)
- Japanese Society of Gastroenterological Surgery (Council, Board Certified Surgeon, Board Certified Supervisory Surgeon, Board Certified Surgical Oncologist)
- Japan Society for Endoscopic Surgery (Council, Laparoscopic Skill Certification, Medical Engineering Collaboration Committee Advisor)
- Japanese Board of Cancer Therapy (Certified Instructor, Board Certified Cancer Therapist)
- Japanese Society of Gastroenterology (Board Certified Gastroenterologist)
- American College of Surgeons, Fellow (FASC)
- Society of American Gastrointestinal and Endoscopic Surgery (SAGES)(Member)
- European Association for Endoscopic Surgery (Technology Committee member)
- Endoscopic and Laparoscopic Surgeons of Asia (Vice Chairman of Asian Innovation Committee)
- World Endoscopy Organization (Surgical Endoscopic Committee member)
- Japanese Gastric Cancer Association, The Japan Esophageal Society, The Japan Society of Coloproctology, Japan Surgical Association, Japan Gastroenterological Endoscopic Society, J-CASE (Faculty, Future Committee), Japan TANKO Society (Council), Japan LECS (Council), Kinki Surgical Association (Council), The Kinki Society for Endoscopic Surgery (Faculty), Japanese Society of Medical Instrumentation, Japan Medical Association Certified Occupational Physician
Area of Expertise
- 1. Gastroenterological Surgery
- 2. Minimally Invasive Surgery
- 3. Functional Gastrointestinal Diseases and Motility Disorders
- 4. Inflammatory Bowel Diseases (Crohn’s Disease, Ulcerative Colitis)
- 5. Surgical Oncology especially in Gastrointestinal Stromal Tumors
- 6. Minimally Invasive Endoscopic Treatments and Related Medical Devices
- 7. Education, especially in Effective Endoscopic Surgery Training
- 8. Human Resource Development for Medical Device R&D
- 9. R&D of Medical Devices for Universal Health Coverage
- 10.International Standardization and Global Deployment of Medical Devices
Achievements (as of April 1, 2026)
- Publications
- 40 English papers (including 23 original articles), 82 Japanese papers, 7 English Surgical Text Books, 15 Japanese Medical Text Books
- Conference Presentations
- 365 talks as main speaker (248 domestic, 117 international meetings)
- Intellectual Property
- Patent: 160 applications, 65 Patent registrations (10 in US, 7 in CN and 8 in EPC and 40 in JP)
Design Rights: 20 registrations
Trademarks: 3 registrations - Honors
-
2009 DDW Crystal Award, USA
2013 MEDTEC Japan MEDTEC Innovation Award
2013 Monodzukuri Nippon Grand Award Special Award
2014 Resona Small and Medium Enterprise Promotion Foundation Small and Medium Enterprise Excellent New Technology/New Product Award, Industry-Academia-Government Collaboration Special Award
2014 Osaka University President's Award
2018 Ogami Award, Japan Society of Endoscopic Surgery
2019 Ozawa Award from the First Department of Surgery Alumni Association (Kyusenkai) of Osaka University
2020 Good Design Award "Fluorescent Ureteral Catheter"
2021 Certificate of Appreciation for Policy Meritorious Service from the Kinki Bureau of Fconomy, Trade and Industry
2022 Japanese Society of Medical Devices Authorship Award
2023 Furukawa Medical and Welfare Equipment Promotion Foundation Award
2023 Best Doctors® Award
2023 Innovation Producer, Small and Medium Enterprise Agency
2024 WILEY Publisher TOP Cited Article 2022-2023
2025 Osaka Chamber of Commerce and Industry MDF Medical Engineering Co-creation Award JAPAN Special Award
- Competitive Research Funds :
- Ministry of Economy, Trade and Industry; Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labor and Welfare; Japanese Society for Promotion of Sciences; National Federation of Small Business Associations; Private Grants and other International Subsidies