Results and Achievements

Human Resource Development Achievements

Number of Total MDP Training Program Participants

Name of Course Training Period Number of Participants Breakdown of Participants
Needs Exploration Training (1st Term) November 2017 - October 2018 11 11 from companies
Medical Device Development Expert Training (2nd Term) May 2018 - February 2019 12 11 from companies, 1 development support specialist
The 3rd MDP Training Program Entry Course I October 2019 - March 2020 18 15 from companies, 3 healthcare professionals
The 3rd MDP Training Program
Entry Course II
June 2020 - April 2021 6 4 from companies, 2 healthcare professionals
The 4th MDP Training Program Entry Course I November 2020 - March 2021 13 7 from companies, 6 healthcare professionals
The 5th MDP Training Program Entry Course I May 2021 - November 2021 18 10 from companies, 5 healthcare professionals, 1 engineering researcher, 1 development support specialist, 1 medical student
The 4th MDP Training Program Entry Course II November 2021 - August 2022 13 7 from companies, 4 healthcare professionals, 1 engineering researcher, 1 development support specialist
The 6th MDP Training Program Entry Course I May 2022 - July 2022 14 9 from companies, 3 healthcare professionals, 1 engineering researcher, 1 engineering student
The 5th MDP Training Program Entry Course II November 2022 - August 2023 7 4 from companies, 1 healthcare professional, 1 engineering student, 1 medical student
The 7th MDP Training Program Entry Course I May 2023 - June 2023 24 13 from companies, 9 healthcare professionals, 2 development support specialists
The 6th MDP Training Program Entry Course II November 2023 - March 2025 4 3 from companies, 1 healthcare professional
The 8th MDP Training Program Entry Course I May 2024 - August 2024 15 10 from companies, 3 healthcare professionals, 1 development support specialist, 1 medical student
The 7th MDP Training Program Entry Course II November 2024 - (currently in progress) 5 2 from companies, 3 healthcare professionals,
The 9th MDP Training Program Entry Course I May 2025 - July 2025 16 10 from companies, 4 healthcare professionals including 2 working graduate students, 1 development support specialist, 1 agriculture student
Total 176 116 from companies, 44 healthcare professionals, 7 development support specialists, 3 engineering researchers, 3 medical students, 2 engineering students, 1 agriculture student

* "Needs Exploration Training (1st Term)” and “Medical Device Development Expert Training (2nd Term)” were the predecessor programs of the MDP Training Program Entry Courses I and II.

Medical Devices and Other Equipment Developed in Collaboration Under the Framework

Joint development of the “Safety Forceps”

Mr. Sotaro Ishihara, a clinical engineer at the Clinical Engineering Department of Kobe University Hospital, collaborated with Nara Seiko Inc. to jointly develop the “Safety Forceps” (Medical Device Notification Number: 29B1X00001000102), a tool designed to prevent accidental cutting of dialysis tubes during dialysis procedures.

Feature Article Published: “Medical Device Innovation through the Japanese-Style Ecosystem”

On June 23, 2023, Harvard Business Review published an interview article titled “Medical Device Innovation through the Japanese-Style Ecosystem” featuring Kobe University.
Professors Takahiro Yasuda and Yoshihiro Muragaki from the Graduate School of Medicine Department of Medical Device Engineering and the Center for Advanced Medical Engineering Research & Development (CAMED), discussed the formation of a Japanese-style ecosystem and the future direction of innovative medical device development.

Joint Development of an Otolaryngology Videoscope

On June 26, 2023, Nipro Corporation and its subsidiary, MACHIDA Endoscope Co., Ltd., together with Professor Kenichi Nibu from the Department of Otolaryngology–Head and Neck Surgery, Part-time Lecturer Dr. Go Inokuchi from the Division of Medical Device Systems, Department of Medical Device and Systems Development, Graduate School of Medicine, and Specially Appointed Professor Yoshiaki Fujiwara from the Device Development Promotion Division of the Kobe University Center for Advanced Medical Engineering Research and Development, announced the joint development of an otolaryngology videoscope.

OFDI Intravascular Imaging System

In collaboration with Terumo Corporation, we successfully expanded the clinical application of the OFDI (Optical Frequency Domain Imaging) Intravascular Imaging System, which uses near-infrared light to visualize cross-sectional images of blood vessels. Previously, its use had been limited to the coronary arteries of the heart. However, in June 2021, regulatory approval under Japan’s Pharmaceuticals and Medical Devices Act (PMD Act) was obtained for use in the lower limb arteries—from the thigh to below the knee—and in November of the same year, the system was approved for insurance coverage. Among optical coherence-based diagnostic devices employing similar principles, the OFDI system became the first in Japan to receive approval for use in lower limb arteries. The project was initiated by the hospital’s Department of Cardiovascular Medicine and achieved approval following a physician-led, multicenter clinical trial.

Software for Real-time Detection of Non-Convulsive Epileptic Seizures in EEG

On October 10, 2020, the final round of the 3rd MedTech Grand Prix KOBE, a contest focused on next-generation health and medical technologies, was held with 12 finalist teams selected from 106 applicants. The team “Protect Kid’s Brain,” led by Professor Hiroaki Nagase (Department of Pediatrics, Division of Pediatric Acute Diseases, Graduate School of Medicine, Kobe University), presented their project under the theme “Protecting Children’s Brains and Hearts from Non-Convulsive Epileptic Seizures.” The team received the ExaWizards Award, presented by the sponsor company ExaWizards Inc., and also won first place in the audience vote. This project is being advanced through medical-engineering collaboration with Professor Zhiwei Luo from the Graduate School of System Informatics. Moving forward, the team plans to integrate the software into existing electroencephalography (EEG) devices and evaluate its performance in clinical settings.

(Photo: From left — Mr. Ko Ishiyama, President and CEO of ExaWizards Inc.; Professor Hiroaki Nagase; Professor Zhiwei Luo.)

Active Mask for Infection Control against COVID-19 and Other Viruses

On August 6, 2020, Professor Tomoo Ito of the Department of Pathology and Division of Diagnostic Pathology, Kobe University Hospital, and Matrix Co., Ltd. jointly developed an active mask designed to help prevent infections such as the novel coronavirus (COVID-19) in medical and clinical settings.

Active Mask for Infection Control against COVID-19 and Other Viruses

“Easy O₂ Tiger”: Dedicated Timer for Medical Oxygen Cylinders

Hiroshi Kato, Deputy Director of the Medical Technology Department at Kobe University Hospital, served as a member of the development team for the “Easy O₂ Tiger,” a timer specifically designed for medical oxygen cylinders released by Shinwa Industrial Co., Ltd. He was responsible for identifying and analyzing medical needs throughout the development process.

Clean Unit for Infection Control against COVID-19 and Other Viruses

On June 11, 2020, Professor Tomoo Ito of the Department of Pathology and Division of Diagnostic Pathology, Kobe University Hospital, and Soda Kogyo Co., Ltd. announced the joint development of a clean unit designed to help prevent infections, including COVID-19, in various medical and clinical settings.

Absorbable Tissue Spacer for Radiation Therapy: Neskeep®

Professor Takumi Fukumoto (Department of Hepato-Biliary-Pancreatic Surgery) and Professor Ryohei Sasaki (Department of Radiation Oncology) at Kobe University Graduate School of Medicine, together with Alfresa Pharma Corporation, successfully developed the absorbable tissue spacer for radiation therapy, Neskeep®. The device received regulatory approval in December 2018 and was launched commercially on June 27, 2019. In 2019, Neskeep® was added to insurance coverage. After spacer placement prior to particle therapy became reimbursable, as of September 2023, spacer placement before X-ray therapy is also covered by insurance.
(Approval Number: 23000BZX00381000)