2026 Academic Year
Entry Course II of the 7th Medical Device Producer (MDP) Development Program, launched in November 2024, was attended by five participants, including corporate professionals who had completed Entry Course I, healthcare professionals, and physicians. The course consisted of 10 workshop-style sessions, conducted primarily online with some sessions held in person. As part of a Project-Based Learning (PBL) program in medical device development, participants engaged in simulated exercises covering the process from identifying clinical needs to developing device concepts. Based on needs information provided by physicians, participants repeatedly discussed and refined their ideas with physician and other expert tutors.
As part of the PBL program, participants visited clinical settings in interventional radiology (IVR), gastrointestinal endoscopy, and hepatobiliary-pancreatic surgery in February 2025. In March 2026, they participated in a mock consultation on medical device reimbursement led by Dr. Manabu Sasada, Assistant Professor at the Hiroshima Clinical Research and Development Support Center at Hiroshima University Hospital. In April, with the cooperation of the Pharmaceuticals and Medical Devices Agency (PMDA), they also participated in a mock consultation on regulatory affairs.
The course concluded with a final presentation session in May 2026.
・I appreciated the opportunity to learn how to efficiently gather, evaluate, and organize information within a limited amount of time.
・It was valuable to have the opportunity to learn how to identify and draw out needs directly from healthcare professionals working in clinical settings.
・I appreciated being able to learn about areas that was not covered in Entry Course I, particularly through the mock consultations on regulatory affairs and medical device reimbursement.
・One challenge was that the goals were not clearly defined, and because my knowledge had not yet been fully consolidated, communication within the team was sometimes difficult.
・It was challenging that we were not members of the same organization, which made it more difficult to establish communication rules and maintain regular opportunities for communication.
・Having highly capable team members helped us overcome some of the difficult tasks. However, there were periods when the project did not move forward or when there were long gaps between activities, making it difficult to maintain focus. I also felt that the needs we identified were relatively limited, which may have made it difficult to generate truly innovative ideas.
・In my usual work, I do not have opportunities to visit medical institutions, so this was a valuable experience.
・I found it very valuable to have the opportunity to simulate the R&D process, from identifying clinical needs to considering regulatory affairs and reimbursement.
・It was valuable to have the opportunity to hear directly from physicians working in clinical settings and the tutors involved in the program.
・I realized that it is impossible to move everything forward entirely on my own, and I developed a mindset of seeking help from people I can rely on.
・The course further increased my motivation to pursue medical device development.
・Since I had not previously worked with specified medical materials, I became interested in taking on the challenge.