Introduction of Medical Device Development through Industry–Academia Collaboration by the Hamamatsu Method

To develop medical devices, collaborations are necessary between universities and hospitals that have technological problems and companies with the appropriate technological facilities to solve these problems. Large companies do not generally compete in niche markets, where large sales and profits are not expect-ed, which then become the target for small and medium enterprises (SMEs). In this study, the “ Mono-Dzukuri region ” was considered because of its dense concentration of universities or hospitals and SMEs. However, interventions by industry–academia collaboration coordinators (CDs) are required to ensure smooth collaborations between academia and SMEs that are unfamiliar with medical device development as well as companies that lack market presence in the medical device field. In this study, the Hamamatsu area, a locality that is actively engaged in medical device development through collaborations, was evaluated for different hypotheses. The CDs are integral to forming an appropriate ecosystem for the development team to educate doctors, medical workers, SMEs, and venture companies. Specifically, seminars on medical and clinical research methods are used to educate stakeholders on the importance of collaboration. These seminars provide collaborative op-portunities, R&D expenses, and technology transfer and sales promotion support from commercialization to sales. Local governments and banks also support these efforts. CDs from different institutions also actively col-laborate with each other; they use co-working spaces and the Coordinator Support System to share information and consult on problems. Through these efforts, CDs have successfully assisted the continuous development of medical devices. Both successful and failed commercialization cases are reported herein. After examining the causes of failure, it was found that collaborations often failed when the needs of the marketing authorization holders could not be met and when the medical and technical needs were not fully understood. To gradually increase the number of successful cases of medical devices developed in Japan, it is necessary to build a development model, expand it to other geographical areas, such as Shinshu, Oita, and Tottori, and support the development of CDs. Additionally, it is important to develop a knowledge base while utilizing the advantages of the local characteristics of these areas.