Research Note
Medical device development in crisis: A movement for technology innovation in health and medicine in Japan
Shinya Numata
Center for Research and Development Strategy, Japan Science and Technology Agency; Graduate School of Urban Environment Sciences, Tokyo Metropolitan University, Tokyo, Japan
Shinobu Oguchi
Center for Research and Development Strategy, Japan Science and Technology Agency, Tokyo, Japan
Yuji Yamamoto
Center for Research and Development Strategy, Japan Science and Technology Agency, Tokyo, Japan
Hiroo Imura
Center for Research and Development Strategy, Japan Science and Technology Agency, Tokyo; Foundation for Biomedical Research and Innovation, Kobe, Japan
Koji Kawakami
Center for Research and Development Strategy, Japan Science and Technology Agency, Tokyo; Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan
PP: 330 - 336
Abstract
Japan is currently confronting a serious decline in medical device innovation. We identified some of the many barriers posed by the current clinical development system in Japan, as they relate to academia, industry and regulatory agencies: a scarcity of medical engineering and bioengineering scientists, two separate categories of clinical trials in Japan, a high level of uncertainty in any R&D schedule, leading to stagnation in the development of medical devices.
We propose a new clinical development system (CDS) to stimulate medical device development in Japan, with a central body to facilitate the CDS process with appropriate coordination of interdisciplinary and translational research, and through rational public funding arrangements. With the recommendations, a new organization (Council on Health Research Promotion) has been established in the cabinet of office of Japan, and is expected to work in an effective and efficient manner.
Keywords
clinical development; innovation; Japan; medical devices; regulatory affairs; research and development policy
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