Medical device development in crisis: A movement for technology innovation in health and medicine in Japan

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 scienti...

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Bibliographic Details
Published inInnovation (North Sydney) Vol. 12; no. 3; pp. 330 - 336
Main Authors Numata, Shinya, Oguchi, Shinobu, Yamamoto, Yuji, Imura, Hiroo, Kawakami, Koji
Format Journal Article
LanguageEnglish
Published Maleny Routledge 01.12.2010
Taylor & Francis Ltd
Subjects
Bioengineering
Clinical development
Clinical development system (CDS)
Clinical trials
Cooperation
Deformities
Economic policy
Engineering
Engineers
FDA approval
Financing methods
Innovation
Innovations
Japan
Jurisdiction
Medical device industry
medical devices
Medical equipment
Medical instruments
Medical instruments and apparatus
Medical technology
Pharmaceuticals
R&D
Regulation
regulatory affairs
Regulatory agencies
Regulatory approval
Research & development
Research and development
research and development policy
Research, Industrial
Stagnation
Studies
Technological change
Technological innovations
Japan
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Summary: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.
Bibliography:Innovation: Management Policy and Practice, Vol. 12, No. 3, Dec 2010: 330-336
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ISSN:1447-9338
2204-0226
DOI:10.5172/impp.12.3.330