The Proceedings of Manufacturing Systems Division Conference
Online ISSN : 2424-3108
2008
Session ID : 3101
Conference information
3101 Comparative Study of the Japanese and American Medical Device Development Process
[in Japanese]
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CONFERENCE PROCEEDINGS FREE ACCESS

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Abstract
The proportion of the aged in the total population of Japan has increased to a level unprecedented anywhere else in the world. If this proportion continues to increase, markets related to illness prevention and improvement of the quality of medical services will further enlarge. However, Japan has an unfavorable balance of trade in medical equipment or devices. Large Japanese companies hesitate to enter the medical device industry. This paper goes on to investigate the process of the expansion of the American medical industry. It was concluded that the propensity of risk in the U.S.A. and Japan is different. A system called IDE, Investigational Device Exemption, indicates that the US medical industries are in a stronger position than their Japanese counterparts.
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© 2008 The Japan Society of Mechanical Engineers
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