Definition of the Device Lag and Its Measurement

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  • Nakano Shohei
    Graduate School of Engineering Management, Shibaura Institute of Technology
  • Kodama Fumio
    Graduate School of Engineering Management, Shibaura Institute of Technology
  • Kano Shingo
    Graduate School of Engineering Management, Shibaura Institute of Technology

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  • デバイスラグの定義と測定
  • デバイスラグ ノ テイギ ト ソクテイ

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The purpose of this study is to examine the improvement of the Device Lag. In this report, we are defining the Device Lag, after distinguishing sharply to period of time and lag, and we are measuring the Device Lag about medical devices approved on Japan between April 1, 2001 and March 31, 2008. The number of medical devices was 30. As a result of the analysis, it was revealed that "period of review in U.S." was 1.20 year, "period of review in Japan" was 2.90 year, "lag of review between U.S. and Japan" was 1.70 year, "lag of file from U.S. to Japan" was 2.42 year, "period after approval in Japan until Public Health Insurance cover in Japan" was 0.65 year, "period after file in Japan until Clinical Use in Japan" was 2.92 year, and "period after file in U.S. until Clinical Use in Japan" was 5.44 year. Review time in Japan is significantly lengthy compared with Review time in U.S (P<0.01). It was suggested by these analytical results that the Device Lag is solved by reviewers increase, global harmonization of regulation, deregulation of Public Health Insurance cover, and Clinical Trials with the Bayesian Statistics.

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