Research to promote the development of innovative medical devices based on the optimization of clinical evaluation methods by subjective evaluation

2019 Fiscal Year Final Research Report

• Project/Area Number: 17K13040
• Research Category: Grant-in-Aid for Young Scientists (B)
• Allocation Type: Multi-year Fund
• Research Field: Medical engineering assessment
• Research Institution: Tohoku University
• Principal Investigator: HOSAKA MIKI 東北大学, 大学病院, 特任助教 (10793911)
• Project Period (FY): 2017-04-01 – 2020-03-31
• Keywords: 医療機器開発 / レギュラトリーサイエンス / 主観的評価項目

Outline of Final Research Achievements

In medical device development, subjective evaluation is a typical evaluation method that differs from drug development. Subjective evaluation had been employed in about 10-20% of the medical devices approved in the last few years. In the case of medical devices for which subjective evaluation items were adopted in the clinical trials, it is considered that the optimal evaluation method for issues to be evaluated was subjective evaluation. In the future development of medical devices, it is necessary to understand the characteristics of the medical devices, consider whether there are established objective evaluation indicators or whether subjective evaluation by non-patients is possible, and select the most appropriate evaluation indicators.

Free Research Field

レギュラトリーサイエンス

Academic Significance and Societal Importance of the Research Achievements

本邦においては、国民が受ける医療の質の向上のための医療機器の研究開発が国としての課題として認識され、医療機器産業の発展が望まれている。医療機器開発において技術のみが進歩しても臨床における適切な評価が伴わなければ、医療現場へ出ていくことはない。したがって、本研究において医療機器の臨床評価を検討することにより、より適切な臨床評価手法を選択できることになることで、医療機器の開発が促進され、ひいては国民が享受する医療の質向上につながることが期待される。