2B25 革新的医療機器実用化のためのEngineering Based Medicineに基づく非臨床性能評価系と評価法の確立  [in Japanese] 2B25 Establishment of Non-clinical In Vitro Testing System and Methodology of Innovative Medical Devices for Approval : Facilitating Engineering Based Medicine  [in Japanese]

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Abstract

We have developed in vitro test methodologies modeling in vivo practical-use situations, to quantitatively assess safety and effectiveness of innovative medical devices. We believe that expediting development of these in vitro methodology not only reinforce preclinical evaluation and enhance timely access to innovative medical devices for patients but also reduce potential risk when used in real-world clinical practice, because controlled clinical trials have certain limitation in fully demonstrating benefit and risk. With the grant from Ministry of Health, Labour and Welfare intended for "Promotional Project for Practical Application of Innovative Pharmaceutical, Medical Device, and Tissue Engineering Products", we have developed drafts on in vitro test guideline for "Durability testing methods for coronary artery stent", "Durability testing methods for vascular stent intended for Superficial femoral - Popliteal artery", and "Method for in vitro thrombogenicity testing for inflow cannula of left ventricular assist system". Further 5 guideline drafts are under preparation. Here, we introduce impacts of in vitro test methods modeling in vivo intended-use situations on expediting availability of new medical devices and timely assessment and management of risk.

Journal

  • The Proceedings of the Bioengineering Conference Annual Meeting of BED/JSME

    The Proceedings of the Bioengineering Conference Annual Meeting of BED/JSME 2016.28(0), _2B25-1_-_2B25-5_, 2016

    The Japan Society of Mechanical Engineers

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