Methodology of evaluation for medical devices using in-vitro/in-silico biomodel

Abstract

Several ways to assess medical devices has been prepared such as in-silico, in-vitro, animal test and clinical evaluation. These ways have specific advantages, respectively. For example, in-silico may be the strongest way to evaluate the flow reduction or mechanical properties of stent, or artificial joints. Anzai H et al. suggests that 3-D visualization will help the flow especially in-flow to aneurysm called as Bundle of Inflow (BOI). Nakayama T develops optimization of design of stent. On the contrary, in-silico is difficult to evaluate the handling stent, and clots in cerebral aneurysm or stress to parent arterial wall has strong influences on the vascular response.