Verification and validation are amongst the most critical activities in the development lifecycle of cardiovascular implantable devices, leading to recalls which can cost companies millions of dollars, ruin reputation and directly affect share price. Meanwhile, clinical safety and performance standards and relevant regulations are constantly growing.
In-silico methodologies for medical device testing and validation represent a promising opportunity for enhancing their safety, efficacy, time and cost effectiveness. However, their integration into the product cycle demands the establishment of agreed protocols, standards and shared resources between device manufacturers, authorities and regulatory bodies.
SIMCor aims to establish a computational platform for in-silico development, validation and regulatory approval of cardiovascular implantable devices.
The platform, composed of (1) a virtual cohort generation and validation domain, (2) a device implantation and effect simulation domain, and equipped with a variety of in-silico modelling resources, will represent an open environment for collaborative R&D among device manufacturers, researchers, medical authorities and regulatory bodies.