The complexity and speed of technological innovation, with increasingly short product cycles, creates huge demand for standardized best practices to apply in-silico validation methods in a statistically robust, repeatable, and efficient way. SIMCor will address this challenge by providing manufacturers of cardiovascular implantable devices with an open, reusable, cloud-based platform for in-silico testing to accelerate development and regulatory approval of their products. The platform will support device validation along the whole R&D pipeline: from initial modelling and in vitro experiments, to animal studies and device implantation and effect simulation on human cohorts. In particular, SIMCor innovative virtual cohort technology will allow to generate and expose new or existing devices to a range of clinically realistic and diversified anatomies and (patho)physiological conditions, also including extensive paediatric populations, meeting the critical need of testing devices in young patients. A standardized multi-level validation process and sensitivity analysis will guarantee statistical credibility for in-silico tests and the platform as a whole, proving solid experimental ground for regulatory authorities, thus accelerating approval and time to market for new products, reducing the burden of human and animal studies and boosting innovation at large. High-priority safety, efficacy and usability endpoints will be investigated, focusing on device implantation and effect simulations in two representative areas: transcatheter aortic valve implantation (TAVI) and pulmonary artery pressure sensors (PAPS). Based on proof-of-validation results and regulatory approval for these use cases, SIMCor will define standard operational procedures (SOPs) and a generalised technical framework for the in-silico testing, validation and regulatory approval of cardiovascular devices, to be put at the service of researchers, medical device manufacturers and regulatory bodies.
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