The growing standards for clinical safety and performance of medical devices and the complexity and speed of technological innovation, with increasingly short product cycles, create a huge demand for innovative, computer-based solutions, standards and guidelines for a statistically robust, repeatable and efficient validation of biomedical devices, to become closer to the market and the clinics. 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, validation and regulatory approval of their products. The platform will support device verification and validation along the whole research and development pipeline: from initial modelling and in-vitro experiments, to animal studies, device implantation and effect simulation on human cohorts. In particular, SIMCor’s 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. SIMCor is a 3-year (1 January 2021 - 31 December 2023), 7.2 M€ Research and Innovation Action (RIA) funded under the topic SC1-DTH-06-2020 (Accelerating the uptake of computer simulations for testing medicines and medical devices) of the call H2020-SC1-DTH-2018-2020 (Digital transformation in Health and Care), in the Health, Demographic Change and Wellbeing area of the Horizon 2020 Framework Programme.
SIMCor is a 3-year (2021-2023) Research and Innovation Action funded under the topic SC1-DTH-06-2020 (Accelerating the uptake of computer simulations for testing medicines and medical devices) of the Horizon 2020 Framework Programme. The project is developing an open, reusable, cloud-based platform for in-silico development, validation and regulatory approval of cardiovascular implantable devices. The platform will support device verification and validation along the whole research and development pipeline: from initial modelling and in-vitro experiments to animal studies, device implantation and effect simulation on human cohorts.Read more
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