SIMCor implemented a computational infrastructure that integrates preclinical, clinical and synthetic data resources, virtual cohorts, simulation models, methods, guidelines and SOPs to serve as a digital testing environment at the service of researchers, manufacturers and regulatory bodies. The SOPs have been made publicly available together with relevant information, models and data, allowing evaluation and adoption by other stakeholders.
The project defined a methodology for the generation of virtual cohorts for replacement of in-vitro, preclinical and human testing, reproducing a variety of geometries, pathophysiologic conditions and clinical features. SIMCor elaborated a framework for the virtual implantation of medical devices, as well as for the assessment of device performance in regard to safety, efficacy, and usability for its two use cases. Thus, the project demonstrated the robustness and reliability of in-silico testing methodologies for the evaluation and regulatory approval of cardiovascular devices. Based on results on TAVI and PAPS, SIMCor extrapolated best practices and guidelines for the development, validation and regulatory approval of any type of cardiovascular device.
Through a series of interviews, focus groups, literature research, and four dedicated ISCTs, SIMCor informed its frameworks to assess the impact of integrating in-silico testing solutions into traditional clinical trials, as well as to evaluate and quantify the benefits for the clinical research workflow, industry, market, and broader societal perspective. These analyses highlight strengths and relevant barriers to the adoption of in-silico testing solutions into routine workflow and therefore will be beneficial for accelerating this adoption of virtual cohorts and simulation models into the development, testing and regulatory approval process of cardiovascular devices.
