SIMCor will define a methodology for the generation of virtual cohorts as a replacement of in-vitro, animal and human trials reproducing a variety of geometries, pathophysiologic conditions and clinical features.

SIMCor will elaborate a framework for the virtual implantation of medical devices on bench test environments, animal and patient cohorts, and the assessment of device performance in regard to safety, efficacy and usability.

SIMCor will implement and apply a standardised, multi-level validation and refinement process based on the use of preclinical, clinical and synthetic data, to demonstrate robustness and reliability of in-silico testing methodologies for the evaluation and regulatory approval of cardiovascular devices.

The process chain of SIMCor will be exemplarily applied to two representative use cases, transcatheter aortic valve implantation (TAVI) and pulmonary artery pressure sensors (PAPS), based on their large potential socio-economic impact, the wide range of pathophysiologic conditions and biomechanical properties involved.

Based on proof-of-validation results for TAVI and PAPS, SIMCor aims to extrapolate best practices, standards and guidelines to be translated into standard operating procedures (SOPs) at the service of the device manufacturing community.

SIMCor will define and apply a framework for assessing the impact of the integration of virtual cohorts and computer-based models in traditional clinical trials, and its benefits on the clinical research workflow, the industrial development cycle and the market, as well as on a broader societal perspective, based on proof-of-validation results, literature, databases and interviews with relevant stakeholders.

Expected benefits include:

• increased treatment efficacy and patient safety through reduction in device failure and adverse events, improved clinical indications, implantation strategies and device designs;
• reduced use of animal and human testing;
• decreased development costs and time-to-market, in turn leading to reduced costs and wider accessibility of device-based treatments, boosting of innovation and creation of economic added value.

SIMCor will work to accelerate the adoption of virtual cohorts and simulation models into the development, testing and regulatory approval process of medical devices in cardiology as a complement or substitution of traditional clinical trials, as well as the translation of in-silico validated devices into the market and the clinics.

SIMCor will leverage its developed resources, proof-of-validation and impact assessment results and widely disseminate them among researchers, manufacturers, healthcare professionals and patients, to increase trust towards in-silico solutions, address needs, expectations and concerns, making them an active part of the innovation process and fostering the creation of a community of interest.

SIMCor will implement a computational infrastructure that will integrate resources developed in the course of the project to serve as a virtual research environment at the service of researchers, manufacturers and regulatory bodies.