SIMCor (In-Silico testing and validation of Cardiovascular IMplantable devices)

The main goals of SIMCor are:

  • To accelerate the adoption and integration of computer simulations in the regulatory evaluation of medical devices through dissemination of results, increasing trust of users and community building
  • To provide proof-of-validation for two types of in-silico testing solutions: a virtual cohort generation and a computer-based simulation of device implantation and performance
  • To quantify the added value of the proposed in-silico testing concept against traditional human trials for the healthcare system, the medical device industry and market, as well as the society as a whole
  • To develop standards and protocols to describe the entire in-silico testing and validation workflow and integrate computer modelling solutions into the regulatory approval process
  • To contribute to the European Open Science Cloud (EOSC) initiative by providing data, virtual cohorts, simulation models, SOPs and in-silico methodologies

The Institute for Advances Studies (IHS) is leading WP 10 which aims to

  • Develop a conceptual framework to model effects of computer simulation for medical device testing on clinical trial planning
  • Based on the conceptual framework, assess the clinical impact of in-silico trials and estimate benefits allowed by in-silico device testing technologies including:
    • reduction in the duration and sample size of clinical human trials and preclinical animal studies
    • increased clinical efficacy and patient safety, through the reduction in adverse events
  • Develop an evaluation framework for the quantitative assessment of socioeconomic effects, taking into account impacts on the healthcare system, industrial development cycles and the medical devices market
  • Based on the conceptual framework, assess the impact of in-silico technologies on the healthcare system, the medical device industry and the market (e.g., clinical trial cost reduction, faster regulatory approval time, decreased treatment costs, inclusion of underserved populations, etc.)

SIMCor started on 1 January 2021 and will last until 31 December 2023.