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.
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.
Project Website: https://www.simcor-h2020.eu/