Project description
An in silico platform for virtual device testing on patient cohorts
Research and development of healthcare products and devices is a time-consuming process that involves many steps. The EU-funded SIMCOR project aims to improve and accelerate the entire process through a platform for the in silico testing of cardiovascular implantable devices. The platform supports device validation through modelling as well as in vitro and preclinical experiments on animals. The validation is also performed by virtual clinical cohorts. Importantly, it offers the potential to test the device virtually in a range of clinically relevant pathologies or conditions. This simulation of device testing on human cohorts provides statistical credibility and is expected to shorten the time for the regulatory approval and commercialisation of healthcare products.
Objective
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.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.
- engineering and technology electrical engineering, electronic engineering, information engineering electronic engineering sensors
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being
MAIN PROGRAMME
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H2020-EU.3.1.5.3. - Using in-silico medicine for improving disease management and prediction
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
RIA - Research and Innovation action
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) H2020-SC1-DTH-2018-2020
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
10117 Berlin
Germany
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.