SIMCOR · Project

Virtual Testing Platform That Speeds Up Heart Device Regulatory Approval

healthTestedTRL 5

simcor-h2020.eu

Imagine you're building a new heart valve or pressure sensor. Right now, testing it means years of animal studies and expensive clinical trials before regulators even look at it. SIMCOR built a cloud-based computer simulation platform — like a flight simulator, but for heart implants — where you can test your device on thousands of virtual patients with different body types, ages, and heart conditions. It even covers pediatric patients, a group notoriously hard to test devices on in real life.

By the numbers

consortium partners

countries represented

total deliverables produced

validated clinical use cases (TAVI and PAPS)

industry partners in consortium

The business problem

What needed solving

Getting a new cardiovascular implant from lab bench to patient bedside takes years of costly animal studies and clinical trials, with no guarantee regulators will approve the results. Pediatric devices are even harder — recruiting children for clinical trials is ethically and practically near-impossible, leaving a gap in validated devices for young patients. Manufacturers need a faster, cheaper, statistically credible way to prove their devices are safe before submission.

The solution

What was built

SIMCOR built an open, cloud-based platform for in-silico (computer-simulated) testing of cardiovascular implantable devices, validated on 2 clinical use cases: transcatheter aortic valve implantation (TAVI) and pulmonary artery pressure sensors (PAPS). Key outputs include validated virtual patient cohorts covering diverse anatomies including pediatric populations, a multi-level statistical validation process, and standardized SOPs for regulatory submission of in-silico test results.

Audience

Who needs this

Heart valve and transcatheter device manufacturersPediatric cardiac device developersMedical device regulatory affairs consultanciesContract research organizations running pre-market device evaluationsHospital-based clinical engineering teams evaluating new implant technologies

Business applications

Who can put this to work

Medical device manufacturing

enterprise

Target: Manufacturers of transcatheter heart valves and cardiac implants

If you are a heart valve manufacturer spending years and millions on animal studies and clinical trials before regulatory submission — this project developed a cloud-based in-silico testing platform validated on 2 representative use cases (TAVI and pulmonary artery pressure sensors) that lets you simulate device implantation across diverse virtual patient anatomies. This could cut your pre-approval testing timeline and reduce reliance on animal and human studies.

Pediatric cardiac devices

any

Target: Companies developing cardiovascular devices for children

If you are a device company struggling to test cardiac implants in pediatric populations — where clinical trials are extremely difficult to recruit for — this project built virtual cohort technology that generates clinically realistic pediatric anatomies and conditions. The validated virtual cohorts from SIMCOR's 41 deliverables offer a path to test device safety and efficacy in young patients without the ethical and practical barriers of pediatric trials.

Regulatory and clinical consulting

mid-size

Target: Contract research organizations and regulatory affairs consultancies serving medtech

If you are a CRO or regulatory consultancy advising medical device clients on EU approval pathways — SIMCOR defined standard operational procedures and a technical validation process for in-silico testing of cardiovascular devices, built by a 12-partner consortium across 8 countries including regulatory input. These SOPs could become your blueprint for guiding clients through computer-model-based regulatory submissions.

Frequently asked

Quick answers

What would it cost to use this in-silico testing platform?

The project data does not include pricing or licensing costs. The platform was developed as an open, reusable, cloud-based tool under an EU Research and Innovation Action. Contact the consortium coordinator at Charité Berlin for current access terms and any commercial licensing arrangements.

Can this platform handle testing at industrial scale — hundreds of device variants?

The platform was designed to support device validation along the whole R&D pipeline, from initial modelling through to device implantation and effect simulation on virtual human cohorts. The virtual cohort technology can generate diverse anatomies and conditions at scale, though production throughput details are not specified in the project data.

Who owns the IP and can we license this technology?

SIMCOR was funded as a Research and Innovation Action with 12 partners across 8 countries, including 3 industry partners. IP ownership typically follows EU grant rules where each partner owns the results they generate. Based on available project data, specific licensing terms would need to be discussed with the coordinating institution, Charité Berlin.

Does this meet current regulatory requirements for medical device approval?

A core goal of SIMCOR was to provide proof-of-validation results acceptable to regulatory authorities, with a standardized multi-level validation process and sensitivity analysis guaranteeing statistical credibility. The project produced SOPs specifically designed for regulatory approval of cardiovascular devices using in-silico methods.

How long would integration into our existing R&D pipeline take?

The platform was built as a cloud-based tool covering the full pipeline from modelling and in-vitro experiments to animal studies and human cohort simulation. Based on available project data, integration timelines are not specified, but the open and reusable design suggests it was intended for adoption by external manufacturers.

Has this been validated on real clinical cases?

The project delivered validated virtual cohorts for in-silico trials across 2 specific use cases: transcatheter aortic valve implantation (TAVI) and pulmonary artery pressure sensors (PAPS). A multi-level validation process was applied to guarantee statistical credibility against real clinical outcomes.

Consortium

Who built it

The SIMCOR consortium brings together 12 partners from 8 European countries, led by Charité — one of Europe's largest university hospitals — based in Berlin. The mix is research-heavy: 6 universities and 3 research organizations provide deep clinical and computational expertise, while 3 industry partners (including 1 SME) bring device manufacturing perspective. The 25% industry ratio is typical for a platform-building project where academic validation is the priority before commercial uptake. The geographic spread across Austria, Belgium, Germany, France, Italy, Netherlands, Romania, and the UK gives the results broad European regulatory relevance.

CHARITE - UNIVERSITAETSMEDIZIN BERLINCoordinator · DE
INSTITUT FUR HOHERE STUDIEN - INSTITUTE FOR ADVANCED STUDIESparticipant · AT
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORKparticipant · FR
LYNKEUSparticipant · IT
VIRTUAL PHYSIOLOGICAL HUMAN INSTITUTE FOR INTEGRATIVE BIOMEDICAL RESEARCH VZWparticipant · BE
TECHNISCHE UNIVERSITAET GRAZparticipant · AT
PHILIPS ELECTRONICS NEDERLAND BVparticipant · NL
UNIVERSITY COLLEGE LONDONparticipant · UK
TECHNISCHE UNIVERSITEIT EINDHOVENparticipant · NL
UNIVERSITATEA TRANSILVANIA DIN BRASOVparticipant · RO

How to reach the team

Charité - Universitätsmedizin Berlin, Germany. Use SciTransfer's coordinator lookup service for direct contact details.

Order a report on this consortium See CHARITE - UNIVERSITAETSMEDIZIN BERLIN profile →

Next steps

Talk to the team behind this work.

Want to explore how SIMCOR's in-silico testing platform could accelerate your device approval? SciTransfer can connect you with the right people on the consortium team.

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