EU project TBMED

Aiming to support European manufacturers of medical devices the global competition, the EU has initiated the project TBMED – An Open-Innovation Test Bed for the Development of High-Risk Medical Devices. Together with 12 project partners from Spain, France, Ireland and Germany, Fraunhofer ITEM is actively participating in the development of a test bed for medical devices of risk classifications IIb and III. The project will receive 8.5 million euros funding under the European Union’s Horizon 2020 Framework Program and will run until the end of February 2023.

TBMED is an EU-funded collaborative research project that aims to increase patients’ access to high-risk medical devices by helping SMEs minimize time to market and reimbursement process time, thus optimizing the process of transforming a prototype into a valuable innovative medical device (MD).

The EU project TBMED sets out to tackle two of the most pressing issues in the EU health-care system: first, the large variation in patient outcomes and second, continually increasing costs. The new EU-wide Medical Device Regulation (MDR) poses enormous challenges, especially for European small and medium-sized manufacturers of medical devices. In order to help these companies deliver better care at more reasonable costs and thereby enable them to face global competition by large suppliers, the consortium aims to develop an open-innovation test bed (OITB) focusing on the most challenging devices with high-risk classifications IIb and III.

Fraunhofer ITEM has initially focused on the regulatory strategy and data gap analyses according to ISO 10993-1, and the development of specific, product-adapted toxicological testing strategies. Further on in the project, material-specific, (geno)toxicological screening methods providing first clues to possible adverse effects of the products under development will be devised, to enable detection of toxicological risks at an early stage in the development process. In addition, Fraunhofer ITEM will be responsible for test methods that are relevant for regulatory purposes, i.e. biocompatibility testing of medical devices according to ISO 10993-3 (genotoxicity) and ISO 10993-5 (cytotoxicity).