EU project TBMED

Open-innovation test bed for high-risk medical devices

TBMED in brief

Together with 12 project partners from Spain, France, Ireland and Germany, Fraunhofer ITEM is participating in the development of an Open-Innovation Test Bed for the Development of High-Risk Medical Devices. The aim is to support small and medium-sized manufacturers of medical devices.

Objectives of the project

  1. Increase the quality and reduce risks of MDs and facilitate subsequent clinical testing.
  2. Build the arguments to demonstrate real benefits (value/final outcomes) of new devices to increase their success in entering the market.
  3. Reduce costs, variability of the manufacturing process and the speed of product release to the market by carrying out statistically designed experiments for process validation.

Cooperation opportunities

 

“We want to make our approach sustainable through the strategic involvement of existing European clusters and the use of collaboration opportunities. Our aim is to strengthen the growth and development of SMEs in many different regions and increase their chances of success by bringing them in contact with potential investors interested in new products,” said Iraida Loinaz from the Fundación CIDETEC Nanomedicine, coordinator of the project, during the TBMED kick-off meeting held in San Sebastián (Donostia), Spain, on February 21 and 22, 2019.

Increasing patients’ access to high-risk medical devices

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).

TBMED will establish an open-innovation test bed (OITB) consisting of a connected network of labs providing a single entry point to services along the whole value chain, from preclinical development to clinical testing. The entire process is based on a Quality-by-Design (QbD) concept.
© www.tbmed.eu
TBMED will establish an open-innovation test bed (OITB) consisting of a connected network of labs providing a single entry point to services along the whole value chain, from preclinical development to clinical testing. The entire process is based on a Quality-by-Design (QbD) concept.

Support small and medium-sized manufacturers of medical devices

In dem EU-Projekt TBMED entwickeln 13 Projektpartner aus Spanien, Frankreich, Irland und Deutschland gemeinsam eine Open-Innovation-Testplattform für Hochrisiko-Medizinprodukte.
© TBMED
In the EU project TBMED 13 project partners from Spain, France, Ireland and Germany are developing an open-innovation test bed for high-risk medical devices.

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).

Your contact

Christina Ziemann

Contact Press / Media

Dr. Christina Ziemann

Manager of the Working Group on Genetic Toxicology and Tumor Research

Phone +49 511 5350-203

Ulrich Froriep

Contact Press / Media

Dr. Ulrich Froriep

High-Performance Center Translational Biomedical Engineering

Phone +49 511 5350-294