Galway devices centre part of high-risk medtech project

The CÚRAM Medical Devices Centre is one of the institutions taking part in a European programme to help high-risk medtech get to market, according to the Galway Daily.

The centre is one of 13 European partners in the project which has received €8.5 million from the Horizon 2020 framework. Other partners are located in Spain, France and Germany, and is coordinated by the Spanish Research Institute CIDETEC.

The new EU research project TBMED aims to support European medtech companies in global competition by reducing the time-to-market of high-risk medical devices.

The project sets out to tackle two of the most pressing issues in the EU healthcare system: the large variation in patient diagnosis and continually increasing costs which result in a need to create and incorporate value in healthcare.

In order to help SMEs to deliver better care at more reasonable costs and 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 of high-risk classification.

The programme will use GlycoBone, keratoprosthesis and new magnetic nanoparticle devices to improve cancer treatments based on hyperthermia. The choice of three very different cases could facilitate the development of an OITB suitable for a broad range of applications in the field.

In a quality-by-design approach, the test bed could help companies to accelerate the development of medical devices, reduce their time to market and offer additional business management services. Counselling and advisory sessions with experts on clinical investigations and an advisory health technology assessment team (through EUnetHTA) will make sure that evidence on the safety and efficacy of the new devices and adequate comparators is generated during preclinical development.

Iraida Loinaz from Fundación CIDETEC Nanomedicine who coordinates the project, said: “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.”