27 | 01 | 2022

Supporting med-tech companies to win the innovation race: New TBMED video crosses the finish line


Medical device development, from conception to timely release to market, can be expensive and risky. This is particularly true for high-risk medical devices affected by the EU’s current Regulation 2017/745. Increasing med-tech companies’ chances of success in this process is the major goal of the TBMED project. To accomplish this, TBMED is establishing the Open Innovation Test Bed (OITB) go.Med. go.Med is the first OITB specifically designed to improve the innovation capacity of European small and medium-sized enterprises (SMEs).

A just-released video clip introduces viewers to the novel approach of TBMED and the benefits go.Med offers to SMEs and other interested parties in the highly competitive med-tech sector. The animated video highlights go.Med as a valuable acceleration platform that covers the entire development process for medical devices (from preclinical development to clinical testing). It shows the necessary steps in the journey towards developing a high-risk medical device, goes into detail on go.Med’s service portfolio, and shines a light on the innovative Quality-by-Design (QbD) concept that the TBMED OITB employs.

“Although these last years have been quite challenging, we are making good progress in building a very useful test bed. So far, we have provided services to our partners that are already involved in the consortium as well as to several additional companies that have been included after two open calls,” says TBMED coordinator Iraida Loinaz (CIDETEC Nanomedicine).

“For example, we have already provided a market analysis and early dialogues with clinicians and regulators to assist them in defining their products during the concept phase. In the development phase, we are developing manufacturing processes that will be scalable and we are providing these companies with advanced in vitro and in vivo models to validate their products. This whole process is being done on the basis of our Quality by Design methodology. In the validation phase, we start with a gap analysis that will map the regulatory roadmap. This has already been done for two of the devices and we are planning the first Good Laboratory Practice (GLP) studies for one of the devices. Finally, we have recently submitted a dossier to the Spanish Agency of Medicines and Medical Devices (AEMPS) to start our first clinical trial in the test bed, and we are working to start the second one, which will be conducted in different countries simultaneously. Overall, we are very happy with our progress so far and are looking forward to the coming project months,” Iraida Loinaz concludes.

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