Patient access to high-risk medical devices can take up to four times longer in Europe than in the United States. The delays arise from a combination of a stringent regulatory environment and long reimbursement times, especially for high-risk devices. SMEs make up 95 % of the European medical device industry, and the EU has a clear interest in ensuring that they are prosperous and successful. The EU-funded TBMED (A testing bed for the development of high-risk medical devices) project has been tasked with creating and implementing an Open Innovation Test Bed to support SMEs that specialise in the development of high-risk medical devices such as heart valves and hip replacements. TBMED’s guiding philosophy is centred on the ‘Quality-by-Design’ (QbD) concept that introduces quality assessment as early as possible in a product’s development life cycle, identifying and correcting possible problems before a product reaches an advanced stage of development. There are five distinct phases between drawing board and marketplace, and the project aims to lend companies a helping hand through all of them. With medical devices in mind, the mass adoption of QbD would also help to improve safety and efficacy. Other benefits of following QbD principles include a more efficient manufacturing process, reduced costs and potentially faster regulatory approval.
Intellectual property advice and support for medical device manufacturers
Launched in 2019 with 13 partners, the EUR 9.6 million project will establish a dedicated office that will provide business advice and intellectual property support to MedTech companies. Companies can contact the project team through the TBMED website and provide a brief description of their product and the services they are interested in. For qualifying SMEs, the TBMED technical committee will perform an in-depth analysis and review technical documents, working under a confidentiality agreement. TBMED will then devise a detailed proposal on how it can address the company’s request, and assign a dedicated team to the project. If the company agrees with the proposal, a contract is signed and the collaboration begins. To facilitate this support, TBMED will be able to draw on many resources, including a biomaterial synthesis lab and a testing lab for in vivo and in vitro efficacy testing. The project team will also provide advice on QbD procedures, Health Technology Assessment (HTA) and safety assessment. To get the TBMED test bed off the ground, the project team is focusing on three high-risk medical devices as case studies – an osteoinductive hydrogel, keratoprosthesis (where a diseased cornea is replaced with an artificial one) and magnetic nanoparticles for hyperthermic cancer therapy. TBMED is due to run until August 2023.
TBMED, open innovation test bed, testing lab, Quality-by-Design, QbD, medical devices, SMEs