| Project Detail |
Making medical devices accessible to patients
Medical device companies are in the business of making people’s lives better. The EU-funded TBMED project aims to support these med-tech companies in the development of high-risk medical devices by reducing their time to market for the European sector. Specifically, it will assist European SMEs to maintain their competitiveness and innovation capacity in the face of global competition. The project will assist in promoting real benefits (value/final outcomes) of new devices. Also, by establishing an open innovation test bed with a connected network of labs, it aims to minimise time to market and facilitate efforts for reimbursement. The overall objective is to make medical devices accessible to patients more easily while increasing the quality, reducing the risk and facilitating clinical testing.
TBMED will establish an open innovation testing bed specialized in the development of high-risk devices (=Class IIb). Due to a long reimbursement processes, patient access to innovative high-risk medical devices in Europe can take four times longer than in the U.S. In addition to this, the new regulations will stricter ex-ante controls for this type of devices. This scenario represents a big challenge for European high-tech SMEs (representing 95% of the MedTech sector in Europe) to maintain their competitiveness and innovation capacity. TBMED will provide an integral service to accelerate the development of medical devices reducing time to market, covering technology development from TRL4-7 based on Quality-by-Design (QbD) concept and business management services. QbD concept enhances product and process understanding together with process control, based on robust scientific knowledge and quality risk management.
Once operating (M37) the OITB will integrate: 1) an SME office that will provide business advice and IP management, 2) services on regulation, early health technology assessment advice and QbD, 3) a biomaterial synthesis lab, 4) characterization facilities, 5) a testing lab for in vivo and in vitro efficacy testing, 6) safety assessment and 7) clinical testing. Three case studies will be used to validate the concept and will help to establish the OITB: 1) An osteoinductive hydrogel, 2) Keratoprosthesis and 3) Magnetic NPs for hyperthermia. TBMED consists of 13 complementary partners composed by 1 Industry and 2 SMEs developers of 4 different medical devices used as case studies, 5 RTD institutions experts in the development of medical devices, 1 SME expert in QbD methodology, 2 RTD Institutions that will provide the access to a hospital network with experience in regulation, health technology assessment and clinical investigation design and testing and 2 consultancy (SME) experts on business plan development, IPR management and communication activities. |
