TBMED

TBMED

Abstract

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.

Consortium

Fundacion Cidetec (Coordinator), AJL Ohpthalmic S.A., Eurice European Research And Project Office GMBH, Institut National De La Sante Et De La Recherche Medicale, Societe Industrielle Limousine D'application Biologique, Universidad De Zaragoza, Nanoscale Biomagnetics Sociedad Limitada, Fraunhofer Gesellschaft Zur Foerderung Der Angewandten Forschung E.V., NUI Galway, Cybernano, Ecrin European Clinical Research Infrastructure Network, Fundacion Vasca De Innovacion E Investigacion Sanitarias, Antares Consulting SL.