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TBMED

Financiado

Cerrado

A testing bed for the development of high risk medical devices

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... ver más

31/08/2023

CIDETEC

10M€

Presupuesto del proyecto: 10M€

Líder del proyecto

FUNDACION CIDETEC No se ha especificado una descripción o un objeto social para esta compañía.

TRL 2-3 | 14M€

Fecha límite participación Sin fecha límite de participación.

Ver 21 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2023-08-31

DT-NMBP-02-2018: Open Innovation Test Beds for Safet...

I+D

Cerrada hace 7 años

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Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

21 Participantes

CIDETEC

1.41M€ | Lider

UNL

246.14K€ | Participante

ADDITION OPHTALMIC AIE

66.51K€ | Participante

FUNDACIO CLINIC PER A LA REC...

365.63K€ | Participante

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Duración del proyecto: 56 meses Fecha Inicio: 2018-12-12
Fecha Fin: 2023-08-31

Líder del proyecto

FUNDACION CIDETEC No se ha especificado una descripción o un objeto social para esta compañía.

TRL 2-3 | 14M€

Presupuesto del proyecto 10M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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.

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