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A testing bed for the development of high-risk medical devices

Objective

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.

Field of science

  • /social sciences/economics and business/business and management/commerce
  • /social sciences/sociology/governance/crisis management
  • /social sciences/economics and business
  • /social sciences/sociology/governance/public services

Call for proposal

H2020-NMBP-HUBS-2018
See other projects for this call

Funding Scheme

IA - Innovation action

Coordinator

FUNDACION CIDETEC
Address
Paseo Miramon 196 Parque Tecnologico De Miramon
20014 San Sebastian
Spain
Activity type
Research Organisations
EU contribution
€ 1 310 000

Participants (12)

AJL OHPTHALMIC S.A.
Spain
EU contribution
€ 326 637,50
Address
Parque Tecnologico De Alava
01510 Minano-alava
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EURICE EUROPEAN RESEARCH AND PROJECT OFFICE GMBH
Germany
EU contribution
€ 394 100
Address
Heinrich-hertz-allee 1
66386 St Ingbert
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 600 393,75
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
SOCIETE INDUSTRIELLE LIMOUSINE D'APPLICATION BIOLOGIQUE
France
EU contribution
€ 643 008,63
Address
Madrias
19130 Objat
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSIDAD DE ZARAGOZA
Spain
EU contribution
€ 502 335
Address
Calle Pedro Cerbuna 12
50009 Zaragoza
Activity type
Higher or Secondary Education Establishments
NANOSCALE BIOMAGNETICS SOCIEDAD LIMITADA
Spain
EU contribution
€ 454 688,50
Address
Calle Panama 2, Local 1
50012 Zaragoza
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.
Germany
EU contribution
€ 676 192,50
Address
Hansastrasse 27C
80686 Munchen
Activity type
Research Organisations
NATIONAL UNIVERSITY OF IRELAND GALWAY
Ireland
EU contribution
€ 750 000
Address
University Road
H91 Galway
Activity type
Higher or Secondary Education Establishments
CYBERNANO
France
EU contribution
€ 415 970,63
Address
193 Avenue Paul Muller
54600 Villers-les-nancy
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
EU contribution
€ 882 248,75
Address
5 Rue Watt
75013 Paris
Activity type
Research Organisations
FUNDACION VASCA DE INNOVACION E INVESTIGACION SANITARIAS
Spain
EU contribution
€ 999 446,25
Address
Ronda De Azkue,1
48902 Barakaldo
Activity type
Research Organisations
ANTARES CONSULTING SL
Spain
EU contribution
€ 525 522,38
Address
Av Josep Tarradellas, 8-10 P.4 Pta.5
08029 Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)