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TBMED SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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Project "TBMED" data sheet

The following table provides information about the project.

Coordinator
FUNDACION CIDETEC 

Organization address
address: PASEO MIRAMON 196 PARQUE TECNOLOGICO DE MIRAMON
city: SAN SEBASTIAN
postcode: 20014
website: www.cidetec.es

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Spain [ES]
 Total cost 9˙663˙370 €
 EC max contribution 8˙480˙543 € (88%)
 Programme 1. H2020-EU.2.1.3. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials)
2. H2020-EU.2.1.2. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies)
 Code Call H2020-NMBP-HUBS-2018
 Funding Scheme IA
 Starting year 2019
 Duration (year-month-day) from 2019-01-01   to  2023-02-28

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    FUNDACION CIDETEC ES (SAN SEBASTIAN) coordinator 1˙310˙000.00
2    FUNDACION VASCA DE INNOVACION E INVESTIGACION SANITARIAS ES (BARAKALDO) participant 999˙446.00
3    ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK FR (PARIS) participant 882˙248.00
4    NATIONAL UNIVERSITY OF IRELAND GALWAY IE (Galway) participant 750˙000.00
5    FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V. DE (MUNCHEN) participant 676˙192.00
6    SOCIETE INDUSTRIELLE LIMOUSINE D'APPLICATION BIOLOGIQUE FR (OBJAT) participant 643˙008.00
7    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE FR (PARIS) participant 600˙393.00
8    ANTARES CONSULTING SL ES (BARCELONA) participant 525˙522.00
9    UNIVERSIDAD DE ZARAGOZA ES (ZARAGOZA) participant 502˙335.00
10    NANOSCALE BIOMAGNETICS SOCIEDAD LIMITADA ES (ZARAGOZA) participant 454˙688.00
11    CYBERNANO FR (VILLERS-LES-NANCY) participant 415˙970.00
12    EURICE EUROPEAN RESEARCH AND PROJECT OFFICE GMBH DE (ST INGBERT) participant 394˙100.00
13    AJL OHPTHALMIC S.A. ES (MINANO-ALAVA) participant 326˙637.00

Map

 Project 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.

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The information about "TBMED" are provided by the European Opendata Portal: CORDIS opendata.

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