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TBMED SIGNED

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

Total Cost €

EC-Contrib. €

Partnership

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TBMED project word cloud

Explore the words cloud of the TBMED project. It provides you a very rough idea of what is the project "TBMED" about.

smes medical specialized plan experts regulations innovation hospital rtd validate bed advice regulation innovative business enhances risk lab integrate communication industry reimbursement safety ipr office service once quality qbd facilities accelerate health trl4 tech hyperthermia scientific iib keratoprosthesis ip hydrogel vivo services osteoinductive sme class 13 controls m37 big efficacy ge competitiveness market consists longer stricter characterization vitro scenario consultancy ante representing ex magnetic complementary times patient medtech integral reducing capacity methodology investigation developers synthesis nps biomaterial network tbmed 95 oitb clinical expert time

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 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.	ES (SAN SEBASTIAN)	coordinator	1˙310˙000.00
2	FUNDACION VASCA DE INNOVACION E INVESTIGACION SANITARIAS FUNDACION VASCA DE INNOVACION E INVESTIGACION SANITARIAS Organization address address: RONDA DE AZKUE,1 city: BARAKALDO postcode: 48902 website: http://www.bioef.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (BARAKALDO)	participant	999˙446.00
3	ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK Organization address address: 5 RUE WATT city: PARIS postcode: 75013 website: www.ecrin.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	882˙248.00
4	NATIONAL UNIVERSITY OF IRELAND GALWAY NATIONAL UNIVERSITY OF IRELAND GALWAY Organization address address: UNIVERSITY ROAD city: Galway postcode: H91 website: www.nuigalway.ie contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IE (Galway)	participant	750˙000.00
5	FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V. FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V. Organization address address: HANSASTRASSE 27C city: MUNCHEN postcode: 80686 website: www.fraunhofer.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (MUNCHEN)	participant	676˙192.00
6	SOCIETE INDUSTRIELLE LIMOUSINE D'APPLICATION BIOLOGIQUE SOCIETE INDUSTRIELLE LIMOUSINE D'APPLICATION BIOLOGIQUE Organization address address: MADRIAS city: OBJAT postcode: 19130 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (OBJAT)	participant	643˙008.00
7	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE Organization address address: RUE DE TOLBIAC 101 city: PARIS postcode: 75654 website: www.inserm.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	600˙393.00
8	ANTARES CONSULTING SL ANTARES CONSULTING SL Organization address address: AV JOSEP TARRADELLAS, 8-10 P.4 PTA.5 city: BARCELONA postcode: 8029 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (BARCELONA)	participant	525˙522.00
9	UNIVERSIDAD DE ZARAGOZA UNIVERSIDAD DE ZARAGOZA Organization address address: CALLE PEDRO CERBUNA 12 city: ZARAGOZA postcode: 50009 website: www.unizar.es contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (ZARAGOZA)	participant	502˙335.00
10	NANOSCALE BIOMAGNETICS SOCIEDAD LIMITADA NANOSCALE BIOMAGNETICS SOCIEDAD LIMITADA Organization address address: CALLE PANAMA 2, LOCAL 1 city: ZARAGOZA postcode: 50012 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (ZARAGOZA)	participant	454˙688.00
11	CYBERNANO CYBERNANO Organization address address: 193 AVENUE PAUL MULLER city: VILLERS-LES-NANCY postcode: 54600 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (VILLERS-LES-NANCY)	participant	415˙970.00
12	EURICE EUROPEAN RESEARCH AND PROJECT OFFICE GMBH EURICE EUROPEAN RESEARCH AND PROJECT OFFICE GMBH Organization address address: HEINRICH-HERTZ-ALLEE 1 city: ST INGBERT postcode: 66386 website: www.eurice.eu contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (ST INGBERT)	participant	394˙100.00
13	AJL OHPTHALMIC S.A. AJL OHPTHALMIC S.A. Organization address address: PARQUE TECNOLOGICO DE ALAVA city: MINANO-ALAVA postcode: 1510 website: www.ajlsa.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.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.