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

Project description

Making medical devices accessible to patients

Medical device companies are in the business of making people’s lives better. The EU-funded TBMED project aims to support these med-tech companies in the development of high-risk medical devices by reducing their time to market for the European sector. Specifically, it will assist European SMEs to maintain their competitiveness and innovation capacity in the face of global competition. The project will assist in promoting real benefits (value/final outcomes) of new devices. Also, by establishing an open innovation test bed with a connected network of labs, it aims to minimise time to market and facilitate efforts for reimbursement. The overall objective is to make medical devices accessible to patients more easily while increasing the quality, reducing the risk and facilitating clinical testing.

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.

Keywords

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Programme(s)

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Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

IA - Innovation action

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-NMBP-TO-IND-2018-2020

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Coordinator

FUNDACION CIDETEC
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 411 480,91
Address
PASEO MIRAMON 196 PARQUE TECNOLOGICO DE MIRAMON
20014 San Sebastian
Spain

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Region
Noreste País Vasco Gipuzkoa
Activity type
Research Organisations
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 411 480,91

Participants (20)

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