4health. Research into new methods to design, develop, manufacture, evaluate and certify medical devices in the context of Industry 4.0.
The 4Health project’s main aim is to generate new knowledge via R&D activities in order to improve the IBV’s competitiveness and capabilities as regards all stages that must be overcome before bringing a medical device to the market in the new Industry 4.0 environment, providing a response to the new needs of companies in the industry and in particular SMEs in the Valencia Community region.
All of the industrial sectors in the Valencia Community region are undergoing great change as a result of the appearance of new technologies and especially Industry 4.0. In the field of healthcare, this change is becoming ever clearer, making it necessary to collaborate with Valencian companies to include these technologies in their processes for the development of new products.
To do so, the 4Health project will concentrate its research on:
1. Knowledge about new biomaterials in the field of healthcare that can be used by means of 3D printing.
2. Introducing technologies for made-to-measure product development via 3D printing technologies and mechanisation with high-performance machines. The main studies carried out by IBV whose results will subsequently be transferred are:
a. Digital medical imaging analysis to convert images into virtual models and bio-models into materials that cannot be implanted.
b. Research and development of new product design methods based on medical imaging, automating processes as a way of reducing costs.
c. Research and development of new methods for analytical evaluation of made-to-measure medical devices based on medical imaging. These methods enable device verification times to be reduced, and therefore costs, too. Research and development of new testing methods to evaluate medical devices depending on their functional characteristics and manufacture.
3. The European regulation on medical devices (2017/747) issued on 5 may, whose many aspects include new and demanding requirements regarding certification of design and manufacture processes for standard and made-to-measure devices before they enter the market. Definition of strategies.
Taking all of this into account, the main outcome for this project is to develop the knowledge and lines of R&D necessary to be able to assess companies in the Valencia Community region about new methods of design, manufacture, evaluation and certification of medical devices. It is expected that the outcomes will be achieved by taking on board new manufacture and design technologies, as well as the changes in regulations introduced by the new EU Regulation 2017/745, all within the context of the emerging industrial revolution (Industry 4.0).
Participants and collaborating companies
FRESDENTAL INNOVACIÓN Y MANUFACTURAS, S.L.
SURGIVAL CO, S.A.U.
DESARROLLOS BIOMECÁNICOS INNOVASAN, S.L.
Duration and reference no.
Start date: 01-01-2019
End date: 31-12-2019
Project reference no.: IMDEEA/2019/16
Project (IMDEEA/2019/16) funded by the 2019 programme of aid from the Valencia Institute of Business Competitiveness (IVACE) aimed at technological centres in the Valencia Community region to carry out R&D projects of a non-economic nature in cooperation with companies.