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ISSN : 2456-3676

Title:
THE INNOVATION PROCESS OF MEDICAL DEVICES IN GERMANY RESPECTING THE NEW EU REGULATION

Authors:
Raphael G.D. MURSWIECK, Ioana CEAUSU, Sven IRMER , Vanessa JUST, Romania

Abstract:
Regulations create a supplementary burden for organizations when it comes to confirm compliance of innovations by third parties. On the one hand, new products cannot be developed strictly confidentially and on the other hands, marketable products have not the certainty being certified according to the regulations by the so-called notified bodies (NB) if certain conditions are not met. The present article analyses the innovation process from idea to monetarization of medical devices based on the upcoming medical device regulation (MDR) of the European Union (EU) coming into effect in May 2020. In the new framework, newmedical device ideas need to undergo a certain innovation procedure in order to be accepted by the NB. This implies the use of external stakeholders and respecting European and national laws. Looking to the German market, five steps within the innovation process can be described from idea to monetarization: research, product development, certification, reimbursement policies and finally marketing. Within each of these steps external sources are mandatory to be included along the innovation process. The present article demonstrates that the traditional internal way of innovation development and hence management is no longer applicable. Organizations are forced to open their innovation processes if they want them to promote them on the European market. Medical regulations should not only be seen as a burden but as chance to increase the innovation success by involvement of the customers.

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