Report - The medical device innovation. France's attractiveness and development of the sector
The medical device industry is sometimes wrongly considered as a sub-sector of the pharmaceutical industry. It is true that the identification of this unknown sector is complicated by the vast and diverse field that covers medical devices or "DM": this ranges from simple to sophisticated dressing heart valves, through the material of medical imaging mere crutch to hip replacement, through diagnostic software.
Such a variety of products involves equally impressive diversity of scientific disciplines mobilized. It is there at the confluence of multiple knowledges: mechanics, biology, physics, chemistry, electronics, computer ... With it involves skills and cross-collaborations between businesses, this is a multidisciplinary extremely fertile ground for innovation. In fact, the medical device industry has emerged as a very dynamic sector, which improves year after year offer health. It has a market pulled by both the aging of the population, which assumes ever greater medical needs, and the increasing complexity of treatments that go far beyond mere pharmacology. The specificities of the sector, whether the innovation process, knowledge required clinical assessments or health safety, deserve to be recognized by the government.
Especially as France has a leading role to play in this dynamic technological innovation. It has a number of strengths, including its high quality medicine and research, the source of many innovations. However, in this sector of the medical device, the French industry is fragmented, with companies often small, struggling to cross thresholds, or are absorbed by companies of foreign origin. The role of public authorities in the development of this sector is therefore crucial.
The report of the Strategic Analysis Centre aims to propose ways that will bring about a French sector of medical devices and export dynamics. Mission chaired by Jacques Lewiner in collaboration avecJacques Pope explores all sides of the issue: research and technological innovation, management training, but also the financing of innovative enterprises and clarifying the regulatory pathway.
To take full advantage of these innovations in French industry, it seems necessary to facilitate the process of start-up. But should also ensure a long-term support for innovative companies. The creation of an investment fund specific medical devices will respond in part to funding difficulties.
The long-term development of the sector is also conditioned by the existence of a range of training tailored to the needs of different stakeholders. It is, for example, to promote contacts between physicians and engineers from the initial training and throughout their careers, but also to offer both public courses through which they can better understand the specificities of the sector.
Finally, it should clarify and streamline the regulatory process for obtaining an assumption by health insurance. Such a development is possible without having to waive the requirements guaranteeing the highest safety niveauxde. Recent news has reminded the importance of regulation in this area and elsewhere. Effective regulation and innovation dynamics, these two aspects are not contradictory, they are even necessarily compatible, since it is always to improve the health of patients.
Keywords: medical devices, innovation, medicine, research, supported by health insurance, CE, and training.
- Report of the committee chaired by Jacques Lewiner, Scientific Director Emeritus, Graduate School of Industrial Physics and Chemistry - ParisTech
in collaboration with Jacques Le Pape, Inspector General of Finance - General Rapporteur: Aude Rigard-Cerison
- Rapporteurs: Aurélien Croq, Aude Teillant
- CAS and references DGCIS: Dominique Auverlot, Jean-Paul Nicolaï, Pierre Angot, Daniel Vasmant