First of all, when we talk about medical devices, we mean " any instrument, apparatus, equipment, material, product, with the exception of products of human origin, or other article used alone or in combination, including the accessories and software necessary for its proper functioning, intended by the manufacturer to be used in humans for medical purposes and whose principal intended action is not obtained by pharmacological or immunological means or by metabolism, but whose function can be assisted by such means. Software intended by the manufacturer to be used specifically for diagnostic or therapeutic purposes shall also constitute a medical device. " Article L5211-1 of the Public Health Code.
More simply, medical devices are health products, used by prescribing health professionals and patients, they cover for example medical equipment (MRI, scanner), masks, gloves, implants, mobile health applications, surveillance monitors, medical beds...
Seres Technologies is a company of the Groupe Gorgé We offer support in engineering, ergonomics and mechanics. Our goal is to remain a recognized specialist in our fields while adapting to the markets and sectors we target.
The medical device market is very large and presents a lot of opportunities for us. This is why we created a Life Sciences Compliance and Engineering Division at the beginning of 2020. This pole of competence allows us to have a specialized team composed of doctors, biologists and engineers in charge of supporting companies such as Sanofi, GSK, General Electric on the realization of compliance studies, design, management of regulations etc..
This choice is based on well-founded (numerical) data. The medical device sector in France is showing great momentum with a turnover of €30 billion in 2019 against €28 billion in 2016.
With a network of 224 production sites covering all technologies (excluding bio-production) and a number of companies registered in France that has increased by more than 200 to reach the figure of 1502 companies in 2019. Pharmaceutical production in France has several advantages based on historical expertise. France has the capacity to manage industrial complexity (1 pharmaceutical speciality = 38 references on average). Lastly, France is the leader in vaccines, although there are still some areas to watch out for that require a proactive approach.
You will note that this sector is very diversified, remains essential and generates jobs (nearly 90,000 direct jobs) on the national territory with a more important establishment in the regions of Ile-de-France and Auvergne/Rhône-Alpes.
Finally, technological developments are also opening up new perspectives in many fields such as 3D or even cardiac prosthesis implants.
In the current context of health crisis, French manufacturers are currently in an unprecedented awareness of the importance of developing medical devices.
For example, Eysins-based Swiss commercial diagnostics company Quotient Limited announced the completion of the development phase of a fully automated SARS-CoV-2 antibody test (COVID-19) in response to the global coronavirus pandemic.
The antibody test, based on MosaiQ technology, promises up to 3000 tests per day per device, with the first result available after 35 minutes. The company says it is already in contact with the federal and cantonal authorities in order to prioritise the deployment of existing systems for maximum impact.
There are many issues that need to be addressed, such as improved supplies, better organisational management, ergonomic studies of equipment and implants to cope with possible future pandemics more quickly.
The French sites offer obvious advantages which must however be amplified / adapted in a proactive approach. This is exactly what Seres Technologies and its teams can do.
Our teams offer, among other things, assistance with the new European standards in connection with the COVID-19EU in order to be able to market medical devices (MD), active implantable medical devices (AIMD) and in vitro diagnostic medical devices (IVDD). This may also concern everything related to CE marking and possible derogations in this context.
Finally, Seres Technologies brings its expertise in Ergonomics (with a specialised team of Ergonomists, Psychologists and UX designers) to help medical device manufacturers improve their health products (implants, applications, organisation).