Biomedical Engineering Reference
In-Depth Information
biomaterials. Indeed, and despite this misunderstanding of their
importance, medical devices have well-identified purposes:
- the diagnosis, the prevention, the control, the treatment of a
disease;
- the diagnosis, the control, the treatment, the compensation of a
wound or a handicap;
- the study, the replacement or the modification of the anatomy or
of the physiological process.
2.3.2.
Definition of a medical device
Medical devices are products of health, including software,
claiming a use in medical purposes and from which the mode of the
deliberate main action is not obtained by pharmacological or
immunological means nor by metabolism, otherwise the product
qualifies as medicine (Article R5211-2 of the French Public Health
Code).
Within this definition it is easy to understand how and why
medical devices cover a very large domain of health engineering with
applications as different as diagnostics, therapeutics, disease follow
ups or handicap compensation. Medical devices are characterized
by: (1) a very large diversity of products going from the simple patch
to the most sophisticated cardiac valve, from wheelchairs to hip
prostheses, from syringe or catheter to a vascular prosthesis, all the
materials of diagnosis to heavy equipment of medical imaging; (2) a
high number of referenced products (
1 to 2 million in France, IGAS
report 2010) have been developed in response to the targeted needs of
many small groups of patients (e.g. aortic endo-prostheses only a few
thousand patients in France).
∼
The market of medical devices holds an increasing place both at
the world and European levels and represents a market of several
hundred billion euros. Within this market, France takes fourth or fifth
place with 10% of the world market. It is characterized by its
industrial network made of 94% of small and medium sized
