Today, there is no standard or reference for the reliability of electronic components in medical devices.
In recent years, medical devices have evolved rapidly, and electronics are increasingly present.
Until present, the reliability of electronic components has had little impact, but more and more frequently an electronic failure provokes an immediate impact on the patient, whether it be that they need emergency surgery or whether the impact is the death of the patient. Estimating and demonstrating reliability is paramount to the device's market authorization.
Contrary to other applications such as aeronautics, space or nuclear applications, where reliability is already a key element, medical devices (especially implantable ones) are limited in terms of redundancy, and the reliability of the system depends directly on the reliability of the electronic components.
However, to date, there is no standard or established reference for electronic components used in medical applications.
RECOME and our partners
Tame-Component and the medical branch of the TRONICO group have embarked with the laboratory LARIS and OUEST VALORISATION on the ambitious project of creating a standardized medical grade for electronic components. The project has been named RECOME.
This project has already succeeded in building a great amount of support, for example from the region Pays de la Loire, BPI France, France Relance as well as from recognized players in the field of implantable medical devices: CARMAT, UROMEMS, FINE HEART, and in the field of electronics: VISHAY, Exxelia, NCAB and TechCI.
Description of the project
RECOME is a project which aims above all to make medical electronics more reliable, particularly for the design and manufacture of so-called critical medical devices (class II, III and implantables).
Through RECOME, our objectives are:
- To define a standard to qualify electronic components and validate their use in medical applications
- To harmonize the requirements of the medical sector, this standard will be the pillar on which all medical device manufacturers, equipment manufacturers, electronic subcontractors and component manufacturers will rely
- To create a database of qualified components which for medical device manufacturers would represent an economic and logistic gain as well as an accelerated design process, by guiding them in their technological choices.
The different stages
The purpose of the RECOME project is to create an environment where the reliability of components for medical use can be demonstrated:
- Optimization of reliability models, while considering stresses related to biocompatibility
- Validation of reliability models
- Drafting of an experimental standard
- Creation of a database of qualified component batches
- Distribution of qualified component batches
This work is projected to be carried out on 10 major families of components, each represented by 5 references in components to be representative of the manufacturers present on the market.
Tame-Component and its partners wish to provide the solution for reliability of current and future medical devices so that new medical technologies can keep all their promises of minimizing risks for users.