Definition of reliability qualification tests of electronic components for active implanted medical devices

Type
Rattachement
LARIS - Université d'Angers
Description

Within the framework of the regional project RECOME (Reliability of Electronic COmponents for MEdical devices), the purpose of this research work is to define a methodology to qualify an electronic component to respect a level of safety of MD. It will be a question of defining the tests to be carried out according to the type of components and the medical application.

This study will be based on the various standards for the qualification of components and/or their manufacturing process, on the requirements for the safe operation of medical devices, and on the ageing models for electronic components. It will have to evaluate, if necessary, processes of implementation of these components allowing to increase their reliability in application (underfill, coating...) with technological locks and in particular the miniaturization and the impossibility of carrying out traditional tests (functional tests, tests in situ).

This post-doctoral fellowship aims at applying the methodology, based on the design of experiments and established during the current thesis work, to several types of components including integrated circuits and MEMS accelerometer. This consists in defining accelerated test plans from the study of the failure mechanisms and the mission profile specific to active implanted medical devices, to define the associated test protocols, and then to analyze the observed failures. The results will allow the definition of a reliability model by family of components according to the design characteristics.

Subsequently, it will characterize the impact of implementation processes (underfill, coating) on the reliability of a product that are not yet quantified.

In order to achieve this objective, the principle envisaged is (by mission profile and by component technology):

  • To identify the weaknesses of the component and the failure modes by feedback or by research analysis,
  • To define qualification and validation processes for components,
  • Define reliability demonstration methods based on accelerated life tests.

 

The research carried out will bring an innovation on the recent processes of manufacture and integration of electronic embedded systems of miniaturization. It will allow on these evolutions to improve the implementation of a component in a product to optimize its reliability.

It will allow to establish predictive models of the physics of failure associated to guarantee the reliability of a couple product / process. This research will lead to a gain in competitiveness by limiting the costs of qualification and testing of components by precisely defining the "right need".

A valorization of the scientific work is to be carried out in particular in reviews like Microelectronic reliability, Reliability Engineering and System Safety, IEEE Transactions on reliability or IEEE Transactions on device and materials reliability.