New dependability approach for implanted medical devices

Abstract

Functional electrical stimulation (FES) is an attractive solution to restore some lost or failing physiological functions. Obviously, the FES system may be hazardous for patient and the reliability and dependability of the system must be maximal. Unfortunately, the present context, where the associated systems are more and more complex and their development needs very cross-disciplinary experts, is not favorable to safety. Moreover, the direct adaptation of the existing dependability techniques from domains such as space or automotive is not suitable. Firstly, this paper proposes a strategy for risk management at system level for FES medical implant. The idea is to give a uniform framework where all possible hazards are highlighted and associated consequences are minimized. Then, the paper focuses on one of the most critical part of the FES system: analog micro-circuit which generates the electrical signal to electrode. As this micro-circuit is the closest to the human tissue, any failure might involve very critical consequences for the patient. We propose a concurrent top-down and bottom-up approach where the critical elements are highlighted and an extended risk analysis is performed.