An integrated approach for implantable medical devices fatigue reliability prediction

For implantable medical devices that must have sufficient fatigue durability to last for many years of implantation, the current fatigue reliability characterization/demonstration method has several drawbacks. In this paper, by combining the feasibility testing, FEA analysis, material level probabilistic stress-life (P-S-N) curve, use condition based fatigue loading, we developed an integrated approach to predict implantable medical device fatigue reliability.