Comprehensive Fatigue Analysis: Complex Loading of Implantable Medical Device

Medical device manufacturers are increasingly required to demonstrate that their products are safe and effective when subjected to complex loading conditions in the human body such as when the device may experience combinations of bending, twisting and compression.  Physical test methods are difficult to implement in such cases, can only consider a finite number of conditions and do not provide prompt relevant feedback to the medial device design process.

Dr. Paul and I have developed a comprehensive methodology for quantifying the fatigue performance of devices subjected to multiple coupled loading conditions. It is relevant for quantifying the fatigue performance as required by the FDA of peripheral vascular stents and other devices with FEA that experience coupled multiple loading conditions and is based on a stochastic implementation of Miners rule.

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