Risk Based Bayesian Design for Fatigue Reliability for Implantable Medical Devices  
Author Mingxiao Jiang


Co-Author(s) Haitao Zhang


Abstract Implantable medical devices have been providing abundant therapy solutions in treating a variety of patient disease conditions. Those medical devices could consist one or more parts that are manufactured from metals, and these parts undergo cyclic physiological loading conditions inside patient’s body, and must have sufficient fatigue reliability for many years of implant duration. During product development, there are limit samples of prototypes to be tested to drive reliability growth. This paper integrates physics of failure (PoF) analysis, ALT, virtual testing for reliability growth, Bayesian reliability and risk based reliability target, to ensure a robust and reliable design. Such a Design for Reliability (DFR) approach yields more cost-effective and reliable design for medical device development.


Keywords Implantable Medical Devices, Design for Reliability, Risk, Virtual Testing, Physics of Failure, Accelerated Life Testing, Bayesian Method
    Article #:  2468
Proceedings ISSAT International Conference on Reliability and Quality in Design 2018
August 2-4, 2018 - Toronto, Ontario, Canada