Application of modeling and simulation for high risk failure modes

In this paper, application of modeling and simulation (M&S) in conjunction with FMEA/FMECA for high-risk failure modes in the product development stages is demonstrated. The effectiveness of the proposed approach is illustrated with a suitable example in the area of bio medical devices, a complete hip-replacement implant. Identifying and mitigating failure modes associated with this product is highly critical. Load at the interfaces of the hip joint is considered for identifying the failure modes. Geometry of implant and selection of the material necessary to mitigate failure modes are discussed. Failure Modes are summarized in Figure 4. Sensitivity analysis determines factors that can mitigate or eliminate the failure modes. Probabilistic analysis such as the burden capability method is employed for assessing the probability of failure mode occurrences, which provides a structured approach to ranking of the failure modes, based on a combination of their probability of occurrence and severity of their effects.