Laboratory testing is essential in understanding the fatigue durability limits of a medical device. Only a limited number of tests, however, are feasible considering the time and cost of manufacturing and testing the device. Many geometries and materials are available as design alternatives and testing is typically constrained to a limited number of devices. Additionally, physical test method capability typically has limitations and uncertainty for such breath of design alternatives. The time and cost is greatly magnified if the designs do not meet the durability test requirements. This leads to an important question, “How do we combine results from the laboratory testing of similar designs and similar materials with state-of-the-art computational methods to create the best possible understanding of the design space? The Virtual Life Management® (VLM) methodology accomplishes this by creating a Virtual Design of Experiment: a computational method that combines...

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