Finite Element Analysis (FEA) has been widely used to analyze the in vivo structural response of implantable medical devices and assess device performance, reliability and durability. Take stents for example. Several characteristics like radial force, peak stresses and strains and fatigue safety factors can be determined using these modeling techniques. As all physical phenomena are stochastic, all design parameters have built-in variability. On the other hand, stents are typically modeled with nominal dimensions and material properties. Minimum and maximum dimensions are used in certain instances, while other dimensional variances are often not considered. In addition, the in vivo boundary conditions also vary widely across patient population.
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