Computer simulation using finite element analysis (FEA) is now a integral part of the design process for nearly all new medical device products. The FDA strongly recommends analyses to be performed to quantify the strength and/or fatigue life of implant products. Analysis categories include stress, heat transfer, electromagnetics and fluid flow. Often these disciplines are linked through multiphysics applications. The increases in computer speed and reduced time in computer modeling have made FEA economical for almost all new medical products. Bi-directional links to popular CAD packages enable two-way geometry interchange of complex components that automate the design process using optimization and robust design procedures. Commercial finite element codes have a diverse library of material models, as well as solution procedures, thus enabling multiple analysis disciplines from a single model. Fully coupled fluid-structure interaction (FSI) provides an simulation tool to more accurately solve complex problems such as artificial heart valves.
Example applications in the biomedical field include modeling cardiac pumps, cardiac stents, spine implants, artificial hips to dental implants. This paper will demonstrate the procedure used for incorporating the finite element method into the medical device design process. Applications will be categorized from simple, to moderately difficult to very difficult problems to solve using finite element analysis.
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