Rheumatoid arthritis is an autoimmune disorder that frequently affects the fingers and results in swollen and/or painful joints. Total joint replacement surgery is commonly required, in which a silicone elastomer prosthetic is implanted to restore patient hand/finger function and alleviate pain. Design qualification requirements specify that the prosthetic must endure at least 10 million cycles in which the finger joint is flexed through 90 degrees, which is typically determined and verified through a battery of costly physical testing routines. However, physics-based simulation is becoming a commonly used method as an enhancement or replacement to physical testing by medical device companies to save time and money when submitting a device for approval to the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA). The workflow presented here describes why and how to leverage patient-specific anatomical data, non-linear structural simulation, fatigue simulation and shape optimization to generate a customized simulation workflow to enhance device design of a total finger joint replacement. This presentation will discuss software that is used to assure durability when designing silicone rubber medical implants. Implants often have stringent regulatory durability requirements, and it is quite time-consuming and expensive to build prototypes and to test them physically. Software enables designers of silicone parts to estimate durability, taking into account the material properties, the geometry of the part and the loads and motions experienced by the part.
SPEAKER: Will Mars - Speaker Ph.D., Founder and President, Endurica LLC