Verification and Validation of an Open Source–Based Morphology Analysis Platform to Support Implant Design

Availability of medical image data and ongoing advancement of image-processing and mathematical-modeling techniques are increasingly enabling device manufacturers to conduct clinically relevant morphological and mechanical analyses across populations to support device development. Gaps in the ability of contemporary commercial codes to fully realize these analytical goals frequently requires some amount of in-house code development and deployment. Verification and validation (V&V) of these custom modules or platforms is an essential requirement for deployment of the software within a medical device design controls system. One such software platform to support orthopedic morphological analysis, zibra, has been successfully developed through a collaborative relationship between Zimmer, Inc. and Kitware, Inc. The development process involved configuration of commercial code, open-source toolkits, and custom code. Here, the V&V strategy to support deployment of zibra is described.