Abstract
Temporomandibular joint replacement is a critical intervention for severe temporomandibular joint disorders, enhancing pain levels, jaw function and overall quality of life. In this study, we compare two finite element method-based simulation workflows from both academic and industrial perspectives, focusing on a patient-specific case involving a custom-made temporomandibular joint prosthesis. Using computed tomography data and computer-aided design data, we generated different 3D models and performed mechanical testing, including wear and static compression tests. Our results indicate that the academic workflow, which is retrospective, purely image-based and applied post-operatively, produced peak stress values within 9-20% of those obtained from the industrial workflow. The industrial workflow is prospective, pre-operative, computer-aided design-based and guided by stringent regulatory standards and approval protocols. Observed differences between workflows were attributed primarily to distinct modelling assumptions, simplifications and constraints inherent in each method. To explicitly quantify these differences, multiple additional models were generated within the academic workflow using partial data from the industrial process, revealing specific sources of variation in stress distribution and implant performance. The findings underscore the potential of patient-specific simulations not only to refine temporomandibular joint prosthesis design and enhance patient outcomes, but also to highlight the interplay between academic research methodologies and industrial standards in the development of medical devices.