NAFEMS Americas and Digital Engineering (DE) teamed up (once again) to present CAASE, the (now Virtual) Conference on Advancing Analysis & Simulation in Engineering, on June 16-18, 2020!

CAASE20 brought together the leading visionaries, developers, and practitioners of CAE-related technologies in an open forum, unlike any other, to share experiences, discuss relevant trends, discover common themes, and explore future issues, including:
-What is the future for engineering analysis and simulation?
-Where will it lead us in the next decade?
-How can designers and engineers realize its full potential?
What are the business, technological, and human enablers that will take past successful developments to new levels in the next ten years?

Resource Abstract

Industry routinely uses finite element analysis (FEA) to prescribe the amount of physical testing and identify the highest risk scenarios. At the same time, regulators need to have confidence that analysts are producing valid and repeatable simulation results. The ASME V&V 40 Standard – Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices – provides a framework for establishing the credibility requirements of a computational model for a context of use (COU) based on model risk.

This presentation describes a formalized process based on the ASME V&V 40 standard to allow practitioners to demonstrate the credibility of their computational models, minimize the required fatigue testing, and save time and money associated with manufacturing and testing of these devices. To provide practical insights into the credible use of computational modeling that can be adapted and applied when developing medical devices, the V&V 40 framework is presented as an end-to-end example of a tibial tray component of an artificial knee implant.

This example includes a combination of computational modeling and physical nonclinical testing to assess the fatigue resistance of a new metal tibial tray design for a total knee arthroplasty. Specifically, we use the V&V 40 framework to assess the credibility of a computational model that represents an ASTM test method for tray fatigue strength to predict the peak stresses that occur in the worst-case device size(s) from a family of tibial trays. The specific role and scope of the computational model is referred to as its COU.

The computational model risk is established by combining the model influence with the model’s decision consequence. Next, a gradation and subsequent selection of verification and validation activities, which are driven by the risk assessment, are provided for each of the 13 credibility factors. The credibility factors allow the practitioner to determine the rigor needed for the verification, validation, and applicability activities. To illustrate how the V&V 40 may be put into practice, the results of specific plan activities are shown. Finally, the credibility of the computational model is determined



The intention is to provide attendees with ideas that can be adapted and applied within their own organizations

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Presentation developed by:

• Linda Knudsen, Principal Engineer, Syncroness

• Sudeep Sastry, Engineering Analyst, W.L. Gore & Associates

• Brandon Lurie, Engineering Analyst, W. L. Gore & Associates

• Marc Horner, Principal Engineer, Healthcare, ANSYS, Inc.

• Dana Coombs, Principal Engineer, DePuy Synthes Trauma

• Michael Bushelow, Group Manager, DePuy Synthes