A Risk-based Framework for the use of Computational Modeling of Medical Devices to Support Regulatory Decisions

Computational models and simulations (CM&S) are used in multiple stages within the Total Product Life Cycle (discovery and ideation, regulatory decision, product launch, and post market monitoring) of medical devices. The Food and Drug Administration (FDA) has been proactive in establishing a risk-based framework for the use of CM&S to support regulatory decisions utilizing research from the field of Verification, Validation, and Uncertainty Quantification (VVUQ). This framework includes an American Society of Mechanical Engineering Standard (ASME V&V 40) that includes code and calculation verification as well as validation of CM&S for medical devices. This talk will present: 1) an overview of this risk-based framework; 2) examples of the use of CM&S in regulatory; 3) a summary of an in-depth example of the execution of a VVUQ plan for a computational model of heart-device interactions in the form a benchtop mock-circulatory loop with a left-ventricular assist device (SDSU-CS-LVAD); and 4) a comparison of the intraventricular flow dynamics of the SDSU-CS-LVAD and clinical results. Overall, this presentation should provide an overview of a concrete framework that is enabling innovative advances of CM&S in the TPLC of medical devices.