A D V A N C E D M A T E R I A L S & P R O C E S S E S | O C T O B E R 2 0 2 2 4 1 inputs. A wide adaption of methods such as these can help make the paradigm of using a risk-informed approach for incorporating computer simulation results in the design and performance evaluation of nickel-titanium-based implantable medical devices a standard practice. Notes This article is based on the authors’ work, Reference 3, which is licensed under the CC BY license (creativecommons. org/licenses/by/4.0/). The findings and conclusions in this article have not been formally disseminated by the U.S. FDA and should not be construed to represent any agency determination or policy. The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services. ~SMST For more information: Harshad M. Paranjape, principal research engineer, Confluent Medical Technologies Inc., 47533 Westinghouse Dr., Fremont, CA 94539, 510.683.2184, harshad.paranjape@confluentmedical.com. FEATURE References 1. ASME, Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices, 2018. 2. U.S. Food and Drug Administration, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, 2022. 3. H.M. Paranjape, K.I. Aycock, C. Bonsignore, et al., A Probabilistic Approach with Built-in Uncertainty Quantification for the Calibration of a Superelastic Constitutive Model from Full-field Strain Data, Comput. Mater. Sci., 192:110357, 2021, https://doi.org/10.1016/j.commatsci.2021.110357. 4. F. Auricchio, R. Taylor, J. Lubliner, Shape-memory Alloys: Macromodeling and Numerical Simulations of Superelastic Behavior, Comput. Methods Appl. Mech. Eng., 146, 1997. 5. H. Rappel, L.A.A. Beex, J.S. Hale, et al., A Tutorial on Bayesian Inference to Identify Material Parameters in Solid Mechanics, Arch. Comput. Methods Eng., 27:361–385, 2020, https:// doi.org/10.1007/s11831-018-09311-x. 6. R. Marrey, B. Baillargeon, M.L. Dreher, et al., Validating Fatigue Safety Factor Calculation Methods for Cardiovascular Stents, J. Biomech Eng., 140:061001, 2018, https://doi. org/10.1115/1.4039173. 1 3
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