• Computational modeling and sim...

*Result*: Computational modeling and simulation for medical devices: a summary of the 2024 FDA/MDIC Symposium.

Title:
Computational modeling and simulation for medical devices: a summary of the 2024 FDA/MDIC Symposium.
Authors:
Craven BA; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, United States of America.; Present address: Department of Mechanical Engineering, Baylor University, Waco, TX, United States of America., Basciano CA; Becton, Dickinson and Company, Durham, NC, United States of America., Afshari P; Johnson & Johnson MedTech, Raynham, MA, United States of America., Aycock KI; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, United States of America., Ballyns JJ; Becton, Dickinson and Company, Durham, NC, United States of America., Baumann AP; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, United States of America., Bischoff JE; Zimmer Biomet, Warsaw, IN, United States of America., Bodner J; Medtronic plc, Minneapolis, MN, United States of America., Briant P; Exponent, Inc, Menlo Park, CA, United States of America., Driscoll M; McGill University, Montréal, QC, Canada., Frangi AF; University of Manchester, Manchester, United Kingdom., Grant CJ; Johns Hopkins University Applied Physics Laboratory, Laurel, MD, United States of America., Guler I; Boston Scientific Corporation, Maple Grove, MN, United States of America., Hoganson DM; Boston Children's Hospital, Boston, MA, United States of America., Imhauser CW; Hospital for Special Surgery, New York, NY, United States of America., Knudsen L; Zimmer Biomet, Warsaw, IN, United States of America., Liu XC; Stryker Orthopaedics, Mahwah, NJ, United States of America., Lurie BA; W.L. Gore & Associates, Flagstaff, AZ, United States of America., Pai VM; Digital Health Center of Excellence, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, United States of America., Palmer M; ANSYS, Inc, Canonsburg, PA, United States of America., Pathmanathan P; Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, United States of America., Quevedo Gonzalez FJ; Hospital for Special Surgery, New York, NY, United States of America., Shrivastava D; Office of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, United States of America., Voisin E; Voisin Consulting Life Sciences, Boulogne (Paris), France.
Source:
Progress in biomedical engineering (Bristol, England) [Prog Biomed Eng (Bristol)] 2026 Feb 02; Vol. 8 (1). Date of Electronic Publication: 2026 Feb 02.
Publication Type:
Journal Article
Language:
English
Journal Info:
Publisher: IOP Publishing Country of Publication: England NLM ID: 101771567 Publication Model: Electronic Cited Medium: Internet ISSN: 2516-1091 (Electronic) Linking ISSN: 25161091 NLM ISO Abbreviation: Prog Biomed Eng (Bristol) Subsets: MEDLINE
Imprint Name(s):
Original Publication: Bristol : IOP Publishing, [2019]-
MeSH Terms:
United States Food and Drug Administration* , Equipment and Supplies* , Computer Simulation*, United States ; Humans ; Device Approval ; Congresses as Topic
Contributed Indexing:
Keywords: computational modeling and simulation; digital twins; good simulation practice; in silico clinical trials; medical devices; model credibility; verification and validation
Entry Date(s):
Date Created: 20251105 Date Completed: 20260202 Latest Revision: 20260202
Update Code:
20260202
DOI:
10.1088/2516-1091/ae1c05
PMID:
41192059
Database:
MEDLINE

*Further Information*

*Computational modeling and simulation (CM&S) is a powerful tool that can be used to support the development, evaluation, and regulatory authorization of medical devices. CM&S can provide valuable insights into device performance, safety, and effectiveness, as well as reduce the need for animal or human testing. Computational models are, however, idealized digital representations that often have many assumptions and need to be credible before they are used in decision making that could incur patient harm. While the medical device community has made great strides to advance the use of CM&S, a number of challenges remain. To begin addressing these challenges, the US Food and Drug Administration (FDA) and the Medical Device Innovation Consortium (MDIC) co-sponsored theFDA/MDIC Symposium on Computational Modeling and Simulationon April 16-17, 2024 in College Park, Maryland, USA, where attendees from around the world convened to hear from leaders in the field through a unique blend of invited presentations and interactive panel discussions. The symposium agenda covered several major themes, including credibility considerations for CM&S used across the medical device total product life cycle, practical examples of performing model credibility assessment, and the use of CM&S for clinical decision making and the emerging areas ofin silicoclinical trials and digital twins. The objective of this article is to summarize the major takeaways of the symposium. We first provide an overview of the invited presentations followed by summaries of the topics covered during the interactive panel discussions. In doing so, we highlight the main takeaways and identify areas in which panelists had shared perspectives or differences of opinion. Next, we present the results of a survey conducted at the symposium that sought attendees' perspectives on different aspects of medical device CM&S. Finally, we conclude by summarizing the major outcomes of the symposium, including areas where more work and investment are needed to advance the field.
(Creative Commons Attribution license.)*