Treffer: 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; Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, UNITED STATES., Basciano CA; Becton, Dickinson and Company, 21 Davis Dr, Durham, North Carolina, 27713, UNITED STATES., Afshari P; Johnson & Johnson MedTech, 325 Paramount Drive, Raynham, Massachusetts, 02767, UNITED STATES., Aycock KI; Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, UNITED STATES., Ballyns JJ; Becton, Dickinson and Company, 21 Davis Dr, Durham, North Carolina, 27713, UNITED STATES., Baumann AP; US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, UNITED STATES., Bischoff JE; Zimmer Biomet, P.O. Box 708, Warsaw, Indiana, 46581, UNITED STATES., Bodner J; Medtronic plc, 710 Medtronic Parkway, Minneapolis, Minnesota, 55432, UNITED STATES., Briant P; Exponent Inc, 149 Commonwealth Drive, Menlo Park, California, 94025, UNITED STATES., Driscoll M; McGill University, Macdonald Engineering Building, Rm 153, Montreal, Quebec, H3A 0C3, CANADA., Frangi A; University of Manchester - The Victoria University of Manchester Campus, Rm G530, Stopford Building, Oxford Road, Manchester, M13 9PL, UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND., Grant CGJ; Johns Hopkins University Applied Physics Laboratory, 11100 Johns Hopkins Rd, Laurel, Maryland, 20723, UNITED STATES., Guler I; Boston Scientific Corporation, 1 Scimed Pl, Maple Grove, Minnesota, 55311, UNITED STATES., Hoganson DM; Boston Children's Hospital, 300 Longwood Ave, Boston, Massachusetts, 02115, UNITED STATES., Imhauser CW; Hospital for Special Surgery, 535 E 70th St, New York, New York, 10021, UNITED STATES., Knudsen L; Zimmer Biomet, P.O. Box 708, Warsaw, Indiana, 46581, UNITED STATES., Liu XC; Stryker Orthopaedics, 325 Corporate Dr, Mahwah, New Jersey, 07430, UNITED STATES., Lurie B; W.L. Gore & Associates, 3750 W. Kiltie Lane, Flagstaff, Arizona, 86005, UNITED STATES., Pai VM; Center for Devices and Radiological Health, Digital Health Center of Excellence, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, UNITED STATES., Palmer M; ANSYS Inc, 2600 Ansys Dr, Canonsburg, Pennsylvania, 15317, UNITED STATES., Pathmanathan P; Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, UNITED STATES., Quevedo González FJJ; Hospital for Special Surgery, 535 E 70th St, New York, New York, 10021, UNITED STATES., Shrivastava D; Center for Devices and Radiological Health, Office of Product Evaluation and Quality, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, UNITED STATES., Voisin E; Voisin Consulting Life Sciences, 64, avenue Pierre Grenier, Boulogne-Billancourt, Île-de-France, 92100, FRANCE.
Source:
Progress in biomedical engineering (Bristol, England) [Prog Biomed Eng (Bristol)] 2025 Nov 05. Date of Electronic Publication: 2025 Nov 05.
Publication Model:
Ahead of Print
Publication Type:
Journal Article
Language:
English
Journal Info:
Publisher: IOP Publishing Country of Publication: England NLM ID: 101771567 Publication Model: Print-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]-
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 Latest Revision: 20251105
Update Code:
20251106
DOI:
10.1088/2516-1091/ae1c05
PMID:
41192059
Database:
MEDLINE

Weitere Informationen

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 the FDA/MDIC Symposium on Computational Modeling and Simulation on 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 of in silico clinical 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.)