Toward trustworthy medical device

ISCT In silico clinical trial computational modeling and simulation hierarchical verification and validation model credibility

Journal

Frontiers in medicine
ISSN: 2296-858X
Titre abrégé: Front Med (Lausanne)
Pays: Switzerland
ID NLM: 101648047

Informations de publication

Date de publication:
2024
Historique:
received: 15 05 2024
accepted: 10 07 2024
medline: 27 8 2024
pubmed: 27 8 2024
entrez: 27 8 2024
Statut: epublish

Résumé

Computational models of patients and medical devices can be combined to perform an

Identifiants

pubmed: 39188879
doi: 10.3389/fmed.2024.1433372
pmc: PMC11346031
doi:

Types de publication

Journal Article

Langues

eng

Pagination

1433372

Informations de copyright

Copyright © 2024 Aycock, Battisti, Peterson, Yao, Kreuzer, Capelli, Pant, Pathmanathan, Hoganson, Levine and Craven.

Déclaration de conflit d'intérêts

TB, JY, and SL were employed by the company Dassault Systémes, makers of the software applications 3DEXPERIENCE, Abaqus, and Dymola that were used in this study. AP was employed by Thornton Tomasetti, Inc. SK was employed by Exponent, Inc. DH receives gift-in-kind software from several modeling and simulation companies including Dassault Systémes, Ansys, Materialize, and Realize Medical. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.

Auteurs

Kenneth I Aycock (KI)

Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, MD, United States.

Tom Battisti (T)

Dassault Systèmes, Waltham, MA, United States.

Ashley Peterson (A)

Thornton Tomasetti, Inc., New York, NY, United States.

Jiang Yao (J)

Dassault Systèmes, Waltham, MA, United States.

Steven Kreuzer (S)

Exponent, Inc., Menlo Park, CA, United States.

Claudio Capelli (C)

Institute of Cardiovascular Science, University College London, London, United Kingdom.

Sanjay Pant (S)

Faculty of Science and Engineering, Swansea University, Swansea, United Kingdom.

Pras Pathmanathan (P)

Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, MD, United States.

David M Hoganson (DM)

Department of Cardiac Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, United States.

Steve M Levine (SM)

Dassault Systèmes, Waltham, MA, United States.

Brent A Craven (BA)

Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, MD, United States.

Classifications MeSH