Advancing medical technology innovation and clinical translation via a model of industry-enabled technical and educational support: Indiana Clinical and Translational Sciences Institute's Medical Technology Advance Program.
Translational research
academic–industry collaboration
engineering
medical technology
regulatory affairs
Journal
Journal of clinical and translational science
ISSN: 2059-8661
Titre abrégé: J Clin Transl Sci
Pays: England
ID NLM: 101689953
Informations de publication
Date de publication:
19 Jan 2021
19 Jan 2021
Historique:
entrez:
19
5
2021
pubmed:
20
5
2021
medline:
20
5
2021
Statut:
epublish
Résumé
The success rate for translation of newly engineered medical technologies into clinical practice is low. Traversing the "translational valleys of death" requires a high level of knowledge of the complex landscape of technical, ethical, regulatory, and commercialization challenges along a multi-agency path of approvals. The Indiana Clinical and Translational Sciences Institute developed a program targeted at increasing that success rate through comprehensive training, education, and resourcing. The Medical Technology Advance Program (MTAP) provides technical, educational, and consultative assistance to investigators that leverages partnerships with experts in the health products industry to speed progress toward clinical implementation. The training, resourcing, and guidance are integrated through the entire journey of medical technology translation. Investigators are supported through a set of courses that cover bioethics, ethical engineering, preclinical and clinical study design, regulatory submissions, entrepreneurship, and commercialization. In addition to the integrated technical and educational resources, program experts provide direct consultation for planning each phase along the life cycle of translation. Since 2008, nearly 200 investigators have gained assistance from MTAP resulting in over 100 publications and patents. This support via medicine-engineering-industry partnership provides a unique and novel opportunity to expedite new medical technologies into clinical and product implementation.
Identifiants
pubmed: 34007464
doi: 10.1017/cts.2021.1
pii: S2059866121000017
pmc: PMC8111604
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e79Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR002529
Pays : United States
Commentaires et corrections
Type : ErratumIn
Informations de copyright
© The Association for Clinical and Translational Science 2021.
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