Software to manage regulatory workflows for medical device development at academic medical centers: A critical gap
Research from academic institutions is a significant driving force in developing new medical devices. In 2020, the Association of University Technology Managers (AUTM) reported 27,112 invention disclosures. Despite these impressive efforts, disclosures do not translate into commercialized products due to numerous barriers, including weak support infrastructure and the lack of institutional knowledge in regulatory sciences. There is a critical need to develop and deploy tools and processes that support regulatory management in academic settings.
Authors
- Juan Espinoza (ORCID: https://orcid.org/0000-0003-0513-588X)
- Payal Shah (ORCID: https://orcid.org/0000-0001-5211-6169)
- Grzegorz Zapotoczny (ORCID: https://orcid.org/0000-0003-2036-2992)
- Jennifer McCaney
- Lynn M. Rose (ORCID: https://orcid.org/0000-0001-7823-2846)
- David C. Sheridan (ORCID: https://orcid.org/0000-0001-9472-1818)
- Gaurav Dave (ORCID: https://orcid.org/0000-0003-0825-1595)
- Kimberly A. Brownley (ORCID: https://orcid.org/0000-0002-1381-1852)
Institutions
- University of North Carolina at Chapel Hill (US)
Publication Details
- Journal
- UNC Libraries
- Published
- 2025-02-13
- DOI
- https://doi.org/10.17615/vxax-br78
- Citations
- 1
- Primary Topic
- Biomedical Ethics and Regulation
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- National Institutes of Health
- National Center for Advancing Translational Sciences