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Proceedings Paper

Navigating the leap from lab to market for a parathyroid identification device: an academic’s perspective (Conference Presentation)
Author(s): Giju Thomas; Melanie A. McWade; Constantine Paras; Alexa Magner; Tyler Metcalf; Emmanuel A. Mannoh; Melinda E. Sanders; Lisa M. White; James T. Broome; Lawrence D. Shirley; John E. Phay; Naira Baregamian; Carmen C. Solorzano; Adnan Abbas; Roshan Shetty; Anita Mahadevan-Jansen

Paper Abstract

The process of translating lab-built innovations into viable tools for clinical applications is complex and costly. Clearing the regulatory processes is the pivotal step that eventually enables these devices to be implemented for the intended clinical applications. Unfortunately this task could be challenging and time-consuming for unprepared academics aiming to translate their inventions/discoveries from bench to bedside. Therefore there is a vital need to educate researchers on adopting the best approach when dealing with regulatory submissions to ensure smoother translation of their respective technologies. To understand the bench to bedside pathway more clearly, we will utilize the example of the first-ever discovery of near infrared autofluorescence in parathyroid glands at Vanderbilt University. Subsequently a lab-built system was designed for label-free intraoperative parathyroid identification during thyroid and parathyroid surgeries, which was tested across 162 patients with high accuracy. Subsequently Vanderbilt University partnered with AiBiomed (Santa Barbara, California) to develop a clinical prototype called ‘PTeye’ that was user-friendly for surgeons and ready-to-use in operation rooms. The ‘PTeye’ was then evaluated across 81 patients in a single-blinded, multi-centric study that yielded 96% accuracy. Relying on this data, Vanderbilt University and AiBiomed initiated the ‘de novo’ application process with the Food and Drug Administration (FDA) for regulatory clearance of the ‘PTeye’. The ‘de novo’ approach was selected since the instrument design and intended use of ‘PTeye’ did not resemble that of any pre-existing medical devices. Following a successful review, the FDA eventually granted permission to market ‘PTeye’ as an adjunct intraoperative tool for label-free parathyroid identification.

Paper Details

Date Published: 7 March 2019
Proc. SPIE 10868, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XVII, 108680W (7 March 2019); doi: 10.1117/12.2522358
Show Author Affiliations
Giju Thomas, Vanderbilt Univ. (United States)
Melanie A. McWade, Vanderbilt Univ. (United States)
Constantine Paras, Vanderbilt Univ. (United States)
Alexa Magner, Ohio State Wexner Medical Ctr. (United States)
Tyler Metcalf, Ohio State Wexner Medical Ctr. (United States)
Emmanuel A. Mannoh, Vanderbilt Univ. (United States)
Melinda E. Sanders, Vanderbilt Univ. Medical Ctr. (United States)
Lisa M. White, Murfreesboro Surgical Ctr. (United States)
James T. Broome, St. Thomas Medical Partners Endocrine Surgical Specialists (United States)
Lawrence D. Shirley, Ohio State Wexner Medical Ctr. (United States)
John E. Phay, Ohio State Wexner Medical Ctr. (United States)
Naira Baregamian, Vanderbilt Univ. Medical Ctr. (United States)
Carmen C. Solorzano, Vanderbilt Univ. Medical Ctr. (United States)
Adnan Abbas, AiBiomed (United States)
Roshan Shetty, Photothermal Spectroscopy Corp. (United States)
Anita Mahadevan-Jansen, Vanderbilt Univ. (United States)

Published in SPIE Proceedings Vol. 10868:
Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XVII
Anita Mahadevan-Jansen, Editor(s)

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