From Event: SPIE BiOS, 2019
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.
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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, and Anita Mahadevan-Jansen, "Navigating the leap from lab to market for a parathyroid identification device: an academic’s perspective (Conference Presentation)," Proc. SPIE 10868, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XVII, 108680W (Presented at SPIE BiOS: February 04, 2019; Published: 7 March 2019); https://doi.org/10.1117/12.2522358.6011370241001.