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Proceedings Paper

Rapid product development and commercialization in a regulated industry, the path to success. (Conference Presentation)
Author(s): Eman Namati

Paper Abstract

You have a novel optical technology and have demonstrated feasibility in solving a real clinical need. Better yet, you have further matured the technology and shown early success within an academic clinical study. Now it’s time to take the leap towards commercialization to disseminate and bring your disruptive product to the masses. Successful commercialization of a Medical Device extends beyond good product development and in fact is underpinned by establishing the right Regulatory strategy. In this presentation, we will provide an overview for the rapid development of an Optical Coherence Tomography Imaging System and discuss regulatory strategy, challenges and best practices to help future entrepreneurs navigate this critical yet delicate pathway.

Paper Details

Date Published: 7 March 2019
Proc. SPIE 10868, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XVII, 108680Y (7 March 2019); doi: 10.1117/12.2522722
Show Author Affiliations
Eman Namati, NinePoint Medical (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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