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7 March 2019 Rapid product development and commercialization in a regulated industry, the path to success. (Conference Presentation)
Eman Namati
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Proceedings Volume 10868, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XVII; 108680Y (2019) https://doi.org/10.1117/12.2522722
Event: SPIE BiOS, 2019, San Francisco, California, United States
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.
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Eman Namati "Rapid product development and commercialization in a regulated industry, the path to success. (Conference Presentation)", Proc. SPIE 10868, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XVII, 108680Y (7 March 2019); https://doi.org/10.1117/12.2522722
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KEYWORDS
Imaging systems
Medical device development
Navigation systems
Optical coherence tomography
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