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Medical Device Software Expert Witness #3076

This Expert is a multi-disciplinary technologist specializing in the development and commercialization of medical products requiring innovations on both indwelling disposable sensors and software-based algorithm fronts. He has nearly 30-years of R&D, operations and business experience in the development of industry-first life science products addressing multi-billion dollar opportunities by meeting a wide array of unmet needs in fields ranging from diagnostic imaging, urology, ob-gyn, oncology, cardio-vascular monitoring to neurology. He has a track record of developing medical devices with significant disposable sensor, electronic, photonic, ultrasonic and algorithm-driven software systems content. Having successfully taken several of these from concept to clinically validated products using FDA’s QSR controlled protocols and procedures; he brings a thorough understanding of both the product and business development processes in highly regulated environments.

This Expert’s hands-on expertise includes analyzing sensing systems and prototyping signal/image/spectral/information processing algorithms; as well as integrating, refining and V&V-ing the necessary systems. He also has expertise in additional areas that include technical/product strategy creation, system architecture development, feasibility assessment, IP analysis, software-intensive product development, operations growth to support expanded clinical trials and pilot manufacturing

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