Challenges in Commercializing Medical Devices

Challenges in Commercializing Medical Devices

Dr William New gave a talk at UND “Challenges in Commercialization of Medical Devices” Thursday, Nov. 19, in 130 Gamble Hall.


Application of engineering hardware and software to human illness and wellness creates products and services that range from drugstore consumer devices to complex diagnostic and therapeutic medical tools for surgery and critical care.  However, all need to be based on solid physiologic or biochemical science.  They differ in risk, reliability, operator skill, price and regulatory oversight, which together determine the optimum design and best path to commercialization. Consumer wellness devices can be freely manufactured and sold via retail and online, whereas true medical devices demand tightly controlled design, highly organized fabrication, extensive quality control, and professional distribution. Many innovative devices begin with academic research and bioengineering development.  Optimum translation from laboratory workbench into successful commerce and positive impact on human health begins first with understanding the end user; from there technology can be developed and a business model to serve the market crafted in parallel.  The three legs of identifying user/market need, innovating a responsive technology/product, and creating a sustainable profitable business to deliver product with maximum social benefit will be discussed to provide guidelines for bringing academic R&D to commercial success.


About William New

William New has a 50-year career in the design and development of successful commercial medical electronics, beginning with 1960s recording of physiologic signals on magnetic tape (replacing ink splashes and reams of paper), the earliest application of microcomputers (8-bits, 4K memory) to control intravenous drip medication in the 1970s, on to development of the pulse oximeter in the 1980s (now used worldwide), mass screening for newborn deafness during the 1990s (over 250 million children to date), and today wireless wearable microchip sensors leading to Big Data cloud applications for countless millions of impaired individuals young and old around the globe.

He received both B.S. and M.S. in Electrical Engineering at Stanford University, his Ph.D. at UCLA,  and M.D. in the Duke University Medical Scientist Program, his master’s degree with the Kaiser Health Foundation in the Stanford Business Sloan Program, and recently was recognized as a Fellow in the American Institute for Medical and Biological Engineering as well as membership in the National Academy of Engineering.

Dr New particularly enjoys interaction with students across academic and commercial settings, transitioning technology from applied laboratory research to daily use in clinical medicine, particularly primary care, building startup businesses through to successful public companies. He has taught and lectured as a faculty member across the US, Canada, Europe and Japan.

His avocation and lifelong interest has been childhood education and development, serving as a trustee and contributor to numerous independent schools, most recently the progressive Putney School in rural Vermont and the AltSchool based in urban San Francisco.

Bill enjoys rare moments of spare time with his poodle Tallulah, and appreciating Pinot Noir from younger days managing the family vineyard in Napa/Sonoma, comparing wineries in Oregon and British Columbia.

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