An effective team-building leader who takes new medical devices from concept through design, pilot & production manufacturing, clinical trial, FDA regulatory approval, production and service. As an associate professor of medicine, surgery and ophthalmology at the Boston University School of Medicine, led interdisciplinary teams in creating, designing, developing, implementing and testing innovative biomedical instrumentation. Wrote proposals which secured over $1 million in federal research grants. Commercialized one of four patented inventions, designed and ran clinical trial and secured FDA 510(k) clearance. Used over 30 years of laser experience to develop diagnostic and therapeutic instrumentation.Current goals are to take Floelle Inc.'s patented small medical device through its Early Feasibility Study, pivotal clinical trial and FDA de novo 510(k) process (and the equivalent in Europe) into the market to restore the quality of life to one billion incontinent women worldwide, and to bring high value to physicians, third party payers, investors and governments, and well as removing trillions of absorbent products from landfills.Specialties: Development of new product concepts, taking concepts all the way to servicing the finished product in the field, regulatory affairs, all aspects of medical device manufacturing, purchasing, program management, engineering management, operations management, ophthalmology, dermatology, gynecology, urology, laser surgery, 3-D imaging, image processing, pharmacodynamics, among many others.