Medical Device Bioengineering & Patent Litigation

Specialties & Experience of this Expert Witness

Additional Information

Dr. Fletcher is Founder and Principal Consultant at RnDDx Solutions LLC, a consulting firm focused on industrial biomedical and mechanical engineering, and research and product development, in medical devices, diagnostics, optical devices, point-of-care blood sample testing, and on expert witness patent litigation, including subject matter expertise in medical device mechanical engineering, and subject matter expertise in medical devices for blood collection and blood sample processing for diagnostics and therapeutics. He has particular expertise in mechanical engineering design and development of non-invasive and minimally invasive biomedical diagnostics systems, blood collection and stabilization, blood separation, and blood and cell preparation for both diagnostic and therapeutic applications, including the development of sample collection devices, needles, and lancets. He is co-inventor on 23 patents for devices and methods in blood collection and processing. Yale educated PhD Physicist with 30 years experience in medical devices, diagnostics, and biomedical engineering. Expertise in product development, in vitro diagnostics, point of care testing, blood collection, separation, and sample preparation, optics, sensors, infrared, optical, & X-ray spectroscopy & imaging instrumentation for measurements of physical, chemical, & biological material properties. Expert Witness in patent infringement cases involving medical device and diagnostic biomedical engineering, blood collection, separation, fluidic preparation, and cell therapy preparation devices. R&D leadership expertise in both large company [Becton Dickinson] and multiple startup product development teams. o Startup medical device leadership generated $55M in angel investment o Contract R&D team developed & spun-off new painless minimally invasive blood glucose monitoring technology o Developed noninvasive in-ear vital signs monitor o Development and research release of microcirculation imaging technology platform to assess blood reperfusion following transplant surgery o Developed, executed two adjacent business plans and technology strategies, achieving $2M internal investment for medical device product development. o Developed, released to OEM market next generation anesthetic gas analyzer o Developed, executed POCT strategy o COO - Cell Therapy Manufacturing Startup Technology Scout, identifying and screening technologies needed for new products Lean Startup Coach, driving entrepreneurial change in both startups and mature companies Lean Customer Development – developed training to help companies understand what customers want and need BA DePauw University - Physics and Math PhD Yale University - Experimental Atomic Physics American Association for Clinical Chemistry American Chemical Society