Gary D Fletcher
RnDDx Solutions LLC -- Medical Devices & Biomedical Engineering Expert Witness
About
Medical Devices, Biomedical Engineering, Mechanical Engineering, R&D, Product Development, Clinical diagnostics, Biospecimens, Point of care testing, Microfluidics, Spectroscopy, Cell therapy, Intellectual Property, Microscopy, Physics, Biomedical sensing, Optics, Imaging, Mathematics, Laboratories & Testing, Lasers
Expert in Blood and Biospecimen Collection, Separation, Preparation for Diagnostics & Therapeutics
Expert in Infrared, Optical, X-ray, Spectroscopy & Imaging Instrumentation for Measurements of Physical, Chemical, & Biological Material Properties
Dr. Fletcher’s consulting includes supporting companies with product development challenges, conducting technology scouting and competitive assessments of current products, technologies, and business models. He advises companies developing blood cell separation technologies to improve both diagnostics and cell therapy manufacturing.
Details:
Dr. Fletcher is the Founder and Principal Consultant at RnDDx Solutions LLC, a consulting firm founded in 2015, 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 thirteen issued US Patents and ten issued European patents for devices and methods in the area of blood collection and processing including lancing devices and blood separation for diagnostic testing.
Dr. Fletcher received his PhD in Physics from Yale University. His doctoral research was in experimental atomic physics, where he gained experience in mechanical, electrical, and software engineering, optical physics, and vacuum engineering. He conducted postdoctoral research in experimental atomic and laser physics as a Postdoctoral Research Associate in Physics and Assistant Professor of Physics at the University of Virginia. At Lawrence Livermore National Laboratory he expanded his expertise in mechanical and optical engineering by developing x-ray spectroscopic and imaging instruments to measure x-rays emitted from laser-produced high-temperature plasmas. He has 23 years of senior industrial executive experience building new products and new businesses in the healthcare, life sciences, material sciences, medical device, imaging, and diagnostics spaces. That experience includes leading R&D and product development engineering teams of mechanical, electrical, optical, and software engineers. His industry experience includes engineering leadership role in 1996 in a company attempting to develop a noninvasive glucose measurement sensor. From 1996 to 2001, he led Engineering and Advanced Technology, including teams of optical, mechanical, electrical, software imaging, and clinical laboratory engineers, developing a noninvasive human complete blood count diagnostic device and diagnostic blood perfusion assessment tool, for a medical diagnostic startup company. As technical manager at Sarnoff Corporation from 2001 – 2004 he led a team developing and licensing a painless minimally invasive blood glucose monitor. While at Becton Dickinson (“BD”), from 2004 to 2014, he developed blood collection devices for point of care diagnostic testing.