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Automated Chemical Sensors
LABORATORY COMPUTERIZED ANALYTICAL INSTRUMENTATION DESIGN; CHEMICAL AUTOANALYSIS. Expert has spent much of his career developing systems or subsystems for devices accomplishing automated chemical analysis. He has experience in all phases of this process, from basic research into sensors to the…
Design for Manufacturability, Mass Customization, Build-to-Order, Concurrent Engineering
Expert is a const reduction expert that helps companies reduce cost as much as half the total cost through product development and cost savings through on-demand production and spontaneous (pull based) supply chains. He has developed leading-edge methodologies that show…
Biomedical Device Engineering
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…
Blood Wetted Devices and Biomaterials
BLOOD-WETTED BIOMATERIAL; CARDIOVASCULAR PROSTHESES; ARTIFICIAL INTERNAL ORGANS. Expert has been involved in the design, development, and evaluation of extracorporeal and implantable artificial internal organs for many years, first with the artificial kidney (including hemodialyzers and those based upon selective absorption)…
Medical Device Total Quality
FDA REGULATION. A significant portion of Expert's career has been devoted to FDA approval and regulation of medical devices, particularily those with significant risk. He is the President of a consulting company specializing in process validation, FDA/regulatory consulting, and auditing.…
Molecular Biology, Molecular Pathology, Polymerase Chain Reaction Technology
Expert has expertise in the adaptation and development of molecular biological techniques to answer medical questions of human genetics, differential gene expression, diagnostics, epidemiology, and pathogenesis, particularly in regard to infectious agents and genetic diseases. The CGS is a multidisciplinary…
Laboratory Medicine, Pathology
Expert is experienced in the application of basic sciences to clinical and biomedical problems. Most recently, his interests have centered on infectious diseases, concentrating on pathogen-host interactions and biomaterials with special emphasis on biocompatibility. Expert's laboratory has recently elucidated the…
Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…