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Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization
As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and clinical use. Expert is an expert in drug clinical development from planning to protocol design,…
Electronics, Software, Sensors, Motion Control, Wireless, and Medical Devices
Expert and his senior team have many years of experience designing embedded circuits, instruments, medical devices, and software. Expert in all types of measurements. Analog circuit design, digital circuit design, and mixed signal design, as well as measurement and control…
Clinical Microbiology, Infectious Diseases, and Healthcare Associated Infections
Expert has over 25 years experience in academic, hospital-based, and commercial diagnostic microbiology. He has held laboratory director positions in university and private hospital settings, and as the national director of microbiology in industry. Expert has expertise in general clinical…
Optical Instruments, Inertial Instruments, Laser and Fiber Optic Gyros, Thin Film Coating
Over 41 years of experience in fiber optics sensors and fiber optic devices for telecommunication networks. The experience includes all phases of product development from conceptual design to prototyping, design-to-cost, production planning, and transition to production. Has nine patents and…
Industrial Hygiene, Occupational Health, Hazardous Materials Management, Emergency Response
He championed the implementation of a variety of strategies to reduce workplace accidents and injuries. Strategies included establishment of on site workplace health and safety teams. These teams included both management and labor employees who worked together to identify safety…
Statistical Consulting, Biostatistics, Statistical Support to Litigation
Expert has over 13 years experience as statistician and Director of Biometrics in the pharmaceutical industry. In addition, he has 8 years experience as a Professor of Statistics at the University of Florida. He served as functional manager for statistics,…
Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Biomedical Engineering; Medical Devices
IP Projects Catheter stabilizing device Dental Instrument Implant Seeds Intrauterine pressure catheter Vascular Catheters (3) Over 30 years experience in medical product design and development experiences in Anesthesiology, Assistive Technology, Cardiovascular, Catheters, Critical Care, Endoscopy, Implants, Instruments, IV Systems, Home…
Medical Device, Diagnostic, and Pharmaceutical Clinical Trial Design and Strategy
Expert has over 25 years experience in commercializing medical products. Her experience includes management at Abbott Labs in clinical research and regulatory affairs and as a CEO of a venture capital backed medical diagnotic company. Expert has raised venture money…
Hardware Reliability Testing; Vibration and Shock, Climatic Testing
Expert has actively worked with clients for many years to specify, set up, perform, and report on accelerated environmental testing. Sample products include electro-optical systems, cell phones, roller coaster audio systems, helmet mounted displays, automotive and medical equipment. Expert has…