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Physics, Mechanical Engineering, Medical Device Product Development, Blood Collection for Diagnostics & Therapeutics, Patent Litigation Expert Witness
Expert is Founder and Principal Consultant at a consulting firm founded in 2015, focused on industrial mechanical engineering and research and product development, in medical devices, diagnostics, optical, imaging, and laser devices, point-of-care blood sample testing, and on expert witness…
Clinical Laboratory Science, Lab Directing, Lab Diagnostics, Medical Technology, Hospitals, Testing
Expert is a clinical laboratory scientist with 30 years of experience in the industry covering laboratories in the hospital, national reference, and large physician office settings. He is the founder of a consulting company which began in 2009. The company's…
Environmental and Spatial Statistics, Especially Site Assessment and Remediation
Expert is a statistician with many years of experience in environmental statistics, especially related to site characterization and remediation. He has developed numerous environmental sampling designs for field projects and experimental designs for studies and has analyzed and reported the…
In Vitro Diagnostics Industry Including Clinical Laboratory, Immunohematology & Donor Screening
Expert's 40+ year career has spanned a variety of business disciplines and functions including information management, supply chain management, customer service, new product development, sales, and new business start-up. He began his career at Eastman Kodak Company as a Systems…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Strategy and Sales Analysis for In Vitro Diagnostics and Biopharmaceuticals
Expert has multiple experiences in evaluating and proposing strategy for brands or individual products. This list includes several existing diagnostic products where lifecycle planning needs require judicious selection of new and novel add-ons to an existing line. It also includes…
Medical/Hospital Equipment: Markets, Unmet Needs, Concept, Design, IP, Automation, Manufacturing
Biomedical Devices range from simple items we use as consumers to complex instruments controlled by proficiently trained professionals. Expert's involvement and experience has been in the development of capital equipment that often included one or more disposables, were used in…
Mechanical Engineering, New Product Design and Development, Fluid Systems, Electronics Packaging
Expert has been in business developing new products since 1985, specializing in instrumentation, medical and laboratory equipment. Besides electronics, some other areas of expertise include: mechanical components and systems, plastics, pneumatic and fluid systems, thermal design and analysis, packaging of…
Facilitating Business Growth Through Commercialization of New Medical and Biotechnology Products
Expert has extensive experience supporting clients in pharmaceutical, medical and industrial markets. An electrical engineer by training, and the principal of his own consultancy for more than 12 years, he brings strong market, business development and technical skills to his…
Mechanical Engineering Design and Prototype Development
Expert received a Ph.D. in mechanical engineering from the University of California, Berkeley (UCB), with an emphasis in composite manufacture and analysis. His Ph.D. dissertation dealt with manufacturing analysis for axisymmetric composite structures. Part of the research included building a…