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Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices and/or materials in the…
Medical Polymer Sterilization
MEDICAL POLYMER SELECTION; MEDICAL POLYMER STERILIZATION. With knowledge of material selection for medical devices, Expert has specific expertise in selecting materials based on cost, physical properties, radiation or other forms of sterilization, blood and tissue compatibility, permeability, and aging properties.…
Technology Commercialization, Business Development, Material Science, Photonics, Business Incubation
In 2006 expert was promoted to Director of Business Incubation at Boston University. He was responsible for incubating new technology companies originating from all disciplines at BU and other major research institutions in the region. In a period of four…
Web Coating Technology
Expert has spent over 28 years in the web coating industry. He has experience in wax coating, hot melt, solvent coating, solventless coating, and emulsion coating on a wide variety of webs, from light weight films and foils to SBS…
Tribology, Wear, Coatings, Materials Selection, Materials Testing, Computer Modeling, Lubrication
Expert has experience with numerous types of abrasive wear problems, including the design of optimal surface topography to minimize abrasive wear. This includes surface design, wear testing, and the use of coatings in abrasive wear environments to enhance system life…
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 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…
Adhesives and Sealants
Throughout his career, Expert has focused his work on high-performance thermoplastic and thermosetting adhesives and sealants for the bonding and sealing of metals, plastics, and glass. Expert is an international authority on the synthesis and application of "instant adhesives" ("super…
Materials Processing
SIZE REDUCTION OF SOLIDS; GRINDING (COMMINUTION). Expert (prefers "Expert") has spent a significant portion of his career in size reduction technology, chiefly involving himself with the identification, selection, and qualification of crushing, grinding, and milling processes. He has developed processes…