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Medical Practice Consulting, Physician Contracting, Medical Billing
I have extensive background in evaluation of physician-physician, physician-hospital and third-party-payor contracts. I have assisted physicians and hospital administrators in evaluating and negotiating contracts, resulting in agreements having an equal exchange of value for service. I have an acute awareness…
Medical Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc.
Expert has authored and submitted 510(Experts for more than 25 IVD (In Vitro Diagnostics) products. These 510(Experts encompass a variety of IVD products from manual, semi-automated to fully automated non-isotopic diagnostic tests including point-of-care devices. Expert has the expertise to…
All Construction Related Issues: Defects, Standards of Care, Water Intrusion, Cost to Remedy
Expert's expertise in construction dating to 1976 has afforded him the ability to successfully testify competently and factually in many arbitration's since 1996. His abilities to sift through discovery documents in combination with his review of the completed project and…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Engineering and Operations in Thick Films, Components and Fuel Cells
He has cost engineering experience in materials system and component development and manufacturing. As part of broader product development activities, only materials and processes which are consistent with cost targets are selected. Validating that cost targets are met are critical…
Many Trades: Windows Software, Photography, CAD, Stirling Engines, Electric Guitar Hardware
Applications have ranged from medical data acquisition and processing (statistics, graphs) to image processing to real-time data acquisition and analysis to whole-house power controllers to Stirling engine simulations to web site monitoring and data acquisition to system utilities to duplicate…
Due Diligence, Competitive Differentiation, Science Scouting, Innovation Assessment, Research Tools, Expert Witness, Cancer Biomarkers, Cancer Immunology, Assay Development, Research Devices
Developed multiple novel immunoassays and immunology products for start-up biotechnology company. Founding Director, Research and Development for privately held company in San Diego. Oversaw innovation and entrepreneurship at Mitchell Cancer Institute resulting in 5 spin-out biotechnology companies in the area…
Tire Design, Construction, Performance, Failure and All Related Matters
Expert has extensive experience in tyre (tire) design and failure analysis, having held senior positions with two of the world's largest tyre (tire) manufacturers, with experience spanning Australasia, Asia, the Middle East and parts of Africa. His subsequent consulting work…
Applied Mathematics & Techniques, Solid/Fluid Mechanics, Acoustics, Seismology, Fracture Mechanics
He has wide research experience spanning over four decades in various fields of Applied Mathematics. Most of the work are published in very reputed journals like the Royal Society, London, Cambridge Philosophical Society, Royal Astronomical Society J. Applied Mechanics, (USA),…
Operational Streamlining, Organizational Transformation, Program Management, and Technology Integration
Expert has extensive experience in Software Project Management of over 20 years in federal and commercial sectors. He has managed projects involving application development, system integration that required integration of commercial software products (COTS) with application code, software conversion, and…