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Medical Device Quick Prototyping/CAD Design/Concepting
Expert (pronounced "munch"; ) has designed and developed a cast base for biometric scanning. This base resulted in stable dimensions and functionality when subjected to change in temperature. Scans were used for both hand and finger use. He developed a…
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…
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…
Microcontroller-based Product Design
Most of the projects expert has been involved with have been real-time dependent. He has designed high-speed bit-slice-based data acquisition units for military aircraft radar, high-speed machinery controls, home automation, cordless telephones, fitness equipment, arcade games, and other consumer products.…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
Skeletal Biomechanics, Design and Evaluation of Orthopaedic Implants, Artificial Joints, etc.
Expert's research interest centers on the biomechanics of bone, cartilage, tendons, and ligaments. This includes studying the causes of fracture of bone and the mechanics of fracture healing. Other areas of orthopaedic biomechanics include the design, development, and evaluation of…
Medical Device Design and Manufacturing: Laboratory Devices, Surgical Instruments, and Disposables
Expert has expertise in the design and development of laboratory devices, surgical instruments, and disposables for the biotechnology, pharmaceutical, medical device, electronic, cosmetic, and consumer product industries. Examples of products he has developed and/or patented are an I.V. disposable product…
Product Design and Manufacturing, Materials, Fastening and Joining, Consumer Product and Safety
Expert was responsible, as a project engineer, for the origination of four product lines that have achieved No.1 with Consumer Reports, plus a significant contributor to others. Clients have ranged from start-ups to Kirby, Stratasys, Black & Decker, Toro, Andersen…
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…