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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…
Management, New Product Development, and Plant Relocation and Startup
As part of top management's efforts to maximize revenue, growth and profitability, Expert has applied over 35 years of business, engineering and manufacturing expertise to provide cost effective solutions across a wide-range of industries. Expert maintains that it all starts…
Membranes, Filters, Separations, Validation, Extractables, Leachables
Expert was responsible for building a new manufacturing facility for hollow-fiber thin film composite membranes for industrial gas and liquid. He helped design the equipment, created the plant layout, hired staff, and led the trouble-shooting phase. He led the engineering…
Engineering Management
Expert has been involved with the re-engineering of new product development processes, creation of total quality management programs, and organizational structure changes for process engineering and research and development functions for two major medical device manufacturers (i.e. Johnson & Johnson…
Organic Process Chemistry
Expert has developed, scaled-up, and commercialized a key step in vitamin A synthesis. The step was commercialized at the Belgorod Vitamin Plant in Russia. This gave him an in-depth knowledge of fine organic synthesis. Expert has developed, scaled-up, and commercialized…
Blow Molding, Plastic Bottles, and Packaging
Expert has extensive experience in all aspect of PET bottle blowing, starting from preform and product design, through prototype operations and into full production. He has extensive knowledge of the injection molding process and machinery for the manufacturing of preforms…
Food Product Development: Organic Nutritional Products; Sports Nutrition. Non-Meat Products.
FOOD FORMULATION; FOOD PRODUCT DEVELOPMENT; FOOD PRODUCT PROCESS DEVELOPMENT. Expert has extensive experience in food product development. He performs initial concept literature and patent searches and summarizes the results. He then develops a final marketing or medical concept formulation for…
Chemical Competitor Process/Formulation & Improvement and Tech/Invest Analysis
Experienced in chemical process improvement, Expert has reduced the fouling of manufacturing equipment using variables like pH, temperature, inhibitors for chemical process troubleshooting and process optimization.This helped in reducing production down time and saving money. He has improved analytical instruments,…
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.…
Knowledge Management
Expert is an internationally recognized authority on knowledge-management theory and practice. A pioneer in the knowledge-management field, he began designing and guiding the implementation of knowledge-management solutions for Fortune 500 companies in the late 80's, well before such terms as…