Silicone Polymer and Silicone Formulation Consultant for Biomaterials and Medical Devices
Technical Consultant #1387
- Silicone polymers, silicone formulations and silicone processing.
- Silicone material for FDA applications.
- Proficient in catheter balloon technology.
- Silicone materials for breast implants and other medical devices.
- FDA requirements for GMP's and preclinical testing of materials for medical devices and ISO 9001.
- Specialty silicone systems for medical, aerospace, and industrial applications.
- Knowledge of international market segments, customers and demand for specialty silicon materials.
- New business formation, start up, divestiture and purchase.
- Expert witness on the manufacture, testing and characterization of silicone implants and testified as a fact witness for defense in 16 cases.
Undisclosed Company, President, Present
- Leader as one of the largest independent suppliers of silicone breast implant materials.
- Silicone expert related to the formulation, testing, use and FDA regulatory issues of silicone based medical devices.
Rhodia, Inc., Business Director of Rhodia Silicones-Ventura, 1999 - 2001
- Worldwide Product Manger for Human Care Silicones.
- Expert in silicone products and markets in the global health care industry.
Undisclosed Company, Founder and President, 1987 - 1999
- Designed and built new facilities to comply with more extensive FDA requirements for GMP's and preclinical testing of materials for medical devices and ISO 9001 Quality Systems.
- Expanded staff to 60 including three Ph.D. chemists.
- Product lines include over 50 FDA Master Filed implantable silicone products and over 200 specialty silicone systems for medical, aerospace, and industrial applications serving over 300 customers in a worldwide market.
Admiral Materials Corporation, Co-Founder and President, 1985 - 1987
- Through asset buyout of International Silicone Corporation, expanded product line developed at International Silicone Corporation.
International Silicone Corporation, Co-Founder, 1979 - 1985
- Start up operation to produce quality silicone for medical products with special emphasis on breast prostheses.
- Developed all formula and processes for manufacturing.
American Heyer-Schulte Corporation, 1974 - 1979
- Developed production processes and equipment for manufacturing silicone medical devices.
- Led team to develop technology to manufacture silicone materials from basic ingredients.
- Responsible for technical marketing support for plastic surgery products.
- Responsible for interfacing with physicians and analyzing returned and failed products.
- My group was the first to recognize the failure mode of "fold fatigue" in saline inflatable prostheses.
- Served on several ASTM industry groups including ASTM F703 which created the original standard for implantable breast prostheses.
Honors & Publications
Academic and Professional Affiliations
- American Chemical Society; Rubber Division
- ASTM, Including Breast Implant Standard Committee, F703
- Health Industry Manufacturers Association (HIMA), Silicone Task Force
- Society for Biomaterials
- Completed courses; Mechanical, Electrical and Materials Engineering.
- Advanced Polymer Science Program, University of Akron, Ohio.
Publications and Patents
- RTV Silicone Adhesives for Medical Devices
- Medical Silicones, Medical Plastics and Biomaterials
- 4 U.S. Patents Issued
- B.S. Biochemistry, University of California, Santa Barbara