Silicone Polymer and Silicone Formulation Consultant for Biomaterials and Medical Devices

Expertise

• 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.

Experience

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

Process Engineer

• Developed production processes and equipment for manufacturing silicone medical devices.
• Led team to develop technology to manufacture silicone materials from basic ingredients.

Product Engineer

• 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

Credentials

• 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

Education

• B.S. Biochemistry, University of California, Santa Barbara