Silicone Polymer and Silicone Formulation Consultant for Biomaterials and Medical Devices

Technical Consultant #1387


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
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