- Specialists in the characterization and qualification of silicone medical devices.
- Chemical, physical, and biocompatibility testing to support 510k, IDE, and PMA submissions to FDA, particularly related to silicone medical devices and silicone applied technology.
- Pre-clinical chemical testing and evaluation.
- Testing protocol preparation; testing protocols of silicone based medical devices.
- Mechanical testing for manufacture of implantable silicone devices.
- Polymer characterization, specializing on silicone systems.
- Technical report writing.
- Pre market approval (PMA) module preparation.
- Interface with FDA staff opposite product compliance and fitness for use.
- Toxicity testing of materials.
- Biocompatibility testing of silicone materials and devices.
- Expert witness related to silicone medical devices.
Experience: 30 years in the Medical Device Industry
Independent Consultant 1997 - Present
- Focus on supplying product quality testing and consulting services for support of FDA, 510(k), Investigational Device Exemption (IDE) and PMA Submission.
- Preparation of technical reports to support FDA PMA submission including chemical and mechanical testing for manufacture of implantable silicone devices.
- Consultant to Medical Device Manufacturers and Distributors in the areas of business/product development, chemical, physical, and biocompatibility testing to support 510k, IDE and PMA submissions, product and raw material sources and FDA regulatory issues.
Biodermis Corporations, Las Vegas, NV, General Manager 1993 - 1997
- Development of new products for wound care, dermatology and podiatry.
- Responsible for establishing sales activities in the United States and international markets.
- Developed 510(k) approved cryrosurgery product for international known oncologist/crytosurgeon.
McGhan Medical Corp., Santa Barbara, California, Manager of Corporate Development & Research 1989 - 1992
- Coordination of new product development for U.S. and international plastic surgery markets.
- Identification of new products/technologies for acquisition or licensing.
Alcon Laboratories, Inc., San Leandro, CA, Director of Manufacturing Operations/Surgical Instrumentation 1985 - 1989
- Manufacturer of ophthalmic surgical equipment and sterile disposable products.
- Responsible for all aspects of operation management, including new product development.
- As Director of Technical Affairs/Surgical Division, coordinated and allocated resources to develop and produce new products form newly acquired R&D and manufacturing operations.
- As Technical Director of Optics Division, provided technical direction and guidance, unifying international manufacturing of contact lenses.
Barnes-Hind Hydrocurve, San Diego, CA, Director of Research 1974 - 1985
- Directed R&D to create new materials for opthalmic applications and managed raw material testing and manufacturing.
Ph.D., Organic Chemistry, Arizona State University, Tempe, Arizona
Bachelor of Science, Wayne State University, Detroit, Michigan