Expertise DescriptionI have more than 25 years experience in the Biomedical field with expertise in all aspects of product development, including bench and animal testing and documentation, controlled clinical (patient) studies, FDA and Int'l regulatory filings, early manufacturing, quality assurance, IP development, and early marketing - applied to multiple diagnostic, monitoring, and therapeutic technologies. I have experience consulting on specialty medical device operations, research and development associated with IP, product development, and clinical and regulatory issues. I have spent over 10 years providing consultations, deposition, and courtroom testimony as a biomedical expert witness.
Areas of Expertise
My expert witness experience includes multiple technical and practical aspects, as well as intellectual property and associated data.
My Consulting experience includes raising capital, product development, business development, intellectual property planning, and pre-clinical and clinical study planning.
My professional experience includes being Consultant to multiple medical technology companies, with prior experience consulting with various other technology companies and firms.
I have over 30 years of experience with specialty medical products, including extensive work with the preparation, associated regulatory submissions and overall conduct of controlled clinical trials. Typical components of these efforts included protocol preparation and formalization, reach-outs to selected medical professionals, assembly of requisite documents such as Informed Consents, monitoring of clinical sites, preparation and summary of clinical data and integration of produced clinical data into documents sent to regulatory authorities. The inherent safety and/or efficacy aspects of particular products have dictated the level of detail, scrutiny, and control required for appropriate clinical data collection and reporting.
My consulting and expert witness experience includes several depositions and providing testimony in jury trial. In addition to my experience with FDA-controlled products, I have consulted on numerous cases involving online product (supplements, for example) advertising, reviewed by the FTC, requiring peer-reviewed, scientific data publication meeting FTC standards. My expert opinions were used in formal court cases.
|Ph.D.||Biomedical Engineering||Univ. of Michigan|
|M.S.||Aerospace Engineering||Univ. of Michigan|
|B.S.||Aerospace Engineering||Univ. of Notre Dame|