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.
|Ph.D.||Biomedical Engineering||Univ. of Michigan|
|M.S.||Aerospace Engineering||Univ. of Michigan|
|B.S.||Aerospace Engineering||Univ. of Notre Dame|