Expertise DescriptionI have over 20 years experience in Medical Devices with expertise in medical device product development and R&D, manufacturing and operations, quality assurance, regulatory affairs and clinical trial management, and FDA regulation. I have provided numerous clients with consultations, courtroom testimony, and deposition for more than 10 years as a medical device expert witness.
Areas of Expertise
As a consultant in the medical device industry for the past 13 years, I routinely evaluate clients' marketing information and methods to evaluate and assure alignment between product capabilities, regulatory approvals, and marketing claims. I have expertise with a broad spectrum of Class II and Class III devices and technologies, and have consulted for Fortune 50 medical device manufacturers (e.g. General Electric, J&J) as well as small to mid-size companies (e.g. Cardiac Science).
As Senior VP and COO, I had direct responsibility for clinical trials for Class II and Class III medical devices and reported results of these trials to FDA.
I have testimony experience (depositions and in-court testimony in a jury trial).
|Ph.D.||Acoustics Engineering||Pennsylvania State University|
Awards & Affiliation
Expert-in-Residence (EiR), UC Irvine Center for Innovation
GE Inventor Award
Honor Societies of Phi Kappa Phi, Eta Kappa Nu, Sigma Xi.
Outstanding Contributions Award and Fast Pitch Chairman, Tech Coast Angels