Independent consultant specializing in regulatory and clinical research with extensive experience in Class II and III medical devices. Has significant expertise in the clinical investigation of devices within FDA and ISO-regulated environments. Also has a background in rapid-growth, technology-focused, timeline- and budget-driven entrepreneurial environments and his consulting practice focuses on providing pre-clinical, clinical, and regulatory consulting services to the medical device industry.

Formal Education

  • Ph.D. in Engineering Mechanics, Virginia Tech
  • M.S. in Engineering Mechanics, Virginia Tech 
  • B.S. in Engineering Science and Mechanics, Virginia Tech

Career Highlights

  • Thrice received FDA’s Breakthrough Device designation for a cancer detection combination product
  • Recent experience with interventional cardiology, orthopedics, robotics, cancer therapeutics, neurosurgery, and critical care
  • Led all aspects in the design and implementation of a European multi-center CE Mark study
  • Led the design and implementation of a multi-center US IDE study for a home-based hemodialysis machine
  • Led FIM clinical investigation of a myocardial implant at six sites in Europe, South America, and Australasia
  • Designed and developed cardiac surgical delivery systems and myocardial implant devices investigated in clinical trial
  • Spearheaded a regulatory strategy for three 510(k) filings in a year
  • Managed product development department and project teams in the introduction of new antimicrobial dressings to the wound care market
  • While director of clinical research and health outcomes for a major medical device maker, also designed and released an iPad-based economic calculator app for field use that was featured in Forbes blog
  • Earlier in his career, used his engineering skills to design, develop, and test prototype composite spinal implant devices

Expert Qualifications

  • Expert witness in medical device litigations in Pennsylvania and Texas courts, including testimony before a jury in one case that went to trial
  • Submitted an expert report and rebuttal witness statement in an ITC matter relating to non-invasive aesthetic body-contouring devices