|Minimizing Risk & Optimizing Use of Medical Products

The opinions that I express in this paper are based on a thorough review that I conducted of industry standards and procedures for risk management, FMEA techniques, and FMEA applications in aviation and other industries. I also base these opinions on my 25 years of experience in transportation management and analysis, airline flight operations, safety investigation management, safety research, and airline accident investigation. I have ten years of experience on the staff of the U.S. National Transportation Safety Board (NTSB), concluding my service there as the Chief of the Major Investigations Division. In that position, I managed the overall investigative effort for U.S. air carrier accidents from the field investigation to the public board meeting and final accident report. I also managed the U.S. Government’s participation in foreign aviation accidents. My previous NTSB experience included management of flight operations, air traffic control, and meteorological aspects of air carrier accident investigations; on-scene and follow-up investigations of flight operations for several major accident investigations including the USAir flight 427 Boeing 737 accident near Pittsburgh and ValuJet flight 592 DC-9 accident in the Everglades; and management of research programs on flight crew human factors and regional air safety issues, both of which were adopted and published by the NTSB. I am a pilot for a major U.S. air carrier, qualified in the Boeing 737 and two other transport category aircraft types. I have consulted with the National Aeronautics and Space Administration (NASA), the World Bank, the European Bank for Reconstruction and Development, the U.S. President’s Aviation Safety Commission, and several airlines, financial institutions, airport authorities, and other private entities on safety and analytical matters. I received the A.B. degree summa cum laude in Economics from Harvard College and am a member of the Phi Beta Kappa Society.