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Engineering Failure Analysis Medical Devise Expert Witness

Keywords

Medical Device Accident Investigation, Consultation On Healthcare Safety, Policies, Medical Technology Evaluation, Public Speaking, Failure Analysis, Engineering Mechanics, Surgical Fires, Accident Investigation, Lasers, Medical Gas Systems, Problem Reporting, Technology Issues

Pennsylvania




Expert No. 3571


Fields of Competence

Medical device accident investigation; consultation on healthcare safety and policies; medical technology evaluation; public speaking; failure analysis; engineering mechanics; and areas of specialization including surgical fires, accident investigation, mechanical failure, lasers, medical gas systems, problem reporting, and technology issues.

Background

Expert 3571 is currently the senior engineering consultant for a LLC company. He investigates medical device accidents and fires, writes healthcare articles, researches engineering issues, and assists other firms with engineering problems. In this position, he has been deposed once and testified at trial once. He also consults for the Forensic Safety Group.

Until June 2010, Expert 3571 was the Associate Director, Accident and Forensic Investigation for ECRI Institute. He transferred to this position in 2001. His duties included investigating medical device failures and fires caused by medical devices in the critical care and surgical settings and assisting other engineers and reviewing their work. He also wrote short articles for Health Devices and other ECRI Institute publications, consulted on a wide variety of medical device related issues, and lectured on healthcare technology issues. He conducted more than 250 investigations, was deposed 10 times, and was at trial twice. He published more than 150 articles on many subjects in Health Devices and other journals and lectured on many subjects at more than 160 venues.

Expert 3571 joined ECRI in 1987 as a Product Evaluation Engineer, was promoted to Senior Project Engineer in 1990, and was promoted to Associate Director of the Health Devices Group in 1995. In this last position, he operated ECRI's Problem Reporting System and helped manage the group. His last Evaluations as a project engineer were of mobile high-efficiency-filter air cleaners used for localized reduction of airborne TB droplet nuclei and of Ho:YAG surgical lasers used mainly in orthopedics. He wrote a detailed Guidance Article on medical gas and vacuum systems, their problems, and the standards that govern them and has also lectured about these systems and their applicable standards. His Evaluation of laser safety eyewear was the first comprehensive examination of these devices in 15 years. He has written many articles and several book chapters on and has widely lectured about surgical fires. As part of a team, he evaluated surgical lasers. His Evaluation of the laser resistance of tracheal tubes used during laser surgery in the airway helped ASTM define guidelines and standard test methods for these devices. He held the primary engineering responsibility for the first comprehensive Evaluation of voting systems.

Expert 3571 has worked in various industries, including aerospace, material processing, and electronics. His work usually involved ensuring that a product performed as desired and
suggesting modifications for improvement. He has broad experience in stress analysis, mechanical analysis, and material analysis. His abilities have been brought to bear in many failure analyses on such diverse items as large grinding machines, gears, machine parts, small electronic devices, and thin films.

Expert 3571's education includes work in life sciences, organic chemistry and mathematics at Virginia Tech, geophysics and mathematics at Drexel University, and completion of Ph.D. coursework at Drexel University. As an undergraduate, he assisted in a study of artery mechanical properties as related to arteriosclerosis and, as a graduate student, he taught basic mechanics courses.

Employment History

2010 to Present
Senior Engineering Consultant, A Company, LLC, Doylestown, PA

2010 to Present
Senior Engineering Consultant, forensic safety group, Willow Grove, PA.

2001 - 2010. Associate Director, Accident and Forensic Investigations, ECRI Institute, Plymouth
Meeting, PA

1995 - 2001. Associate Director, Health Devices Group, ECRI, Plymouth Meeting, PA

1990 - 1995. Senior Project Engineer, ECRI, Plymouth Meeting, PA

1987 - 1990. Product Evaluation Engineer, ECRI, Plymouth Meeting, PA

1984 - 1987. Project Engineer, Robinson Halpern, Plymouth Meeting, PA

1980 - 1984. Senior Development Engineer, Fuller Co., Bethlehem, PA

1976 - 1979. Laboratory Supervisor, Pennsylvania Crusher Corp., Broomall, PA

1974 - 1976. Engineer, Structural Analysis, General Electric Re-entry and Environmental
Systems Division, Philadelphia, PA

Education, Training, and Certifications

Certified Medical Gas Inspector, 1993, 1996

PhD studies, 1976-1979 and 1983-1986. Drexel University, Philadelphia, PA. Registered Professional Engineer in Pennsylvania, 1983 Certified Engineer-In-Training in Pennsylvania, 1979.
 
Certified Emergency Medical Technician in Pennsylvania, 1976

M.S., Engineering Science and Mechanics, 1974. Virginia Polytechnic Institute and State
University, Blacksburg, VA

B.S., Engineering Mechanics, 1972. The Pennsylvania State University, University Park, PA

Member, Board of Directors, Anesthesia Patient Safety Foundation

Member, American Society of Materials

Member, American Society of Mechanical Engineers Member, National Society of Professional Engineers Member, National Academy of Forensic Engineers Member, Mensa

Publications

Available Upon Request



Winter 2012

 


NEWSLETTER ARTICLES 

 

Newsletter Winter 2012

Surgical Staplers: Not as simple as they appear.

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