Failure Analysis Expert for Medical Devices

Expertise

• Over 30 years investigating expertise of failures, malfunctions, and misuses of devices, systems, methods, and procedures in various industries.
• Evaluating and investigating healthcare technology. providing over 20 years' experience.
• Surgical fires, oxygen safety, surgical lasers, failure analysis, root cause analyses (RCA), and failure modes and effect analysis (FMEA).
• Quickly and accurately determine problem causation for hospitals, law firms, insurance companies, regulatory agencies, and manufacturers.
• Educator - Instructor, Physics.

Expert Witness Experience

Deposition and Trial

• Operating room stool: A surgeon fell from a rolling OR stool and was injured. Surgeon claimed the stool was hazardous.
• Bariatric air mattress: Overheating death of a quadriplegic patient involving a bariatric air mattress.
• Surgical fire: A surgical fire occurred during biopsy surgery.
• Ophthalmic laser: Laser purportedly caused laser eye injury to surgeon.
• Surgical fire: Surgical fire occurred during neck surgery.
• Surgical fire: A surgical fire occurred during biopsy surgery.
• Orthopedic brace: An orthopedic brace failed during use, causing the user to fall.
• Thermal printers and thermal paper: Served as defense expert on thermal printers and thermal paper in a case concerning a monopoly.
• Syringe: A glass anesthetic syringe failed during preparation for use, causing severe injury to anesthesia provider's hand.

Experience

Undisclosed Company, Owner, 2001 - Present

Senior Engineering Consultant

• Provide consultation, research, investigation, writing, and expert witness testimony for healthcare technology, engineering, and law firms.

Undisclosed Company, Senior Engineering Consultant, 2010 - Present

• Provide expert witness investigation and testimony in medical device cases.

ECRI Institute, Plymouth Meeting, PA, 1987 - 2010

Associate Director, Accident and Forensic Investigation, 2001 - 2010

• Investigated more than 250 medical device accidents and fires for healthcare organizations, insurers, and law firms.
• Exceeded goals for client billing. Participated in development of several national standards in U.S. and Canada.

Associate Director, Health Devices Group, 1995 - 2001

• Assisted in management of group of 26 engineers and scientists in engineering projects and journal publication.
• Also wrote journal articles, article templates, and job descriptions.

Senior Project Engineer, 1987 - 1995

• Planned, executed, and wrote evaluations of medical devices, several evaluations were the first ever done for that device, for example: voting machines and laser safety eyewear.

Additional Work Experience

• Lehigh Carbon Community College, Schnecksville, PA, Instructor of Physics
• Robinson Halpern Company, Plymouth Meeting, PA, Project Engineer
• Fuller Company, Bethlehem, PA. Senior Development Engineer
• Pennsylvania Crusher Corporation, Broomall, PA, Laboratory Supervisor
• General Electric Re-Entry & Environmental Systems Division, Philadelphia, PA. Engineer, Structural Analysis
• Virginia Polytechnic Institute, Blacksburg, VA, Graduate, Teaching Assistant
• Alan I. W. Frank Corporation, Exton, PA, Maintenance Technician.
• Clifton Precision Products of Litton Industries, Clifton Heights, PA, Drafter
• Pennsylvania State University, University Park, PA, Student Researcher.

Honors & Publications

Credentials

• Ph.D. course work completed, Applied Mechanics, Drexel University
• Supplemented major course work with additional courses in the physiology, histology, organic chemistry, engineering geology, and mathematics.

Licenses

• Professional Engineer in Pennsylvania
• P.I.P.E. Certified Medical Gas System Inspector
• Former emergency medical technician and fire fighter.

Languages

• Some French, spoken and written

Academic and Professional Affiliations

• Member National Academy of Forensic Engineers
• Member of National Society of Professional Engineers
• Member of American Society of Mechanical Engineers
• Member of American Society for Materials
• Member of American College of Clinical Engineers
• Board of Directors of Anesthesia Patient Safety Foundation
• Chair of NFPA Committee: Recommended Practice On Materials, Equipment, And Systems Used In Oxygen-Enriched Atmospheres

Publications and Patents

• List of more than 150 published articles available on request. Articles on such subjects as surgical fires, oxygen safety, electrosurgical safety, surgical laser safety, and medical gas and vacuum systems.
• List of more than 160 lectures available on request. Lectures on such subjects as surgical fire safety, electrosurgical safety, and investigating medical device accidents.

Education

• M.S. Engineering Science and Mechanics, Virginia Polytechnic Institute, Blacksburg, VA
• B.S. Engineering Mechanics, Pennsylvania State University, University Park, PA