Failure Analysis Expert for Medical Devices

Technical Consultant #1891


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
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