MEDICAL DEVICES EXPERT WITNESSES

Expert Witness Directory: E-099215
This expert has experience in Medical devices since 1992. Design experience since 1986. Areas of expertise include full life cycle product development of medical devices from conception through development including manufacturing, bench testing, verification, validation, packaging, labeling, clinical trials, regulatory approval, marketing, and sales training. Granted 28 patents (others pending), 7 awards, designs published by Life Magazine, was recognized as one of 100 ...
Expert Witness Directory: E-160599
This highly qualified engineer earned his BS and MS in mechanical engineering from California Polytechnic State University. He went on to earn his PhD in mechanical engineering from the University of California, Berkeley. He has over 10 years of experience conducting failure analysis for various products including biomedical devices. He formerly served as Principal Mechanical Engineer at COR Innovations, Inc., a biomedical device start-up. In this role, he was ...
Expert Witness Directory: E-026336
This qualified electric shock expert obtained his BS and MS in Bioengineering and Engineering Science from Stanford University and his PhD in Biomedical Engineering from Duke University. He is a Certified Professional Engineer and is a member of multiple engineering and bioengineering associations. The expert has published 75+ articles on electric shock and medical devices. He is an Emeritus Professor of Biomedical Engineering at a top university in the South and remains ...
Expert Witness Directory: E-053014
This certified Regulatory Affairs Professional has more than 20 years of experience ensuring compliance with the FDA. Throughout his career, he has managed 510(k) submissions, reviews, appeals, and clinical trials for a multitude of devices with applications ranging from dentistry to cardiology and neurology. Prior to launching his current consultancy, he served as a Director of Regulatory Affairs at medical device firms that manufacture class II and class III products. ...
Expert Witness Directory: E-032781
This expert received his undergraduate and doctoral degrees in Biomedical Engineering from Iowa State University. He has worked for and consulted with leading medical device, pharmaceutical & biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the FDA, Health Canada, the US & European Patent Offices, the Centers for Medicare and Medicaid Services, and other regulatory agencies around the world. As an ...
Expert Witness Directory: E-007962
This highly qualified expert specializes in engineering and regulatory affairs for medical device commercialization. She earned a BS in mathematics from Oregon State University and a MS in Medical Device and Diagnostic Engineering from the University of Southern California. This expert currently owns and operates her own medical device company where she prepares and submits FDA regulatory services 510k applications.
Expert Witness Directory: E-007585
This expert has over 40 years of experience as a mechanical engineer. His research in tribology, machining of advanced materials, medical device design, dental materials, and high temperature coatings is widely recognized in the scientific and engineering communities. He has published over two hundred fifty papers and reports related to machining of ceramics, mechanisms and mechanics of interfaces, wear and friction, boundary lubrication, and biotribology; and has given ...
Expert Witness Directory: E-007664
This expert has over 15 years of experience in the medical device industry as a quality engineer, quality systems and complaint investigator with emphasis on cardiovascular devices. A Certified Quality Engineer and Biomedical Auditor, his expertise includes managing quality systems, design and development of new product lines, product risk management and complaint investigations. He currently serves as Principal quality management systems and business Consultant for an ...

MEDICAL DEVICES EXPERT WITNESS CASE STUDIES

Medical Device Manufacturer Infringes On Competitor’s Patents MEDICAL DEVICES Expert Case

This case involves a dispute over intellectual property relating to the research and development of orthopedic implants. The manufacturer of several implant products for tibial and femoral shaft fractures alleged that a competitor infringed on patented …

Faulty Implantable Medical Device Causes Patient Fatality MEDICAL DEVICES Expert Case

Faulty Implantable Medical Device Causes Patient Fatality

…  off, and the child soon became unstable and died. A biomedical engineering expert with experience designing implantable medical devices was sought to assess the device for a manufacturing …

Medical Device Manufacturer Allegedly Violates FDA Regulations MEDICAL DEVICES Expert Case

…  who suffered complications related to a birth control medical device. The plaintiffs suffered perforation of the uterus and other …  failed to comply with FDA requirements. An expert in medical device regulation was sought to discuss FDA requirements for medical …

Elderly Man Sustains Injuries From Power Wheelchair MEDICAL DEVICES Expert Case

Elderly Man Sustains Injuries From Power Wheelchair

This case involves an elderly man in a long-term care facility who was injured while in his power wheelchair. He had been prescribed a power wheelchair by his primary care doctor because his mobility had become very limited. He had just received the ch …

Medical Device Company Infringes On Competitor’s Intellectual Property MEDICAL DEVICES Expert Case

…  a patent infringement involving several varieties of medical devices. Senior management officials at the …  system as well as a balloon catheter from a smaller medical device development company and attempted to secure a patent for the …

Business Ethics Expert Discusses Alleged Sale of Defective Medical Devices MEDICAL DEVICES Expert Case

…  case involves a dispute against a medical device company. The plaintiff alleges that the company was engaged in …  they were selling and marketing defective imaging devices that eventually ended up getting recalled shortly after they were put …  contracted serious infections after doctors used the devices on their patients. It was further alleged that the company was aware of …

FDA Expert Discusses Adverse Event Reporting Requirements MEDICAL DEVICES Expert Case

This case involves a middle-aged female in Maryland who presented to the hospital with bleeding after defecation caused by hemorrhoids. The decision was made to perform a hemorrhoidopexy to correct her condition. Following the procedure, the woman complai …