MEDICAL DEVICE EXPERT WITNESSES

Expert Witness: E-015772
This expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality solutions and training to both small and large companies, and entrepreneurs. ...
Expert Witness: E-098458
This expert is board certified in Pediatrics, Pediatric Cardiology, Pediatric Cardiac Electrophysiology, with further cardiac specialty training in Congenital Heart Interventional Catheterization. His education began in Saudi Arabia where he trained and practiced as a pediatric cardiologist but then came to the states to gain US residency training in pediatrics, followed by fellowships in Neonatology and perinatal medicine, Pediatric Cardiology, and Cardiac ...
Expert Witness: 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: 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: 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: E-009108
This highler qualified expert has two decades of experience in basic and applied reserach in the thermal sciences. He has published well over 100 scientific papers dealing with biological heat transfer, burn injuries, and medical devices, among others. He has consulted for many companies in the medical device field and has presented well over 100 technical presentations at conferences and meetings. He is a Full Professor at a major Minnesota University.
Expert Witness: E-079468
This qualified expert of Hospital Procurement obtained his AA from Enterprise State Community College and his BS from Troy State University. He is a certified Pharmacy Technician, Licensed Practical Nurse, and an Emergency Medical Technician. He is a Member of The Association for Healthcare Resource and Materials Management and is Currently a Senior Sales Executive for a Healthcare/Medical Device Corporation.
Expert Witness: E-076798
This expert is a former Senior Sales Executive with over 30 years of success in the medical device field. His experiences include integration activities at a senior management level before and after acquisitions at two companies, as well as working closely with the FDA during an FDA consent decree shutdown.
Expert Witness: E-073741
This highly qualified expert has over a decade's experience in orthopedic trauma medical device sales in both a field capacity as well as executive, following a career in law enforcement in special operations. Extensive experience, has been in thousands of surgical procedures; and has previously conducted hundreds of criminal investigations. At DePuy Synthes, Companies of Johnson & Johnson, he managed a large territory in Orthopedic Trauma devices, providing ...
Expert Witness: E-065526
This highly credentialed biomedical engineer has significant experience in the design and development of cardiothoracic medical devices. He earned his Master's degree from Georgia Tech and the Emory University School of Medicine; After six years of industry experience he returned to academia and obtained the PhD from the University of Aarhus in Denmark. Then at the Aarhus University Hospital he achieved the Doctor Medicinae (DrMed) degree, which denotes medical research ...
Expert Witness: E-056921
This medical device sales professional has been in the industry since 1999. He earned his B.A. in Economics from Emory University and eventually went to work for Boston Scientific as a Territory Sales Manager in Men's and Women's Health. After 10 years with Boston Scientific, the expert joined St. Jude Medical's Neuromodulation device team as a Territory Manager in the Gulf Coast region. He was involved in 800+ implants and worked on device servicing for an additional ...
Expert Witness: E-041708
This Boston based expert earned his Bachelor's of Science degree in electrical engineering from Tufts University. He began his career in medical device design at Siemens Medical Systems, thereafter serving as the Director of Engineering for Aspect Medical Systems, the developer of the world's first anesthesia monitor, which is now in 90% of operating rooms worldwide, and has served at least 200 million patients. He serves on the scientific advisory boards of several ...

MEDICAL DEVICE EXPERT WITNESS CASE STUDIES

Negligent Hip Replacement Surgery Allegedly Causes Implant To Fail MEDICAL DEVICE Expert Case

This case involves an 80-year-old male patient who underwent a hip replacement revision for his left hip. He required a revision due to infection in his first implant. Because of the infection, the patient required a second implant as well as a femur …

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

Faulty Implantable Medical Device Causes Patient Fatality

…  case involves the failure of a vagus nerve stimulator. The device was implanted in a child with severe epilepsy. Within two weeks, the …  off, and the child soon became unstable and died. A biomedical engineering expert with experience designing implantable medical …

Elderly Man Sustains Injuries From Power Wheelchair MEDICAL DEVICE 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 …

Patient Develops Bacterial Infection Following Pacemaker Implant Surgery MEDICAL DEVICE Expert Case

This case involves an elderly female patient who was given an EKG after experiencing persistent chest pain for several weeks. A heart block was diagnosed and a pacemaker was implanted. While the patient was recovering from the surgery, she developed se …

Medical Device Company Infringes On Competitor’s Intellectual Property MEDICAL DEVICE 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 …