DEVICE DESIGN EXPERT WITNESSES

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 ...
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-030330
This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry ...
Expert Witness: 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: 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 ...
Expert Witness: E-015769
This highly experienced biomedical engineer has directed comprehensive hospital-based biomedical engineering department at the largest medical center in the country, taught at both medical and technical post-secondary institutions, including the Baylor College of Medicine, West Virginia University, and a prominent Mexican university. He earned his undergraduate and graduate degrees in electrical engineering from West Virginia University. He is a licensed Professional ...
Expert Witness: E-028291
This extremely qualified clinical expert is an internationally recognized clinical pharmacist, author, patient advocate, and expert in patient adherence with medications and the development of multi-component patient education programs that increase patient adherence from worldwide clinical trials through product launch through post-marketing stages and increase patient safety. She has expertise in the translation of complicated medical terminology into language the ...
Expert Witness: E-008569
This expert graduated from a joint Harvard-MIT MD program, completed his OB/GYN residency at Johns Hopkins and his Urogyn Fellowship at Mayo Clinic, Scottsdale. He has 15 years of experience as a urogynecologic surgeon, clinical researcher and patient-safety expert. He is a master vaginal surgeon who is regularly referred patients who have suffered complications from previous pelvic surgeries, including those involving mesh. He has experience in the design and ...
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-057945
A 17-year veteran of the U.S. Food and Drug Administration (FDA), this expert served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and previously, in scientific, inspectional, compliance and criminal and civil enforcement capacities as an FDA Consumer Safety Officer (CSO), Compliance Officer (CO), a Senior Special Agent (SA) with the Office of Criminal Investigations (OCI) and as an analytical regulatory microbiologist. During his last ...

DEVICE DESIGN EXPERT WITNESS CASE STUDIES

Faulty Implantable Medical Device Causes Patient Fatality DEVICE DESIGN 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 …  and died. A biomedical engineering expert with experience designing implantable medical devices was sought to assess the device for a …

Woman Severely Burned By Allegedly Defective Headphones DEVICE DESIGN Expert Case

 This case involves an allegedly defective model of headphones that exploded. The plaintiff was using her headphones while biking in 95-degree weather and was sweating profusely. As the headphones became wet, they began to smoke and spontaneously explode …

Technology Experts Opine on USB Design Dispute DEVICE DESIGN Expert Case

Technology Experts Opine on USB Design Dispute

…  the analysis of USB technology in multi-host capable devices. The plaintiff corporation holds various patents pertaining to multi-host capable USB device controllers as well as automatic switching between multiple USB host …

Biomechanical Engineer Discusses Botched Robotic Hysterectomy DEVICE DESIGN Expert Case

This case involves a patient who suffered severe burns during a robotically assisted hysterectomy. The patient was a middle-aged woman who was under the care of the Defendant for an ongoing gynecological issue, for which total hysterectomy was recommende …

Computer Software Experts Opine on Programming Error in Defective Ventilator System DEVICE DESIGN Expert Case

…  case involves a now-recalled bedside device used to accommodate medical patients with respiratory disorders such as …  patient in an Alaskan hospital who depended on the device for respiration. One week after the device was purchased, it suddenly ceased functioning, but provided no alarm to …