Dr. David T. Durack has over 49 years of experience in the field of Infectious Disease with additional expertise in the Medical Device and Diagnostic Industry. He earned his MBBS from the University of Western Australia School of Medicine and his Ph.D. in Experimental Medicine from the University of Oxford. He completed his residency in Internal Medicine and his fellowship in Infectious Diseases...
This expert has over 30 years of experience in the medical device industry, with broad expertise in cardiovascular and endovascular fields with a focus on percutaneous catheters, heart assist devices, brain and aortic aneurysm treatment, and vascular closure products. He earned his MS in mechanical engineering at Moscow State Technical University and worked as the lead engineer at the Scientific...
This expert has over 20 years of experience in mechanical engineering, focusing on cryobiology. He earned his BS from the University of Madras, and his MS and PhD in mechanical engineering from the University of Colorado Boulder and the University of Minnesota, respectively. He has developed multiple courses related to biological thermodynamics and developed the bio-manufacturing and design lab...
This highly-qualified expert has extensive experience in automated external defibrillator (AED) program design and compliance. He earned his BS in public affairs from the University of Oregon and his JD from the Lewis & Clark Northwestern School of Law. He is a member of the Oregon State Bar and an advisory board member of the Sudden Cardiac Arrest Foundation and the National Center for Early...
This highly-qualified expert in cardiology received his MD from the University of Toronto. He then went on to complete an internship and residency in internal medicine at the Newton-Wellesley Hospital. This expert also completed a fellowship in cardiovascular disease at St. Elizabeth’s Medical Center of Boston and another in cardiac electrophysiology at Tufts Medical Center. He is also a member...
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...
This expert has over 30 years of experience in mechanical engineering, with a focus on developing new techniques, protocols, and instruments for long-term cryopreservation of human tissues. He is widely considered a world leader in cryobiomedical engineering with applications in cryopreservation, regenerative medicine, gene and cell therapy, bio-instruments, artificial organs, and organ...
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...
This highly qualified expert has over 30 years of experience in the medical device services and supply industry. He earned his bachelor's of science in electrical and clinical engineering from Northeastern University. He then went on to work in the clinical engineering department as a supervisor at Tufts New England Medical Center, where he oversaw the clinical department's equipment needs. He...
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...
This expert specializes in pacemaker devices and has 30 years of experience in the healthcare industry. He earned his BSN from Wichita State University and his MHA from the University of Kansas. He is a Licensed Registered Nurse and is a Certified Cardiac Device Specialist. He has formerly served as a Staff Nurse at Olathe Medical Center, as Cardiovascular Data Manager at Shawnee Mission Medical...
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...
This expert has over 15 years of experience in progressive engineering, operations, and project management leadership in the highly regulated automotive, medical device & food manufacturing industries. He was a senior continuous improvement engineer for American Medical Systems, where he managed CAP and various engineering projects to improve system compliance for FDA class III medical devices....
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...
This highly qualified expert has over 40 years of experience in medical device regulations. He received his BS in chemical engineering from Lowell Technological Institute and earned his MS in chemical engineering from the University of Iowa. He currently has 5 patents. Over the years, his work has included antimicrobial development and application, hydrophilic coating development and...
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...
This expert has over 25 years of experience with medical device and manufacturing quality assurance and engineering. He earned his MSEP in engineering physics and applied physics from Uppsala University and his MSME in mechanical engineering from the University of Houston. He has formerly served as a materials engineering consultant at Law Engineering, a manager of quality engineering at Boston...
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...
This expert earned his BS in bioengineering from the University of California, San Diego. He has over 20 years of experience in the medical device design industry, and holds over 40 issued patents. Previously, this expert served as a group manager and senior R&D engineer with Pfizer-Shiley & Mallinckrodt Medical, as vice president of operations at Pulmonx Incorporated, and as vice president at...
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),...
Published on - November 17, 2020
Over the past several years, medical device manufacturers have been facing a growing number of lawsuits stemming from hernia mesh products—surgical...Read more
Published on - September 24, 2020
The latest in an eventful year for Bayer Pharmaceuticals is a $1.6 billion settlement to resolve claims against its Essure contraceptive device.Read more
Published on - September 8, 2020
The Class I recall, the most serious type of FDA recall, announced the regulatory agency’s discovery that the insulin pumps were incorrectly dosing...Read more
Published on - August 6, 2020
A mass tort action against manufacturing giant, 3M, centered on defective combat earplugs is now poised to become one of the largest product...Read more
Published on - May 24, 2016
The FDA receives thousands of reports each year detailing the deaths, serious injuries, and malfunctions associated with medical devices. This is in...Read more
Published on - November 20, 2023Read more
Published on - April 3, 2018
This case involves a patent infringement involving several varieties of medical devices. Senior management officials at the...Read more
Published on - March 20, 2018
This case involves a breach of an employee confidentiality agreement after a senior employee of a biopharmaceutical firm left the company in order to...Read more
Published on - April 24, 2018
This case involves a hip implant with package labeling that failed to disclose that it contained a number of cobalt components. The man had undergone...Read more
Published on - April 17, 2018
This case involves the alleged failure of a knee implant in a 63-year-old male patient. The original surgery was successfully completed but the...Read more
Published on - October 2, 2018
This case involves a class action against a food and beverage giant following the launch of a microwavable food product. The new product was marketed...Read more
What is a biomedical expert witness?
A biomedical expert witness is a professional with extensive knowledge in the field of biomedical science. They provide testimony or informed opinions in legal cases involving medical devices, pharmaceuticals, and healthcare technology.
In what types of cases can a biomedical expert witness be beneficial?
Biomedical expert witnesses are crucial in cases involving medical device failures, patent disputes, pharmaceutical litigation, personal injury claims related to medical equipment, and more.
What subspecialties exist within the field of biomedical expertise?
Subspecialties include biomechanics, biomaterials, bioinformatics, medical imaging, genetic engineering, and regenerative medicine. Each has unique applications in legal proceedings.
How can a biomedical expert witness assist in a case involving medical device failure?
They can analyze the device's design, manufacturing process, and usage to determine if there were any flaws or negligence that could have led to its failure.
Why is it important for a biomedical expert witness to have experience with FDA regulations?
Understanding FDA regulations is key as they govern the approval and monitoring of medical devices and pharmaceuticals. This knowledge can help identify non-compliance or malpractice.
How does Expert Institute select its Biomedical expert witnesses?
Expert Institute offers a personalized approach to help you find the highest quality experts. We source actively-practicing professionals who match all your requirements for specialty areas, work experience, litigation history, fee range, certifications, location, and more.