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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 Engineer and certified as a Clinical Engineer. He is member of technical standards writing bodies, and is widely published in his field and his expertise is frequently sought by hospitals, manufacturers, and litigators. He received numerous professional awards including the FDA Commissioner, Special Citation for protecting the public safety.
Principal, A Biomedical Engineering Consulting Firm
Bachelor of Science (BS), West Virginia University
Houston,
Texas
This expert joined the Departments of Bioengineering and Mechanical Engineering at a major TX University in June 2013 as an Assistant Professor. Prior to joining that university, he was a Research Scientist at the Rehabilitation Institute of Chicago and a Postdoctoral Fellow at Northwestern University. This expert investigates the control mechanisms of human locomotion for the development of high-performance wearable control systems (e.g., robotic prostheses and orthoses) to enable mobility in persons with disabilities. He is a recipient of the NIH Director's New Innovator Award and the Career Award at the Scientific Interface from the Burroughs Wellcome Fund. His work has been recognized with the Best Student Paper Award of the American Control Conference and the IEEE Conference on Decision & Control, the Best Technical Paper Award of the 2011 CLAWAR Conference, and the O. Hugo Schuck Award from multiple control conferences and councils, respectively. He is a Senior Member of the IEEE Control Systems Society and the IEEE Robotics & Automation Society.
Assistant Professor of Mechanical Engineering, A Major Texas College
Doctor of Philosophy (PhD), University of Illinois at Urbana-Champaign
Richardson,
Texas
This expert is a world renowned Biomedical Engineer specializing in prosthetics. He received a BA in mathematics and a BAI in microelectronics and electrical engineering from Trinity College Dublin, Ireland, in 1983. After working as a control engineer in England, he moved to the USA and obtained his MS and PhD degrees in biomedical engineering from Northwestern University in Evanston, IL. He has extensive experience working with lower and upper limb prosthetics research. His recent research is focused on the development an artificial hand replacement capable of true dexterous manipulation for use by persons with upper-limb loss. He covers all aspects of the problem ranging from neural control and sensing, mechatronic design and development, novel actuator technologies, and clinical deployment of these systems. He is currently the Director of the Biomechatronics Development Laboratory at a university in CO. He is also a Research Healthcare Scientist for a VA Health Care System, and holds Research Associate Professor appointments in the Departments of Bioengineering and Physical Medicine & Rehabilitation.
Research Healthcare Scientist, A VA Medical Center in CO
Doctor of Philosophy (PhD), Northwestern University
Lafayette,
Colorado
This expert specializes in injury biomechanics and automotive accident reconstruction. An alumnus of Texas A&M University's bioengineering program, he has 20+ years of accident analysis experience. In addition to consulting, he is involved in the research and testing of automotive bumper systems, having conducted numerous vehicular test collisions with human test subjects.
Owner, A Biomechanics Consultancy
Bachelor of Science (BS), Texas A&M University
Truckee,
Texas
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 expertise above and beyond a PhD. He is an active member of several scholarly societies in the biomedical field and is a regular reviewer of the Annals of Biomedical Engineering, the Journal of Surgical Research, and Cardiovascular Engineering and Technology. He currently serves on the biomedical engineering faculty of a major Southern university.
Owner, A Biomedical Consultancy Firm in AR
Doctor of Philosophy (PhD), University of Aarhus
Fayetteville,
Arkansas
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.
Senior Sales Executive, Corporation
Bachelor of Science (BS), Troy State University
Coppell,
Texas
This highly qualified expert has nearly a decade of experience in the field of Prosthetics. This expert received a BS in Computer Science from Texas Tech University and, after serving in the US Navy, this expert became a Certified Prosthetist at the California State University Dominguez Hills. He completed a residency at New England Orthotics and Prosthetics Systems and then went on to work as a Prosthetist at Gulf Prosthetics. This expert then worked as a Licensed Prosthetist at Advanced Biomechanics and RGV Prosthetics concurrently. Currently, this expert is the Head of Prosthetics at a Rehabilitation center.
Head of Prosthetics, A Rehabilitation Center
Bachelor of Science (BS)
Mission,
Texas
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 Electrophysiology. He is currently a Professor of Pediatrics in the Department of Cardiology at one of the nation's top university medical centers. Additionally, he serves as Director of Pediatric Electrophysiology, Co-founding Director of the Dysautonomia Center at one nation's most prestigious children's hospitals, and an attending Pediatric Cardiologist. He has been celebrated with numerous awards, including top doctor three years in a row in one of the US's largest cities. He has numerous publications on the subject of pediatric cardiac care and has been invited to present at various professional clinical meetings and conferences.
Attending Physician, Multiple Hospitals in TX
Bachelor of Medicine, Bachelor of Surgery (MBBS), King Faisal University
Houston,
Texas
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. This expert has been invited to speak nationally, and has authored 6 publications in FDA regulatory and quality matters.
FDA Regulation Consultant
Bachelor of Science (BS), University of South Carolina
Dallas,
Texas
This highly qualified expert has over 15 years of experience specializing in the electro-mechanical systems in medical devices. Specifically, this expert specializes in oxygen concentrators, oxygen conserving devices, breathe detection, power circuit design, instrumentation, and sensing. He earned his BS in electrical engineering from Northwestern and his MBA from Kellogg Graduate School of Management and has his six sigma black belt certification. He has held several roles including VP of engineering at Joslyn Hi-Voltage, director of electrical engineering at Baxter Healthcare and director of device risk management at Hospira. This expert also served as the director of global respiratory engineering in the home medical equipment division of Invacare. Currently, this expert owns a consultancy focused on the medical device product development in TX.
Owner, A medical device product development consultancy in TX
Master of Business Administration (MBA), Kellogg Graduate School of Management
Austin,
Texas
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What Can a Medical Devices Expert Witness Opine On?
Device Design
Creating functional medical device prototypes.
Regulatory Submission
Preparing documents for regulatory approval.
Quality Assurance Testing
Ensuring device safety and efficacy.
Clinical Evaluation
Assessing device performance in clinical settings.
User Training
Educating users on device operation.
Post-Market Surveillance
Monitoring device performance after launch.
FAQs for Medical Devices Expert Witnesses
What is the role of a medical devices expert witness?
A medical devices expert witness is a qualified specialist who explains device design, safety, and standards in legal cases. They assist by reviewing records, testing devices, writing reports, and testifying to clarify complex technical issues.
What types of cases can a medical device expert witness opine on?
A medical device expert witness opines on product defects, FDA compliance, labeling, adverse events, device failures, recalls, design, testing, manufacturing, and post‑market surveillance.
How can a medical devices expert witness strengthen product liability claims?
A medical devices expert witness strengthens product liability claims by explaining device design, testing, standards compliance, and causation in clear, evidence-based testimony.
What qualifications should attorneys prioritize in a medical devices expert witness?
Attorneys should prioritize a medical devices expert witness with advanced clinical or engineering credentials, device-specific experience, regulatory knowledge, and strong testifying history.
How does a medical devices expert witness evaluate device design compliance?
A medical devices expert witness evaluates device design compliance by reviewing design controls, risk management, testing data, regulatory standards, and documentation against FDA and ISO requirements.
What is Expert Institute’s process for selecting medical devices expert witnesses?
Expert Institute delivers a tailored approach to connect you with top-tier experts. We identify actively practicing professionals who meet your exact criteria for specialty, experience, litigation background, fee structure, credentials, location, and more.