Biomedical Engineering Expert Witness Listings

Welcome to our Biomedical Engineering expert directory. Browse the profiles below to find the right expert witness in Biomedical Engineering for your case. Our SEAK Expert Witness Database is always free to search.

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Michelle R Hoffman, MS Forensic Injury Analysis, LLC

Tempe, Arizona
Biomechanics Expert Witness, Biomedical Engineering Expert Witness - Injury Analysis, Injury Causation, Motor Vehicle Accidents, Child Seat Related Injuries, Use of Force Incidents, Helmet/Restraint Issues, Domestic Altercations, Falls from Heights, Product Liability, Diving Accidents, Backover/Runover Accidents, Aircraft Accidents, Personal Watercraft Accidents
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Morten O Jensen, PhD, DrMed Jexpert LLC

Fayetteville, Arkansas
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - Biomedical Engineering, Medical Engineering, Biomechanics, Medical Equipment, Heart, Intellectual Property (IP), Patent, Patent Infringement, Inter Partes Review (IPR), Surgery, Medical Malpractice, Medical Instrument, Prosthetic Device, Medical Device, Blood, Medical Electronics, Device Failure
Dr. Jensen has participated as an expert witness in about ten cases, on both the plaintiff's and defendant's side. These cases have involved medical devices and equipment, including their failure modes, design issues, usage, and patent infringement. The involvement in several of the case have been disclosed to opposing counsel, and Dr. Jensen has been deposed and participated in on-site device interrogation. Dr. Jensen’s educational background is from top ranked universities at the interface of engineering and medicine. He has two decades of academic and industry experience in both Europe and the United States. He worked for six years for a global measurement, automation and instrumentation provider in the company’s consulting services department. He has also spent more than a decade as a faculty member at highly renowned universities in Europe and the United States, winning numerous prestigious awards for his work with research, teaching, and service. The results from his work ...
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Kimberly Balogh, MSBE BiCoastal Forensics, LLC

Torrance, California
Biomechanics Expert Witness, Biomedical Engineering Expert Witness - Injury Causation, Injury Analysis, Motor Vehicle Collisions, Slip Trip & Fall, Pedestrian Accidents, Occupational and Work Place Injuries, Sports & Recreational Injuries, Fights & Assaults, Criminal Investigations, Playground Accidents, Falls from Height
Ms. Balogh is an expert in biomechanical engineering. Her expertise include providing technical investigations, analysis, reports, and testimony toward the resolution of commercial and personal injury litigation involving accident reconstruction and biomechanical analysis of human injury, specializing in computational, impact injury and orthopedic biomechanics. Ms. Balogh has a unique combination of research and industry experience. Her research background includes studying typical and perturbed patterns of postural and gait initiation and computational biomechanics of the human finger. Ms. Balogh experience in industry includes working with product development and the testing of medical manufacturing machine products, and has contributed to a variety of Small Business Innovation Research (SBIR) programs primarily geared towards safety/survivability technology for various divisions of the military. The primary projects of which she contributed to include a sh...
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John B. Slate, PhD Slate Engineering

Encinitas, California
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - Medical Instrumentation, Product Development, Safety, Risk Management, Patents, FDA, Quality Systems, Infusion Pumps, Injection Devices, Dry Eye Treatment Devices, Embedded Control Systems, Sensors
Over 35 years of experience developing medical devices for use in hospitals, clinics, and home care. Dr Slate has held senior management positions leading teams from product conception through manufacturing including conducting clinical studies, obtaining safety certifications, and preparing FDA submissions. A technical contributor skilled in the design of electromechanical systems and embedded controllers, he is an inventor on 24 issued U.S. patents, which are primarily in the field of infusion pumps and injectors for self-administration of insulin and other medications stored in prefilled containers. Experienced in complying with FDA regulations for Quality Management Systems including design control activities such as documenting product requirements, developing the risk management file, and conducting product verification and validation testing.
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Macarthur Drake, Jr., M.D., M.S.

Miami Beach, Florida
Neuroradiology Expert Witness, Radiology Expert Witness - Brain, head and neck, spine imaging, CT, CTA, MRI, MRA, Myelography, Diagnostic Radiology, Teleradiology, Mammography, Medical Expert, Internal Medicine, Medical Device Expert, Biomedical Engineering, Mechanical Engineering
11 Medical Licenses including FL, CA, NY, OH, IL. Neuroradiology Fellowship Trained & Board Certified. Neuroradiology lecturer. Diplomat, American Board of Radiology. Former NASA Engineering Intern. Former GE Aircraft Engineering Intern.
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Sasha M Demos, MD, PhD Dupage Valley Anesthesiologists

Naperville, Illinois
Anesthesiology Expert Witness, Biomedical Engineering Expert Witness - Airway Management, Failed Intubation, Epidural and Spinal Anesthesia, Obstetrical Anesthesia, General Anesthesia, Surgical Fires, Drug Errors, Positioning Injuries, Regional Anesthesia, Ambulatory Anesthesia, Intraoperative and Postoperative Complications, Sedation Complications Outside of the OR
Board certified anesthesiologist and Chairman of the Department of Anesthesia at a large community hospital. PhD in Bioengineering with research and publications in the areas of liposomes, ultrasound contrast agents, and targeted therapies. Administrative experience has provided involvement in the areas of quality, drug diversion prevention and risk management. Extensive experience in airway management, prevention of surgical fires, general, obstetrical, pediatric, thoracic, neuro, regional, and ambulatory anesthesia as well as sedation outside of the operating room.
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J. Lawrence Stevens, RAC ONE WAY CONSULTANTS. LLC, FDA Regulatory Experts

East Alton, Illinois
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - FDA, Medical Devices, FDA Compliance, FDA law, FDA Inspections, FDA medical device regulation, FDA medical device labeling, FDA regulation of clinical trials, FDA approval of medical devices. Medical Device Recalls, Medical Device Complaints, FDA Inspections
A recognized expert on the FDA regulation of Medical Devices. Experience as an expert witness involving medical device firms and FDA requirements regarding approvals, recalls, complaint investigations, and labeling. Over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. Personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular device. Serve as an expert witness for cases involving FDA regulation compliance for medical devices. Regularly perform webinars regarding FDA and issues regarding clinical studies and medical devices. Finally, a ...
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Christopher M Byrd, PhD BSquared Consulting, LLC

Bethesda, Maryland
DNA Expert Witness, Biomedical Engineering Expert Witness - Bioengineering, Biochemistry, Nucleic Acids, Bacteria, Virus, Biological Engineering, Military, Government, Technology, Biotechnology, Laboratory
Dr. Byrd is an executive and former senior military officer with extensive expertise in biotechnology, chemistry, and life science research and development strategic efforts, ventures and processes. He has held multiple scientific lead positions including Director of Biosciences at the Army Research Laboratory and Lead Scientific Advisor to the Chief of Staff of the Army. He has also worked as a professor of chemistry, biochemistry, and biology and has collaborated in research efforts with federal, academic, and industry partners such as DARPA, DHS, FBI, MIT, UCSB, and MedImmune, among others. His areas of expertise include: ➢ Bioengineering ➢ Biochemistry ➢ Microbiology ➢ DNA and Nucleic Acids ➢ Research and Development ➢ Biotechnology ➢ Bacteria ➢ Laboratory documentation and research review
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Alan Lipschultz, PE, CCE, CSP, CPPS, FACCE Healthcare Technology Consulting LLC

North Bethesda, Maryland
Medical Devices Expert Witness, Products Liability Expert Witness - Patient Safety, Biomedical Engineering, Clinical Engineering, Healthcare Technology, Medical Accident Investigation, Infusion Pumps, Defibrillators, Electrosurgical Units, Insulin Pumps, Joint Commission, Hospital Safety, Patient Safety, Patient Monitoring
37 years of hospital experience as Director of Clinical Engineering at two major hospitals; Responsible for managing all of the medical devices at those institutions; including overseeing the preventative maintenance, repairs, and incident investigation; Active member of Patient Safety Committee, Environment of Care Committee, Technology Management Committee, & Medical Product Implementation Committee. Professional Engineer (PE); Certified in Clinical Engineering (CCE); Certified Safety Professional (CSP); & Certified Professional In Patient Safety (CPPS) Fellow, American College of Clinical Engineering (FACCE) 2006 Recipient, Clinical/Biomedical Engineering Achievement Award from Association for the Advancement of Medical Instrumentation (AAMI) Co-Chair, AAMI Standards Board (1993-2015) Chair, National Fire Protection Association (NFPA) Technical Committee on Medical Equipment (2007-2015), Member 2015-present ECRI Institute – Health Devices Advisory Board (2007-2...
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David Preiss, MD PhD

Newton, Massachusetts
Anesthesiology Expert Witness - Anesthesiology, Endoscopy, Procedural sedation, Physiology, Biomedical engineering, Airway management, Ambulatory anesthesia, Preoperative assessment, General anesthesia, Anesthesia information management systems (Epic)
I am a Harvard trained physician with a background in biomedical engineering. I completed a PhD focused on designing respiratory equipment based on innovative physiological principles. I have been awarded 7 patents and have published 20 papers in the field. I have also developed an expertise in medical IT and electronic medical information systems, including Epic. I have practiced in diverse clinical environments, including academic, private and community. My areas include general surgeries, neurosurgery, orthopedics, urology, gynecology, ambulatory, plastics, gastrointestinal, endoscopy, interventional radiology and other procedural sedations.
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Bradley E Layton, PhD PE Human Powered Future PLLC

Missoula, Montana
Neurophysiology Expert Witness, Biomedical Engineering Expert Witness - neurology, diabetes, injury, forensics, biomechanics, nanotechnology, imaging, statistics, neuropathy, proteins, soft tissue, modeling
ASME member - www.asme.org IEEE-EMBS Editor - www.embs.org Author - Molecular and Cellular Biomechanics https://www.crcpress.com/Molecular-and-Cellular-Biomechanics/Layton/p/book/9789814316835 Professor - Drexel University www.drexel.edu Professor - University of Montana www.umontana.edu Recipient - Montana Governor's Innovator Award 2015 www.youtube.com/watch?v=reuWbbNbU1Y Inventor - AFM Nanomanipulation https://patents.google.com/patent/US7647848 Scientist - 100+ papers and abstracts: http://www.humanpoweredfuture.com/Layton_CV_180618.pdf Post-doctoral Fellow - University of Michigan MRI laboratory Lunar Scientist - US Department of Energy - Office of Space Fire Protection Engineer - US Department of Energy - Savannah River Site Legal Consultant - http://www.humanpoweredfuture.com/Layton_CV_180618.pdf Machinist - Merlin Metalworks - titanium bicycle design Machinist - http://www.stillwaterdesign.com/pages/launches.html Oath of the Engineer - http://www.order-of-t...
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Ediuska V. Laurens, MS, Dr.Eng.

Jersey City, New Jersey
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - Craniomaxillofacial/ Cranioplastic Implants, Medical Devices Regulations & Standards: 21 CFR 820, ISO 13485, FDA QMS & Design Controls, FDA 510k & CE Mark clearance, Risk Management, Pediatric Mandibular Distraction, Distraction Technology, Biomaterials, Bioresorbles, Hydrogels
As a biomaterials and medical device product development expert with 8 years plus of experience, I have developed pediatric Craniomaxillofacial implants from concept to global commercialization in Fortune 500 medical firm. I have successfully developed, FDA-CE Mark cleared, and launched Distraction, Bioresorbable, and Bone Cement technologies. I am the author of several published scientific articles in hyaluronan and collagen hydrogel biomaterials for cartilage and spine repair, and conference speaker in the same fields. I am the inventor of 2 patents in: pediatric mandibular distraction and bioresorbable polymer plating, respectively. I have led the entire product development process from concept, design, development, verification and validation testing, production and commercialization. My strong research background provides me with extensive experience and enhanced ability to analyze scientific data and identify strengths and weaknesses in both scientific methods and data. I am a...
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David H Darnel, CCE, JD MedProductsLaw, Inc.

Middletown, New York
Engineering Expert Witness, Medical Devices Expert Witness - Patient Safety, Medical Devices, Accident Investigations, Failure Analysis, Preventive Maintenance, Biomedical Engineering, Clinical Engineering, , Joint Commission Compliance, Medical Equipment Repair, Surgical Equipment, Patient Monitors, Defibrillators, Anesthesia Machines
30 years in-Hospital, hands-on, experience investigating medical device incidents in academic medical centers. Certified Clinical Engineer consulting in medical equipment management, patient safety, FDA, Joint Commission compliance audits. Perform accident investigations involving patient injuries, equipment defects, maintenance and operator error. Lectured at National Meetings. 20 years teaching experience. Expert Witness.
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Denis M. Boyle, BA, MS, PhD CMC BioPharma Consulting, LLC

Hampstead, North Carolina
Intellectual Property Expert Witness, Biomedical Engineering Expert Witness - Patent Infringement, Biopharmaceuticals, Bioprocess Technology, Biologics Manufacturing, Recombinant Proteins, Biochemistry, Engineering-Chemical, Engineering-Biomedical, GMO, Genetics, Microbiology, Natural Products Chemistry, Biomedical Research
Dr. Denis Boyle is an internationally recognized bioprocess expert with more than 25 years of experience in the development, validation and patent protection of technologies to produce biopharmaceuticals for commercial launch. He has led protein therapeutic development teams for nearly 20 years, including GMP animal health vaccines. He led both microbial and mammalian upstream production technology development teams, recognized as a downstream bioprocess and chromatography expert, and was responsible for the transfer and scale up of commercial GMP production of multiple recombinant protein products. These products ranged from engineered growth factors or fusion proteins in E. coli requiring refolding, PEGylation or other chemistries, to secreted proteins in yeast and to monoclonal antibodies from Chinese hamster ovary (CHO) cells. He also designed or completed Process Characterization and Process Validation studies with the successful registration and commercialization of biophar...
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George J. Shaw, MD, PhD Shaw Biomedical Consulting, LLC

Cincinnati OH , Ohio
Biomechanics Expert Witness, Biomedical Engineering Expert Witness - Emergency Medicine, mechanism of injury, traumatic injuries, accident analysis, medical record review, IME
Dr. George Shaw is both an actively practicing emergency medicine physician and a biomedical engineer who holds a Ph.D. in Physics. For over 19 years, he has drawn from his experience in his dual professions to develop a unique expertise in biomedicine and biomechanics. Dr. Shaw is board certified in Emergency Medicine and was tenured as an Associate Professor in Emergency Medicine at the College of Medicine, University of Cincinnati. He practices Emergency Medicine physician in a Level 1 trauma center. He is the holder of a patent in the area of biomedical engineering, is the recipient of numerous professional awards, and has authored many peer-reviewed medical and technical publications. In addition, Dr. Shaw is an experienced national and international speaker. Dr. Shaw is the founder of Shaw Biomedical Consulting, LLC, which provides medico-legal consultations in the areas of biomechanics, biomedicine, and mechanism of injury. Dr. Shaw is an experienced e...
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Gary D Fletcher, PhD RnDDx Solutions LLC

Media, Pennsylvania
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - New Product Development, Clinical in vitro diagnostics, Blood collection and separation, Point of care testing, Microfluidics, Spectroscopy, Cell therapy, Intellectual Property, Microscopy, Physics, Biomedical sensing, Optics and imaging,
Yale educated PhD Physicist with 28 years experience in medical devices, diagnostics, and biomedical engineering. Areas of expertise include product development, in vitro diagnostics, point of care testing, blood collection and sample preparation, optics and optical imaging, sensors, spectroscopy, and image analysis. Dr. Fletcher is currently serving as Expert Witness in patent infringement case involving blood collection, separation, and cell therapy preparation devices. Intellectual Property experience includes patent development, IP strategy and analysis, due diligence, implementing IP portfolio for startup new technology company, in-licensing and out-licensing agreements. Inventor on 9 granted US patents. R&D leadership expertise in both large company [Becton Dickinson] and multiple startup product development teams. o Startup medical device leadership generated $55M in angel investment o Contract R&D team developed and successfully spun-off new painless minimally invasive ...
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John D Jarrell, PhD, PE Materials Science Associates LLC

Coventry, Rhode Island
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - implants, hip, knee, joint replacement, spinal, stent, Nitinol, surgical, mesh, catheter, patch, stapler, asbestos, IVC, patent, orthopedic, biomaterial, stainless steel, friction, wear, metallosis, biomedical, biomechanical, corrosion, fracture, fatigue, FDA, risk analysis, 510K, warnings. labeling
Dr. John D. Jarrell, PhD, PE, is an experienced multi-discipline biomedical engineer and doctor of medical science specializing in consultation and expert opinions related to product development, intellectual property, risk, failure analysis, legal cases, product liability, accidents and personal injuries. His expertise includes the analysis of complex systems, designs and failures involving materials, mechanical, medical systems and warnings. As a licensed Professional Mechanical Engineer, he is actively involved in design, product development and research. He earned three degrees from Brown University, a Bachelors and Masters of Science in Materials Science and Engineering and a Doctorate in Biology, Medical Science and Engineering and received Medical training in histology, physiology, microbiology and pathology. He has an appointment in the Department of Orthopaedics at the Alpert Medical School of Brown University and at the Weiss Center for Orthopaedic Trauma Research at Rhode...
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Troy D. Drewry, MSBE, MEM Ragin Cajun Consulting, LLC

Memphis, Tennessee
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - Medical Device Mfg./Design Defects, Surgical Instruments, Spinal Instrumentation, Medical Implants, Medical Device Patents, Pedicle Screws, Bone Screws, Spinal Cages, Knee Replacement, Patents Medical Devices, Hip Replacement, Spinal Rods
With 25+ years of design and development experience, Troy Drewry provides forensic engineering, litigation consulting and expert witness testimony regarding medical devices, including biomechanical devices and orthopedic implants and instrumentation, in cases involving FDA and regulatory processes, failure analysis, product liability, medical malpractice, and intellectual property, including trade secrets. He has hands-on experience in medical device companies, from startups to large corporations and knows their environments, constraints, issues, and concerns. He is ranked 17th out of the Top 100 Spinal Device Inventors (1971-2003). 62 US Issued Patents to date 27 US Patent Applications pending 17 Foreign Issued Patents to date 33 Foreign Patent Applications pending His company, Ragin Cajun Consulting LLC, is a product development consulting firm helping innovators and inventors take their ideas from concept to commercialization. He has a breadth of knowledge in the medical devi...
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