Biomedical Engineering Expert Witness

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This page contains biomedical engineering expert witnesses who testify, consult and provide litigation support on biomedical engineering and related issues. Biomedical engineering expert witnesses and consultants on this page may form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts. The issues and subjects these biomedical engineering expert witnesses testify regarding may include: Biomedical Engineering, Medical Devices, Airway Management, Ambulatory Anesthesia, Biomechanics, Fda Inspections, General Anesthesia, Intellectual Property, Microfluidics, Patient Safety, Product Liability, Accident Analysis, Aircraft Accidents, Anesthesia Information Management Systems (Epic), and Anesthesiology.

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Michelle R Hoffman, MS Forensic Injury Analysis, LLC

Tempe, Arizona
Biomechanics, Biomedical Engineering - 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

Morten O Jensen, PhD, DrMed Jexpert LLC

Fayetteville, Arkansas
Medical Devices, Biomedical Engineering - Biomedical Engineering, Medical Engineering, Biomechanics, Medical Equipment, Intellectual Property (IP), Patent Infringement, Inter Partes Review (IPR), Patent Invalidity, Surgery, Medical Malpractice, Medical Instrument, Prosthetic Device, Medical Device, Blood, Medical Electronics, Device Failure
Dr. Jensen has participated as a successful expert witness in cases supporting both the plaintiff's and defendant's sides. These cases have involved medical devices and equipment, including their failure modes, design issues, usage, and patent infringement. Dr. Jensen has been at trial and deposed several times, and participated in on-site device interrogations. Dr. Jensen’s educational background is from top ranked universities at the interface of engineering and medicine. He has more than two decades of academic and industry experience in both Europe and the US. 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 some of his work has been adopted by the FDA guidelines fo...

Peter Crosby Biomedical Business Resources, LLC

San Juan Capistrano, California
Biomedical Engineering, Intellectual Property - Medical devices, commercially reasonable efforts, patent, intellectual property, product liability, corporate governance, licensing, strategy, inter partes review, theft of intellectual property
Peter Crosby has over 40 years experience in the medical device industry, and has been the CEO of six medical device companies, public and private, in 4 countries. He has served as a member of the Board of 12 companies, and is currently Chairman of the Board of three companies. He is an inventor of 38 issued US patents and foreign equivalents. His clinical domain and specialty experience includes otolaryngology, diagnostic imaging, cardiology, cardiac surgery, anesthesia, pain management, radiology and diagnostic imaging, in vitro diagnostic devices, orthopedic surgery devices, and oncology. His product experience includes cochlear implants, diagnostic ultrasound, mammography, implantable cardiac pacemakers and implantable defibrillators, in vitro diagnostics, LVAD (left ventricular assist device or artificial heart), implantable neurostimulator, patient monitoring and software. His business function experience includes research and development, clinical trials, regulatory appro...

Giacomo Vacca, PhD Kinetic River Corp.

Mountain View, California
Optics, Biomedical Engineering - flow cytometry, cell sorting, cell analysis, particle analysis, hematology analysis, fluorescence, light scattering, optical systems, microfluidics, biomedical instrumentation, life science instrumentation, in vitro diagnostics
* 90 patents filed, 55 issued, 19 pending * 81 patents filed in flow cytometry and sorting * 55 invited talks * 51 conference presentations * 30 years experience in optics and lasers * 24 years experience in research and product development * 21 publications * 20 years experience in flow cytometry and sorting * 15 years experience performing technical IP evaluations, due diligence, technology assessment * 5 years experience managing IP portfolio in hematology for business unit of Fortune 100 company * 1 book chapter in Flow Cytometry Protocols * Expert witness testimony: 13 cases, 12 reports, 5 depositions * Trial experience: district court trial (Madison, WI, Sept. 2019); provided 3 testimonies (infringement, validity, damages) * Founded two companies: Kinetic River Corp. (custom flow cytometry instrumentation) and BeamWise Inc. (co-founder, optical system design software) * Senior Member of The Optical Society * Senior Member of SPIE * Volwiler Research Fellow of Abbott Laboratori...

Dori R Jones, MSE D Squared Consulting

Riverside, Connecticut
Medical Devices, Biomedical Engineering - Cardiac Devices, Heart Failure Devices, Cardiac Technology, Medical Device Engineering, Heart Assist Device, Left Ventricular Assist Device, Balloon Pump, Ultrafiltration, Heart Failure Diagnostic Devices, Implantable Devices, Mechanical Circulatory Support
Previous positions in medical devices include R&D Engineer, Mechanical/Quality Engineer, Field Clinical Engineer, Senior Field Clinical Engineer, Senior Clinical Education Manager, Senior Product Manager. Device experience includes extra-aortic balloon pump, left ventricular assist device (LVAD), neuromodulation device, fully implantable heart assist device, ultrafiltration device, and blood volume analysis device. Vast knowledge of mechanical circulatory support and implantable devices. Over 10 years in hospital setting including direct support in the Operating Room. Large network of clinicians including cardiac surgeons, cardiologists, nephrologists, intensivists, and nurses/nurse practitioners. Pending patent on blood filtration system (WO2020142533).

Macarthur Drake, Jr., M.D., M.S.

Miami Beach, Florida
Neuroradiology, Radiology - 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.

Sasha M Demos, MD, PhD Dupage Valley Anesthesiologists

Naperville, Illinois
Anesthesiology, Biomedical Engineering - 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.

J. Lawrence Stevens, RAC ONE WAY CONSULTANTS. LLC, FDA Regulatory Experts

East Alton, Illinois
Medical Devices, Biomedical Engineering - 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 ...

Christopher M Byrd, PhD BSquared Consulting, LLC

Bethesda, Maryland
Laboratories & Testing, DNA - Pharmaceutical Research, Bioengineering, Forensic Science, Biomedical Engineering, Biochemistry, Chemistry, Bacteria, Infection, DNA, Biological Engineering, Testing and Laboratories, Infectious Disease research, Laboratory,
Dr. Byrd is an executive and former senior military officer with extensive expertise in biotechnology, chemistry, and life science research 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 ➢ Forensic Science ➢ Microbiology ➢ DNA and Nucleic Acids ➢ Research and Development ➢ Biotechnology ➢ Pharmaceutical Development ➢ Bacteria and infection ➢ Laboratory documentation and research review

Alan Lipschultz, PE, CCE, CSP, CPPS, FACCE, FAAMI Healthcare Technology Consulting LLC

North Bethesda, Maryland
Medical Devices, Products Liability - 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, Association for the Advancement of Medical Instrumentation (AAMI) 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), Me...

David Preiss, MD PhD

Newton, Massachusetts
Anesthesiology - 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.

Bradley E Layton, PhD PE Human Powered Future PLLC

Missoula, Montana
Accident Reconstruction, Biomedical Engineering - neurology, diabetes, injury, forensics, biomechanics, nanotechnology, imaging, statistics, neuropathy, proteins, soft tissue, modeling
American Concrete Institute - https://www.concrete.org 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 International Code Council - https://www.iccsafe.org 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 ...

George J. Shaw, MD, PhD Shaw Biomedical Consulting, LLC

Cincinnati, Ohio
Biomedical Engineering, Biomechanics - 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...

Gary D Fletcher, PhD RnDDx Solutions LLC

Media, Pennsylvania
Medical Devices, Biomedical Engineering - 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 29 years experience in medical devices, diagnostics, and biomedical engineering. Expertise in product development, in vitro diagnostics, point of care testing, blood collection, separation, and sample preparation, optics, sensors, infrared, optical, & X-ray spectroscopy & imaging instrumentation for measurements of physical, chemical, & biological material properties. Expert Witness in patent infringement cases involving blood collection, separation, fluidic preparation, and cell therapy preparation devices. IP experience - patent development, IP strategy and analysis, due diligence, implementing IP portfolio for startup new technology company, in-licensing and out-licensing agreements. Inventor on 11 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 & spun-off new painle...

Troy D. Drewry, MSBE, MEM Ragin Cajun Consulting, LLC

Memphis, Tennessee
Medical Devices, Biomedical Engineering - 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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