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Medical Devices Expert Witnesses

The SEAK Expert Witness Directory contains a comprehensive list of medical devices expert witnesses who testify, consult and provide litigation support on medical devices and related issues. Medical devices expert witnesses and consultants on this page may form expert opinions, draft expert witness reports, and provide expert witness testimony at deposition and trial. The issues and subjects these medical devices expert witnesses testify regarding may include: Medical Devices, Intellectual Property, Patents, Failure Analysis, Product Liability, Biomedical Engineering, FDA, Medical Device, Biomechanics, Cardiovascular Disease, Manufacturing, Mechanical Engineering, Patent, Software, and Artificial Intelligence.

T. Kim Parnell, PhD, PE

PhD Stanford - Mechanical Eng
Expert Witness,Patent,Forensic
Medical Device,FailureAnalysis

Susan M Bowley, Ph.D.

Medical Devices & RA
Mechanical/Biomedical Engineer
PhD UVa, MS Stanford, BS UConn

Gary D Fletcher, PhD

Med. Devices/Biomed Engineer
Yale Educated PhD Physicist
Experienced Expert

Denise S. Holliday

Medical Device Quality Expert
FDA Regulatory Compliance
Device Failure & Risk Expert

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Peter Crosby

>45 years experience in medical devices & patents

Biomedical Business Resources, LLC

Biomedical Engineering, Intellectual Property - Medical devices, commercially reasonable efforts, patent, intellectual property, product liability, corporate governance, licensing, strategy, inter partes review, misappropriation of trade secrets, ITC, IPR, ITC, fiduciary duty, pacemaker, defibrillator, neurostimulator, biomedical engineering

Peter Crosby is a biomedical engineer with over 45 years experience in the medical device industry, and has served as CEO of six medical device companies, public and private, in 4 countries. He has served as a member of the Board of 13 companies, and is currently serving as a member of the Board of three companies. He has brought many medical devices from concept to market release, through R&D, clinical trials, regulatory approval (FDA and CE Mark) and market launch. He is an inventor of over 50 issued US patents and applications and foreign equivalents. He has served as an expert in multiple patent cases - infringement, ownership, validity, IPR and ITC. His clinical domain and specialty experience includes otolaryngology, 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...

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Shishir Shah, DO, CWS, ABPM

Top Doctor Award Winning Wound Expert

SCOTTSDALE, Arizona

Wound Care, Medical Devices - bedsores, skin injuries, surgical wounds, burns, pressure ulcers, venous ulcers, hyperbaric oxygen, infections, nursing home, medical devices, telemedicine, scar, qui tam, medical necessity, fraud, patents, medical director, decubitus ulcers, diabetic ulcers, regenerative medicine

Award-winning wound care physician in active clinical practice. Wound care clinical, safety ,and leadership experience in acute care, skilled nursing (nursing homes), rehabilitation, and home health settings. Certified Wound Specialist (CWS) with additional Board Certifications in Hyperbaric Medicine and Family Practice. Has served as the medical director of several wound programs. Over twenty years of medical necessity/utilization review and expert witness experience. Midwestern University and Creighton Medical School faculty. Significant private equity, medical device CMO , startup, and consulting experience. Undergraduate degree in aeronautical engineering, Rensselaer Polytechnic Institute. Deposition and trial experience in multiple states. Over 85,000 wound encounters. Key roles have included medical director oversight of several level 1 hospital trauma wound programs, 5 community hospital wound programs, and over 15 SNF/LTACHs. Co-implemented one of the largest wound care/hyp...

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Morten O Jensen, PhD, DrMed

Biomedical Engineering and Medical Devices

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 is a Professor of Engineering and has been retained by representation for both plaintiffs and defendants in cases involving medical devices and equipment, including their failure modes, design/manufacturing issues, usage, and IP litigation issues (infringement, invalidity, etc.). He has testified at trials and depositions, and participated in on-site 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 with a global measurement, automation, and instrumentation provider in the company’s consulting services and business development departments. He has 20 years of faculty member experience at highly renowned universities in Europe and the US, winning numerous prestigious awards for his work with research, teaching, and service. The results from some of his work has been adopted by th...

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Shawn A Hayden, MD, PhD, MBA

Harvard Trained Orthopedic Spine/Trauma Surgeon

Shawn A. Hayden MD PA

California

Spine Surgery & Spine Care, Orthopedic Surgery - Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation, Trauma

Dr. Hayden graduated from Harvard College. He received his medical degree from the University of Massachusetts Medical School and his orthopedic training at the Harvard Combined Orthopedics Residency Program. He has been providing high quality medical expert opinions on orthopedic surgical spine and trauma care for years. Dr. Hayden is also fellowship trained in orthopedic trauma and spine surgery at The Massachusetts General Hospital and The Beth Israel Deaconess Medical Center. Diplomate of the American Board of Orthopedic Surgery and a Fellow in the American Academy of Orthopedic Surgeons. Dr. Hayden is board certified in Orthopedic Surgery. His Ph.D was received at the UT Southwestern Medical Center with research in computer science and anatomy. In 2011, Dr. Hayden received his MBA from the University of Tennessee. Today Dr. Hayden runs Onto Orthopedics, a high quality private orthopedic medical practice in Plano, TX. Dr. Hayden’s focus has always been in providing high-tec...

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Susan M Bowley, Ph.D.

Biomechanics, Medical Devices & Consumer Products

Bowley Inc.

California

Biomechanics, Medical Devices - Injury Causation Biomechanics & Personal Injury, Consumer & Medical Product Liability, Premises Liability, Slip, Trip & Falls, Accident Reconstruction, Animations and Illustrations, 3D Laser Scanning, Drone Aerial Mapping, Criminal and Shooting Reconstruction

Dr. Bowley started her own engineering consulting firm in 2008 and has been a testifying expert since 2006. Corporate offices are located in Connecticut (HQ), Maryland, and Northern California. Additionally, Dr. Bowley teaches Engineering courses at local Universities. Susan M. Bowley, Ph.D. has been a practicing engineer since 1988. Dr. Bowley grew up in Ashford, CT and completed her B.S. in Mechanical Engineering at the University of Connecticut. She then started her professional engineering career at NASA Ames Research Center in Northern California where she worked in various capacities for over 13 years. While at NASA, Dr. Bowley earned her M.S. in Mechanical Engineering at Stanford University with a concentration in Thermosciences, including completion of an independent research study on Transpired Epidermal Water Loss in Premature Infants. After competitive selection for a NASA Full-time Graduate Study Fellowship, Dr. Bowley earned her Ph.D. in Biomedical Engineering at ...

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Alison Marsden, PhD

Biomedical engineer - Stanford Faculty

Stanford University

Stanford, California

Biomedical Engineering, Medical Devices - digital health, finite element modeling, cardiovascular disease, surgical devices, biomechanics, fluid mechanics, pediatric cardiology, pediatric devices, machine learning, artificial intelligence, computational modeling, coronary artery disease, congenital heart disease, artificial heart, stents

Dr. Marsden is a full professor at Stanford and head of the Cardiovascular BioComputational Lab. Dr. Marsden has broad expertise in cardiovascular disease biomechanics and computational modeling. She trained as a mechanical engineer (Princeton BS, Stanford PhD) with expertise in computational science and fluid mechanics before moving into the biomedical field. She has extensive experience with cardiovascular medical devices, including stents, ventricular assist devices, hemolysis and thrombosis, pediatric devices, catheters, and heart valves. She has a particular focus on computational fluid dynamics simulations and finite element modeling of the cardiovascular system, including the incorporation of machine learning and artificial intelligence into clinical decision making. She has worked extensively in pediatric cardiology, applying computational modeling to congenital heart disease for surgical planning and medical device evaluation. She has served as a consultant for medical...

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Christopher M Daft, PhD

Patents, Trade Secrets and Medical Devices

River Sonic Solutions, LLC

San Francisco, California

Intellectual Property, Medical Devices - Imaging, Patent, Ultrasound, Electronics, Transducer, ASIC, MEMS, FDA, Signal Processing, Neuromodulation, Regulatory, Integrated Circuit, Semiconductors, Biometric Security, Wearable Biometrics, Tomography, Neural Networks, Artificial Intelligence, Wearable Medical Device, Product Liability

Award winning, Oxford Educated scientist whose areas of expertise include medical imaging, electronics, semiconductors, medical devices, sensors, MEMS, signal processing and image processing. - 5 trial testimonies and 15 depositions. - Litigation experience includes district court, ITC and PTAB matters. - Extensive Intellectual Property experience including patent development, analysis, licensing, and litigation. - Serial inventor holding 27 U.S. Patents with 20 applications pending. - Diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung and Siemens as well as several start-ups. - Well published. - Winner of grants from National Institute of Health and DARPA. - Extensive international consulting experience. - IEEE (Institute of Electrical and Electronic Engineers) Senior Member since 2004. - Three years’ experience teaching electrical and computer engineering at the University of Illinois. Holds BA and MA in Physics from...

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T.Kim Parnell, PhD, PE

Intellectual Property, Failure, Medical Device

Parnell Expert Consulting

Sunnyvale, California

Medical Devices, Intellectual Property - Mechanical Engineering, Equipment & Machinery, Medical Device, Nitinol, Biomedical, Patent, IP, Consumer Products, Failure Analysis, Fracture, Fatigue, Truck Rollover, Crashworthiness, Finite Element, FEA, Reliability, Cell Phone, IVC, Composite Material, Piping

T.Kim Parnell, PhD, PE is President of Parnell Engineering & Consulting. Dr.Parnell holds PhD and MSME degrees in Mechanical Engineering from Stanford University, a BES from Georgia Tech, and is a registered Professional Mechanical Engineer (PE) in the State of California. Dr.Parnell is an ASME Fellow, an IEEE Life Senior Member, and a Member of NAFEMS, SAMPE, ASMI and SAE. Parnell is Past-Chair of the IEEE Santa Clara Valley Section (IEEE-SCV) (over 13,000 members) and Past-Chair/Board Member of the IEEE Consultants' Network of Silicon Valley (IEEE-CNSV). Vice-President of Silicon Valley Engineering Council (SVEC-ca.org) Dr.Parnell is an experienced Expert Witness, has provided testimony in both trial and deposition, and has authored numerous expert reports, ITC and IPR declarations. He has worked extensively as an expert in medical devices, patents, product failure, product liability, and personal injury. Dr.Parnell has been retained in medical device litigation cases that ...

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Alexander R. Marmureanu, MD

Cardiothoracic Surgeon | Clinical Faculty

Los Angeles, California

Cardiothoracic Surgery, Vascular Surgery - Cardiac Surgery, Thoracic Surgery, Vascular & Endovascular Surgery, Trauma Surgery, Minimally Invasive Cardiovascular Surgery, Cardiovascular Disease, Pulmonary Critical Care, VATS, Lung Cancer, Minimally Invasive Thoracic Surgery, Robotic Surgery, Medical Devices, Hospital Administration, General Surgery, CABG, Bylaws

I am a board-certified cardiothoracic and general surgeon with an active clinical practice in Los Angeles, California, specializing in complex cardiovascular and thoracic surgery, including minimally invasive, robotic, and endovascular techniques. I am licensed to practice in California and New York. I serve as President and CEO of California Heart & Lung Surgery Medical Center, Director of Cardiothoracic Surgery at Centinela Hospital Medical Center, and Director of Cardiovascular Surgery at Southern California Hospital at Culver City. I also hold an academic appointment as Assistant Professor of Surgery and serve as Chair of the Bylaws Committee as well as a Member of the Faculty Assembly Committee at the California University of Science and Medicine. My training includes a General Surgery residency and research fellowship at New York University and Mount Sinai Medical Center, followed by a Cardiothoracic Surgery fellowship at UCLA, where I subsequently served on faculty. My cli...

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Gavin Huntley-Fenner, Ph.D.

Human Factors and Cognitive Sciences Expert

Rimkus

Irvine, California

Human Factors, Safety - Risk Analysis, Risk Perception, Hazard Communications, Safety and Human Development, Human Perception-Response Time, Decision Making, Cognitive Psychology, Consumer Electronics, Pharmaceuticals, Professional Products, Medical Devices, Human Behavior, Literature Reviews, Incident Database Reviews, Surveys and Human Subject Test

Dr. Gavin Huntley-Fenner is a nationally recognized expert in human factors and safety whose problem-solving skills and communication style have made him widely sought after as a consultant. Along with providing comprehensive risk analyses for a wide variety of product types, Dr. Huntley-Fenner often serves as an expert witness for matters relating to risk perception, hazard communications, safety and human development, human perception-response time, and decision-making. With a background of over 25 years as a researcher, author, educator, and business consultant, Dr. Huntley-Fenner applies the latest findings and research methods in cognitive psychology and related disciplines to real-world, often life-and-death, situations. Dr. Huntley-Fenner’s recent consulting and forensic projects have involved diverse products such as consumer electronics, pharmaceuticals, professional products, and medical devices. He has conducted investigations into human behavior in home, school, workpl...

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Roberto Contreras II, MD, CLCP

California Life Care Planning Association

Seal Beach, California

Life Care Planning, Internal Medicine - medical billing, life care planner, hospitalist, medical devices, medical management, medical coding, legal medicine, legal nurse consulting, nurse practitioner, obstetrics and gynecology, addiction medicine, family medicine, general practice, gynecology, consultative examinations

The California Life Care Planning Association was created by experts in the field of Life Care Planning, with more than 30 years of experience working in the health care industry. All of our professionals are Certified Life Care Planners, as well as active medical practitioners dedicated to assessing lifetime cost of care for individuals with catastrophic injuries/illness. What sets us apart from many other Life Care Planning organizations and individuals is that all of our Life Care Planners have active direct experience with patient care. We hold ourselves to a higher standard and hold all of our affiliates to that same higher standard. Whether it be plaintiff, defense , or any other client, our methodology is transparent and consistent. Given the healthcare backgrounds of our founders, all Life Care Plans and services are overseen by a Physician. Similar to a hospital setting, many of our services go through "rounding" with senior partners and physicians to make sure we are keep...

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Brian McVerry, PhD

Medical Devices/Materials - Founder and CTO

Axiom Scientific

Marina del Rey, California

Chemistry & Chemicals, Medical Devices - Polymer Chemistry, Surface Modification, Surface Chemistry, Medical Device Complications, Material Properties, Material Characterization, Catheters, Stents, Implant Coatings, Chemical Characterization, Pathogenesis, Medical Device Manufacturing, Chemistry Intellectual Property, Formulating Chemistry, Biomedical Engineering

Brian T. McVerry, Ph.D., is a scientist, inventor, entrepreneur, and medical device executive with deep expertise in biomaterials, anti-fouling surface chemistry, medical device design, regulatory strategy, and clinical evidence generation. He is the Co-Founder and Chief Scientific Officer of Silq Technologies, where he conceived and developed a clinically demonstrated zwitterionic surface treatment for implantable medical devices and led its translation from laboratory concept to FDA-cleared commercial products. Dr. McVerry holds a Ph.D. in Chemistry from the University of California, Los Angeles (UCLA). His doctoral work produced multiple high-impact publications, patents, and licensed technologies, including a universal anti-fouling surface modification licensed to Silq Technologies and a non-flammable electrolyte technology licensed to a private energy storage company. He is a recipient of the National Science Foundation Graduate Research Fellowship, a Finalist in the U.S. Pate...

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Jason C. Goodwin, RN, MS, MPH, CNOR

Procedural, CNOR, Pre / Post Op Director Expert

Granite Bay, California

Nursing Administration, Nurse - Wrong site surgery , Retained surgical item, Operating Room Nurse, Ambulatory Surgery Nurse, Anesthesia error, Falls, Perioperative Services Administration, Post Anesthesia Nurse, Procedural Sedation, GI procedures, CNOR, RN, Med Surg, Medical Devices, Nurse, Preoperative, Consent, Failure to rescue , Standard of Care, Pressure injuries

I am a highly skilled and decorated Veteran Nurse Corps Lieutenant, honorably discharged in 2006. An experienced RN and perioperative leader, I have successfully influenced high-quality care and service excellence since 2002. I am committed to building strong relationships and providing detailed clinical assistance. Facilitation with relevant stakeholders including C-suite healthcare administrators and Physician has been a growing responsibility as my career progressed. An expert with quality and safety compliance regulation, I have successfully prepared teams for Joint Commission, AAAHC, Medicare, Inspector General, and State audits. I have experience managing as many as 20 managers, 4 Lean/Six Sigma processimprovement personnel, 500 total employees, and $1.8 Billion in annual gross revenue. Clinical Experiences include:  Medical Surgical Nursing  Shock / Trauma Intervention  Procedural Services  Preoperative, Intraoperative, and Postoperative Care  Procedural Sedatio...

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Peter Crosby

>45 years experience in medical devices & patents

Biomedical Business Resources, LLC

Aliso Viejo, California

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Patrick Jurney, PhD, FAHA

Bio/Mech Eng (PhD, FAHA) – Cardiovascular Expert

San Jose State University

San Jose, California

Biomedical Engineering, Medical Devices - Cardiovascular Devices, Vascular Biomaterials, Cardiovascular Disease, Fluid Mechanics, Nanoparticles, Drug Delivery, Biomedical Device Manufacturing, Microfluidics, Bypass Grafts, Mammalian Cell Culture, Biotransport Phenomena, Mechanotransduction, Thrombogenicity and Hemostasis, Endothelial Cells

Kordestani Endowed Chair & Associate Professor of Biomedical Engineering San José State University Visiting Scholar, Department of Chemical and Systems Biology, Stanford University Dr. Patrick Jurney is both a Biomedical and Mechanical Engineer specializing in cardiovascular devices, microfluidics, and vascular biomaterials. As the Kordestani Endowed Chair and Associate Professor of Biomedical Engineering at San José State University, and a Visiting Scholar in the Department of Chemical and Systems Biology at Stanford University, Dr. Jurney integrates engineering innovation with translational biomedical research. His Stanford affiliation expands his expertise into pharmacological and molecular approaches, strengthening his ability to evaluate how medical devices and engineered biomaterials interface with complex biological systems. He has been recognized as a Fellow of the American Heart Association (FAHA) and has secured funding from the National Institutes of Health (NIH), the Am...

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David Schaafsma, PhD

Medical Diagnostics, Optics, Networks

California Optical Engineering, Inc.

Fallbrook, California

Medical Devices, Intellectual Property - optics, electronics, software, medical device, diagnostics, medtech, biotech, optical networks, physics, optical materials, intellectual property

My company provides engineering consulting and product development services across the spectrum of entrepreneurs, small businesses, and large firms, as well as expert services. We are a network of skilled professionals with backgrounds including all engineering disciplines, science, manufacturing, regulatory affairs, and a wide range of others. We specialize in projects involving optics, electronics, software, and various aspects of materials physics, but have made happy customers in a broad range of endeavors. As of 2025, I have served as an expert on more than 30 matters, have been deposed over 12 times, and have testified in District and Superior Court, as well as the ITC. My primary focus has been in intellectual property, but I have experience in personal injury and product liability cases as well. I was also an adjunct professor of Applied Physics at Cal State San Marcos for over 16 years, teaching electronics, optics, embedded programming, and physics. I have worked i...

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Jeffrey Brown, PhD

Device/biologic design and manufacturing failures

Compass Consulting Engineers

Westminster, Colorado

Medical Devices, Biomedical Engineering - Medical device, Biologics, Manufacturing, Risk Management, Design History File, FMEA, Stem Cells, Biomaterials, Product Liability, Intellectual Property, Implant, Collagen, Device testing, Design Controls, Product labeling, CDMO, Quality/Regulatory, Allograft, Forensic Science

10+ years in medical device/biologics design, development, and manufacture 15 years in design and operational engineering Inventor on two biomedical patents Qualified Nuclear Engineering Officer in the US Navy First author for 3 peer-reviewed original scientific research articles

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Eric C Beppler, PE

Embedded Systems and Software Expert

Ringtail Labs

Broomfield, Colorado

Electrical Engineering, Software Engineering - Source Code Analysis, Firmware, Forensic Engineering, Product Liability, Trade Secret Misappropriation, Wireless Communications, Internet of Things (IoT), Medical Devices, Electronics, Software Development, Signal Processing, Root Cause Analysis, Digital Health Devices, Life Sciences Instrumentation

Eric C. Beppler, PE is a Colorado-based electrical and software engineer with extensive hands-on experience in embedded systems development and firmware programming. A licensed Professional Engineer in Colorado, Mr. Beppler has led multi-disciplinary engineering teams and co-founded a biomedical device R&D firm, spearheading the creation of wearable health devices and IoT sensor systems for continuous data monitoring. He has served as Director of Software & Electrical Engineering for a life-sciences instrumentation startup (acquired by a Fortune 500 company), where he architected complex electronic control systems and oversaw product compliance under FDA and IEEE/IEC standards. Mr. Beppler’s technical expertise spans circuit design, wireless communications (Bluetooth Low Energy, LTE-M), and software development, enabling him to analyze and troubleshoot devices ranging from consumer electronics to medical devices. He is the co-inventor of a patented continuous methane monitoring devi...

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Steven B Levine, MD

Steven Levine

Milford, Connecticut

Otolaryngology, Allergy & Immunology - Audiology, ear, Ear Nose & Throat, ENT, delayed diagnosis, causation, hearing, hearing loss, vertigo, dizziness, Otology, sleep apnea, snoring, tinnitus, patent, medical devices, intellectual property, voice, loss of smell, anosmia

Actively practicing award-winning board-certified Otolaryngologist-Head & Neck Surgeon (Ear, Nose & Throat). Former Yale, Cornell and Penn faculty. Medical degree from University of Rochester and residency at University of Pennsylvania. National and international invited speaker with publications related to hearing, sinus, allergy and throat disorders. Patent holder in hearing diagnostic device. Castle Connolly Top Doctor for >20 consecutive years. Leadership positions at state and national medical societies. Experienced expert witness (both deposition and trial).

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Susan M Bowley, Ph.D.

Biomechanics, Medical Devices & Consumer Products

Bowley Inc.

Mansfield, Connecticut

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Timothy Hawkins, FACHE

Experienced direct facility negligence expert

Hospital Experts

Cape Coral , Florida

Medical Management, Medical Devices - Hospital Administration, Hospital Liability, Joint Commission Standards, IRB, Medical Devices, daVinci Robot Credentialing, Operating Room, Informed Consent, Negligent Credentialing, Patient Safety, Environment of Care, Hospital Negligence, Sexual assault and abuse, Policies and procedures

Mr. Hawkins is an accomplished Hospital Executive with experience in hospital departmental operations and regional healthcare systems. He held the positions of Chief Executive Officer, Executive Vice President, and Chief Operating Officer. He is Board Certified in Healthcare Administration, and a Fellow of the American College of Healthcare Executives.

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Lloyd A Marks, MD, MBS, FACC, FAIMBE

Medical Device Inventions, IP & Commercialization

Medical Invention Consulting, LLC

Tampa, Florida

Medical Devices, Intellectual Property - Medical Devices, Medical Technology, Patents, Intellectual Property, Inventions, Entrepreneurship, Due Diligence, Medical Device Assessment, Medical Device Protection, Medical Device Commercialization, Human Factors, Medical Twechnology Assessment, Medical Technology Protection, Medical Technology Commercialization

I’m an electrical engineer (MIT), physician (University of Michigan), pediatric cardiologist (Johns Hopkins), MBA (UTK), inventor with 20 medical device and 5 sporting equipment patents, and entrepreneur with three startup companies, one of which, MGI Medical, LLC (www.mgimedical.com), is commercializing an invention of mine, the Pulse Flowmeter, which can detect hemodynamically significant occult blood loss well before the blood pressure drops. This is for the management of trauma, post-operative bleeding, battlefield triage, GI bleeders and battlefield injuries). I am a fellow of the American College of Cardiology and the American Institute of Medical and Biological Engineering. Honors include membership in Tau Beta Pi (Engineering Honorary) , membership in Eta Kappa Nu (electrical engineering honorary), a listing in Marquis Who's Who in America and Physician Leader of the year at the Physician's Executive MBA Program at the University of Tennessee, Knoxville. Because of my ba...

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Shawn A Hayden, MD, PhD, MBA

Harvard Trained Orthopedic Spine/Trauma Surgeon

Shawn A. Hayden MD PA

Florida

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Shaun L. Samuels, MD, FSIR

Miami, Florida

Interventional & Vascular Radiology, Medical Devices - endovascular, aneurysm repair, vascular surgery, endovascular surgery, interventional oncology, ablation, chemoembolization, catheter, radioembolization, bland embolization, biliary intervention, nephrostomy, venous access, dialysis intervention, peripheral intervention, stents, angioplasty, filters

Six years faculty Stanford University. 14 years a partner at the prestigious Miami Cardiac & Vascular Institute. Fellow of the Society of Interventional Radiology. Program Director International Symposium on Endovascular Therapy (ISET)--14 years. Leading Program Director of Symposium on Clinical Interventional Oncology (CIO)--10 years; Medical device expert with 14 US patents/patents pending. International expert speaker/lecturer. Faculty at major US and International Conferences: TCT, ISET, CIO, SIR, AIM, CIRSE, ECIO, WCIO, ACIR, TOPE. Particular expertise in vascular and endovascular procedures, catheter-based medical devices, peripheral arterial disease, abdominal aortic aneurysm interventions, Endovascular Aneurysm Repair (EVAR), Thoracic Endovascular Aneurysm Repair (TEVAR), balloon angioplasty, peripheral stent placement, vascular access, dialysis interventions, interventional oncology procedures, radiofrequency ablation, cryoablation, microwave ablation, chemoem...

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Willa L Carter

CQG

Conyers, Georgia

Chemistry & Chemicals, Pharmaceutical Regulation - Medical devices, pharmaceutical research, patents, drug formulation, quality control, laboratories, manufacturing, drug packaging, cosmetics, food, ISO, International Standards of Harmonization (ISO), environmental conditions, compliance, sterilization, chemical synthesis, fermentation, components

Experienced Chemist with 25+ years of experience in quality control, raw materials, manufacturing, validation, and stability. Experience in pharmaceutical, medical device, cosmetics, and food industries. Former odor panel scientist at Proctor & Gamble as a contractor. Extensive teaching experience. International inspector.

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Shawn A Hayden, MD, PhD, MBA

Harvard Trained Orthopedic Spine/Trauma Surgeon

Shawn A. Hayden MD PA

Georgia

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Eugene Lipov, MD

Westmont, Illinois

Pain Management - Medicine, Medical Devices - PTSD, Post Traumatic Stress Disorder, Complex Regional Pain Syndrome, CRPS, Reflex Sympathetic Dystrophy, RSD, Stellate Ganglion Block, SGB, Ketamine, Nerve Injury, Injections, Chronic Pain, Opioids, Addiction, Fraud, IME, Independent Medical examinations, hot flashes, patents, intellectual property

Pain Medicine thought-leader. Founding member of the American Society of Interventional Pain Physicians. Developer of multiple innovative pain treatments. Developed hybrid stimulator that combined convention dorsal column stimulator and sub-q stimulator. Evaluated needle design that lead to improvement of Sprotte needle. Pioneered the use of Stellate Ganglion Block (SGB) for the treatment of post-traumatic stress disorder (PTSD) and hot flashes. Developed the Dual Sympathetic Reset (DSR) protocol to treat PTSD. Work has been written about in the Wall Street Journal, the Los Angeles Times, and the Chicago Tribune, and featured on ABC, NBC and WGN. Experienced expert witness – has given over 1,000 depositions. Significant medical device experience. Active clinical practice. Board Certified in both pain medicine and anesthesiology. University of Illinois faculty. Performs the entire range of pain procedures including: dorsal column stimulators (DCS), radio frequency ablati...

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J. Lawrence Stevens, RAC

FDA Medical Device Expert

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

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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Eric Anttila, PhD

Medical Device Expert Witness

MED Institute

West Lafayette, Indiana

Medical Devices, Intellectual Property - MRI, Medical Devices, Cardiovascular Disease, MRI Safety, Intellectual Property, Patent Analysis, Medical Imaging, Medical Device Failure Analysis, Endovascular Repair, Mechanical Engineering, Demagnetization, ISO 13485, Biomedical Engineering, Medical Device Testing, Fluoroscopy, Failure Analysis

Eric Anttila, PhD is the Manager of Advanced Engineering at MED Institute. He graduated from Hastings College in 2015 with his bachelor’s degree in Engineering Physics. Eric completed his Ph.D. in Engineering (Specialization in Biomedical Engineering) from the University of Nebraska-Lincoln in 2021 with a concentration in cardiovascular biomechanics and devices. Eric has worked for the past 4+ years as a medical device consultant, working on development and testing for a multitude of devices spanning many medical specialties.

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David C. Gross, PhD, PE

Medical Device Expert Witness

MED Institute Inc.

West Lafayette, Indiana

Biomedical Engineering, Intellectual Property - Medical Devices, Failure Analysis, Products Liability, Mechanical Engineering, Biomechanics, Laboratories & Testing, MRI safety, FDA and Regulatory, Finite Element Analysis, Electromagnetic Compatibility, Magnetic Resonance Imaging, MRI, Patent Analysis, ISO 13485

David Gross, PhD, PE, is Vice President of MED Institute, a Medtech contract research organization (CRO). As a graduate research associate, he was awarded a Pre-Doctoral Fellowship from the American Heart Association (AHA) for his research focusing on improving the MRI safety of patients with implanted cardiovascular devices. He is a member of numerous societies, including the International Society for Magnetic Resonance in Medicine (ISMRM) where he received the Magna Cum Laude Merit Award at the 2016 ISMRM Annual Conference. Additionally, he was a member of the Ethics Subcommittee for the Biomedical Engineering Society. He graduated from Purdue University with a B.S. in Biomedical Engineering and M.S.E. in Interdisciplinary Engineering. He also holds M.S. and Ph.D. degrees in Biomedical Engineering from Ohio State University and is a licensed Professional Engineer.

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Mari S Truman, MS, PE

Injury Biomechanics, Orthopaedics Medical Devices

OrthoBioMech LLC

Warsaw, Indiana

Biomechanics, Medical Devices - Occupant Motion, Injury Biomechanics, Orthopedics, Medical Product Liability, Duties of Manufacturer, Design, Testing, Manufacturing, Warnings, Instructions for Use, Injury Event Reconstruction, Failure Analysis, Injury Pattern, Soft Tissue Injury, Low Speed Collisions, Falls, Impacts, Sports

Licensed Professional Engineer Medical Device Design & Development  40+ years orthopaedic device development  14 patents Testified in State and Federal Courts , Injury Biomechanics and Medical Device Litigation  35+ trials  150+ depositions 46 years of experience in the biomechanics and orthopedics fields, 24 years forensic case analyses. I routinely deal with forces that are applied to the human body during many activities, including impact and injury scenarios. To assure the safety and efficacy of new medical devices, we define clinically relevant performance requirements for their installation and use, and then test to define the product specific performance characteristics. The physical principles and methods used in orthopedic biomechanics are the same as those used to reconstruct injury events. I am familiar with forces and loads applied to the hips, knees, wrist, shoulder, head, neck, lower back and skeleton in many typical activities, including sitting, walking, jumpin...

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Gary Fischman, PhD, FACerS, FNICE

Materials Science - medical and dental ceramics

Future Strategy Solutions

Gambrills, Maryland

Medical Devices, Products Liability - ceramics, Dental Ceramics, Dental zirconia, hard materials, coatings, device failures, medical ceramics, zirconia, medical device standards, properties of materials, FDA, IP, Patents, Manufacturing and Processing

Gary Fischman is the principal and owner of Future Strategies Solutions LLC. He is a domain specialist in hard materials, specifically ceramics and hard coatings. He has done legal expert work in issues in medical and dental ceramics. Dr. Fischman has worked with discovery, written expert reports, been deposed and testified as an expert witness. Formerly, a tenured faculty member at the New York State College of Ceramics at Alfred University, Dr. Fischman worked in processing hard, strong materials that ranged from non-oxide semiconductors to oxide ceramics for biomedical applications. During the early years of biomedical applications of materials, Dr. Fischman was front and center developing classes, doing research specifically in hard material (non-oxides) as well as medical oxides (aluminas and zirconias). During that time, he teamed with a colleague and created a small business that made ceramics for biomedical applicationsn (Xylon Ceramic Materials). Dr. Fischman then tr...

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Susan M Bowley, Ph.D.

Biomechanics, Medical Devices & Consumer Products

Bowley Inc.

Maryland

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Joshua Sharlin, PhD

SHARLIN CONSULTING

STEVENSVILLE, Maryland

Pharmaceutical Regulation, Medical Devices - FDA, FDA Compliance, FDA Regulations, FDA MAUDE, FDA Drug Safety, FDA Warnings, FDA Drug Warnings, FDA Medical Device, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability

Worked as an FDA regulatory expert witness in over 50 cases, deposed 16 times and testified 5 times. Based on experience training over 40,000 staff at FDA-regulated companies on technical and regulatory topics, skilled in explaining FDA related topics to juries. Broad and deep skills in drug, biologic and medical device development. Hands-on experience in the entire lifecycle of product development from initial regulatory strategy, clinical trial planning and execution, to submission preparation and review at FDA. Authority in the collection, statistical analysis, interpretation, and presentation of information to FDA. Expert in understanding FDA reviewer’s actions and reactions. Specialist in analyzing FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it? Provide FDA related ...

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Vipul M Kella, MD, MBA FACEP

Emergency and Hospital Administration Expert

Vipul Kella

Potomac, Maryland

Emergency Medicine, Hospital Administration - COVID, overdose, anaphylaxis, appendicitis, fraud, hospital administration, mental health, aortic dissection, sexual assault, myocardial infarction, fractures, negligence, sepsis, wound care, trauma, cardiac arrest, brain hemorrhage, stroke, medical devices, aneurysm

Background: Dr. Kella is a board-certified emergency medicine physician who practices in the Washington, D.C. area. In his twenty years of practice, he has worked both clinically and as a hospital executive in large hospital systems and has received awards for hospital safety and quality initiatives. He currently practices in the Washington, D.C. area and has been retained in high-profile civil and federal matters by firms across the country. Dr. Kella has both a clinical and executive background, with an MBA in hospital administration and 15 years of experience in hospital administrative and consulting roles. He is frequently retained for his expertise in corporate negligence and complex hospital administrative matters. He is also a chief medical officer and an experienced health tech expert, and he has been retained for his experience with medical devices and products. Board-certified in Emergency Medicine, and a highly experienced expert witness, having reviewed over 400 ...

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Charlotte L. Kohler, [RN], CPA, CVA, CRCE-l, CPC, CHBC, CPCO

Kohler Healthcare Consulting, Inc.

Woodstock, Maryland

Investigation, Medical Management - Acute Care, Ambulatory Surgery Centers, Dermatology, Internal Medicine, Medical Devices, Medical Management, Orthopedic Surgery, Pain Medicine Management, Physical Medicine & Rehab, Radiation Oncology, Radiology, Healthcare Compliance

Healthcare Consultant, Litigation Support, Certified Valuator, CPA [RN] Retired RN. ACS Advanced Coding Specialist -Board of Medical Specialty (BMSC) CPA Certified Public Accountant -State of Maryland CVA Certified Valuation Analyst - National Association of Certified Valuators and Analysts CRCE Certified Revenue Cycle Executive -American Association of Healthcare Administrative Management (AAHAM) CPC Certified Professional Coder -American Academy of Professional Coders (AAPC) CHBC Certified Healthcare Business Consultant -National Society of Certified Healthcare Business Consultants CPCO Certified Professional Compliance Officer

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Steven W Opolski, MS

Atlantic Engineering, Inc.

Ipswich, Massachusetts

Medical Devices, Engineering - Stent, Septal Occluder, Medical Devices, Vena Cava, Filter, heart, brain, colon, valve, mitral, aortic, finite element, FEA, AAA, disposables, nitinol, percutaneous, aneurysm , failure analysis, surgical instrument

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Bob Weiman

Software Product Design Expert

Oracle Engineering LLC

Sudbury, Massachusetts

Software Engineering, Medical Devices - Medical Software, Patents, Tort, Trade Secret, C/C++, Infringement, Engineering, Software, Embedded systems, Real Time Control, Firmware, Source Code Review, Robotics, Computer, Programming, Algorithms, Safety Critical, Software Malfunction, Intellectual Property, Electrical Engineering

Bob Weiman is the founder of Oracle Engineering LLC, a consulting firm that has been designing electronic medical devices, consumer, and industrial products for over 35 years. He was head of the Electrical Engineering department for a Medical Products group and continues to design software for safety critical systems such as computerized medical devices including an artificial heart, a cancer radiation treatment system, a heart defibrillator, insulin pumps and other high-tech devices used in hospitals, operating rooms and doctors office's. Bob has designed Embedded Systems for the DOD and the Navy. He has designed consumer products sold in computer stores. He designed a satellite remote control system that was demonstrated at The White House for the President. Bob has experience as an Expert Witness in medical tort cases, patent cases, workers’ compensation, and trade secret cases.

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Rouzbeh R. Taghizadeh, Ph.D.

Regenerative Medicine Expert - MIT Trained

Kendall Innovations

Cambridge, Massachusetts

Regenerative Medicine, Biomedical Engineering - Regenerative Medicine, Cellular Therapies, Stem Cells, Extracellular Matrix, Perinatal Tissues (Placenta, Amnion, Chorion, Umbilical Cord Blood/Tissue), Transplantation, Cellular & Tissue Engineering, Biotechnology, Bioengineering, Medical Devices, Tissue Processing/Banking, HSCs, MSCs

Rouzbeh R. Taghizadeh, PhD, is a Cellular Therapy, Regenerative Medicine and Biomedical Engineering Expert offering more than 20 years of expertise as a Scientist, Innovator, and Entrepreneur in the development, processing, manufacturing of tissues, including bone marrow, umbilical cord (blood & tissue), amnion, chorion, placenta, adipose (fat), and other organs for clinical and non-clinical use, while considering the complex regulatory, trade secret, patent claims that arises from these areas. Litigation Support - Dr. Taghizadeh provides subject matter expertise and expert witness testimony for scientific, technical, regulatory, trade secret and patent claims in the areas of: Regenerative Medicine Blood / Tissue Banking Cellular and Tissue Based Therapeutics Stem Cell Bioengineering Extracellular Matrix HSCs / MSCs Processing Cryopreservation Longevity Cellular and Tissue Engineering Biotechnology Medical Devices Perinatal Tissues Transplantation Quality Control Regulatory and Po...

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Matthew Sarkar

Patent Litigation | Hatch-Waxman | Inhaler Devices

Cambridge, Massachusetts

Medical Devices, Intellectual Property - Patent litigation, Hatch Waxman, ANDA, Inhaler, Inhalation, Inhaled drug delivery, Drug delivery device, Intellectual property, Branded Pharmaceutical, Generic Pharmaceutical, Respiratory, Medical device, Device design, Device development, Trade secret, Asthma, COPD, Consulting expert, Hatch-Waxman, Expert Witness

Matthew Sarkar brings a rare combination of insider industry experience and expert witness credentials to Hatch-Waxman patent litigation involving inhaled drug delivery and respiratory device technology. As a co-founder of the device business acquired by Vectura plc — one of the UK's leading inhaled therapeutics companies — he led the development of novel inhalation devices from concept through clinical trials, and subsequently took strategic responsibility for Vectura's device IP portfolio, managing licensing, due diligence, and technology transfer across the respiratory sector. He is a named inventor on more than 20 granted patent families in medical and drug delivery technology, giving him direct, first-hand insight into the inventive process that is central to patent validity and infringement analysis. Mr Sarkar has provided expert analysis in Hatch-Waxman litigation involving inhaler technology, breath actuation, and dose counter mechanisms. His technical expertise spans the f...

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Ilonna J. Rimm, MD PhD CFA

Healthcare Valuation Expert - Physician

Rimm Healthcare Capital Advisory LLC

Newton Center, Massachusetts

Financial, Pediatric Hematology Oncology - Appraisal and Valuation, Banking, Business Valuation, DNA, Financial, Securities and Investments, Biotechnology, Medical Devices, Healthcare Services, Life Science Tools, Pharmaceuticals, Entrepreneurial Companies, Start-up companies

Ilonna Rimm, MD PhD CFA, is a healthcare investor who has significant expertise related to the valuation of healthcare companies. She recently served as an expert witness related to the valuation of early-stage biotechnology companies. In addition to drafting the expert report and rebuttal, she served as a deponent, and she testified in the trial. As the CEO and Founder of Morninglight Healthcare Capital, LLC, a family office, she invests in small cap public companies (0 to $4B market cap). She also serves as an Advisor to Life Sciences CEO’s who are raising a Seed or Series A Round of capital, as Rimm Healthcare Capital Advisory, LLC. She recently provided services to Immuneering Corp., who raised a Series A round of $20M in January, 2020, and a Series B round of $62M in January, 2021. Immuneering is now a public company (IMRX). Ilonna currently works as a Financing Expert at the Harvard Innovation Lab, which is associated with Harvard Business School. Ilonna's advisory s...

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Moiz Khan, PhD

Surgical Robotics Expert Witness

Consult Robotics

North Grafton, Massachusetts

Engineering, Medical Devices - surgical robotics, medical robotics, robotics, rehabilitation, simulation, design, strategy, marketing, endoluminal, orthopedic, artificial intelligence, AI

Dr. Moiz Khan is a senior robotics and artificial intelligence expert with deep experience at the intersection of advanced engineering systems, AI enabled physical technologies, and real world deployment. He currently serves as Head of Market Development, where he leads strategy and technical engagement across robotics, autonomy, embedded systems, and AI driven manufacturing, working closely with industry, academia, and government stakeholders. Dr. Khan holds a PhD in Mechanical Engineering with a focus on medical and rehabilitation robotics from Columbia University and completed postdoctoral training at Harvard Medical School in surgical robotics, where he developed minimally invasive surgical systems and algorithms. His academic background spans robotics, control systems, perception, simulation, and human machine interaction, with applied experience across healthcare, autonomous systems, industrial automation, and embedded AI platforms. He has published numerous papers in leading...

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Eugene Lipov, MD

Michigan

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James M. Miller, PE, PhD

Engineering Safety, Agricultural, Batteries, Nano

J.M. Miller Engineering, Inc.

Ann Arbor, Michigan

Safety, Agriculture Engineering - Accidents, Auto ADAS, Agriculture, Battery Fires, Cannabis Processing, Chemical Exposure, Child Safety, Construction, Electrocution, Ergonomics, Fitness Equipment, Fires/Explosions, HazCom, Human Factors, HVAC, Mechatronics/Nano, Medical Devices, OSHA, Recalls, RV/ATV

There are four PhD and registered Professional Engineers at Miller Engineering who are celebrating 40 years of Professorships at three universities along with providing services to Government, Insurance, and Industry—through research, publications, presentations, and expert testimony. These co-founders and associates are James M. Miller, PE, PhD; Mark R. Lehto, PhD; David R. Clark, PE, PhD; Adam M. Olshove, PE, MSE; and Jeffrey D. Rupp, MSE. Miller Engineering has a dedicated office with a full-time staff of engineers, researchers, and technical writers. The span of our collective academic and experiential expertise includes the Mechanical, Electrical, Chemical, Agricultural, Industrial, Human Factors, Ergonomic and Safety fields of engineering. Miller Engineering’s principle engineers wrote the original books on warnings and instructions, have published in several other areas, have participated in product designs and patents, and have analyzed, reconstructed and/or animated numerou...

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Jay Vincelli, PhD, PE

Medical Device Expert - Dartmouth - Design & FDA

Quantify Engineering, LLC

Orford, New Hampshire

Medical Devices, Biomedical Engineering - Failure Analysis, Design History File (DHF), FDA Regulatory, Orthopedic Implants, Hip Implants, Knee Implants, Cardiovascular, Neurological Devices, Urological, Surgical Tools, Surgical Mesh, Warming Systems, EEG, Biosensors, Biomaterials, Polymers, Metals, ISO Standards, Patent Litigation, Rehab Devices

Dr. Jay Vincelli, PhD, PE, is a licensed Professional Engineer (PE) in mechanical engineering and a PhD-level biomedical engineer specializing in the forensic analysis and development of medical devices for manufacturers, product liability, and patent litigation matters. Litigation Support & Forensic Leadership Dr. Vincelli has directed the technical investigation and forensic strategy for over 110 medical device matters. As a former Laboratory Director, he managed the protocol development and testing for complex litigation involving orthopedic implants, surgical mesh, IVC filters, forced-air warming systems, and many other devices. He combines this high-volume experience with deep technical rigor, notably conducting a large-scale retrieval study at Dartmouth College involving the failure analysis of over 500 metal-on-metal hip implants. Dr. Vincelli has served as the designated expert witness in multiple depositions, including the Christiansen v. Wright bellwether trial. Regulat...

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Tamanna Nahar, MD, MBA, FACC, FASE

Englewood Cliffs, New Jersey

Cardiovascular Disease, Interventional Cardiology - Vascular/Interventional Cardiology, Cardiovascular Ultrasound, Preventive Medicine, Medical Management, Medical Devices, Cardiac Electrophysiology, Cardiovascular Genetics, Heart Failure, Interventional Cardiology, Onco-Cardiology, Peripheral Artery Disease (PAD), Structural Heart Disease

I am a board certified well rounded cardiologist with a broad range of skills spanning over 20 years. My experience has encompassed academic and clinical medicine with a focus on noninvasive cardiology for the past 23 years at premier Institutions. I have strong leadership and mentorship skills in addition to budgeting and revenue cycle management. I have been a Co-PI for Phase 2 and 3 clinical trials for Ultrasound Enhancing Agents and participated in clinical trials for various antihypertensive, lipid lowering, oral anticoagulant and heart failure drugs. In addition to serving as a Co-PI for Phase 3 trials for PFO/ASD device deployment trials. My expertise includes formulating and reviewing IRB protocols and serving on CRO committees. Previously served at the Harlem Hospital, Columbia Affiliate, NY as Chief of Cardiology and was also involved in the training of medical students, residents and nurse practitioners. Current Medical Licenses: • Pennsylvania • New York • New Jersey ...

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Dr. Ediuska Laurens, M.S, EngD.

Medical Device FDA Regulation & Quality Expert

Genius Shield LLC

New York City , New York

Medical Devices, Pharmaceutical Regulation - Medical Device FDA Regulation, Biologics FDA Regulation, FDA Compliance, FDA Warning & Labels, Product Liability, FDA Regulations, Medical Device Product Liability, Clinical Trials FDA Regulation, Medical Device FDA Approvals-Clearance, Medical Device Recalls, Medical Device Complaints, Biomedical Engineering

Dr. Ediuska Laurens is a highly credentialed biomedical engineer and expert in FDA regulation, compliance, and product liability for medical devices and biologics. She provides expert witness services to both plaintiff and defense counsel in litigation involving medical device and biologics FDA approval and clearance, labeling and warnings, quality systems, adverse event reporting, clinical trials, and post-market surveillance. Dr. Laurens brings over 20 years of combined industry, research, and regulatory experience. She has led regulatory and quality efforts across the entire medical device lifecycle, from concept through commercialization, supporting product development, regulatory submissions, and quality compliance for a wide range of technologies, including cranial and orthopedic implants, spinal and neural devices, tissue engineered-biologics and combination products, hydrogel biomaterials, as well as pediatric and women’s health innovations, among others. Attorneys rely on...

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David M. Lehmann, PhD

Toxicologist - Drugs, Alcohol, & Chemicals

Intertox

Raleigh, North Carolina

Toxicology, Infectious Diseases - Alcohol & drug impairment, Liquor liability & dram shop, Immunology, Allergic reactions, Skin & eye irritation, Inhalation toxicology, Medical devices, Postmortem toxicology, Metals, Air pollutants, Pesticides, Lead poisoning, Carbon monoxide poisoning, Solvents, Volatile organic compounds (VOCs), Toxic torts, Infectious diseases

Dr. Lehmann is an accomplished toxicologist with nearly 20 years of cross-sector experience spanning academia, industry, and government. He brings deep expertise in human and ecological risk assessment, toxicological mechanisms, pharmacology, and drug-related signal transduction pathways. Dr. Lehmann applies his scientific expertise to complex questions involving alcohol, drugs, environmental exposures, consumer products, and medical devices. His work integrates experimental toxicology, exposure assessment, and weight-of-evidence evaluation to assess potential health effects and causation. Drawing on his extensive research background and teaching experience, he is skilled at translating complex toxicological concepts into clear, accessible explanations for attorneys, courts, and other non-scientific audiences. Experience & Expertise: -Alcohol and Drug Toxicology: Expertise in the toxicology and pharmacology of alcohol, opioids, stimulants, cannabinoids, benzodiazepines, and other...

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Shawn A Hayden, MD, PhD, MBA

Harvard Trained Orthopedic Spine/Trauma Surgeon

Shawn A. Hayden MD PA

Ohio

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Christopher L DeArmitt, PhD FIMMM FRSC CChem

Authority on plastics, microplastics, environment

Phantom Plastics LLC

Terrace Park, Ohio

Environmental, Medical Devices - Microplastics, Nanoplastics, Ocean Plastics, Litter, Plastic Degradation, Marlex Medical Mesh, Plastics recycling, Plastic Waste & Landfill, Plastics & Health, Plastic implants, Plastic Materials, Nanoplastic, Copper toxicity, PET Bottles, Plastic Pipes, Drinking water, Bisphenol A BPA, Bottled water, phthalates

Dr. DeArmitt obtained a BSc (Hons) in chemistry with polymer science from the University of Sussex, United Kingdom. He then obtained his MPhil and PhD on the topic of conductive polymer colloids, also from the University of Sussex. A very wide range of analytical techniques were used to characterize the new polymers and colloids made. He has over 30 years of industrial experience in plastics and formulation of plastics including additives such as fillers, reinforcements, antioxidants (stabilizers), impact modifiers and slip aids. Dr. DeArmitt was Manager of the Polymeric Materials Group at the Institute for Surface Chemistry in Stockholm. He created multi-national, multi-client projects on the topics of polymers, mineral fillers and antioxidants. During that time, he worked with the KTH Stockholm to create new hyperbranched, high molecular weight antioxidants to provide extraction resistance and long-term performance. He was Senior Project Manager at Electrolux (known as Frigidai...

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Jon Washington, BSME, MBA, PMP

Engineering, Design, Manufacturing & Patent Expert

The Innovation Garage, LLC

Clinton, Ohio

Engineering, Mechanical Engineering - Automotive, Aerospace, Gaming, Casinos, Financial Self Service, Manufacturing, Design, Systems, Polymers, Project Managment, Contracts, Security, Software, Metal Forming Processes, Patent Process, Business Process, Operations, Medical Devices, Supply Chain, Consumer Products

Jon Washington is the Founder and Proprietor of The Innovation Garage, a business consulting firm he has operated since 2012. The Innovation Garage focuses on providing education, tools, technology, and expert consulting in change management related to Strategy, Innovation, and Supply Chain. The Innovation Garage provides organizational leadership teams with resources, education, and consulting services to design strategies, develop internal capabilities, and implement systems, processes and solutions. Its diverse client base includes startups, nonprofits, mid market privately held and recognized publicly traded organizations such as Fortune 500 companies and large international entities, including DoD-based support organizations. Since its inception, The Innovation Garage has collaborated with over 100 organizations, with Mr. Washington personally training more than 2,000 organizational leaders and their extended teams. His expertise spans various sectors, including medical, ...

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Lei Li

PhD Biostatistician & FDA Clinical Trial Expert

LunarAI LLC

Landenberg, Pennsylvania

Statistics, Medical Devices - biostatistics, FDA, Pharmaceutical Statistics, Sanofi, Edwards, Gilead, AI/ML expert, machine learning, clinical trial, Medical Device, Vaccine, Group Sequential Design, Bayesian Adaptive Design, Statistical Review of Evidence, Oncology, Epidemiological, Regulatory Submissions, Survival Analysis, Statistical Expert Witness, RWE

Lei Li, PhD, is a biostatistician and former FDA CDRH statistical reviewer with extensive experience in regulatory statistics, Real-World Evidence (RWE), medical device submissions, and pharmaceutical development. At FDA, Dr. Li evaluated statistical components of 510(k) and PMA submissions, assessed safety and effectiveness evidence for medical devices, reviewed RWE and post-market studies, and advised on complex statistical issues for regulatory decision-making. His FDA work included evaluation of study design adequacy, endpoint justification, sample-size rationale, bias and confounding, missing data robustness, and interpretation of clinical performance metrics under regulatory standards. In industry, Dr. Li served as Statistical Project Leader at Sanofi and Principal Biostatistician at Edwards Lifesciences, supporting global clinical and regulatory programs across multiple therapeutic areas, including rare diseases, inflammatory diseases, vaccines, oncology, and cardiovascular ...

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Boyle C. Cheng, PhD

Total Spine Solutions, Inc.

Mars, Pennsylvania

Medical Devices, Spine Surgery & Spine Care - Neurosurgery, Orthopaedic Surgery, Biomechanics, Intellectual property, Engineering, Biomedical, Firearms and Ballistics, Trauma

Rank of Full Professor at Drexel University College of Medicine, and Adjunct Full Professor at Carnegie Mellon University.

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Gary D Fletcher, PhD

Medical Device Bioengineering & Patent Litigation

RnDDx Solutions LLC

Media, Pennsylvania

Medical Devices, Biomedical Engineering - Mechanical Engineering, R&D, Product Development, Clinical diagnostics, Blood collection, Biospecimens, Point of care testing, Microfluidics, Spectroscopy, Cell therapy, Intellectual Property, Microscopy, Physics, Biomedical sensing, Optics, Imaging, Mathematics, Laboratories & Testing, Lasers

Dr. Fletcher is Founder and Principal Consultant at RnDDx Solutions LLC, a consulting firm focused on industrial biomedical and mechanical engineering, and research and product development, in medical devices, diagnostics, optical devices, point-of-care blood sample testing, and on expert witness patent litigation, including subject matter expertise in medical device mechanical engineering, and subject matter expertise in medical devices for blood collection and blood sample processing for diagnostics and therapeutics. He has particular expertise in mechanical engineering design and development of non-invasive and minimally invasive biomedical diagnostics systems, blood collection and stabilization, blood separation, and blood and cell preparation for both diagnostic and therapeutic applications, including the development of sample collection devices, needles, and lancets. He is co-inventor on 23 patents for devices and methods in blood collection and processing. Yale educated Ph...

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Eric S Heinz, MBA, MEM

MedTech Expert - 23 Years of Experience

Heinz Ventures, LLC

Memphis, Tennessee

Medical Devices, Marketing - M&A, Product Liability, Intellectual Property, Commercial Disputes, Mergers & Acquisitions, Venture Capital, Robotic Surgery, Spine, MedTech, Branding, Trademarks, Biomedical Engineering, Trade Secrets, da Vinci Surgery, Securities, Shareholder Litigation, Governance

With 23+ years of broad and deep functional experience in the MedTech/medical device industry, Eric Heinz provides litigation consulting and expert witness testimony related to commercial disputes, marketing, mergers & acquisitions, product liability, and intellectual property. Over his career, he has become a expert in the development and commercialization of surgical robotics, most notably through his past position as product manager for the da Vinci Surgical System at Intuitive Surgical. He is a registered patent agent, and is named as an inventor on 19 Issued US patents. His knowledge across product development engineering, marketing and M&A provide a unique perspective when understanding complex situations in this highly regulated industry. His extensive network in the industry (Top 1% LinkedIn Social Selling Index) facilitates warm introductions between engaged counsel and hard to source subject matter experts. He is known for his expertise in translating complex techn...

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Denise S. Holliday

Medical Device Quality and FDA Regulatory Expert

Capwell Consulting Group LLC

Frisco, Texas

Medical Devices, Biomedical Engineering - Ophthalmology, Spinal Implants, Non-Active Implants, Cardiology, Ventilators, General Hospital, Orthopedic, Gynecology/Obstetrics, General Surgical Equipment, In-Vitro Diagnostics, Dental, Software, Neurology, Prosthetics, Sterilization, 483 Warning Letters, FDA Regulatory Compliance, FDA Approvals

Denise Holliday is a proven strategic innovator and tactical leader in highly regulated environments, including quality management systems, international regulatory compliance, and medical device risk management. As a leading medical device regulatory consultant for Capwell Consulting Group, she provides strategic support to medical technology businesses, healthcare organizations, and startups. She delivers expert testimony for medical device litigation, guiding attorneys and organizations through the complexities of the global medical device industry. Manufacturers and attorneys trust Ms. Holliday to help navigate the complex regulatory landscape of medical device manufacturing and ensure compliance with standards and guidelines. Spanning almost two decades, Ms. Holliday’s career in medical device regulatory compliance and quality assurance showcases her extensive leadership experience. She conducts ISO 13485Medical Device and ISO 9001Quality Management certification audits, spear...

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Tom A LeTourneau, C.P.O.,L.P.O.,F.A.A.O.P.

Award winning Orthotist & Prosthetist ,C.P.O.FAAOP

LeTourneau LIFELIKE Orthotics & Prosthetics , Inc

Beaumont, Texas

Prosthetics, Medical Devices - Amputation, PROSTHETIC EXPERT, Prosthetics, Orthotics, ARM AMPUTATION, AMPUTEE SOLUTIONS, Doctor, loss of foot, ABOVE the KNEE AMPUTEE, BELOW the KNEE AMPUTEE, Artificial legs, Knee amputation, Foot amputee, lower leg amputation, accident injury, life care amputee, leg A.F.O, Finger artificial, Back brace, cost analysis prosthetics

Legal Battles and Lifesavers: The Case for Expert Testimony Tom LeTourneau – Executive Summary 🧑‍⚕️ Professional Identity • Licensed Prosthetist & Orthotist (L.P.O., C.P.O., F.A.A.O.P.) with 40+ years of clinical, technical, and executive experience • CEO & Chief Practitioner of LeTourneau Lifelike Orthotics and Prosthetics, Inc., serving Texas and Louisiana • Nationally recognized innovator, clinician, and medical legal consultant 🏢 Leadership & Practice Management • Founded and expanded a multi office O&P practice to 13 locations, serving 5,000+ patients annually • Built one of the region’s most comprehensive prosthetic and orthotic service networks • Oversaw clinical operations, device design, manufacturing, billing, coding, and compliance • Developed strong referral networks with physicians, therapists, hospitals, and insurers 🛠️ Clinical & Technical Expertise • Advanced proficiency in: o Microprocessor knees, hips, and feet o Myoelectric upper extremity systems o High-perf...

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Shawn A Hayden, MD, PhD, MBA

Harvard Trained Orthopedic Spine/Trauma Surgeon

Shawn A. Hayden MD PA

Plano, Texas

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Bradley N Plank, PE

MME Forensic Consulting, Inc.

Dallas, Texas

Mechanical Engineering, Metallurgy - Product Liability, Failure Analysis, HVAC, Oilfield, Heavy Equipment, Cranes, Cables, Medical Devices, Plastics, Boilers, Water Heaters, Plumbing

Using his combination of mechanical and metallurgical (including plastics) experience and education, Mr. Plank provides forensic and consulting engineering services to attorneys, insurance professionals, and manufacturing companies. A registered engineer in Texas and 23 other states, his experience includes 32 years in manufacturing in the metals processing industries, 29 years performing failure analyses, and 26 years investigating claims. Mr. Plank has testified in a wide variety of matters including personal injury and property damage, in both state and federal court, and his testimony has never been excluded. Assignments have involved mechanical equipment, appliances, oil and gas transmission equipment, plumbing, HVAC, heavy equipment, machine tools, cranes and wire cables, manufacturing processes, and thermal processes, among many others.

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Brian Arenare, MD, MBA, MPH

Occupation Medicine Physician - Aeromedical Expert

SAME DAY RESPONSE : : Email -or- Call/Text

Houston , Texas

Occupational Medicine, Aviation & Aerospace - Aviation Medicine, Certification Standards, Aeromedical Transport, Aeronautical Decision Making, Travel Medicine, Worker Injury, Risk and Hazards, Human Factors and CRM, Cabin Environment, Pilot Crew Flight Attendant, Commercial Pilot, CFI AME FAA, Air Safety, DOT FMCSA, Public Health, Pharmaceutical Drugs, Medical Devices, Patents

Dr. Arenare brings a broad and in-depth background to expert witness work in aviation medicine and occupational injury evaluation and prevention, in the workplace and other settings. He is an experienced board-certified physician, consultant, and medical opinion leader. After graduating Yale Medical School, he completed residency training in general surgery, then practiced trauma surgery and emergency medicine, performing thousands of surgical operations and procedures. He also completed an MBA degree and provided medical, healthcare, and management consulting for a wide range of healthcare industry companies, regulatory agencies, and investors. He has advised and led strategic growth for several biopharma and medical device firms and served on the board of a public biotech company. He held a vital public health leadership role as the Director of Disease Control and Prevention for Harris County, Texas. Upon completing further preventive medicine residency training, with a focu...

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James E Alexander, Jr., MD

Specializes in Medicare Qui Tam False Claims Cases

Healthcare Compliance Management, LLC

Fort Worth, Texas

Medical Billing, Medical Coding - Qui Tam, Health Insurance Fraud, Health Insurance Abuse, Medicare, Medicare Fraud, Medicare Abuse, Medical Policy, Medical Necessity in Medicare, Medicare LCDs, Medicare NCDs, Medicare Coding, Medicare Billing, Health Insurance Coding, Upcoding, Medical Devices, New Medical Technology

Completed SEAK Expert Witness Training. Experience working on 4 large qui tam cases. Retired Captain (O-6) United States Navy. Board Certified General Surgeon. Partner in Healthcare Compliance Management, LLC, a consulting firm incorporated in Texas. Dr. Alexander and his partners established HCM in early 2002 and since that time he has been involved in numerous healthcare compliance consulting projects for major pharmaceutical and medical device manufacturers, large and small hospitals, cancer centers, large and small physician groups, other consulting entities as a special consultant, and legal firms (both as a consultant and as an expert witness).

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Peter Coderre, PhD

Antimicrobial Regulatory Consulting

Lovettsville, Virginia

Pharmaceutical Research, Infectious Diseases - pharmaceutical regulation, FDA, drug development, antimicrobials, antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, medical microbiology, biochemistry, molecular biology, food poisoning, data fraud, biological defense, dairy micro, IP

25 years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science. Initial employment in the Federal Government was with the Agricultural Research Service (ARS) performing genetic engineering of dairy bacteria. From there, he went to the Department of Defense, specifically Naval Surface Warfare Center (NSWC), working in chemical and biological warfare defense. Spent 12 years as a Clinical Microbiology reviewer in the Center of Drug Evaluation and Review (CDER) at FDA. He has extensive experience with FDA submissions including: pre-IND, IND, NDA, labeling supplements, and post-marketing for antibiotics, topical antiseptics, biologics and generic drugs. As an independent consultant, provided guidance on microbiology and regulatory affairs for clients developing antimicrobials, medical devices and biologics allowing clients to navigate through the FDA regulatory process. This guidance included providing advice for deve...

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Eugene Lipov, MD

Wisconsin

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