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, Failure Analysis, Product Liability, Biomedical Engineering, FDA, Mechanical Engineering, Patents, Biomechanics, Fraud, Manufacturing, Patent, Plastics, Cardiovascular Disease, and FEA.
Use the search box above to further refine your search for medical devices expert witnesses by keyword and state. Attorneys contact the experts directly – with no middleman.
Shishir Shah, DO, CWS, ABPM
Top Doctor Award Winning Wound Expert
SCOTTSDALE, Arizona
Wound Care, Medical Devices
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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 Medical School faculty. Significant private equity, medical device, 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/hyperbaric clinical de...
Morten O Jensen, PhD, DrMed
Jexpert LLC
Fayetteville, Arkansas
Medical Devices, Biomedical Engineering
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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 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 patent infringement. Dr. Jensen has been at trial and deposed several times 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 17 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 the FDA guidelines for designing certain medical devices. ...
Susan M Bowley, Ph.D.
Biomechanics, Medical Devices & Consumer Products
Bowley Inc.
California
Biomechanics, Medical Devices
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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 ...
Roberto Contreras II, MD, CLCP
California Life Care Planning Association
Seal Beach, California
Life Care Planning, Internal Medicine
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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...
Peter Crosby
Biomedical Business Resources, LLC
Aliso Viejo, California
Biomedical Engineering, Intellectual Property
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Medical devices, commercially reasonable efforts, patent, intellectual property, product liability, corporate governance, licensing, strategy, inter partes review, theft of intellectual property, trade secret misappropriation
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 serving as a member of the Board of three companies.
He is an inventor of over 50 issued US patents and applications 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, ...
Christopher M Daft, PhD
Patents, Trade Secrets and Medical Devices
River Sonic Solutions, LLC
San Francisco, California
Intellectual Property, Medical Devices
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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 14 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...
Jason C. Goodwin, RN, MS, MPH, CNOR
Procedural, CNOR, Pre / Post Op Director Expert
Granite Bay, California
Nursing Administration, General Surgery
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AAAHC Surveyor, Professor of Nursing at Sacramento City College, Operating Room Nurse, Ambulatory Surgery Nurse, Legal Nurse Consultant, Life Care Planning, Perioperative Services Administration, Post Anesthesia Nurse, Procedural Sedation Nurse, GI procedures RN, CNOR, RN, Med Surg, Medical Devices
Clinical Experiences include:
Medical Surgical Nursing
Shock / Trauma Intervention
Procedural Services
Preoperative, Intraoperative, and Postoperative Care
Procedural Sedation
Clinical Educator
Operational / Leadership Experiences include:
2003 Iraqi War Veteran
Multi-site surgical venues - UC Davis Medical Center, Kaiser Permanente
Level 1 Trauma academic medical center – UC Davis Medical Center
Military – Naval Hospital Camp Pendleton, Operation Iraqi Freedom
Fee for service ambulatory surgery and procedural services – ABSMC Surgery Center
Clinic management – Perioperative Medicine Clinic, Kaiser Permanente
-As a procedural department administrator and clinician, I have personally supervised the safe care in and around various procedures and operating room venues for 18 years, totaling approximately 300,000 individual patient encounters. As a Registered Nurse, Operating Room Manager, Director, and Administrator, I have extensive experience with reg...
Shawn A Hayden, MD, PhD, MBA
Shawn A. Hayden MD PA
California
Spine Surgery & Spine Care, Orthopedic Surgery
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Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Sports Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation
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.
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-tech, high quality care to his patients. For this reason, he is constantly training on some of the latest diagnostic an...
Alexander Marmureanu, MD
Cardiothoracic Surgeon - Faculty - Top Doctor 2024
UCLA
Los Angeles, California
Cardiothoracic Surgery, Vascular Surgery
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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
Current Positions:
President Elect, Chief of Staff – Hollywood Presbyterian Medical Center
Cardiothoracic Surgeon – Board Certified in Thoracic, Cardiovascular & General Surgery
President & CEO – California Heart & Lung Surgery Center
2024 Top Doctors, LA Magazine & Angeleno Magazine
Assistant Professor of Surgery – School of Medicine at California University of Science & Medicine
Director of Cardiothoracic Surgery – Centinela Hospital Medical Center
Director of Cardiothoracic Surgery – Southern California Hospital at Culver City
I currently practice Thoracic and Cardiovascular Surgery in Los Angeles, CA. I am Board Certified in Cardiothoracic Surgery and General Surgery and licensed to practice in the states of California and New York. I am also an Assistant Professor of Surgery and Member of the Bylaws Committee at the School of Medicine at California University of Science and Medicine. I have a very busy practice, performing over 300 procedures per year among 6 hospitals ...
Alison Marsden, PhD
Biomedical engineer - Stanford Faculty
Stanford University
Stanford, California
Biomedical Engineering, Medical Devices
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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...
T.Kim Parnell, PhD, PE
Parnell Expert Consulting
Sunnyvale, California
Medical Devices, Intellectual Property
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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 Expert 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).
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 are in the news. Products include stent, stent-grafts, AAA devices, IVC F...
Joseph Quinn, M.S., P.E.
Materials FACT
Los Angeles, California
Failure Analysis, Metallurgy
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Automobile, Aviation & Aerospace, Motorcycle, Appliance, Engineering, Construction, Construction Defects, Corrosion, Maritime, Equipment & Machinery, Mining, Bicycles, Transportation, Medical Devices, Manufacturing, Plumbing, Products Liability, Fire, Electricity, Pipe
Joseph Quinn, MS, PE, is a Forensic Metallurgy and Metallurgical Engineering consultant. He is a Licensed Professional Engineer in Metallurgical Engineering and is registered in 7 states (CA, PA, UT, NV, AZ, CO, WA). He has provided over 1,000 Failure Analysis investigations on metallic and non-metallic (glass, plastic, rubber, and composite) materials or products.
Mr. Quinn provides metallurgical and materials consultation, expert witness testimony, and forensic failure analysis for civil litigation with retentions by defendants and plaintiffs. He has received awards in the International Metallographic Contest and has conducted several presentations on metallurgical engineering and failure analysis subjects at universities, ASM meetings, and industry events. He is President of the National Society of Professional Engineers in California (NSPE-CA) and is active in several technical societies.
He has taught metallurgical engineering course topics in Principals and Applications of ...
Eric P. Rose, NPDP, MBA
Product Design & Manufacturing Expert
Pinnacle Product Innovation, Inc.
Tarzana, California
Engineering, Industrial Design
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Product Design, Product Development, Design For Manufacturing, Plastic Product Design, Personal Protective Equipment (PPE), N95 Mask, Earplug, Hearing Protection, Respiratory Protection, Dental Device, Medical Device, Toy, Consumer Product, Durable Medical Equipment (DME), Furniture, FMEA, ISO 900
◼ BACKGROUND:
35+ years' experience in product design, product development, manufacturing. Product innovation part-time academic since 2009.
Certified New Product Development Professional (NPDP) since 2008 by the Product Development and Management Association. Member of: Society of Plastics Engineers, American Society for Quality. Expert witness services to Product Liability, Intellectual Property (IP), and Commercial Dispute litigators.
◼ PLAINTIFF COUNSEL RETAINED:
Expert witness in 3M Combat Arms earplug case, retained by two plaintiff law firms. More at, https://bit.ly/3M-earplug-settlement Daubert ruling at, https://bit.ly/EPR-3MEP-Daubert (Page 98). Two depositions.
Expert Witness in furniture injury case, settled after my deposition. N95 mask commercial dispute case, report submitted 5/2024.
◼ DEFENSE COUNSEL RETAINED:
Furniture injury case. Review of the state of competitive product safety, mechanisms, warnings. Defense counsel represented major insurance company.
◼ P...
MEREDITH P VANDERBILT, JD, RAC, CQA, MSE, BSE
Empirical Technologies
Colorado Springs, Colorado
Medical Devices, Orthopedic Surgery
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Regulatory Affairs, Quality Management Systems, Medical Device Testing, Orthopedic Implant Testing, Spinal Implants, 510(k), Premarket Notification, Labeling, Medical Device Failures, Implants
Susan M Bowley, Ph.D.
Biomechanics, Medical Devices & Consumer Products
Bowley Inc.
Mansfield, Connecticut
Biomechanics, Medical Devices
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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 ...
Steven B Levine, MD
Milford, Connecticut
Otolaryngology, Allergy & Immunology
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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).
Macarthur Drake, Jr., M.D., M.S.
Miami Beach, Florida
Neuroradiology, Radiology
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Brain, head and neck, spine imaging, CT, CTA, MRI, MRA, Myelography, Diagnostic Radiology, Teleradiology, Mammography, Internal Medicine, Medical Devices, Biomedical Engineering, Mechanical Engineering
16 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.
Timothy Hawkins, FACHE
Experienced direct facility negligence expert
Hospital Experts
Cape Coral , Florida
Medical Management, Medical Devices
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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.
Shawn A Hayden, MD, PhD, MBA
Shawn A. Hayden MD PA
Florida
Spine Surgery & Spine Care, Orthopedic Surgery
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Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Sports Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation
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.
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-tech, high quality care to his patients. For this reason, he is constantly training on some of the latest diagnostic an...
Shaun L. Samuels, MD, FSIR
Miami, Florida
Interventional & Vascular Radiology, Medical Devices
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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...
Willa L Carter
CQG
Conyers, Georgia
Chemistry & Chemicals, Pharmaceutical Regulation
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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.
William A Wells, MD
Ear, Nose & Throat Expert Witness
Columbia Breathe Free Sinus & Allergy Center
Georgia
Otolaryngology, Trauma Surgery
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Sinus Surgery, Balloon Sinuplasty, Sleep Medicine, Cancer within the Head and Neck, Otology, Plastic Surgery within the Head and Neck, Pediatric Otolaryngology, Medical Devices, Endocrine Surgery, Thyroid and Parathyroid surgery, Allergy and Immunology, Audiology
Co-Investigator on multiple medical device clinical trials.
National and International speaker on minimally-invasive Rhinology treatments.
Medical Device Consultant; Chief Medical Officer
Glenda E Flemister, MD, FACP, FCCP
Medical Health Solutions.us
Frankfort, Illinois
Pulmonary Critical Care Medicine, Critical Care Medicine
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Medical Management, Medical Utilization & Location of Care, Fraud & Abuse, Compliance, Medical Necessity, Medical Devices, Pharmacy Management, Genomics & Personalized Health, Insurance Reviews of Plan Benefits, Insurance Clinical Policy Reviews, Long Term Acute Care & Long Term Care
Triple Board Certified physician executive/consultant, (Board Certified in Internal Medicine, Pulmonary Medicine, and Critical Care Medicine), with vast experience in medical necessity and utilization review. Over 12 years of experience in national insurance and payer companies. Has served as Medical Director for Aetna, Blue Cross Blue Shield Association, and interim CEO for Next Level Health Partners.
Consultation services to companies and manufactures in various areas, (pharmacy, genomics, medical devices, medical management, utilization, etc.), regarding healthcare medical necessity, compliance and educational issues. Fraud and Abuse. Government plans: Medicare & Medicaid. Private insurers all plans: HMO, PPO, Specialty networks. Expert reviews and medical litigation support performed. Sub-specialty medical reviews in Pulmonary and Critical Care Medicine.
Current license: Illinois; New Mexico; Oklahoma; Kentucky; New Mexico
...
Eugene Lipov, MD
Westmont, Illinois
Pain Management - Medicine, Medical Devices
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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...
J. Lawrence Stevens, RAC
FDA Medical Device Expert
ONE WAY CONSULTANTS. LLC, FDA Regulatory Experts
East Alton, Illinois
Medical Devices, Biomedical Engineering
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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 ...
Eric Anttila, PhD
Medical Device Expert Witness
MED Institute
West Lafayette, Indiana
Medical Devices, Intellectual Property
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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
Eric Anttila, PhD is the Team Lead 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 3.5 years as a medical device consultant, working on development and testing for a multitude of devices spanning many specialties.
David C. Gross, PhD, PE
Medical Device Expert Witness
MED Institute Inc.
West Lafayette, Indiana
Biomedical Engineering, Intellectual Property
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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 the Director of MRI Safety Evaluations and Engineering Simulations at MED Institute. 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.
Mari S Truman, MS, PE
OrthoBioMech LLC
Warsaw, Indiana
Biomechanics, Medical Devices
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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
38+ years orthopaedic device development
12 patents
Testified in State and Federal Courts , Injury Biomechanics and Medical Device Litigation
20+ trials
100+ depositions
38 years of experience in the biomechanics and orthopedics fields, 16 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...
Michael Barr
Bethesda, Maryland
Software Engineering, Electrical Engineering
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embedded systems, operating systems, computer software, automotive electronics, medical devices, industrial automation, computer security, software malfunction, programming languages, reverse engineering, source code review, software quality
Michael Barr is a former adjunct professor of computer engineering with more than twenty-five years of experience in the software industry, including over a decade spent developing software for embedded systems. Software he wrote has powered millions of products. Mr. Barr is the author of three books and more than seventy articles and papers about embedded software design and architecture and is internationally recognized as an expert in the field. He is also a founder of three companies, including Barr Group. In his work as a software expert witness, Mr. Barr has testified more than twenty times before judges and juries in matters ranging from patent infringement and validity to product liability to theft of copyrighted software and trade secrets. He has been qualified in U.S. and Canadian courts as an expert in computer software, electrical engineering, and satellite TV security and piracy.
Susan M Bowley, Ph.D.
Biomechanics, Medical Devices & Consumer Products
Bowley Inc.
Maryland
Biomechanics, Medical Devices
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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 ...
Gary Fischman, PhD, FACerS, FNICE
seasoned expert in materials science
Future Strategy Solutions
Gambrills, Maryland
Medical Devices, Products Liability
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ceramics, processing, zirconia, hard materials, coatings, device failures, medical ceramics, dental ceramics, medical device standards, properties of materials, FDA, IP, Patents
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. Dr. Fischman has breadth working in and with academia, industry and government.
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. Fischm...
Vipul M Kella, MD, MBA FACEP
Emergency and Hospital Administration Expert
Vipul Kella
Potomac, Maryland
Emergency Medicine, Hospital Administration
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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 matters. He is also a chief medical officer and experienced health tech expert retained for his experience with medical devices and products.
Board-certified in Emergency Medicine, and highly experienced expert witness, having reviewed over 400 cases and having testified 15 times in the past 2 years. R...
![Charlotte L. Kohler, [RN], CPA, CVA, CRCE-l, CPC, CHBC, CPCO Expert Witness](https://s3.amazonaws.com/seak_members/production/16559/normal/CKohler-Current_Pix-2015.jpg?1589416449 "Charlotte L. Kohler, [RN], CPA, CVA, CRCE-l, CPC, CHBC, CPCO Expert Witness")
Charlotte L. Kohler, [RN], CPA, CVA, CRCE-l, CPC, CHBC, CPCO
Kohler Healthcare Consulting, Inc.
Woodstock, Maryland
Investigation, Medical Management
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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
Alan Lipschultz, PE, CCE, CSP, CPPS, FACCE, FAAMI
Retained for >114 EXPERT Legal cases since 2012
Healthcare Technology Consulting LLC
North Bethesda, Maryland
Medical Devices, Products Liability
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Patient Safety, Biomedical Engineering, Clinical Engineering, Healthcare Technology, Medical Accident Investigation, Infusion Pumps, Defibrillators, Electrosurgical Units, Insulin Pumps, Joint Commission, Hospital 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...
Joshua Sharlin, PhD
SHARLIN CONSULTING
STEVENSVILLE, Maryland
Pharmaceutical Regulation, Medical Devices
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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 ...
Steven W Opolski, MS
Atlantic Engineering, Inc.
Ipswich, Massachusetts
Medical Devices, Engineering
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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
Ilonna J. Rimm, MD PhD CFA
Rimm Healthcare Capital Advisory LLC
Newton Center, Massachusetts
Financial, Pediatric Hematology Oncology
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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 can provide expert witness services related to valuation and financial analysis of Healthcare Companies, including Biotech, Medical Device, Healthcare Services and Life Science Tools companies.
Ilonna Rimm, MD PhD CFA, is a healthcare investor who provides strategic advice on raising early-stage capital. 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 can fully understand the biological science of an emerging company. Then she can organize and polish the science to present it in a way that is attractive to life science investors. 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 (IM...
Rouzbeh R. Taghizadeh, Ph.D.
Regenerative Medicine Expert - MIT Trained
Kendall Innovations
Cambridge, Massachusetts
Regenerative Medicine, Biomedical Engineering
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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...
Eugene Lipov, MD
Michigan
Pain Management - Medicine, Medical Devices
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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...
James M. Miller, PE, PhD
J.M. Miller Engineering, Inc.
Ann Arbor, Michigan
Safety, Agriculture Engineering
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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...
Mark D. Kraft, MD
Pain Medicine & Medical Devices Expert Witness
Advanced Pain Consultants
Las Vegas, Nevada
Pain Management - Medicine, Medical Devices
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Failed back, chronic pain, Complex Regional Pain Syndrome (CRPS), Practice guidelines and standards, Nerve Injury, Injections, Opioids, Addiction, Fraud, IME, Independent Medical examinations, patents, intellectual property, pharma, medical billing, pill mill, spinal cord stimulators, ablation
Fellowship trained pain physician. Experienced expert witness with excellent communication skills. Co-author of international pain practice guidelines. Active clinical practice after recovering from a disabling spine injury. Pharma and medical device experience. Inventor of a patented system and method for objectively verifying internal disc disruption. Former master instructor for International Spinal Injection Society.
Performs pain procedures including: Spinal cord stimulators, radio frequency ablations, stellate ganglion blocks, epidural injections, steroid injections, spinal nerve root injections, facet injections, and nerve blocks.
Licensed in Arizona, California, and Nevada
Karl R Leinsing, PE
ATech Designs, Inc.
Dover, New Hampshire
Medical Devices, Mechanical Engineering
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intravenous, IV, needle-free, heart valves, mitral valve, cardiovascular, FEA, nitinol, pumps, heart valve repair, sutures, stents, hernia, staplers, fasteners, plastics, polymers, textile, injector, syringes
Award winning nationally recognized medical device product development engineer. Experience in cardiovascular (AAA stents, mitral valve repair, heart remodeling, vascular assist devices), intravenous IV disposables & pumps, syringes, auto injectors, pen injectors, catheters, surgical instruments, minimally invasive instruments, e-cigarettes, CPAP, nebuliizers, RF endometrial ablation, Novasure, medical textiles, knitting, weaving, percutaneous devices, endoluminal devices, hernia repair, implants, animal studies, laparoscopic staplers, laparoscopic devices, medical grade plastics, polymers, manufacturing, prototypes, clinical studies, testing, FDA, GMP, and inspection.
Bruce Anneaux, PhD, MS, CP
Polymeric biomaterials and medical devices
Full Circle Biomedical
Boone, North Carolina
Medical Devices, Biomedical Engineering
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Bioabsorbable, Fluoropolymers, Expanded PTFE, Engineered polymers, Polymer processing, Extrusion, Polymer analysis, Vascular devices, Catheter-based, Cardiovascular pathophysiology, Luminal devices, Suture, Electrospinning, Endovascular, Encapsulation, Medical textiles, Perfusion
Dr. Bruce Anneaux is a highly respected, seasoned R&D leader and expert in biomaterials and medical device innovation. With a robust background in electrical engineering, automation, and robotics, he transitioned into the medical field, becoming a cardiovascular perfusionist and significantly impacting patient care through 5 years working alongside several CV surgeons in the Southeastern US.
Dr. Anneaux has over 80 patents and pending patents to his name, showcasing his expertise in biomaterials and bioprocessing. He has published numerous research papers and is a frequent speaker at industry conferences. His career spans over two decades, during which he has held strategic R&D advisory roles for established and startup companies.
From 2007 to 2018, Dr. Anneaux served as the Corporate Director of R&D for Zeus Industrial Products Inc. Recruited by Frank Tourville and John Worley, he was charged with transforming Zeus from a polymer extrusion service provider into a technology comp...
Shawn A Hayden, MD, PhD, MBA
Shawn A. Hayden MD PA
Ohio
Spine Surgery & Spine Care, Orthopedic Surgery
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Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Sports Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation
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.
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-tech, high quality care to his patients. For this reason, he is constantly training on some of the latest diagnostic an...
Jon Washington, BSME, MBA, PMP
Engineering, Design, Manufacturing & Patent Expert
The Innovation Garage, LLC
Clinton, Ohio
Engineering, Mechanical Engineering
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Automotive, Aerospace, Gaming, Casinos, Financial Self Service, Manufacturing, Design, Systems, Polymers, Plastics, Barriers, Security, Software, Metal Forming Processes, Patent Process, Business Process, Operations, Medical Devices, Supply Chain, Consumer Products
Jon Washington is currently Founder and Proprietor of The Innovation Garage, a company he has run since August 2012. The Innovation Garage is a consultancy that provides education, tools, technology, and expert consulting in change management for strategy, innovation, and supply chain.
The Innovation Garage works with organization leadership teams to help design strategy, build internal capability, and execute systems and solutions by providing education tools, and technology. The client base includes start up, not for profit, and globally recognized publicly traded organizations including several global fortune 500. Since founding the organization in 2012, The Innovation Garage has worked with 75+ global organizations and Mr. Washington has personally trained over 1,500 leaders and their extended internal team members.
In addition to his role at The Innovation Garage, Mr. Washington consults with organizations across many industries and sizes including start-ups, mid-market priva...
Shawn A Hayden, MD, PhD, MBA
Shawn A. Hayden MD PA
Oklahoma
Spine Surgery & Spine Care, Orthopedic Surgery
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Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Sports Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation
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.
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-tech, high quality care to his patients. For this reason, he is constantly training on some of the latest diagnostic an...
Boyle C. Cheng, PhD
Total Spine Solutions, Inc.
Mars, Pennsylvania
Medical Devices, Spine Surgery & Spine Care
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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.
Gary D Fletcher, PhD
Medical Device Bioengineering & Patent Litigation
RnDDx Solutions LLC
Media, Pennsylvania
Medical Devices, Biomedical Engineering
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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...
Albert M. Juergens
OST Corporation
Cresco, Pennsylvania
Medical Devices, Intellectual Property
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Patent Infringement, Inter-party review, Infringement contentions, Claim Construction, Medical hand tools, CMOS Camera, Endoscope, Electrosurgical Generator, Laser, Urological Stent, Stone Basket, Guide Wire, Cysto-resection, Lithotriptor, Ureteroscope
40+ years of experience in the development and market introduction of engineering intensive (hardware, software, mechanical, optical) products including multiple class II medical devices. -- Generated and defended expert reports on validity (IPR and district) and infringement. Prepared and delivered training material for presentation to judge. Worked closely with counsel on claim construction, infringement contentions, and rebuttal of invalidity reports. Prepared for hearings on motion for summary judgement. Prepared for trial with favorable settlement. -- Worked with counsel on the preparation of patent applications and responses to office actions. Conferenced with the patent examiner on prior art citations and claim amendment. -- Led multi-site R&D organizations of up to 40+ people & $8MM+ budgets. -- Brought diverse products to market including endoscopic and laparoscopic video cameras: urological wires, stents, and baskets; flexible, rigid, and semi-rigid scopes (conv...
Lawrence M Boyd, PhD
Medical Devices, Intellectual Property
Palmetto Biomedical
Columbia, South Carolina
Biomedical Engineering, Medical Devices
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Intellectual Property, FDA - Devices and Biologics, FDA Design Controls, Risk Management, Product Commercialization, Spinal Devices & Instruments, Regenerative Medicine, Sports Medicine Devices & Instruments, Foot & Ankle Devices & Instruments, Entrepreneurship and M&A
Lawrence Boyd is a Professor of the Practice in Bioengineering at Clemson University. He is President of Palmetto Biomedical Design & Consulting in Columbia, South Carolina (www.palmettobiomedical.com). He is an experienced business leader & entrepreneur, having founded two medical device-focused ventures (OrthoClip LLC and View Medical). He has over three decades of experience leading product development, engineering and business development efforts for medical device companies. He is a prolific inventor, with nearly 70 issued U.S. patents for medical devices and related procedures.
He was most recently the Chief Product Officer for restor3d, a start-up focused on 3-D printing and personalized orthopaedic implants based in Durham, North Carolina. Previously he was Vice President of Product Development for Bioventus, where he led engineering teams in Durham, Memphis and Los Angeles. Dr. Boyd has held product development leadership positions in multiple companies including S...
William A Wells, MD
Ear, Nose & Throat Expert Witness
Columbia Breathe Free Sinus & Allergy Center
Lexington, South Carolina
Otolaryngology, Trauma Surgery
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Sinus Surgery, Balloon Sinuplasty, Sleep Medicine, Cancer within the Head and Neck, Otology, Plastic Surgery within the Head and Neck, Pediatric Otolaryngology, Medical Devices, Endocrine Surgery, Thyroid and Parathyroid surgery, Allergy and Immunology, Audiology
Co-Investigator on multiple medical device clinical trials.
National and International speaker on minimally-invasive Rhinology treatments.
Medical Device Consultant; Chief Medical Officer
Troy D. Drewry, MSBE, MEM
Ragin Cajun Consulting, LLC
Memphis, Tennessee
Medical Devices, Biomedical Engineering
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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...
Eric S Heinz, MBA, MEM
MedTech Expert - 23 Years of Experience
Heinz Ventures, LLC
Memphis, Tennessee
Medical Devices, Marketing
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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...
James E Alexander, Jr., MD
Healthcare Compliance Management, LLC
Fort Worth, Texas
Medical Billing, Medical Coding
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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).
Gregory W Flolid, MBA
Flolid Consulting LLC
Austin, Texas
Medical Devices, Intellectual Property
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Infusion Pumps, Sleep Apnea, CPAP, Humidification, Oxygen Concentrators, Oxygen Conserving Devices, Breathe Detection, Electronic Cigarettes, Instrumentation, Sensing, Patent (IP) Cases, Product Liability Cases
Profile:
* Medical Device, Automotive and Industrial
product development experience since 1987.
* Granted 4 US patents
* Experience with patent cases since 2004.
Areas of expertise:
Peristaltic and Syringe Infusion Pumps, Sleep Apnea or CPAP Devices, Oxygen Concentrators, Oxygen Conserving Devices, Breathe Detection, Electronic Cigarettes, Sensing, Gas and Diesel Engine Control
Engineering experience:
Electrical engineering, System Engineering, Product Development Leadership, Manufacturing, Testing, Circuit Simulations, 6 Sigma Black Belt, Design Control, Risk Management, Failure Analysis, Technology Development
Primary Area of Expertise:
Medical Devices, Electronics
Shawn A Hayden, MD, PhD, MBA
Shawn A. Hayden MD PA
Plano, Texas
Spine Surgery & Spine Care, Orthopedic Surgery
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Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Sports Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation
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.
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-tech, high quality care to his patients. For this reason, he is constantly training on some of the latest diagnostic an...
Bradley N Plank, PE
MME Forensic Consulting, Inc.
Dallas, Texas
Mechanical Engineering, Metallurgy
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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.
Eric M. Simon, MEng
DEXTERITY INC.
SALT LAKE CTY, Utah
Medical Devices, Biomedical Engineering
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Product Design, Medical Devices, Laboratory Instruments, Materials Science, Failure Analysis, Plastics, Product Liability, Patent / IP, Dental, Surgical, Molding, Testing, Adhesives / Bonding, Cardiovascular, Orthopedic, Packaging, Enclosures, Drug Delivery, Optics / Glasses, Recreational Equipment
I have 38 years experience in the design, development, and production of medical devices, laboratory instruments, and other manufactured goods. My career as a consulting engineer and contract product designer, through my consultancy Dexterity Design, has provided me extensive experience in materials and biomedicine, primarily as applied to medical and biotechnical products. Additionally, I have experience with consumer, recreational, and industrial goods.
Specific expertise in biomaterials, mechanical design, diagnostic devices, and therapeutic tools. Award winning designer and developer of biomedical/biotechnical products and mechanical goods. Lecturer on product design and development. Experienced with FDA design controls and submissions. 27 yrs SolidWorks and CAD experience. 22 patents issued or pending; numerous products designed, produced, and marketed.
Expert witness in 13 cases (patent infringement, product liability, medical malpractice) with excellent outcomes. Prior lega...
Peter Coderre, PhD
Antimicrobial Regulatory Consulting
Lovettsville, Virginia
Pharmaceutical Research, Infectious Diseases
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pharmaceutical regulation, FDA, drug development, antimicrobials, antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, 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...
Guerry L Grune, PhD, PA
PhD ChE/Chem/ME/Reg Pat. Agent - Duke Faculty
Former IBM, Celanese, ABB, Mitsubishi Chemical, Linde, and Exponent
Virginia Beach, Virginia
Chemistry & Chemicals, Intellectual Property
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Fuels/Biofuels, Firearms, Energy, Electrophotography, Sunscreen, Nutraceuticals, Wind Turbines, Medical Devices, Oil/Gas Exploration, Patents/Valuation, Semiconductors, Encryption/Security, Toys/Games, Chem/Materials, Adhesives, Polymers, Wire/Cable, Radiation, Personal Care, Robotics
Guerry Grune, Ph.D., PA - Duke University Professor/Registered US Patent Agent
Dr. Grune is a chemical, mechanical, materials science engineer, and chemist with expertise in chemical, mechanical, electrical, and medical products. His combined experience includes assisting clients in the pursuit of intellectual property protection for the last 35+ years. His industrial expertise extends to extrusion and molding of thermoset and thermoplastics, rubbers, textiles, metals, lubricants, surfactants, emulsifiers, fiber optics and associated connecting peripherals, ceramics, liquid gases, and composite materials and systems. He has direct experience in chemical processes, formulation chemistries, polymers and composites, service life prediction, and risk analysis including risk reduction technologies.
His passion involves the development of food grade edible personal care products including sunscreen, food grade edible alternatives to petroleum-based products such as Vaseline® and Neospo...
Eugene Lipov, MD
Wisconsin
Pain Management - Medicine, Medical Devices
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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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