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, Failure Analysis, Intellectual Property, Mechanical Engineering, Patent, Product Liability, Biomechanics, Biomedical Engineering, FDA, FEA, Manufacturing, Medical Management, Nitinol, Patient Safety, and Ablation.

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

SCOTTSDALE, Arizona
Wound Care, Medical Management - 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 devices, 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 - 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. Bowley Inc.

California
Biomechanics, Medical Devices - Injury Causation Biomechanics & Personal Injury, Mechanical & Biomedical Engineering, Medical Devices, Accident Reconstruction, Criminal & Shooting Reconstruction, 3D Printed Replicas, 3D Animations & Illustrations, 3D Laser Scanning, Scene Surveys, Drone Aerial Mapping
Dr. Bowley started her own engineering consulting firm in 2008 and has been a testifying expert since 2006. Corporate offices are located in Maryland (HQ), Northern California, and Connecticut. Additionally, Dr. Bowley teaches Engineering courses at the local University. 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 Engineerin...

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...

Peter Crosby Biomedical Business Resources, LLC

Aliso Viejo, California
Biomedical Engineering, Intellectual Property - Medical devices, commercially reasonable efforts, patent, intellectual property, product liability, corporate governance, licensing, strategy, inter partes review, theft of intellectual property, trade secret misappropriation, product liability
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 River Sonic Solutions, LLC

San Francisco, California
Intellectual Property, Medical Devices - Imaging, Patent, Ultrasound, Electronics, Transducer, ASIC, MEMS, FDA, Signal Processing, Neuro modulation, Regulatory, Integrated Circuit, Semiconductors, Biometric security, Ablation, Tomography, Parallel Computing, Surgical Guidance, 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. Dr Daft has deposition and trial testimony experience including district court, ITC and PTAB matters. Extensive Intellectual Property experience including patent development, analysis, licensing, and litigation. Serial inventor who holds 26 U.S. Patents. 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. 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 Oxford University as well as Doctorate from Oxford in Materials...

Nic Gay, MD Silicon Valley Orthopaedics

Fremont, California
Orthopedic Surgery, Medical Devices - Total Knee Replacement, Total Hip Replacement, Robotic-Assisted Total Joint Replacement, Digital Therapeutics, Stem Cell Therapy, Cellular Therapeutics, Molecular Biology, Platelet Rich Plasma therapy, Immunomodulators
Have co-founded companies in orthopaedic surgery, ambulatory surgery centers, digital therapeutics, home healthcare, payor models and algorithmic healthcare. Have advised for companies in robotic-assisted surgery research and development. Have written algorithmic based treatment algorithms in machine code. Experience in bench research methods and protocols, quality assurance, inspection and federal requirements, legal and regulatory issues. Specific publication topics include: neuroblastoma, inflammatory cascades and wound healing properties in transgenic mice, liver failure support models, fetal wound healing, necrotizing enterocolitis, near-infrared spectroscopy, negative pressure therapy, growth factors, immunomodulators, hip fracture fixation, digital rehabilitation, artificial Intelligence, orthopaedic trauma, humerus fractures, ulnar nerve biology, ivc filter placement, deep vein thrombosis, limb threatening injuries, intramedullary fixation, thromboelastography, renal tumors,...

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

Granite Bay, California
Nursing Administration, General Surgery - 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...

Alexander R Marmureanu, MD UCLA

Hollywood, California
Cardiothoracic Surgery, Vascular Surgery - Cardiac Surgery, Thoracic Surgery, Vascular & Endovascular Surgery, Trauma Surgery, Minimally Invasive Cardiovascular Surgery, Cardiovascular Disease, Pulmonary Disease, Pulmonary Critical Care, VATS, Lung Cancer, Minimally Invasive Thoracic Surgery, Robotic Surgery, Medical Devices
CURRENT POSITIONS CEO & President, California Heart & Lung Surgery Medical Center Director Cardiothoracic Surgery St. Vincent Medical Center Los Angeles, CA Director Cardiothoracic Surgery Centinela Hospital Medical Center Inglewood, CA Director Cardiothoracic Surgery Southern California Center in Culver City Dr. Alexander Marmureanu is a prominent board certified thoracic and cardiovascular surgeon, with special expertise in the field of minimally invasive surgery where he pioneered and developed several techniques and procedures. In his 30 years of practice, he has been able to successfully treat some of the most complex and challenging heart and lung conditions with high rates of success. Dr. Marmureanu completed his General Surgery Residency and a Research Fellowship at New York University Medical Center (NYU) in New York City. He then continued his surgical training at Mount Sinai Medical Center in New York City, where he was actively involved in the field thoracic and cardi...

T. Kim Parnell, PhD, PE Parnell Engineering & Consulting (PEC)

Sunnyvale, California
Medical Devices, Intellectual Property - Mechanical Engineering, Forensic, 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,Equipment,Machinery,Food Processing,Personal Injury
T. Kim Parnell, PhD, PE is Principal & Founder of Parnell Engineering & Consulting (PEC). 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. He is an ASME Fellow, an IEEE Senior Member, and a Member of ASM and SAE. Dr. 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 - 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, HVAC, CPVC, Oil & Gas, Welding
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 ...

MEREDITH P VANDERBILT, JD, RAC, CQA, MSE, BSE Empirical Technologies

Colorado Springs, Colorado
Medical Devices, Orthopedic Surgery - 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. Bowley Inc.

Connecticut
Biomechanics, Medical Devices - Injury Causation Biomechanics & Personal Injury, Mechanical & Biomedical Engineering, Medical Devices, Accident Reconstruction, Criminal & Shooting Reconstruction, 3D Printed Replicas, 3D Animations & Illustrations, 3D Laser Scanning, Scene Surveys, Drone Aerial Mapping
Dr. Bowley started her own engineering consulting firm in 2008 and has been a testifying expert since 2006. Corporate offices are located in Maryland (HQ), Northern California, and Connecticut. Additionally, Dr. Bowley teaches Engineering courses at the local University. 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 Engineerin...

Steven B Levine, MD

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, hyposmia, ear plug litigation, TMJ, facial paralysis, otitis, CPAP
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 - 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 Hospital Experts

Cape Coral , Florida
Medical Management, Medical Devices - Hospital Administration, Hospital Liability, Joint Commission Standards, IRB Institutional Review Board, Medical Devices, daVinci Robot Credentialing, Operating Room, Informed Consent, Negligent Credentialing, Patient Safety, Environment of Care, Hospital Negligence
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 - 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 - 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...

Thomas Zizic, BS, MD

Tierra Verde, Florida
Rheumatology, Medical Devices - Corticosteroids, Avascular Necrosis Bone, Osteoporosis, Osteonecrosis, Systemic Lupus Erythematosus, Connective Tissue Diseases, Osteoarthritis, Arthritis, Vasculitis, Polymyositis, Immunology, Polymyalgia Rheumatica
Associate Professor of Medicine at Johns Hopkins University School of Medicine in Baltimore, MD for approximately twenty years. Major research in osteoarthritis, osteoporosis, osteoneerosis, systemic lupus erythematosus, polymyalgia rheumatica, polymyositis and a variety of other diseases that have an immunologic basis. Published approximately 100 articles and abstracts in peer reviewed journals as well as several dozen chapters in textbooks of medicine. Dr. Zizic has extensive experience as an invalidity and as a non-infringement expert in patent litigation. Research Office: 8415 Bellona Lane, Ste. 811, Towson, MD 20214

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.

William A Wells, MD Augusta ENT & Allergy

Evans, Georgia
Otolaryngology, Trauma Surgery - 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 - 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 ...

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

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

David C. Gross, PhD, PE 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
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 - 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...

Tim Kamerzell, MD, PhD

Overland Park, Kansas
Hospitalist, Internal Medicine - Hospital Medicine, General Internal Medicine, Telemedicine, Perioperative Medicine, Medical Devices, Pharmaceutical Research and Development, Pharmaceutical Regulation, Chemistry, Biochemistry,
Tim Kamerzell, MD, PhD is a board-certified Internal Medicine physician. He is an active Hospitalist and general practice primary care physician at HCA Midwest Health in Overland Park, KS. Dr. Kamerzell received his residency training in Internal Medicine at Washington University in St. Louis and The University of Kansas School of Medicine. He is a core faculty member of the Internal Medicine residency program at HCA Midwest Health and was previously the Associate Program Director of Internal Medicine. He currently serves in various leadership roles including the Vice Chair of the Department of Medicine for Overland Park Regional Medical Center, Physician Advisory Board Member and Facility Lead Physician for the Overland Park Market of HCA Healthcare, Inc. Dr. Kamerzell received a PhD in Pharmaceutical Chemistry from the University of Kansas and has extensive experience working in the pharmaceutical industry as a research scientist at Genentech, Inc. Dr. Kamerzell completed researc...

Michael Barr

Germantown, Maryland
Software Engineering, Cybersecurity - 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. Bowley Inc.

Gaithersburg, Maryland
Biomechanics, Medical Devices - Injury Causation Biomechanics & Personal Injury, Mechanical & Biomedical Engineering, Medical Devices, Accident Reconstruction, Criminal & Shooting Reconstruction, 3D Printed Replicas, 3D Animations & Illustrations, 3D Laser Scanning, Scene Surveys, Drone Aerial Mapping
Dr. Bowley started her own engineering consulting firm in 2008 and has been a testifying expert since 2006. Corporate offices are located in Maryland (HQ), Northern California, and Connecticut. Additionally, Dr. Bowley teaches Engineering courses at the local University. 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 Engineerin...

Vipul M Kella, MD, MBA FACEP Medlegal Advisors

Potomac, Maryland
Emergency Medicine, Long Term Care - 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, nursing home, opioids
Background: Dr. Kella is a board-certified emergency medicine physician who practices in the D.C area. In his eighteen years of practice, he has worked both clinically and as a hospital executive in large hospital systems. He currently practices in the Washington, D.C. area. Experience in hospital administration reviewing standards of care and implementing numerous quality of care and utilization programs. Board-certified in Emergency Medicine, and highly experienced expert witness, having reviewed over 200 cases and having testified in 4 depositions in the past 3 years. Retained in federal, criminal, and civil cases. Education/Training: University of Michigan (B.S.) University of Toledo (M.D.) Johns Hopkins University (MBA) Specialty: Emergency Medicine Areas of focus: Emergency Medicine Sepsis Wound care Cardiovascular Disease Infectious Diseases Stroke Hospital/Healthcare Administration Personal Injury Automobile Accidents Nursing Home Negligence COVID Fraud/Abu...

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

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

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

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 ...

Shawn A Hayden, MD, PhD, MBA Shawn A. Hayden MD PA

Massachusetts
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, 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...

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, inventor, failure analysis, surgical instrument, clip, aneurysm clip, stroke, ASTM, cable, strain relief, balloon, wire, EVAR

Ilonna J. Rimm, MD PhD CFA 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 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. 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
Dr. Rouzbeh R. Taghizadeh has dedicated more than 20 years to bringing stem cell-based therapies to clinical practice. His expertise in adult stem cells, primarily human hematopoietic and mesenchymal stem cells—the regenerative cells involved in successful bone marrow and umbilical cord blood transplantations—uniquely positions him to approach science and business with the same keen powers of insight that have consistently reaped success surmounting scientific and medical barriers in the field. He earned his Ph.D. in Stem Cell Bioengineering in 2006 from the Massachusetts Institute of Technology (MIT) and co-founded AuxoCell Laboratories, Inc. as Chief Scientific Officer in 2008 after completing his post-doctoral training from MIT and the Boston Biomedical Research Institute. At MIT, in the laboratory of Dr. James L. Sherley, Dr. Taghizadeh focused on developing novel technologies to preferentially expand human hematopoietic stem cells ex vivo, a long-standing challenge faced by b...

James M. Miller, PE, PhD 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 Equip, Fires/Explosions, HazCom, Human Factors, HVAC, Mechatronics/Nano, Medical Devices, OSHA, Recalls, RV/ATV, Slip/Fall, Vapes, Warnings/Label
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...

Shawn A Hayden, MD, PhD, MBA Shawn A. Hayden MD PA

Minnesota
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, 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...

Karl R Leinsing, PE ATech Designs, Inc.

Dover, New Hampshire
Medical Devices, Mechanical Engineering - 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, catheters, CPAP, pen injector, e-cigarettes, engineering
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.

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.

Gary D Fletcher, PhD 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...

Albert M. Juergens OST Corporation

Cresco, Pennsylvania
Medical Devices, Intellectual Property - 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...

William A Wells, MD Augusta ENT & Allergy

South Carolina
Otolaryngology, Trauma Surgery - 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 - 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...

James E Alexander, Jr., MD 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).

Gregory W Flolid, MBA Flolid Consulting LLC

Austin, Texas
Medical Devices, Intellectual Property - 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 - 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 - 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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