Medical Devices Expert Witness Listings

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

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Morten O Jensen, PhD, DrMed Jexpert LLC

Fayetteville, Arkansas
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - Biomedical Engineering, Biomechanics, Medical Equipment, Heart Valve, Research, IP, Patent, Experimental Surgery, Medical Instrumentation, Prosthetic Device, Fracture, Device Fatigue, Blood Flow
Since 2016, Dr. Morten Jensen has participated as an expert witness in about ten cases, on both the plaintiff's and defendant's side. These cases have involved medical devices, including their failure modes, design issues, usage, and patent infringement. The involvement in several of the case have been disclosed to opposing counsel, and Dr. Jensen has been deposed and participated in on-site device interrogation. Dr. Jensen’s educational background is from top ranked universities at the interface of engineering and medicine. He has two decades of academic and industry experience in both Europe and the United States. He worked for six years for a global measurement, automation and instrumentation provider in the company’s consulting services department. He has also spent more than a decade as a faculty member at highly renowned universities in Europe and the United States, winning numerous prestigious awards for his work with research, teaching, and service. The results from his...

Susan M Bowley, Ph.D. Bowley Inc.

Sunnyvale, California
Biomechanics Expert Witness, Medical Devices Expert Witness - Injury Causation Biomechanics & Personal Injury, Slip Trip & Fall, Mechanical & Biomedical Engineering, Medical Devices, Accident Reconstruction, Product & Premises Liability, Criminal & Shooting Reconstruction, 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 Northern California (HQ), Connecticut, Hawaii, Vancouver BC Canada, and Birmingham England. Additionally, Dr. Bowley is an Associate Professor of Engineering and teaches Engineering courses at the local Universities and Community Colleges. 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 s...

Christopher M Daft, PhD River Sonic Solutions, LLC

San Francisco, California
Intellectual Property Expert Witness, Medical Devices Expert Witness - Imaging, Patent, Ultrasound, Electronics, Transducer, ASIC, MEMS, FDA, Signal Processing, DFSS, Regulatory, Integrated Circuit, Semiconductors, Biometric security, Ablation, Tomography, Parallel Computing, Minimally Invasive 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. Extensive Intellectual Property experience including patent development, analysis, licensing, and litigation. Serial inventor who holds 22 U.S. Patents with several pending. Completed more than 84 hours of SEAK Expert Witness Seminars, including patent-specific training. 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 Physi...

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

Sunnyvale, California
Medical Devices Expert Witness, Intellectual Property Expert Witness - Mechanical Engineering, Forensic, Medical Device, Nitinol, Biomedical, Patent, IP, Consumer Product, Failure Analysis, Fracture, Fatigue, Truck Rollover, Crashworthiness, Finite Element, FEA, Reliability, Smart Phone, Composite, Pressure Vessel, Piping, Equipment, \Machinery, Personal Injury, Food Processing
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 was 2011 Chair of the IEEE Santa Clara Valley Section (IEEE-SCV) (over 12,000 members) and Past-Chair/Board Member of the IEEE Consultants' Network (IEEE-CNSV). Dr. Parnell brings both breadth and depth of experience to clients. He has over 34 years of professional consulting experience, has taught both graduate and undergraduate University classes (Visiting Professor at Stanford University & Adjunct Professor at Santa Clara University), and has also worked in industry. His industrial positions include sectors such as software, hardware, medical devices, and telecommunications equipment. Dr.Parnell has ext...

John B. Slate, PhD Slate Engineering

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

Jared D Olson, MD Sage Arrow LLC

Boulder, Colorado
Brain Injury Medicine Expert Witness, Physical Medicine & Rehab Expert Witness - Traumatic Brain Injury, TBI, Mild TBI, Anoxic Brain Injury, Hypoxic Brain Injury, Stroke, Neurological Injury, Head Injury, disability and impairments, functional impairments, medical technology, medical devices
Board certified in Physical Medicine and Rehabilitation (Physiatry) and subspecialty board certified in Brain Injury Medicine with expertise across the spectrum of acquired brain injury and neurological injury. Expertise in the impact of disability related to brain injury, including cognitive deficits and mood/ behavior disorders on overall function and ability to work. Completed residency at the University of Washington and previously practiced at the University of Washington and Harborview Medical Center (Level 1 Trauma, Certified Stroke Center). Currently in clinical practice at an academic medical center and a non-profit hospital. Member of several professional societies relevant to disability and head injury, numerous publications and presentations. Brain Injury Medicine includes Traumatic Brain Injury (TBI), stroke, surgical complications, anoxic brain injury (ABI), and others. Engineering background with expertise in medical technology and devices.

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

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

Timothy Hawkins, FACHE Hospital Experts

Cape Coral , Florida
Medical Management Expert Witness, Medical Devices Expert Witness - 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.

Shaun L. Samuels, MD, FSIR

Miami, Florida
Vascular & Interventional Radiology Expert Witness, Medical Devices Expert Witness - 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, chemoembolization, r...

Glenda E Flemister, MD, FACP, FCCP Medical Health Solutions.us

Frankfort, Illinois
Pulmonary Critical Care Medicine Expert Witness, Critical Care Medicine Expert Witness - 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 ...

Dale Hallerberg, P.E. Active Alliance LLC

Lake Barrington, Illinois
Medical Devices Expert Witness, Equipment & Machinery Expert Witness - Underwriters Laboratories, risk management, usability, technical file, CE Marking, UL, testing, 60601-1, BSI
Professional Engineer in Illinois. Worked for Underwriters Laboratories (UL) for over 25 years. Experienced in safety evaluation of medical devices, specifically electrical medical products. Engaging teacher and presenter. Also knowledgeable in European requirements for electrical medical devices.

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

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

Mari S Truman, MS, PE OrthoBioMech LLC

Warsaw, Indiana
Biomechanics Expert Witness, Medical Devices Expert Witness - 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

Germantown, Maryland
Software Engineering Expert Witness, Electrical Engineering Expert Witness - 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 electrical engineering and computer science with many years of hands-on software design and implementation experience. Internationally recognized as an expert in the field of software process and architecture for safe and secure computing, Barr has been admitted as a testifying expert witness in U.S. and Canadian court cases involving issues of reverse engineering (including DMCA), interception of encrypted signals (Federal Communications Act), patent infringement, theft of copyrighted source code (including trade secrets issues), and product liability. Software written by Mr. Barr has powered millions of embedded devices. He is also the author of three books and more than seventy published articles and papers about software design. For more than a decade, he was a regular invited speaker at the Embedded Systems Conferences around the world and, at times, served as a member of the conference's advisory board and as chair for various tra...

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

North Bethesda, Maryland
Medical Devices Expert Witness, Products Liability Expert Witness - Patient Safety, Biomedical Engineering, Clinical Engineering, Healthcare Technology, Medical Accident Investigation, Infusion Pumps, Defibrillators, Electrosurgical Units, Insulin Pumps, Joint Commission, Hospital Safety, Patient Safety, Patient Monitoring
37 years of hospital experience as Director of Clinical Engineering at two major hospitals; Responsible for managing all of the medical devices at those institutions; including overseeing the preventative maintenance, repairs, and incident investigation; Active member of Patient Safety Committee, Environment of Care Committee, Technology Management Committee, & Medical Product Implementation Committee. Professional Engineer (PE); Certified in Clinical Engineering (CCE); Certified Safety Professional (CSP); & Certified Professional In Patient Safety (CPPS) Fellow, American College of Clinical Engineering (ACCE) 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). ECRI Institute – Health Devices Advisory Board (2007-2007). M...

Joshua Sharlin, PhD Sharlin Consulting

Stevensville, Maryland
Pharmaceutical Regulation Expert Witness, Medical Devices Expert Witness - FDA, FDA Compliance, FDA Regulations, FDA Software, FDA Drug Safety, FDA Warnings, FDA Drug Warnings FDA Medical Device Safety, Hip Implant Safety/FDA, Medical Device Safety/FDA, Drug Safety/FDA, Labels/FDA, Biologics Safety FDA, Implant Safety/FDA, 510(k)/FDA, NDA/FDA, IND/FDA
Joshua Sharlin applies his knowledge of science (PhD in physiology), insight about FDA compliance and regulatory affairs (former FDA reviewer), and statistical and data management experience to find errors and non-compliant activity committed by FDA-regulated companies and their outsourcing partners. He has testified and been deposed in cases about drugs and medical devices. Dr. Sharlin is skilled in analyzing technical and regulatory information to answer three questions: What did the company know and when did they know it? What should the company have known and when should they have known it? What should the company have done and when should they have done it? He is a skilled teacher. Over 50,000 people from hundreds of FDA regulated companies have attended his classes on over 40 technical and regulatory topics.

Thomas Zizic, BS, MD

Abingdon, Maryland
Rheumatology Expert Witness, Medical Devices Expert Witness - 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

Albert M. Juergens OST Corporation

Boylston, Massachusetts
Medical Devices Expert Witness, Intellectual Property Expert Witness - Patent Infringement, Claim Construction, CMOS Camera, Endoscope, Electrosurgical Generator, Laser, Urological Stent, Stone Basket, Guide Wire, Cysto-resection, Lithotriptor, Ureteroscope,
35+ years of experience in the development and market introduction of engineering intensive (hardware, software, mechanical, optical) products including multiple class II medical devices. -- Experienced in patent review, patent infringement assessment, patent portfolio management, patent prosecution, claim construction, and defense. -- 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 (conventional and digital); ESU generators and electrodes; surgical and aesthetic lasers. -- Participated in M&A activities on both the buying and selling side of transaction.

Steven W Opolski, MS Atlantic Engineering, Inc.

Ipswich, Massachusetts
Medical Devices Expert Witness, Engineering Expert Witness - Stent, Septal Occluder, Medical Devices, Vena Cava, Filter, heart, brain, colon, valve, mitral valve, finite element, FEA, AAA, disposables, nitinol, expert, percutaneous, inventor, failure analysis, surgical instrument, clip, aneurysm clip, stroke, ASTM, cable, strain relief, balloon, wire, EVAR

Christopher J Fairman, CPO Great Lakes Prosthetics & Orthotics

Ypsilanti, Michigan
Prosthetics Expert Witness, Medical Devices Expert Witness - Orthotics, Prosthetics, Orthopedic Appliances, Braces, Prosthetic Feet, Prosthetic Knees, Orthopedic Bracing, Spinal Orthotics, Upper Limb Orthotics, Lower Limb Orthotics, Lower Limb Prosthetics, Upper Limb Prosthetics
American Board for Certification in Prosthetics, Orthotics and Pedorthics, Board of Directors 2011- Present 2016- President of ABC Independent Practice Owner 2003 - Present Expert in Custom Prosthetics and Orthotics Mr. Fairman is a graduate of the University of Michigan in Cellular Molecular Biology and the Northwestern University Prosthetic and Orthotic Center. He currently serves on the ABC Board of Directors. He is a past President of the American Board for Certification. He currently volunteers as an examiner for the prosthetic certification exam team. He is a Co-owner of Great Lakes Prosthetics & Orthotics serving southern Michigan.

Ann Prewett, PhD

Bloomfield, Michigan
Medical Devices Expert Witness, Products Liability Expert Witness - product development, bone graft, orthopedic, vascular grafts, collagen, biomaterials, FMEA, FDA, CE Mark, Design Control, ISO13485, CAPA, biocompatibility testing, spine product, spine fusion, chemical analysis, polymer characterization, sterilization, ethylene oxide, wear debris, FMEA, 510k
PhD in Chemistry, with 28 years experience in medical device field. Invented and developed many successful medical products in cardiology, spine and orthopedics. Am a named inventor on many patents and have represented law firms both as an expert and fact witness in deposition and at trial leading to successful outcomes in major intellectual property patent cases. Am well-spoken and articulate and can provide convincing and credible testimony. I have authored/co-authored over 60 abstracts and published papers in fields spanning orthopedics, dentistry, cardiology, medical devices and spine. Creative problem solver that can contribute to strategic thinking and approach in legal cases. Key talent is analyzing scientific data and finding strengths or weaknesses in the methods, data and scientific approach. Strong testifier, not easily caught off guard. Have worked in all areas of product development from conception, design, design validation, design transfer, production and comm...

Karl R Leinsing, PE ATech Designs, Inc.

Dover, New Hampshire
Medical Devices Expert Witness, Engineering Expert Witness - intravenous, IV, SmartSite, needlefree, needleless, valves, mitral valve, finite element analysis, FEA, expert, disposables, AAA, nitinol, pumps, percutaneous, mitral valve repair, suture locker, stents, hernia, staplers, fasteners, plastics, polymers, inventor, failure analysis, knitting, textiles
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, surgical instruments, minimally invasive instruments, RF endometrial ablation, 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.

Ediuska V. Laurens, MS, Dr.Eng.

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

Tamanna Nahar, MD, MBA HDD Cardiovascular

Tenafly, New Jersey
Cardiovascular Disease Expert Witness, Preventive Medicine Expert Witness - Vascular/Interventional Cardiology, Cardiovascular Ultrasound, Preventive Medicine, Medical Management, Medical Devices
I am a board certified well rounded cardiologist with a broad range of skills spanning over 20 years. My experience has encompassed academic and clinical medicine with a focus on noninvasive as well as interventional cardiology at premier institutions. I have strong leadership skills, budgeting and revenue cycle management. I have been a Co-PI for Phase 2 and 3 clinical trials for Ultrasound Enhancing Agents and participated in clinical trials for various antihypertensive, lipid lowering, oral anticoagulant and heart failure drugs. In addition to serving as a Co-PI for Phase 3 trials for PFO/ASD device deployment trials. My expertise includes formulating and reviewing IRB protocols and serving on CRO committees. Available for Knowledge Consulting: expert witness, disability reviews, utilization review, remote imaging review, clinical content review, Cardiology 2nd opinions.

David H Darnel, CCE, JD MedProductsLaw, Inc.

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

Jeanine Maria Frumenti, DNP, RN, CLNC HOLISTIC LEADERSHIP CONSULTING, LLC

New York, New York
Emergency Medicine Expert Witness, Critical Care Medicine Expert Witness - Neurosurgery, Physical Medicine & Rehabilitation, Wound Management, Nurse Negligence, Psychiatry, Restraint Management, Pain Management, Family Medicine, Wrongful Death, Risk Management, Falls Management, Medical Devices.
Dr. Frumenti, is a experienced nurse with over 35+ years of Nursing experience; with 18 years as a Sr. Vice-President of Nursing/Patient Care Services in New York area Acute Academic, Level 1 Trauma Medical Center(s). As such, responsibilities included establishing Nursing Standards of Care, Leadership Development, Risk and Quality Management, Education & Competency of Staff and Regulatory Compliance. As a Healthcare Consultant, I assist healthcare organizations in interim management, regulatory compliance, policy development. As a Certified Legal Nurse Consultant and Expert Witness, my caseload consists medical malpractice, personal injury cases & Nursing Standards, serving plaintiff and defense attorneys. Areas of Expertise: •Nursing Standards of Care • Pressure Ulcer Management •Quality and Risk Management •Falls Prevention •Medical Device Safety •Hospital Policy and Procedure •Medication Safety •Nursing Informatics •Hospital Operations •.Regulatory Compliance.

Chris Meadows, MHA, FHRS, CCDS, CM Experts Teach, LLC

Charlotte, North Carolina
Medical Devices Expert Witness, Products Liability Expert Witness - Cardiac Implantable Electronic Device, Cardiac Device, Industry Employed Allied Professional (IEAP), Implantable Cardiac Monitor (ICM), Loop Recorder, Pacemaker, Defibrillator, Remote Monitoring, Magnetic Resonance Conditional Device, Marketing, Vendor Management, Healthcare Administration
Certified and experienced Allied Health Professional. Featured Curriculum Vitae Facts : Fellow of the Heart Rhythm Society, Certified Cardiac Device Specialist, and Certified Manager. The Fellow of the Heart Rhythm Society designation is awarded by the Heart Rhythm Society. Candidate eligibility requires an assessment of education and certification. The designation distinguishes health care professionals for their advanced training, certification, and specialization in the field of cardiac arrhythmia research and treatment. The Certified Cardiac Device Specialist designation is awarded by the International Board of Heart Rhythm Examiners in a joint effort with the National Board of Medical Examiners. Candidate eligibility requires demonstration of active involvement in the practice of heart rhythm management. The examination assesses knowledge of 1) basic science; 2) applied science and technology, and 3) technology, clinical practice, diagnosis, interpretation, and management of...

John D Jarrell, PhD, PE Materials Science Associates LLC

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

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

Memphis, Tennessee
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - Medical Device Mfg./Design Defects, Surgical Instruments, Spinal Instrumentation, Medical Implants, Medical Device Patents, Pedicle Screws, Bone Screws, Spinal Cages, Knee Replacement, Patents Medical Devices, Hip Replacement, Spinal Rods
With 20+ 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). 55 US Issued Patents to date 27 US Patent Applications pending 17 Foreign Issued Patents to date 33 Foreign Patent Applications pending His company, RCC, 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 device industry, a unique w...

James E Alexander, Jr., MD Healthcare Compliance Management, LLC

Fort Worth, Texas
Medical Billing Expert Witness, Medical Coding Expert Witness - 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 3 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 Expert Witness, Electronics Expert Witness - Infusion Pumps, Sleep Apnea, CPAP, Humidification, Oxygen Concentrators, Oxygen Conserving Devices, Breathe Detection, Power Circuit Design, 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, Power Circuit Design, Instrumentation, 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

David B. Francom, MS, PhD Applied Economics Consulting, LLC

Salt Lake City, Utah
Intellectual Property Expert Witness, Economics Expert Witness - Intellectual Property Damages, Lost Profits, Reasonable Royalties, Patents, Copyrights, Trademarks, Trade Secrets, Medical Devices, Food Science, Consumer Products, Healthcare, Technology
Dr. David Francom works with attorneys, businesses, inventors and innovators to provide expert economic analyses associated with intellectual property and complex litigation matters. He has served as economic expert on cases involving calculations of market share, demand, pricing, lost profit and reasonable royalty damages. Dr. Francom provides litigation support and expert witness services for a variety of industries including medical devices, healthcare, technology and food sciences. He has testified at deposition and in court regarding his methodologies, analyses and calculations. Prior to Applied Economics Consulting, Dr. Francom worked at the leading litigation service firms LECG and Campos & Stratis. Dr. Francom teaches economics to college students and has presented internationally on innovation methods. He is a qualified dispute arbitrator with FINRA (Financial Industry Regulatory Authority).
You can also find Medical Devices Expert Witnesses in:
California, New York, Tennessee, Michigan, Texas, Illinois, Florida, Rhode Island, Arkansas, Massachusetts, New Jersey, New Hampshire, Maryland, North Carolina, and Indiana