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, Biomedical Engineering - Biomedical Engineering, Medical Engineering, Biomechanics, Medical Equipment, Heart, Intellectual Property (IP), Patent, Patent Infringement, Inter Partes Review (IPR), Surgery, Medical Malpractice, Medical Instrument, Prosthetic Device, Medical Device, Blood, Medical Electronics, Device Failure
Dr. Jensen has participated as a successful expert witness in cases supporting both the plaintiff's and defendant's sides. These cases have involved medical devices and equipment, including their failure modes, design issues, usage, and patent infringement. Dr. Jensen has been at trial and deposed several times, and participated in on-site device interrogations. Dr. Jensen’s educational background is from top ranked universities at the interface of engineering and medicine. He has more than two decades of academic and industry experience in both Europe and the US. He worked for six years for a global measurement, automation and instrumentation provider in the company’s consulting services department. He has also spent more than a decade as a faculty member at highly renowned universities in Europe and the United States, winning numerous prestigious awards for his work with research, teaching, and service. The results from some of his work has been adopted by the FDA guidelines fo...
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Susan M Bowley, Ph.D. Bowley Inc.

California
Biomechanics, Medical Devices - 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...
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Roberto Contreras II, MD, CLCP California Life Care Planning Association

Huntington Beach, California
Life Care Planning, Internal Medicine - medical billing, life care planner, hospitalist, medical devices, medical management, medical coding, legal medicine, legal nurse consulting, nurse practitioner, obstetrics and gynecology, addiction medicine, family medicine, general practice, gynecology, consultative examinations
The California Life Care Planning Association was created by experts in the field of Life Care Planning, with more than 30 years of experience working in the health care industry. All of our professionals are Certified Life Care Planners, as well as active medical practitioners dedicated to assessing lifetime cost of care for individuals with catastrophic injuries/illness. What sets us apart from many other Life Care Planning organizations and individuals is that all of our Life Care Planners have active direct experience with patient care. We hold ourselves to a higher standard and hold all of our affiliates to that same higher standard. Whether it be plaintiff, defense , or any other client, our methodology is transparent and consistent. Given the healthcare backgrounds of our founders, all Life Care Plans and services are overseen by a Physician. Similar to a hospital setting, many of our services go through "rounding" with senior partners and physicians to make sure we are keep...
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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, 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 25 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...
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Jason Goodwin, RN, MSN, MPH, CNOR, CPAN Innovative Cultures Consulting

Granite Bay, California
Nursing Administration, General Surgery - Ambulatory Surgery, Legal Nurse Consultant, Emergency Preparedness, Life Care Planning, Medical Management, Medical Devices, Medical Legal Evaluation, Nurse, Orthopedic Surgery, Pain Procedures, Pediatric Surgery, Plastic Surgery, Trauma Surgery, Public Health, Sedation,
Oversight Experiences include: - Multi-site surgical venues - UC Davis Medical Center, Kaiser Permanente - Level 1 Trauma academic medical center – UC Davis Medical Center - Military health care – Naval Hospital Camp Pendleton, Operation Iraqi Freedom - Fee for service ambulatory surgery and procedural services – Alta Bates Summit Surgery Center - Clinic management – Perioperative Medicine Clinic, Kaiser Permanente San Francisco I am an accomplished senior healthcare executive. As an administrator, I have personally supervised the safe care in and around various procedures and operating room venues for 15 years, totaling approximately 250,000 individual patient encounters. As a Registered Nurse, Operating Room Manager, Director, and Administrator I have extensive experience with regulatory mandates, expertise in national clinical standards, and ensuring best practices in procedural safety culture. I have expertise in: Surgical Standard of Care, Adverse Quality & Safety eve...
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Morten O Jensen, PhD, DrMed Jexpert LLC

Fayetteville, Arkansas
Medical Devices, Biomedical Engineering - Biomedical Engineering, Medical Engineering, Biomechanics, Medical Equipment, Heart, Intellectual Property (IP), Patent, Patent Infringement, Inter Partes Review (IPR), Surgery, Medical Malpractice, Medical Instrument, Prosthetic Device, Medical Device, Blood, Medical Electronics, Device Failure
Dr. Jensen has participated as a successful expert witness in cases supporting both the plaintiff's and defendant's sides. These cases have involved medical devices and equipment, including their failure modes, design issues, usage, and patent infringement. Dr. Jensen has been at trial and deposed several times, and participated in on-site device interrogations. Dr. Jensen’s educational background is from top ranked universities at the interface of engineering and medicine. He has more than two decades of academic and industry experience in both Europe and the US. He worked for six years for a global measurement, automation and instrumentation provider in the company’s consulting services department. He has also spent more than a decade as a faculty member at highly renowned universities in Europe and the United States, winning numerous prestigious awards for his work with research, teaching, and service. The results from some of his work has been adopted by the FDA guidelines fo...
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Susan M Bowley, Ph.D. Bowley Inc.

California
Biomechanics, Medical Devices - 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...
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Roberto Contreras II, MD, CLCP California Life Care Planning Association

Huntington Beach, California
Life Care Planning, Internal Medicine - medical billing, life care planner, hospitalist, medical devices, medical management, medical coding, legal medicine, legal nurse consulting, nurse practitioner, obstetrics and gynecology, addiction medicine, family medicine, general practice, gynecology, consultative examinations
The California Life Care Planning Association was created by experts in the field of Life Care Planning, with more than 30 years of experience working in the health care industry. All of our professionals are Certified Life Care Planners, as well as active medical practitioners dedicated to assessing lifetime cost of care for individuals with catastrophic injuries/illness. What sets us apart from many other Life Care Planning organizations and individuals is that all of our Life Care Planners have active direct experience with patient care. We hold ourselves to a higher standard and hold all of our affiliates to that same higher standard. Whether it be plaintiff, defense , or any other client, our methodology is transparent and consistent. Given the healthcare backgrounds of our founders, all Life Care Plans and services are overseen by a Physician. Similar to a hospital setting, many of our services go through "rounding" with senior partners and physicians to make sure we are keep...
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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, 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 25 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...
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Jason Goodwin, RN, MSN, MPH, CNOR, CPAN Innovative Cultures Consulting

Granite Bay, California
Nursing Administration, General Surgery - Ambulatory Surgery, Legal Nurse Consultant, Emergency Preparedness, Life Care Planning, Medical Management, Medical Devices, Medical Legal Evaluation, Nurse, Orthopedic Surgery, Pain Procedures, Pediatric Surgery, Plastic Surgery, Trauma Surgery, Public Health, Sedation,
Oversight Experiences include: - Multi-site surgical venues - UC Davis Medical Center, Kaiser Permanente - Level 1 Trauma academic medical center – UC Davis Medical Center - Military health care – Naval Hospital Camp Pendleton, Operation Iraqi Freedom - Fee for service ambulatory surgery and procedural services – Alta Bates Summit Surgery Center - Clinic management – Perioperative Medicine Clinic, Kaiser Permanente San Francisco I am an accomplished senior healthcare executive. As an administrator, I have personally supervised the safe care in and around various procedures and operating room venues for 15 years, totaling approximately 250,000 individual patient encounters. As a Registered Nurse, Operating Room Manager, Director, and Administrator I have extensive experience with regulatory mandates, expertise in national clinical standards, and ensuring best practices in procedural safety culture. I have expertise in: Surgical Standard of Care, Adverse Quality & Safety eve...
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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,MDL,Mesh,IVC, Composite,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 12,000 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 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 and adjudicated in MDLs.  Products include IVC Filters (Inferio...
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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 5 states (CA, PA, UT, NV, AZ). 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 has taught metallurgical engineering course topics in Principals and Applications of Steel Alloy Design at the University of Pittsburgh School of Engineering. He was awarded outstanding graduate, presidents’ list, graduate with di...
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Susan M Bowley, Ph.D. Bowley Inc.

Connecticut
Biomechanics, Medical Devices - 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...
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Tom Wilson, MSME TGWilson Consulting LLC

Guilford, Connecticut
Biomedical Engineering, Medical Devices - Orthopedics, Allograft, Spine, Biomechanics, Failure Analysis, Testing, Clinical Studies, Design Controls, FDA, ISO, Manufacturing, Intellectual Property
Tom is an engineering professional with 30 years of experience in the medical device industry with a focus in orthopedics. Legal services include consulting, analysis and expert witness support in product lability and intellectual property matters. He has held engineering and leadership positions in hip, knee, spine, allograft and craniomaxillofacial sectors in start-up to large size companies with direct involvement in all facets of business from concept to commercialization. He served as Vice President of Research & Development at a spinal device start-up where he and his team grew the portfolio into a full-line offering. Tom founded TGWilson Consulting LLC in 2019 to provide engineering, business development and legal services to the industry. He has extensive field experience with surgeons, OR staff and sales personnel making technical calls and covering surgical cases. Tom also has clinical study experience in the US and abroad including study design, regulatory submissions, en...
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Macarthur Drake, Jr., M.D., M.S.

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

Miami, Florida
Vascular & Interventional 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, chemoembolization, r...
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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 ...
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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 ...
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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...
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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.
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Susan M Bowley, Ph.D. Bowley Inc.

Gaithersburg, Maryland
Biomechanics, Medical Devices - 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...
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Susan M Bowley, Ph.D. Bowley Inc.

Gaithersburg, Maryland
Biomechanics, Medical Devices - 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...
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Charlotte L. Kohler, [RN], CPA, CVA, CRCE-l, CPC, CHBC, CPCO Kohler Healthcare Consulting, Inc.

Woodstock, Maryland
Investigation - 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
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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...
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Joshua Sharlin, PhD SHARLIN CONSULTING

STEVENSVILLE, Maryland
Pharmaceutical Regulation, Medical Devices - FDA, FDA expert FDA Compliance, FDA Regulations, FDA MAUDE , FDA Drug Safety, FDA Warnings, FDA Drug Warnings FDA Medical Device expert, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability
Dr. Sharlin’s experience: My key skill is identifying and developing facts supporting a legal strategy. (1) Drug reviewer at FDA. (2) Expert witness experience: Cases-37, Expert reports-16, Depositions-8, Testimony-1, Successful Daubert challenges-0. (3) Professional experience: Regulatory consultant (25 years), expert witness (10 years). (4) My cases have involved drug and medical device death and injury, patents, mergers, trade secrets, business interruption insurance, product labeling. (5) My skills: biological scientist, statistician, software developer, data integrity specialist, technical writer, educator, and FDA regulatory expert. (6) Talented technical writer, my writing experience includes:  Expert reports, scientific publications, audit reports for FDA compliance, standard operating procedures, FDA submissions, responses to questions from FDA. (7) I write custom software for data mining of safety information from FDA’s adverse event databases:  I extract f...
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Thomas Zizic, BS, MD

Abingdon, Maryland
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
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Albert M. Juergens OST Corporation

Boylston, Massachusetts
Medical Devices, Intellectual Property - Patent Infringement, Claim Construction, Inter-party review, 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. -- Worked closely with counsel on claim construction, infringement contentions, and rebuttal of invalidity reports. Drafted expert reports and rebuttals to opposing expert reports. Deposed twice on claim construction and expert reports. Advised counsel on response to interparty review. 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-r...
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Steven W Opolski, MS Atlantic Engineering, Inc.

Ipswich, Massachusetts
Medical Devices, Engineering - Stent, Septal Occluder, Medical Devices, Vena Cava, Filter, heart, brain,colon, valve, mitral 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
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Ann Prewett, PhD

Bloomfield, Michigan
Medical Devices, Products Liability - medical device, implant,bone graft,orthopedic, vascular grafts, collagen, biomaterials, hydrogels,FMEA,FDA, CE Mark, Design Control, ISO13485: CAPA, biocompatibility testing, spine, spine fusion, chemical analysis, chemical characterization, sterilization, ethylene oxide, wear debris, 510k
Medical device expert with PhD in Chemistry and 28 years experience. Invented and developed many successful medical products in cardiology, spine and orthopedics. Am named inventor on many patents and have represented law firms both as an expert and fact witness in deposition and at trial for product liability and patent cases. Authored/co-authored over 60 abstracts and published papers in fields spanning orthopedics, dentistry, cardiology, medical devices and spine. Have worked in all areas of product development from conception, design, design validation, design transfer, production and commercialization. Responsibilities included preclinical safety, chemical analysis, residual testing, biocompatibility ISO 10993, static/ fatigue biomechanical testing. Invented and commercialized an FDA, 510k cleared product. Invented and launched minimally invasive spine products sold in Europe under CE Mark. Wrote Clinical Evaluation Reports and biological safety for EU MDR 2017/745. Recer...
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Karl R Leinsing, PE ATech Designs, Inc.

Dover, New Hampshire
Medical Devices, Engineering - intravenous, IV, needlefree, valves, mitral valve, cardiovascular, FEA, expert, disposables, AAA, nitinol, pumps, percutaneous, mitral valve repair, sutures, stents, hernia, staplers, fasteners, plastics, polymers, inventor, failure analysis, knitting, textile, injector, syringes, catheters, CPAP
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.
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Tamanna Nahar, MD, MBA, FACC, FASE

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

New Jersey
Medical Devices, Products Liability - medical device, implant,bone graft,orthopedic, vascular grafts, collagen, biomaterials, hydrogels,FMEA,FDA, CE Mark, Design Control, ISO13485: CAPA, biocompatibility testing, spine, spine fusion, chemical analysis, chemical characterization, sterilization, ethylene oxide, wear debris, 510k
Medical device expert with PhD in Chemistry and 28 years experience. Invented and developed many successful medical products in cardiology, spine and orthopedics. Am named inventor on many patents and have represented law firms both as an expert and fact witness in deposition and at trial for product liability and patent cases. Authored/co-authored over 60 abstracts and published papers in fields spanning orthopedics, dentistry, cardiology, medical devices and spine. Have worked in all areas of product development from conception, design, design validation, design transfer, production and commercialization. Responsibilities included preclinical safety, chemical analysis, residual testing, biocompatibility ISO 10993, static/ fatigue biomechanical testing. Invented and commercialized an FDA, 510k cleared product. Invented and launched minimally invasive spine products sold in Europe under CE Mark. Wrote Clinical Evaluation Reports and biological safety for EU MDR 2017/745. Recer...
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Gary D Fletcher, PhD RnDDx Solutions LLC

Media, Pennsylvania
Medical Devices, Biomedical Engineering - New Product Development, Clinical in vitro diagnostics, Blood collection and separation, Point of care testing, Microfluidics, Spectroscopy, Cell therapy, Intellectual Property, Microscopy, Physics, Biomedical sensing, Optics and imaging,
Yale educated PhD Physicist with 29 years experience in medical devices, diagnostics, and biomedical engineering. Expertise in product development, in vitro diagnostics, point of care testing, blood collection, separation, and sample preparation, optics, sensors, infrared, optical, & X-ray spectroscopy & imaging instrumentation for measurements of physical, chemical, & biological material properties. Expert Witness in patent infringement cases involving blood collection, separation, fluidic preparation, and cell therapy preparation devices. IP experience - patent development, IP strategy and analysis, due diligence, implementing IP portfolio for startup new technology company, in-licensing and out-licensing agreements. Inventor on 11 US patents. R&D leadership expertise in both large company [Becton Dickinson] and multiple startup product development teams. o Startup medical device leadership generated $55M in angel investment o Contract R&D team developed & spun-off new painle...
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Frank L Brown, Jr, MD, FACP, FRSM, FCP American Academy of Communications, a subsidiary of The Howard Yale Company

Bluffton, South Carolina
Medical Management, Medical Devices - Patentee, Patents, Inventor, Medical Innovator, Medical Devices, Intellectual Property, Credentialing/Privileging, Peer Review, Healthcare Quality, Physician Performance Management, Value-Based Care, Clinical Mergers & Acquisitions, Dosing Errors, and Healthcare Fraud.
As a Physician Executive with current licensure in Kentucky, North Carolina, Pennsylvania, and Virginia, I currently serve as the Senior Medical Correspondent for station WVGB-FM in Beaufort, South Carolina. In my correspondent capacity, I host daily coronavirus updates, weekly interview programs, and periodic Coronavirus Townhall presentations. With over 35 years of experience in the national health insurance industry, my areas of expertise include: (1) Value-based care (>10 ACO's managed); (2) Appeals (> 500 including face-to-face customer interviews); (3) Boards of directorship representation (AHA, NMSS, United Way); (4) Clinical Mergers and Acquisitions (Oxford/Oaktree, Anthem/Trigon}; (5) Commercial acting representing Cigna (ATL, LA, NY, Philadelphia markets); (6) Executive leadership (CHIE designation, Vice President, Sr. Medical Director); (7) Fraud & abuse (>100 cases); (8) Medical necessity review (>50,000 chart reviews); (9) Peer Review; (10) Medical innovat...
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Troy D. Drewry, MSBE, MEM Ragin Cajun Consulting, LLC

Memphis, Tennessee
Medical Devices, Biomedical Engineering - Medical Device Mfg./Design Defects, Surgical Instruments, Spinal Instrumentation, Medical Implants, Medical Device Patents, Pedicle Screws, Bone Screws, Spinal Cages, Knee Replacement, Patents Medical Devices, Hip Replacement, Spinal Rods
With 25+ years of design and development experience, Troy Drewry provides forensic engineering, litigation consulting and expert witness testimony regarding medical devices, including biomechanical devices and orthopedic implants and instrumentation, in cases involving FDA and regulatory processes, failure analysis, product liability, medical malpractice, and intellectual property, including trade secrets. He has hands-on experience in medical device companies, from startups to large corporations and knows their environments, constraints, issues, and concerns. He is ranked 17th out of the Top 100 Spinal Device Inventors (1971-2003). 62 US Issued Patents to date 27 US Patent Applications pending 17 Foreign Issued Patents to date 33 Foreign Patent Applications pending His company, Ragin Cajun Consulting LLC, is a product development consulting firm helping innovators and inventors take their ideas from concept to commercialization. He has a breadth of knowledge in the medical devi...
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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 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).
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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
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Bradley N Plank, PE MME Forensic Consulting, Inc.

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