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, FDA, Intellectual Property, Medical Management, Biomedical Engineering, FEA, Imaging, Mechanical Engineering, Nitinol, Patent, Patient Safety, Product Liability, Wound Care, and Aaa.

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

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...

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
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 Chairman of the Board of four companies. He is an inventor of 39 issued US patents 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, clinical trials, regulatory approv...

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 including ITC and PTAB matters. Extensive Intellectual Property experience including patent development, analysis, licensing, and litigation. Serial inventor who holds 25 U.S. Patents with several pending. Diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung and Siemens as well as several start-ups. Well published. Winner of grants from National Institute of Health. 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 Mate...

Jason Goodwin, RN, MS, MPH, CNOR

Granite Bay, California
Nursing Administration, General Surgery - 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 17 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 ...

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...

Dori R Jones, MSE D Squared Consulting

Riverside, Connecticut
Medical Devices, Biomedical Engineering - Cardiac Devices, Heart Failure Devices, Cardiac Technology, Medical Device Engineering, Heart Assist Device, Left Ventricular Assist Device, Balloon Pump, Ultrafiltration, Heart Failure Diagnostic Devices, Implantable Devices, Mechanical Circulatory Support
Previous positions in medical devices include R&D Engineer, Mechanical/Quality Engineer, Field Clinical Engineer, Senior Field Clinical Engineer, Senior Clinical Education Manager, Senior Product Manager. Device experience includes extra-aortic balloon pump, left ventricular assist device (LVAD), neuromodulation device, fully implantable heart assist device, ultrafiltration device, and blood volume analysis device. Vast knowledge of mechanical circulatory support and implantable devices. Over 10 years in hospital setting including direct support in the Operating Room. Large network of clinicians including cardiac surgeons, cardiologists, nephrologists, intensivists, and nurses/nurse practitioners. Pending patent on blood filtration system (WO2020142533).

Susan E. Wozniak, MD, MBA, FAPWHc, FAIHM, CMD

Delaware
Wound Care, Nursing Homes - pressure ulcers, wound care, diabetic ulcers, burns, lymphedema, non-healing wounds, venous ulcer, geriatrics, long term care, pressure sores, hyperbaric medicine, skin injuries, surgical wounds, infections, neglect, causation, medical devices, telemedicine, bed sores, decubitus ulcers
Dr. Wozniak practices in post-acute care medicine & geriatric surgery. She has a special interest in wound care prevention, diagnosis and treatment. She maintains an active wound care clinical practice. She is published in peer reviewed medical journals and regularly presents at national and international wound conferences. She is Fellow-Certified from the Academy of Physicians in Wound Healing. She is a Certified Medical Director by the American Board of Post-Acute & Long-Term Care Medicine. She has reviewed many different wound related cases; the top 3 categories: 1. Facility acquired pressure injury, 2. Delayed wound diagnosis and management, 3. Wound causation & nursing home breaches in wound prevention protocols.

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.

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.

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...

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 ...

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...

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, Medicare fraud, hospital administration, mental health, aortic dissection, sexual assault, myocardial infarction, wound care, fractures, negligence, sepsis, wound care, trauma, cardiac arrest, brain hemorrhage, stroke, medical devices, aneurysm
Dr. Vipul Kella is a Board-Certified Emergency Medicine physician who has been practicing for 15 years and has served as a medical expert for 10 years. He has treated over 60,000- patients in rural, trauma, urban and academic emergency departments. He has over 10 years of experience as a hospital executive and expert witness. He has also consulted for healthcare systems and international companies on hospital safety, compliance, and regulatory standards. He has expertise in the following areas: Airway Emergencies Cardiac Arrest Cardiovascular Disease (myocardial infarction, aortic dissection) Drug Overdose Pulmonary Embolism Cerebrovascular Disease (stroke, aneurysms, brain hemorrhage Nursing Home and Assisted Living Care Medical Fraud and Abuse Sepsis Surgical Emergencies Automobile Injuries Mental Health Trauma Digital Health Dr. Kella provides patient care in the Adventist Healthcare system outside Washington DC.

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 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...

Steven D Silverman The Silverman Group

Silver Spring, Maryland
Medical Devices, Pharmaceutical Regulation - FDA, FDA expert, FDA regulatory, FDA medical device, FDA medical product expert, FDA medical product regulation, FDA medical device regulation, FDA compliance, FDA medical product compliance, FDA medical device quality, FDA warning letter, FDA enforcement, FDA consent decree, FDA quality system
Steve Silverman is an FDA regulatory expert with more than a decade in FDA leadership roles, including as the Director of the Office of Compliance in the medical-device center. Steve focuses on areas including post-market regulation, regulatory compliance and enforcement, medical device quality, and building effective business-regulator relationships. Steve is the President of The Silverman Group, a consultancy that serves medical product companies on regulatory, strategy, and policy issues. Before this, Steve worked as Vice President, Technology and Regulatory Affairs, with AdvaMed, the leading medical-device trade association. Steve focused there on device quality and compliance, pre-market approval, advertising and promotion, and combination products. Steve brings to these roles global consulting experience with McKinsey & Co. and a range of FDA leadership positions. At FDA, Steve directed the Center for Devices Office of Compliance, where he led device-quality initiatives, enga...

Susan E. Wozniak, MD, MBA, FAPWHc, FAIHM, CMD

Baltimore, Maryland
Wound Care, Nursing Homes - pressure ulcers, wound care, diabetic ulcers, burns, lymphedema, non-healing wounds, venous ulcer, geriatrics, long term care, pressure sores, hyperbaric medicine, skin injuries, surgical wounds, infections, neglect, causation, medical devices, telemedicine, bed sores, decubitus ulcers
Dr. Wozniak practices in post-acute care medicine & geriatric surgery. She has a special interest in wound care prevention, diagnosis and treatment. She maintains an active wound care clinical practice. She is published in peer reviewed medical journals and regularly presents at national and international wound conferences. She is Fellow-Certified from the Academy of Physicians in Wound Healing. She is a Certified Medical Director by the American Board of Post-Acute & Long-Term Care Medicine. She has reviewed many different wound related cases; the top 3 categories: 1. Facility acquired pressure injury, 2. Delayed wound diagnosis and management, 3. Wound causation & nursing home breaches in wound prevention protocols.

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

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

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.

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 ...

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...

Susan E. Wozniak, MD, MBA, FAPWHc, FAIHM, CMD

Pennsylvania
Wound Care, Nursing Homes - pressure ulcers, wound care, diabetic ulcers, burns, lymphedema, non-healing wounds, venous ulcer, geriatrics, long term care, pressure sores, hyperbaric medicine, skin injuries, surgical wounds, infections, neglect, causation, medical devices, telemedicine, bed sores, decubitus ulcers
Dr. Wozniak practices in post-acute care medicine & geriatric surgery. She has a special interest in wound care prevention, diagnosis and treatment. She maintains an active wound care clinical practice. She is published in peer reviewed medical journals and regularly presents at national and international wound conferences. She is Fellow-Certified from the Academy of Physicians in Wound Healing. She is a Certified Medical Director by the American Board of Post-Acute & Long-Term Care Medicine. She has reviewed many different wound related cases; the top 3 categories: 1. Facility acquired pressure injury, 2. Delayed wound diagnosis and management, 3. Wound causation & nursing home breaches in wound prevention protocols.

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

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.

Susan E. Wozniak, MD, MBA, FAPWHc, FAIHM, CMD

Texas
Wound Care, Nursing Homes - pressure ulcers, wound care, diabetic ulcers, burns, lymphedema, non-healing wounds, venous ulcer, geriatrics, long term care, pressure sores, hyperbaric medicine, skin injuries, surgical wounds, infections, neglect, causation, medical devices, telemedicine, bed sores, decubitus ulcers
Dr. Wozniak practices in post-acute care medicine & geriatric surgery. She has a special interest in wound care prevention, diagnosis and treatment. She maintains an active wound care clinical practice. She is published in peer reviewed medical journals and regularly presents at national and international wound conferences. She is Fellow-Certified from the Academy of Physicians in Wound Healing. She is a Certified Medical Director by the American Board of Post-Acute & Long-Term Care Medicine. She has reviewed many different wound related cases; the top 3 categories: 1. Facility acquired pressure injury, 2. Delayed wound diagnosis and management, 3. Wound causation & nursing home breaches in wound prevention protocols.

Joseph Dagher, Ph.D.

Falls Church, Virginia
Optics, Medical Devices - Imaging, Optics, Medical Imaging, Signal Image & Video Processing, Computer Vision, Magnetic Resonance Imaging, MRI, Image Quality, Data Compression, Cameras, Patents, Intellectual Property, Patent Disputes, Image Reconstruction Algorithms, Image Analysis Algorithms, Image forensics
— More than 20 years of R&D expertise in Image Science: Optical Systems, Sensors and Light Detection Systems, Image and Video Processing Systems and, Data Analysis Algorithms. Accelerated acquisition & compressive sensing methods. Computational Imaging. Joint optimization of acquisition and processing parameters. Inverse problems, Image Reconstruction and Parameter Estimation. — Broad experience with Medical Imaging Systems (Magnetic Resonance Imaging, PET, CT, X-rays), Consumer Cameras (cell phone ISPs, multi-aperture cameras, digital cameras), Scientific Imaging Devices (microscopes, Hyperspectral Cameras, Laser Radar, Acoustic Sensors, Neuromorphic Cameras, and so on), Warfare Technology (LIDAR, RADAR, Interferometric Telescopes) — Specific expertise with Signal and Image Processing Algorithms such as, Image and Video Compression, Computer Vision, Image Enhancement, Image forensics, Image Analysis, Machine Vision, Image Reconstruction, Image Quality, Inverse Problems, etc. — ...

Robert G Freid Contract Manufacturing Consultants, Inc.

Bothell, Washington
Manufacturing, Procurement/Purchasing - electronics, SMT, PCBA, circuit boards, contracts, agreements, EMS, contract manufacturing, NPI, quality defects, China, Southeast Asia, Mexico, IRS, transfer pricing, cost models, production, supply chain, unit demand forecast accuracy, medical devices, outsource, pricing, on-shoring, off-shoring
Mr. Freid is a manufacturing expert for the outsource of printed circuit board assemblies, mechanical modules and complete finished products. Since founding CMC in 1999, he has helped many leading OEMs create successful manufacturing outsource strategies, recommend most suitable and lowest risk suppliers, negotiate best pricing and contract terms, and plan for ramp-up transition. This work often includes assessment of client's unit volumes and mix, forecast accuracy, short/long term service requirements. Comprehensive due-diligence includes setting supplier selection process and criteria, identification of potential global contractor sites, on-site audits of supplier PCBA/SMT and finished product build assembly, test and burn-in/configuration processes, quality performance audits, materials and vendor control plus other important considerations. Besides outsource strategy, other key service areas include in-house vs. outsourcing analysis (make vs. buy) and contract manufacturer ...
You can also find Medical Devices Expert Witnesses in:
Maryland, Pennsylvania, California, Virginia, Tennessee, Texas, Florida, Arkansas, Connecticut, New Hampshire, Massachusetts, Illinois, and Indiana