Medical Devices Expert Witnesses

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...

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...

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...

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...

Nursing Administration, General Surgery - AAAHC Surveyor, Professor of Nursing at Sacramento City College, Operating Room Nurse, Ambulatory Surgery Nurse, Legal Nurse Consultant, Life Care Planning, Perioperative Services Administration, Post Anesthesia Nurse, Procedural Sedation Nurse, GI procedures RN, CNOR, RN, Med Surg, Medical Devices

Clinical Experiences include:  Medical Surgical Nursing  Shock / Trauma Intervention  Procedural Services  Preoperative, Intraoperative, and Postoperative Care  Procedural Sedation  Clinical Educator Operational / Leadership Experiences include:  2003 Iraqi War Veteran  Multi-site surgical venues - UC Davis Medical Center, Kaiser Permanente  Level 1 Trauma academic medical center – UC Davis Medical Center  Military – Naval Hospital Camp Pendleton, Operation Iraqi Freedom  Fee for service ambulatory surgery and procedural services – ABSMC Surgery Center  Clinic management – Perioperative Medicine Clinic, Kaiser Permanente -As a procedural department administrator and clinician, I have personally supervised the safe care in and around various procedures and operating room venues for 18 years, totaling approximately 300,000 individual patient encounters. As a Registered Nurse, Operating Room Manager, Director, and Administrator, I have extensive experience with reg...

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...

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 ...

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...

Otolaryngology, Allergy & Immunology - Audiology, Ear, Ear Nose & Throat, ENT, Delayed Diagnosis Causation, Hearing, Hearing Loss, Vertigo, Dizziness, Otology, Sleep Apnea, Snoring, Tinnitus, patent, medical devices, intellectual property, voice, loss of smell, anosmia, hyposmia, ear plug litigation, TMJ, Facial Paralysis, Otitis, CPAP

Award-winning board-certified Otolaryngologist-Head & Neck Surgeon (Ear, Nose & Throat). Former Yale, Cornell and Penn faculty. Medical degree from University of Rochester and residency at University of Pennsylvania. National and international invited speaker with publications related to hearing, sinus, allergy and throat disorders. Patent holder in hearing diagnostic device. Castle Connolly Top Doctor for 19 consecutive years. Leadership positions at state and national medical societies. Experienced expert witness (both deposition and trial).

Neuroradiology, Radiology - Brain, head and neck, spine imaging, CT, CTA, MRI, MRA, Myelography, Diagnostic Radiology, Teleradiology, Mammography, Internal Medicine, Medical Devices, Biomedical Engineering, Mechanical Engineering

16 Medical Licenses including FL, CA, NY, OH, IL. Neuroradiology Fellowship Trained & Board Certified. Neuroradiology lecturer. Diplomat, American Board of Radiology. Former NASA Engineering Intern. Former GE Aircraft Engineering Intern.

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.

Otolaryngology, Trauma Surgery - Sinus Surgery, Balloon Sinuplasty, Sleep Medicine, Cancer within the Head and Neck, Otology, Plastic Surgery within the Head and Neck, Pediatric Otolaryngology, Medical Devices, Endocrine Surgery, Thyroid and Parathyroid surgery, Allergy and Immunology, Audiology

Co-Investigator on multiple medical device clinical trials. National and International speaker on minimally-invasive Rhinology treatments. Medical Device Consultant; Chief Medical Officer

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 ...

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 ...

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.

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...

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.

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

Spine Surgery & Spine Care, Orthopedic Surgery - Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Sports Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation

Member Phi Kappa Phi Honor Society

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

Regenerative Medicine, Biomedical Engineering - Regenerative Medicine, Cellular Therapies, Stem Cells, Extracellular Matrix, Perinatal Tissues (Placenta, Amnion, Chorion, Umbilical Cord Blood/Tissue), Transplantation, Cellular & Tissue Engineering, Biotechnology, Bioengineering, Medical Devices, Tissue Processing/Banking, HSCs, MSCs

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

Otolaryngology, Trauma Surgery - Sinus Surgery, Balloon Sinuplasty, Sleep Medicine, Cancer within the Head and Neck, Otology, Plastic Surgery within the Head and Neck, Pediatric Otolaryngology, Medical Devices, Endocrine Surgery, Thyroid and Parathyroid surgery, Allergy and Immunology, Audiology

Co-Investigator on multiple medical device clinical trials. National and International speaker on minimally-invasive Rhinology treatments. Medical Device Consultant; Chief Medical Officer

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).

Spine Surgery & Spine Care, Orthopedic Surgery - Orthopedic Surgery, Spine Surgery, Sports Medicine and Surgery, Endoscopic Surgery, Minimally Invasive Surgery, Sports Injury, Back Injury, Neck Injury, Whiplash, Sports Concussion, Causation, Case Valuation, Impairment, Medical Devices, Innovation, Understanding EMR, Vehicle Injury Evaluation

Member Phi Kappa Phi Honor Society

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.

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

Since 1999, Mr. Freid has helped leading electronic device OEMs create low-cost and low risk outsource strategies and programs for printed circuit board assemblies and finished products. His work often includes in-depth audits of assembly and test processes, volumes and mix, supply chain alignment, pricing proposals, etc. of potentially suitable EMS sites in US, Mexico, China, other Asia and E. Europe. He brings unmatched first‐hand perspective of outsourcing pros and cons, deep electronics production expertise plus rigorous analytics to every engagement. His innovative case review and expert witness work is recognized by top law firms as most effective in the electronics manufacturing services (EMS) industry. Besides outsource strategy and litigation support, other key service areas include in-house vs. outsourcing analysis (make vs. buy) and contract manufacturer M&A work including assistance with deal negotiation. Special assignments have been varied e.g., assessing to what ex...