Medical Devices Expert Witnesses

Mr. John F. Schulte, is an accomplished Orthotic and Prosthetic practitioner with 40 plus years of experience consulting and treating Body and External powered upper and lower extremity prosthetics for all age groups.

Mr. Schulte has vast knowledge and experience in clinical practice prosthetic and orthotic component development, design, and manufacturing. A Clinician, Patient Care Consultant, and Senior Manager of 27 offices throughout 5 states, he is considered an expert in his field. Mr. Schulte continues to be asked to consult on Clinical ‘Best Practices’ by physicians, third party payors, peers, and patient users on the most appropriate component utilization and outcome measurements.

A published author, consultant, and Clinical Board Examiner, Mr. Schulte has treated and been involved with the treatment of persons of all ages with congenital birth defects, limb weakness and loss, and spinal cord injury.

Litigation Support - John Schulte's intimate knowledge in prosthetic and orthotic clinical practice and management, component prescription recommendation, and selection and utilization for all patient ages and levels of function make him an excellent expert witness resource. His services are available to attorneys representing plaintiff and defendant and include medical record review, second opinions, written reports, depositions, and trial testimony.

Areas of Expertise:

• Appropriate Prosthetic / Orthotic Component Selection Recommendation
• Utilization and Failures Due to Improper Manufacturing Processes
• Prescription Appropriateness
• Clinical Applications and Negligence Directly Related to Limb Weakness and Loss
• Spinal Cord Injury and Treatment
• Wrongful Death Investigation and Determination
• Limb Damage and Loss in Diabetics as Related to Footwear
• LifeCare Plan Consultation and Preparation as Related to Orthotics and Prosthetics

Education:

• New York University Medical School Orthotics and Prosthetics Certificate Program, Certification as Certified Prosthetist, 1973
• Northwestern University Medical School Orthotics and Prosthetics Certificate Program, Certification as Certified Orthotist, 1973

Tobias A. Mattei, MD, is a academic Neurosurgeon specialized in Complex Spine / Deformity Surgery. Dr. Mattei is currently practices as an Assistant Professor of the Division of Neurosurgery of St. Louis University. He has been an active member of the North American Spine Society, American Association of Neurological Surgeons, Congress of Neurological Surgeons, World Federation of Neurosurgical Societies, as well as many other international societies. 

Dr. Mattei is a member of the editorial board of The Spine Journal and Deputy Editor of the North American Spine Society Journal, the new open access initiative of the North American Spine Society. He is an active reviewer of several other neurosurgical journals including World Neurosurgery, Clinical Neurology & Neurosurgery, Journal of Clinical Neuroscience, Osteoarthritis & Cartilage, Journal of Engineering in Medicine: Part H, British Journal of Neurosurgery and Neurological Sciences.

As a researcher, Dr. Mattei has published more than 130 original research articles, having been cited more than 1400 times. He holds an unrestricted medical license in the states of Ohio, Missouri, New York, and Maine, and has never been submitted to any sanction or disciplinary action by any medical boards.

Litigation Support: Dr. Mattei provides expert witness services in the field of Spine Surgery, Spinal Care, and Neurosurgery. He has provided expert review services for several scientific funding agencies in the U.S. (including the NIH Panel for Clinical Neurophysiology, Devices, Neuroprosthetics, and Biosensors) as well as abroad (including the Innovation and Technology Commission/ Hong Kong SAR Government and The Brain Tumor Charity - New Ideas Award/UK). 

Dr. Mattei's  litigation support services are available to attorneys for plaintiff and defense and include review of hospital records, medical reports, imaging results, operative reports, patient's evolution, depositions, and trial testimony.

Areas of Expertise:

Lumbar Disc Herniation Cervical Disc Herniation Spinal Stenosis Laminectomy Spinal Fusion Spinal Fracture

Kyphoplasty Vertebroplasty Artificial Disc Spinal Cord Injury Spinal Tumors Scoliosis

Robert M. Stark, MD, has 40 years of experience practicing Internal Medicine, Cardiology, and Preventive Medicine. A graduate of Harvard Medical School, he is in full-time practice in cardiology and internal medicine. Dr. Stark is past-president of the Connecticut Society of Internal Medicine. He serves as Adjunct Clinical Professor of Medicine at New York Medical College. and Director of his hospital’s Cardiovascular Prevention Program.  Dr. Stark teaches residents and medical students as Adjunct Clinical Professor of Medicine. He also speaks frequently on cardiovascular topics for lay and professional groups as well as the media. Education: B.S.  University of Michigan  (Phi Beta Kappa) M.D.  Harvard Medical School  (Honors) Medical Residency  U. of Pennsylvania Hospital Cardiology Fellowship  National Institutes of Health  (N.I.H.)

Litigation Support: Dr. Stark has 20 years of litigation experience in state and federal jurisdictions. He has served as a senior member of his state’s Medical Malpractice Claims Review Panel, where he helped determine the defensibility of cases on behalf of malpractice insurers and individual law firms. He also had responsibility for advising on defensibility of cases for Aetna Life & Casualty and CNA Insurance, as well as for individual law firms.

Dr. has given deposition and trial testimony in over 125 cases. He specializes in reviewing and explaining medical treatments and potential complications of cardiac conditions, and in evaluating medical treatments for standard of care. Dr. Stark provides summaries and reports that are cogent and complete. He firmly believes that the ability to communicate effectively is as essential to medicolegal work as it is to quality patient care.

 Cardiovascular Disease and Internal Medicine Expertise:

Preventive Medicine Heart Attack Myocardial Infarction Angina Stroke Syncope

Cardiac Arrest Sudden Death Stress Test Echocardiogram Congestive Heart Failure Aortic Dissection

Atrial Fibrillation Arrhythmia Pulmonary Embolus Anticoagulation Coumadin Valvular Disease

View Dr. Stark's Consulting Profile.

Christopher M. Daft, PhD, is an award winning, Oxford Educated Materials Scientist whose areas of expertise include medical imaging, electronics, semiconductors, medical devices, sensors, MEMS, signal processing, and image processing. A serial inventor who holds 23 United States Patents with several pending, Dr. Daft has diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung, and Siemens as well as several start-ups. He is a well-published winner of grants from the National Institute of Health. Dr. Daft has been an Institute of Electrical and Electronic Engineers (IEEE ) Senior Member since 2004. He has three years of experience teaching electrical and computer engineering at the University of Illinois. Dr. Daft holds a BA and MA in Physics from Oxford University as well as Doctorate from Oxford in Materials Science.

Litigation Support - Dr. Daft provides litigation support in the areas of Intellectual Property and Medical Devices including Imaging, particularly Medical, Patents, Minimally Invasive Surgical Guidance, and more. His experience includes a variety of cases in the areas of wearable electronics, imaging systems, and surgical technology. Dr. Daft has extensive deposition and trial testimony experience.

Areas of Expertise:

Design Engineering Electrical Engineering Electromagnetic Engineering Microelectronics Medical Imaging Electronics Semiconductors

Medical Devices Sensors Software Engineering MEMS Signal Processing Image Processing Physics

View Dr. Christopher Daft's Consulting Profile.

Rapperport Associates, Inc., provides exceptional capability in Failure Analysis, Fire and Explosion Investigation, Accident Reconstruction, Structural Analysis, Mechanical and Electrical Engineering, Metallurgy and Materials Science.

We have provided superior technical support for litigation since 1974, and possess an extraordinarily talented technical team with impeccable academic and industrial credentials and proven analysis capability. Our team of distinguished scientists and engineers is drawn principally from Massachusetts Institute of Technology (M.I.T.) and Stanford University.

AREAS OF EXPERTISE:

Failure Analysis Structural Design Analysis Metallurgical Failures Finite Element Stress Analysis Fracture and Fatigue Analysis Scanning Electron Microscopy Corrosion

Accident Reconstruction Automobiles / Trucks Biomechanics / Injury Mechanism Off-Road Vehicles Occupant Motion Aircraft Animation

Fire & Explosion Analysis Cause and Origin Electrical Gases, Liquids and Dust Industrial Processes

........Safety Machine and Industrial Safety Machine Guarding Construction Failures Slips, Trips, Falls

Engineering

Mechanical

Structural / Civil

Metallurgy

Materials Science

Aeronautics and Astronautics

Electrical

Medical Devices, Biotech, Failure Analysis, Mechanical Eng, Materials, Reliability, Expert Witness

T. Kim Parnell, PhD, PE is a Professional Mechanical Engineering consultant and 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 (Inferior Vena Cava Filters), Pelvic Mesh, Transvaginal Mesh, Intragastric Abdominal Balloon Weight Loss Systems, Back Pain Reduction Systems, and others. Dr.Parnell brings both breadth and depth of experience to clients.  He has over 34 years of professional consulting experience, has taught both graduate and undergraduate University classes (Visiting Professor at Stanford University & Adjunct Professor at Santa Clara University), and has also worked in industry.  His industrial positions include sectors such as software, hardware, medical devices, and telecommunications equipment. He has extensive experience in areas including patents, medical devices, Nitinol shape memory alloy material, mechanical failure of products or equipment, and material failure by fracture or fatigue. Dr.Parnell frequently works with early-stage companies as both a technical consultant and a business advisor in sectors including medical devices and flash memory technology.

Areas of Expertise:

Patents and Intellectual Property Medical Devices Medical Instrumentation Composite Materials Finite Element Analysis (FEA) & Simulation Cell Phones, Personal Electronic Devices Gas Leaks, Pipe Failure, Vapor Cloud Explosions

Shape Memory Materials Heavy Truck Crashworthiness Consumer Products Product Design Refinement Piping, Pressure Vessels Failure Analysis Reliability

Selected Professional Memberships:

• Registered Professional Engineer (Mechanical), California
• ASME (American Society of Mechanical Engineers), Fellow
• SAE (Society of Automotive Engineers), Member
• IEEE (Institute of Electrical & Electronics Engineers), Senior Member
• ASM International, Member
• SMST (Shape Memory and Superelastic Technologies), Member

View Dr. Parnell's Consulting Profile.

Rod O'Connor, C.P.O. has over 30 years experience with Prosthetic and Orthotic Devices. His company has been Orange Countie's premiere Orthotic and Prosthetic supplier. After almost three decades of excellence, Mr. O'Connor sees client’s from around the globe including Spain, Iran, Japan, and more. He uses a combination of tried and true techniques combined with cutting-edge technology to tailor each device to the client’s needs.

O’Connor Orthopedic is the first orthotics and prosthetics clinic in Southern California to incorporate 3d printing and scanning into our everyday practice. Patients will see a reduction in the time it takes them to get their device and also a vast increase in the comfort due to the precision fit they can offer.  

Litigation Support - Mr. O'Connor is available for consulting, expert witness services, forensic work, case viability and second opinions. He is certified by the American Board for Certification in Orthotics & Prosthetics. He has expertise in all types of artificial limbs and orthopedic appliances (braces).

Mari S. Truman, PE, has more than 37 years of experience in Orthopedic Product Design and Development. As Principal Engineer with her company, Orthobiomech, LLC, she acts as an R&D design and development consultant to the orthopaedic industry and an injury biomechanics and medical device forensic expert.

Ms. Truman's design experience includes implants and instrumentation systems used to repair fractured bones, torn ligaments and/or to reconstruct spine, knee, wrist, hip, ankle, elbow, thumb based cmc, and other finger and toe joints for many of the USA based orthopaedic conglomerates and a few Asian, Australian and European firms.

Having designed and developed implants and instruments used for both human joint reconstruction and skeletal trauma repair, Ms. Truman is named on 12 Orthopaedic Patents and frequently gives talks on implant design and injury biomechanics on topics such as: knee and thumb-based joint surfaces and kinematics, joint design, rapid prototyping, medical device design control, and injury biomechanics.

Litigation Support - Ms. Truman has been providing Forensic Impact and Injury Biomechanics and Orthopedic Biomechanics to the legal industry for over 15 years. She draws on her strong knowledge of FDA and ISO EN13485 compliant design control processes, failure modes and effects analysis, clinically relevant tissue loading, and design safety assurance, including device performance requirements and warnings, during her medical device litigation reviews. Ms. Truman has a strong knowledge of the production and quality assurance processes used in the manufacture, cleaning, and sterilization of medical devices and the effects of such processes on product performance.

Analysis of Traumatic Injuries Related To:

Falls and Fall Recovery Vehicular Collisions Assaults and Fights Projectile Impacts Occupation or Workplace

Failed Medical Implants Assistive Devices Orthotics Consumer Products Sports and Recreation, Occupational Overuse / Injury

View OrthoBioMech LLC's Consulting Profile.

John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies.

Mr. Stevens has 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, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices. 

Litigation Support - An FDA expert and seasoned business professional, Mr. Stevens is uniquely qualified to opine on cases involving the FDA's regulation of medical devices. He has served as an expert witness for over 10 court cases involving the FDA regulation of medical device firms. His services include thorough reporting, depositions, and trial testimony. 

Areas of Expertise:

• Submissions (510(k), IDE, PMA, De Novo)
• Medical Device Quality Systems
• FDA Inspections

View Mr. Stevens' Consulting Profile.

Lloyd Marks, MD, MBA, FACC, is an MIT trained Electrical Engineer, Johns Hopkins trained Pediatric Cardiologist, and Inventor. Always active in both medicine and medical engineering, Dr. Marks has been granted 22 Medical Device Patents. He currently gives advice to academic institutions, investors, and corporations regarding the commercialization of medical technology.

Background Experience - Dr. Marks was in academic medicine for 15 years, as the Director of the Cardiac Cath Lab at St. Christopher's Hospital for Children and the Division Chief of Pediatric Cardiology at the Children's Hospital of New Jersey. He was then in private practice for 18 years. In 1997 he opened his clinical practice, specializing in Pediatric and Adult Congenital Heart Disease, where he provided clinical evaluation, electrocardiography, echocardiography, stress testing, Holter/event monitoring, diagnostic cardiac catheterization, and interventional cardiac catheterization.

After closing his clinical practice in 2015, Dr. Marks went to business school and obtained an MBA from the Haslam School of Business, University of Tennessee. While there, he wrote a business plan with financial projections for his startup company, MGI Medical, LLC, commercializing a non-invasive patient monitor for the detection of post-operative bleeding. Dr. Marks has successfully licensed 9 of his inventions to industry and assigned 8 to MGI.

Litigation Support - With his unique background in the field of medical device commercialization, Dr. Marks has been involved in protracted Patent Infringement litigation with a successful outcome. He is adept at explaining to a jury in lay terms complex medical technology and terminology, ranging from MRI readings to the difference between "clinical" and "statistical" significance. Dr. Marks' cases include all matters pertaining to:

• Pediatric Cardiology Medical Malpractice
• Medical Devices Standard of Care
• Intellectual Property Protection
• Invention Commercialization

Areas of Expertise:

Medical Devices / Medical Monitors Cardiology / Pediatric Cardiology  Medical Record Review Medical Technology IP, Patents, Licensing, Royalties

Medical Device Inventions Medical Device Due Diligence Medical Technology Business Plans Medical Technology Financial Projections

View Dr. Lloyd Marks' Consulting Profile.

Glenda E. Flemister, MD, FACP, FCCP, is Board Certified in Internal Medicine, Pulmonary Medicine, and Critical Care Medicine. Dr. Flemister has over 30 years of experience in her field. She received her MD from Loyola University Chicago Stritch School of Medicine and is licensed to practice in Illinois, Kentucky, New Mexico, and Oklahoma.

Dr. Flemister has over 10 years of experience in national insurance and payer companies. She has served as Medical Director for Aetna, Blue Cross Blue Shield Association, and Next Level Health Partners. She is currently the Executive Medical Director for Medical Health Solutions, a company involved in predicting trends to optimize healthcare at an affordable and sustainable rate. In this capacity, she provides education, consultation, and resources to the medical industry, medical providers, and managed care organizations.

Litigation Support - Dr. Flemister has been providing medical legal chart review, depositions, and trial testimony to the legal community since 1994. Her cases involve Pulmonary and Critical Care medical issues. She has performed over 100 file reviews. Her services are available to counsel representing both plaintiff and defendant, private hospitals, ISMIE (Illinois State Medical Inter-Insurance Exchange), and the AMA. Dr. Flemister's cases involve:

Pulmonary Medicine / Disease Critical Care Medicine Internal Medicine Pulmonary Medical Malpractice Pulmonary Care Quality Assurance

Thoracic Surgery Transplant Issues Asthma Obstructive Lung Disease Medical Devices

View Dr. Flemister's Consulting Profile.