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

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 22 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 PGR 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. He is available for consulting, expert witness services, forensic work, case viability and second opinions. Mr. O'Connor 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.

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.

mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.

OUR APPROACH

We utilize the following three part approach to providing high quality services to our clients:

Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients

Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment

Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)

Dr. Mayer is an independent consultant and scholar that holds the position of Visiting Fellow in Human Flourishing, Faculty of Arts and Sciences,  Harvard University. He has been a full-time tenured professor with recent appoints in statistics, biostatistics, epidemiology, biomedical informatics, public health and medicine (psychiatry). He held various titles including , Professor (Part-time), Bloomberg School of Public Health and School of Medicine, Johns Hopkins University, Affiliated Professor, Mayo Clinic/ASU joint program in Biomedical Informatics, a member of the Research Staff at Mayo Clinic, and Professor at Arizona State University He continues to do research and mentor young physicians and medical students while doing a limited amount of consulting in epidemiology, biostatistics, statistics, observatioan studies and clinical trials. His consulting projects often focus on model development, execution and inferences. He is one of the few MD/PhD epidemiologists. He now resides in Dana Point, California.

Mary B. Gloeckner, RN, MS, APN, is a Medical-Surgical Clinical Nurse Specialist who specializes in Wound Care and Ostomy Nursing. She has been a nursing consultant at Trinity Medical Center in Rock Island, Illinois, a 500 Bed hospital, for over 35 years. Ms. Gloeckner started the Wound & Ostomy Clinic (WOC) program at Trinity when she began there in 1983. She currently sits on 2 National Boards, the WOC Certification Board, and the Friends of Ostomates Worldwide. Ms. Gloeckner was also elected to sit on the International Board(ISTAP) on Skin Tears. She was honored with receiving the 2011 Iowa Affiliate Wound, Ostomy and Continence Nurses Society's (WOCN) Nurse of the Year Award and the 2016 USA WOC Nurse of the Year Award. Ms. Gloeckner provides litigation support service to attorneys for Plaintiff and Defense. Her cases include issues related to Wound Care and Colon and Rectal Surgery. Ms. Gloeckner is available to review medical records for standard of care and causation. Areas of Expertise and Consultation:

Wound Care Decubitus Ulcers Colostomy Ileostomy Urostomy

Pressure Ulcers Venous ulcers Vascular ulcers Fistulas Diabetes

Envista Forensics is a global leader in Forensic Engineering & Recovery Solutions. They provide Cause & Origin, Failure Analysis, Fire and Explosion Investigations, Accident Reconstruction, Damage Evaluations and Equipment Restoration Services following disasters of all kinds. Envista has offered Consulting Services to the insurance, legal and risk management industries, as well as businesses, public entities, and universities for over 25 years. Their Experts travel globally from 30 offices located across the U.S., Canada, Mexico, the U.K., Australia and Singapore.

Envista's experience counts when equipment, systems, structures, or data have been threatened by catastrophe or litigation. Their experts and advisors determine cause and responsibility, and identify the nature and extent of damage or loss and provide a full range of solutions to protect their assets. Envista's technical professionals are trusted advisors and industry leaders. Their expertise is broad and deep, capable of withstanding all forms of scrutiny. Envista's services are available globally so that certainty is assured no matter where in the world it is needed. As the recovery from disasters has grown more complex, Envista has developed a comprehensive array of services to help their clients and has associates located around the globe to provide assurance no matter the type of loss or location of the disaster.

Envista helps attorneys quickly get to meaningful answers on the many technical issues at the center of a dispute. Their engineers have decades of experience working with both defendants and plaintiffs. They offer effective Expert Witness Testimony, with the ability to communicate effectively, build rapport with juries and judges, and maintain adherence to structured, methodical approaches in drawing conclusions are all extremely critical. Envista Forensics understands how critical the selection of an expert can be, and we understand what makes experts effective. Their court qualified experts have extensive experience providing expert testimony on a wide variety of engineering and technical matters.

Areas of Expertise:

Aviation & Aerospace Biomechanics Construction Defects Digital Forensics Electrical Injury & Electrocutions Causation Chemical Computer / Network Equipment Failure Construction Defect Disputes over Reparability of Damage Electrical Failure Equipment Restoration Fire & Explosion Analysis Equipment Restoration

Industrial / Manufacturing Equipment Materials Failure Mechanical Accidents Mechanical Failure Medical / Laboratory Equipment Product Failure / Liability Project Management Structural Failure Subrogation Utility & Energy Valuation of Structures or Equipment Vehicle Accident Investigation Workplace / Premises Accidents

View Envista's Consulting Profile.

Kenneth A. Stein, MD
 Board Certified Emergency Medicine & Internal Medicine
Subspecialty Certified in NeuroCritical Care

Kenneth A. Stein, MD, ABPS, ABIM, UCNS, is Assistant Clinical Professor in the Department of Emergency Medicine, St. Louis University School of Medicine (a Level 1 Trauma Center). Dr. Stein currently practices Emergency Medicine and Critical Care / Intensive Care Medicine. For 20 years, Dr. Stein was an Emergency Physician at St. Anthony's Medical Center of St. Louis, one of the busiest emergency departments in the State of Missouri. 

Dr. Stein has extensive experience in providing medical-legal expert services, having reviewed over 500 cases (both plaintiff and defense) and having given testimony  over 200 times. Dr. Stein furnishes an unbiased opinion on medical malpractice/negligence cases. He also provides medical opinion concerning causation. Dr. Stein does not guarantee a favorable outcome but provides an honest assessment.

Dr. Stein has lectured nationally, and consults in the area of Pharmaceutical and Biomedical Product Development and Marketing.

Dr. Stein reviews cases (for both Plaintiff and Defense) of alleged Medical Malpractice / Negligence in areas including:

• Emergency Medicine        
• Critical Care Medicine / Intensive Care Medicine          
• Internal Medicine

Services provided include:

• Medical chart review and analysis   
• Providing opinion concerning the presence or absence of Negligence / Breach of the Standard of Care, Damages / Injury and Causation      
• Survey of case for merit 
• Preparation of reports and / or affidavits        
• Preparation for opposing expert deposition and cross-examination        
• Medical literature search    
• Expert witness testimony at deposition and trial

Call 314-495-7009 for a complete CV, including presentations.

Anthony C Chang, MD, MBA, MPH, MS is internationally recognized as an expert in the field of Pediatric Cardiology. Dr. Chang has 30 years of experience and special expertise in Congenital Heart Disease and Perioperative Care as well as Cardiomyopathy and Sudden Death in pediatric patients.

Dr. Chang has a master’s degree in Healthcare Administration from University of Miami School of Business and a master's degree in Biomedical Data Science from Stanford University. He also has a master’s degree in Public Health from UCLA, from which he graduated with the Dean’s Award for academic excellence.

Doctor Chang - Being A DoctorDr. Chang has been offering litigation support services to the legal community for many years. His expertise is available to attorneys for both Plaintiff and Defense. Dr. Chang has been deposed and/or testified over 200 times since 1990.

Areas of Specialization:

Congenital Heart Disease Cardiac Surgery Sudden Death Cardiac Intensive Care Heart Failure

Postoperative Care Pulmonary Hypertension Public Health Sports Medicine Artificial Intelligence in Medicine

A world-renown leader in pediatric cardiology innovation, Dr. Chang is a member of the grant review committee for pediatric research at the National Institutes of Health. Respected in his field, Dr. Chang is a member the board of directors for the American Heart Association. Providing leadership in education, he has served with the faculty of UCLA School of Public Health (eMPH program) and has taught global health for UCLA’s eMPH. He also teaches pediatric cardiology to cardiology fellows and holds a volunteer faculty appointment at the UCLA School of Medicine.

A prolific author, Dr. Chang is the chief editor of the textbook Pediatric Cardiac Intensive Care and the past president-elect of the Pediatric Cardiac Intensive Care Society (PCICS). He is the chief editor of the textbook Heart Failure in Children and Young Adults. He is a regular reviewer for “Circulation,” “Pediatric Critical Care Medicine,” “Critical Care Medicine,” and numerous other journals.

Dr. Chang has been voted “Physician of Excellence” by the Orange County Medical Association and also selected as one of America’s “Top Doctors,” “Top Pediatricians,” and “Best Cardiologists” by several organizations.

View Dr. Chang's Consulting Profile.