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Biomedical Engineering Expert Witnesses

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Travis J. Barkalow, AAS
65 W. State Road, Suite C
Newaygo MI 49337
USA
phone: 231-652-2228
fax: 231-652-2299
BHBA-Biomedical-Engineering-Logo.jpg
B.H. Barkalow & Associates, LLC (BHBA), has been established to provide consulting and support services in areas of Medical Technology, Software, and Devices as regulated by the FDA. BHBA provides services to a range of clients from healthcare organizations, other consulting firms, the FDA, insurance companies, medical device manufacturers, and law firms throughout the country.

Litigation Support - BHBA provides expert assistance and consultation for matters related to medical technology and medical devices. Their services include confidential case review, incident simulations and investigations, export reports, and deposition and trial testimony when necessary.

Healthcare Organization Related Expertise:
  • In-house, shared service, vendor, or other third party medical device support
  • Analysis of hospital medical technology profile, identification of problem areas, defining required support resources, compliance with JCAHO medical device related standards, identification of medical technology risk exposure, and case-related technical advice as to the quality and quantity of medical technology support
  • Medical Device support personnel job descriptions and performance review
  • JCAHO medical device related compliance
  • Federal and State compliance with medical technology codes and standards
  • Medical Device related User Training and Physician Credentialing criteria
Medical Device Related:
  • Medical Device Failure Analysis
  • Medical Device Incident Simulations
  • Medical Device Labeling including: labels on the device; operator's manuals; and service manuals
  • Representations of the medical device function and suitability for use
  • User training
  • Warranty and after warranty service support
  • FDA 21 CFR related compliance
Alan Lipschultz Clinical Engineering Expert PhotoAlan Lipschultz, MS, PE, CCE, CSP, Clinical Engineering Expert Consultant for BHBA, is a Professional Engineer (PE), Certified Clinical Engineer (CCE) and Certified Safety Professional (CSP). During his nearly 40 years of experience as a Clinical Engineer, he has served as Director of Clinical Engineering for two large hospitals on the east coast. Mr. Lipschultz is the co-chair of the AAMI (Association for the Advancement of Medical Instrumentation) Standards Board and serves on several other AAMI committees (BI&T Editorial Board, Electrical Safety, Infusion Device, Medical Device Alarm and Technology Management).

Mr. Lipschultz's Medical technology experience includes familiarity with the design, use and malfunctions associated with defibrillators, electrosurgical units (ESU), infusion pumps, patient monitors and many other medical devices found in hospitals.

Matthew Baretich Clinical Engineering Expert PhotoMatthew F. Baretich PhD, PE, CCE, Senior Clinical Engineering Expert Consultant for BHBA, has over 30 years of clinical engineering and biomedical engineering experience. He has served as Director of Clinical Engineering for Children’s Hospital of the King’s Daughters as well as Director of Biomedical Engineering for the University of Colorado Health Sciences Center. He is a Certified Clinical Engineer (CCE), Certified Healthcare Facilities Manager (CHFM), as well as a Certified Professional in Healthcare Risk Management (CPHRM). Among Dr. Baretich’s credentials and professional activities are Founder and Past-President of the American College of Clinical Engineering and member of the World Health Organization’s Technical Advisory Group on Health Technology.

Dr. Baretich's medical technology experience includes familiarity with the design, use and malfunctions associated with a variety of medical equipment and building systems. Experience includes surgical equipment, dialysis equipment, critical care equipment, infusion pumps, pulse oximeters, emergency and isolated power systems, and other medical and building equipment and systems.

Theodore Cohen Clinical Engineering Expert PhotoTheodore Cohen, MS, CCE, FACCE, serves as a Clinical Engineering Expert Consultant for BHBA. Mr. Cohen is a Certified Clinical Engineer (CCE) and Fellow of the American College of Clinical Engineering (ACCE). He has more than 36 years of hospital-based experience in the field of clinical engineering, and served as Manager of Clinical Engineering at the University of California Davis Health System.

Mr. Cohen is familiar with the design, application and uses of most FDA-regulated medical devices and technology. This includes such areas of application as for patient monitoring, surgery, clinical laboratory, cardiology, radiology, pulmonary (including respiratory therapy) as well as compliance with Joint Commission, CMMS and FDA standards and regulations. Mr. Cohen is also familiar with, and has experience in, teaching application of medical devices for physicians, nurses, and technicians. Among his accomplishments and professional activities are a Lifetime Achievement Award from the American College of Clinical Engineering, serving as co-editor of ACCE News, and subject matter expert for the AAMI HTM Benchmarking Solutions and AAMI HTM Levels projects.

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Dr. Yadin B. David
M.Sc., Ed.D., P.E., C.C.E.
1111 Hermann Drive,Suite 12B
Houston TX 77004
USA
phone: 713-522-6666
fax: 713-522-6686
Dr. Yadin B. David has over 25 years experience in Managing Medical Technologies from Pre-Purchasing Evaluation, Installation, Training, to Servicing and Incidents Investigation. He is expert familiar with a wide variety of medical devices and accessories including infusion pump, laser, electrosurgery unit, monitors, X-ray, defibrillators and catheters. Dr. David is also an expert in Electromagnetic interferences (EMI) with medical devices and in Telemedicine and TeleHealth systems.

Dr. David serves a Consultant for industry and institutions including the Food and Drug Administration (FDA), Center for Devices and Radiological Health, General Hospital and Personal Use Devices Panel, World health Organization (WHO)and medical devices manufacturers. His services include testing, adverse events investigation, engineering reports, program review and risk assessment. Dr. David has given many national and international presentations about medical technology management, telemedicine and medical devices regulations.
4/24/2012 · Medicine
In a remote village in Central America, an otherwise unmanaged child's infection can take a turn for worse if not for the long distance diagnosis capacity brought about by the recently installed telemedicine system between Zacapa, Guatemala, and Houston, Texas, where subspecialists in the field of Pediatric Dermatology viewed the wound and prescribed the critically needed treatment.

1/16/2012 · Engineering
The dependence in medicine on technology to deliver services is continuously growing. The number of microprocessor-based diagnostic, therapeutic, and patient monitoring devices used in the clinical environment is ever-increasing.

Yadin David, et al
Clinical Engineering focuses on managing the deployment of medical technology and integrating it appropriately with desired clinical practices. It provides a description of the wide range of responsibilities clinical engineers encounter, describes technology management and assessment in detail, and reviews the standards and regulatory agencies of interest.
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Ernest Chiodo
M.D., J.D., M.P.H., M.S., C.I.H.
221 North LaSalle,Suite 1748
Chicago IL 60601
USA
phone: 312-351-0717
Ernest P. Chiodo, M.D., J.D., M.P.H., M.S., C.I.H. is a physician, attorney, Certified Industrial Hygienist (C.I.H), and biomedical engineer. Dr. Chiodo is board certified in the specialties of Internal Medicine, Occupational and Environmental Medicine, and Public Health and General Preventive Medicine. Dr. Chiodo served as the Medical Director of the City of Detroit and was the chief physician in charge of measures designed to protect the public health of over one million persons. He has also been the lead expert witness in a number of high profile cases including serving as the lead expert witness in a mass toxic tort case for Gerry Spence.

Areas of Expertise:
  • Toxicology
  • Epidemiology
  • Industrial Hygiene
  • Mold
  • Asbestos
  • Benzene
  • Biomedical Engineering
  • Accident Reconstruction
  • Electrocution
  • Building Related Disease
  • Biomechanics
  • Bed Bugs
  • Genetic evidence in the form of DNA profiles has proven to be a powerful tool in the advance of justice by proving the innocence of accused persons.

    Low speed motor vehicle collisions are a common occurrence. The use of cellular phones, text messaging, and e-mailing while driving has only increased the frequency of low speed motor vehicle collisions. A motor vehicle collision where there is only minor damage to the vehicles may result in personal injury claims for substantial sums.

    10/11/2012 · Toxicogenomics
    In toxic tort litigation, a person is often claiming to have developed cancer or some other serious disease due to having been exposed to a particular substance. Determining if the exposure to the substance was the cause of the disease is often a central focus of the litigation.

    9/26/2012 · Medical
    It is a common error that an attorney retains the wrong type of expert to testify in a lawsuit. This error is particularly common when the expert is a medical specialist. It is widely believed that a medical doctor who specializes in a particular organ system is qualified to formulate opinions and testify as to all issues concerning that organ system.

    Ernest Chiodo, MD, JD, MPH, CIH
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    Jon M. Crate, President & Chief Executive Officer
    825 Chance Road
    Marietta GA 30066
    USA
    phone: 770-928-1930
    fax: 770-928-9202
    FAI-Materials-Testing-Logo.jpg
    FAI Materials Testing Laboratory, Inc. (FAI) is a full service Analytical, Failure Analysis, and Materials Testing laboratory. They are professional scientists, chemists, and engineers with decades of experience solving problems in a host of industries. Founded in 1999, they have served hundreds of companies across the world.

    Litigation Support - FAI leverages their considerable experience in litigation and extensive laboratory resources to support their expert testimony. Their goal is to effectively support their clients in challenging cases. FAI has one of the finest laboratory environments for conducting joint inspections in the nation including photographic, videographic, and microscopic documentation capabilities.

    Areas of Expertise:
    • Analytical Chemistry
    • Cleanliness Testing
    • Composite / Window Lamination Issues
    • Corrosion
    • Electrical and Electronic Failure
    • Failure of Composites

  • Failure of Pressure Vessels
  • Fatigue Failure
  • Foreign Substance Identification
  • Fractography
  • Materials Compatibility
  • Materials Science
  • Optical and Electron Microscopy
  • Particle Characterization

  • Pharmaceutical Analysis
  • Protein Characterization
  • Polymer Chemistry
  • Support for Patent and Product Litigation
  • Textiles
  • Tire Failure
  • Weld Quality

  • Jon Crate Materials Failure Analysis Expert PhotoJon M. Crate is the founding President and CTO of FAI Materials Testing Laboratory. He received his bachelor's degree in Chemistry from University of Central Florida, his Master's in Polymers from the MSE Department of Georgia Tech and three years of postgraduate education in Molecular Cell Biology and Biochemistry at the University of Alabama in Birmingham.

    Mr. Crate is a Analytical Chemistry and Materials Failure Analysis expert witness who has leveraged leveraged his expertise to determine and prove the true causes of failure of many different products enabling many cases to settle out of court. He has testified by deposition in over 50 cases, before juries more than 10 times, and proven failure cause many more times where litigation was not needed.

    Mr. Crate is experienced and well versed in the chemical analysis and physical characterization of Natural and Synthetic Polymers, Metals, Inorganic and Organic Compounds, and Composite Materials. He has performed failure analysis on a wide variety of products and components including underground gas and water pipe, commercial aircraft tires, large equipment, rig, light truck, automotive and motorcycle tires, swimming pools and pool coatings, tank coatings, assault resistant commercial window laminates, numerous aircraft components, sailing vessel components, weapon system components, power generation equipment components, and medical devices including artificial heart valve.

    Jon M. Crate is capable of designing and validating test and inspection protocols that will enable the determination of the causes of failure for a wide variety of products and components.

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    Alan Lipschultz, PE, CCE, CSP, CPPS
    11420 Strand Drive, #306
    North Bethesda MD 20852
    USA
    phone: 302-584-1050
    Alan Lipschultz, PE, CCE, CSP, CPPS, President of HealthCare Technology Consulting, has 40 years of experience in all aspects of Healthcare Technology. A nationally recognized expert in Clinical Engineering and Healthcare Technology Management, Alan gained experience working as Director of Clinical Engineering in two major medical centers and through active participation in professional societies at the national level. He specializes in Healthcare Technology, Medical Equipment, Medical Devices, Patient Safety, and Hospital Safety.

    Alan provides Expert Witness and Litigation Support services to attorneys for both Plaintiff and Defense. His services include case evaluation for merit, depositions, and testimony when necessary. Alan's scientific and technical observations are admissible in court.

    Areas of Expertise:
    • Patient Safety
    • Clinical Engineering
    • Forensic Engineering
    • Root Cause Analysis
    • Healthcare Technology
    • Medical Accident Investigation
  • Medical Device Failures
  • Patient Safety
  • Defibrillators
  • Electrosurgical Units
  • Infusion Pumps
  • Medical Equipment Repair
  • View Alan Lipschultz's Consulting Profile.
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    Edward E. Elson, MSME, MA MANGT
    President
    4356 E Claytor Circle
    Anaheim CA 92807
    USA
    phone: 714-974-1264
    fax: 714-974-0148
    Edward E. Elson has over 40 years of Engineering Experience including research and development, design, manufacturing and management activities in the Medical Device, Packaging, Toy, Consumer Product, and Aerospace Industries. He holds 30 U.S. Patents, 27 in the medical device field.

    EDUCATION:
    • Adobe Illustrator: North Orange County Regional Occupational Program
    • SolidWorks 3D Design: Orange Coast College, Costa Mesa, CA
    • Graphics Design: University of California, Irvine, C
    • MA Management Peter Drucker School of Management: Claremont Graduate School, Claremont, CA
    • MS Mechanical Engineering: (Bio-Medical Minor) University of Southern California, Los Angeles, CA
    • BS Mechanical Engineering (Deans List): Drexel University Philadelphia, PA
    ORGANIZATIONS:
    • Member, Society of Plastic Engineers
    • Institute of Packaging Professiona
    • Member and former Board Member, Forensic Expert Witness Association (Orange County, CA)
    • Former member of AAMI Standards Sub-Committees: Human Factors for Medical Devices, IV Catheters, Humidifiers & Nebulizers
    AREAS of EXPERTISE:
    • Product Design
    • Patent Infringement, Validity, Trade Marks
    • GMPS, Labeling, Packaging for Medical Devices
    • Syringes, Needles, Catheters
    • Thermal Heating, Thermal Cooling Devices
    • Laser / Thermal Hair Removal Devices
    • Dermal Abrasion Equipment
    • Costume Jewelry
    • Patient Transport Gurneys
    • Patient Walkers, Gait Trainers, Design, Labeling
    • Surgical Staplers
    • Surgical Fluid Warmers
    • External and Implanted Drug Delivery Devices, IV Pumps
  • Failure of Implanted Hip and Spinal Prosthesis
  • Performance and Failure of Pedicle Screws
  • Valuation of Prototypes
  • Valuation of Medical Devices, Equipment, Consumer Products
  • Labeling and Packaging
  • Chiropractic Devices
  • Dental Burr and Drill Failures
  • Defective Seating
  • Exercise Equipment, Pilates Devices
  • Injection Molded Plastic Components
  • Drug Container Packaging
  • Defibrillator Design Issues
  • Shipping Carton Integrity
  • Manufacturing and Assembly

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    Dr. John D. Jarrell, PhD, PE
    President
    315 Commerce Park Road
    North Kingstown RI 02852
    USA
    phone: 800-672-6721 or (401) 290-8823
    fax: (401) 667-0993
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    Materials Science Associates, LLC provides Expert Witness services for complex Materials, Mechanical, and Biological Systems legal cases. The engineers and scientists at Materials Science provide honest and accurate analysis of alleged Product Failures, Personal Injuries, and Manufacturing Processes. Experts in Biomedical Engineering, Forensics, and Pathology the Experts at Materials Science can assist with retrieval and storage of devices. Materials Science Associates specializes in Multi District Litigation (MDL), Class Action, and Consolidating cases. Materials Science Associates LLC provides the following services to legal teams worldwide:
    • Implant Retrieval
    • Products Liability
    • Medical Devices
    • Evidence Storage
    • Orthopaedic Implants
  • Surgical Devices
  • Transdermal & Fentanyl Patches
  • Controlled Delivery Devices
  • Manufacturing Support
  • Process Review
  • John JarrellDr. John D. Jarrell, PhD, PE, is an experienced multi-discipline engineer specializing in the analysis of complex designs and failures involving materials, mechanical and biological systems. He has been a licensed Professional Mechanical Engineer, since 1996 and actively involved in Engineering Analysis, Design, Product Development, and Research. He earned three degrees from Brown University, a Bachelors and Masters of Science in Materials Science and Engineering and a Doctorate in Biology, Medical Science and Engineering and received Medical training in histology, physiology, microbiology and pathology.

    Dr. Jarrell has a faculty appointment in the Department of Orthopaedics at the Alpert Medical School of Brown University. He has several US and foreign patents issued or pending covering Photoactive Materials, Active Delivery Films and Coatings for Green Energy and Medical Applications.

    Jay VincelliJay M. Vincelli, M.Sc, PE, is an experienced multi-discipline engineer specializing in Computational Analysis of Biomechanical Implants and Aviation Components, Fracture Analysis, and Chemical and Metallurgical Analysis of steel, aluminum, titanium, and nickel-based alloys. With expertise in Medical Device Retrieval, Wear Analysis, and Aviation Failure Analysis, he is actively involved in engineering analysis, design, product development and research.

    Mr. Vincelli has filed for a provisional patent covering a miniaturized cardiopulmonary bypass circuit for transgenic mouse testing. He is the author of a peer reviewed publication on a study of laser cleaning and pulsed gas tungsten arc welding of titanium alloy tubes. His collaborative work has been published with investigators at the University of Virginia Department of Electrical and Computer Engineering and the U.S. Naval Air Warfare Center in Cherry Point, NC.

    Donald MongDonald L. Mong, PI, is a highly experienced Traffic Accident Reconstructionist, Private Investigator, Forensic Photographer, and Certified Master Diving Instructor. He is a 22 year Veteran Police Officer with 15 years of experience as a Traffic Officer. He has investigated over 2,000 traffic accidents, including many fatalities and serious injuries involving automobiles, buses, motorcycles, bicycles and pedestrians. He spent 10 years as a Rhode Island Municipal Police Academy Traffic Accident Investigation and Reconstruction Instructor.

    Mr. Mong has been qualified and testified as an expert witness in Rhode Island Superior Court and Vermont District Court for cases involving Motor Vehicles, Bicycles, Pedestrians, and Motorcycles. He has assisted multiple jurisdictions with investigations involving fatalities, serious injuries and police collisions. Donald L. Mong has conducted extensive hands-on research and training in traffic accident reconstruction, including conducting over 20 low, medium and high speed crash tests.

    View Materials Science Associates' Consulting Profile.
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    4015 Watters Lane
    Gibsonia PA 15044
    USA
    phone: 724-255-7176
    fax: 484-991-1952
    Al-Vangura-Biomechanics-Expert-Photo.jpg
    Al Vangura, Jr., MS, CPS, holds an MS in Bioengineering, a BS in Exercise and Sports Science - Biomechanics, and an AS in Mechanical Engineering Technology. Mr. Vangura has over 30 years of product development experience of class I, II, and III medical devices, sports equipment, playgrounds, motor vehicles, appliances, etc. He holds multiple patents and has worked as a machinist for over 10 years.

    Mr. Vangura is a seasoned, hands-on executive engineer with an extensive background and experience in the product development cycle in a variety of settings. He has led cross-functional teams developing Medical Devices for Respironics, Hill-Rom, Alung and CardiacAssist, athletic products for Reebok, Adidas, and the U.S. Olympic Biathlon team. He has also developed Military Aircraft for Sikorsky Aircraft, Boeing Defense and Space and the International Space Station for NASA.

    Litigation Support - Mr. Vangura has participated in forensic engineering evaluations for over 11 years with extensive courtroom experience. He provides forensic evaluations during legal proceedings involving product-related injuries, motor vehicle crashes, and other incidents requiring independent injury evaluation and review. Mr. Vangura has been involved in over 400 biomechanics cases.

    Areas of Specialization:
    • Occupant Biomechanics
    • Walking / Running Biomechanics
    • Trip / Fall Biomechanics
    • Playground Accidents and Safety
    • Sports Equipment Design / Safety
  • Machine Accidents
  • Child Abuse
  • Altercations
  • Medical Devices
  • OSHA, MSHA, FDA, and ADA
  • View Al Vangura's Consulting Profile.