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Medical Devices Expert Witnesses

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Amitkumar Dharia, PhD
8418 Sterling St., Suite A
Irving Texas 75063
phone: 972-915-0516
fax: 972-915-0518
Amitkumar Dharia, PhD has over 27 years of direct experience in new Plastics and Polymer product and process, research and development, market research and analysis, product and project management, and commercialization.

After working with various organizations throughout the United States, Dr. Dharia founded Transmit Technology Group, LLC in 1999. Since then, he has helped numerous clients in conceptualizing, exploring through experimentation, and screening best and novel alternatives, in connecting and coordinating external resources to drive concepts to commercialization. In 2006, he developed a novel testing equipment, Technoform, to determine the thermoformabiltiy of thermoplastics materials. Technoform has been used in over 60 industrial projects related to thermoforming.

During 1999-2014, Dr. Dharia was named inventor or co-inventor on six US and international patents and is named a co-inventor on two pending applications. A patent agent registered with USPTO, he himself has been issued 21 United States patents and has been responsible for more than 30 disclosures of inventions. He has also authored over 24 technical publications.

Litigation Support - Dr. Dharia provides expert witness services in the area of Plastic Part Failure. His services are available to attorneys representing plaintiff and defendant and include product failure analysis, written reports, depositions, and trial testimony.

Areas of Expertise:
  • Plastic Materials
  • Polymer Materials
  • Additives
  • Conductive Plastics
  • Reinforced Materials
  • Flame Retardants
  • Thermoplastic Elastomers (TPE)
  • Thermoplastic Olefin (TPO)
  • Thermophotovoltaic (TPV)
  • Plastic Blends
  • Alloys
  • Reactive Modifications
  • Foams
  • W & C Applications
  • Automotive Applications
  • Packaging
  • Consumer Goods
  • Sensors
  • Medical Devices
  • Construction Markets
  • View Dr. Dharia's Consulting Profile.
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    Matthew I. Stein, PE
    10591 Belford Place
    Truckee CA 96161
    phone: 530-587-7618
    Matthew I. Stein, PE, principal of Stein Design, has 12 patents to his name, 30+ years of Mechanical Engineering experience specializing in Product Design & Development, and 10+ years of Expert Witness experience with Patent Litigation and Product Liability. Multiple Injury cases relating to drinking fountains or involving the use of Safety Showers/Eyewashes. He has designed highly successful products for industry leaders such as Hewlett Packard, Seagate, IGT, Duraflame, Plantronics, and Haws.

    Litigation Support - Mr. Stein’s background as a National Merit Scholar, MIT graduate, and bestselling author, combined with his extensive media experience on television, radio and in public speaking engagements, make him a formidable expert witness who is not only technically savvy but also presents exceptionally well in front of judge and jury.

    Most cases settled out of court, but in one patent infringement case where Stein was the key expert witness for plaintiff, the jury awarded an 8 figure judgment, and in a recent liability case where Stein testified on behalf of plaintiff, the jury awarded $1.8 Million. As a former world class rock climber, and licensed general contractor, he can also offer testimonial on climbing accidents and job site safety.

    Expert Witness Experience:
    • 21 cases total (15 patent related, 2 related to trade secrets, and 4 related to product liability)
    • Authored approximately 34 expert reports
    • Provided deposition on 12 different occasions
    • Provided expert witness court testimonial on multiple days for each of 3 jury trials
    Areas of Expertise:
    • Patent Infringement and/or Invalidity
    • Consumer Product Design & Liability
    • Cash Machines & Paper/Membrane Handling Devices
    • Telephone Head Sets & Small Scale Sonar Devices
    • Water Filtration, Drinking Fountains, & Misc Plumbing Products
    • Safety Showers & Eyewash Equipment
    • ANSI/ISEA/OSHA for Emergency Eyewash & Shower Equipment
    • Plumbing Fixtures & Valves
    • Medical Filters
    • Photovoltaic Panels
    • Plastic Part Design & Application
    View Matthew Stein's Consulting Profile.
    Matthew Stein, PE
    Disasters often strike without warning and leave a trail of destruction in their wake. Yet armed with the right tools and information, survivors can fend for themselves and get through even the toughest circumstances. This book provides a thorough, practical guide for how to prepare for and react in many of life's most unpredictable scenarios.
    Matthew Stein, PE
    This book, comprehensive primer on sustainable living skills—from food and water to shelter and energy to first-aid and crisis-management skills—prepares you to embark on the path toward sustainability. But unlike any other book, Stein not only shows you how to live “green” in seemingly stable times, but to live in the face of potential disasters, lasting days or years, coming in the form of social upheaval, economic meltdown, or environmental catastrophe.
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    Prosthetics and Orthotics Expert Witness and Consultant
    792 Eastern Point Road
    Annapolis MD 21401
    phone: 410-533-1960
    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
    • 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
    2/1/2018 · Medical
    There may be more to the complaint than meets the eye. There may be obvious issues, such as a failed component resulting in a fall, a skin breakdown that on the surface appears that it was as a result of overuse or a rough area within the prosthetic socket.

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    Richard K. Baer, MD
    2727 N Lakewood Ave
    Chicago IL 60614
    phone: 773-477-0201
    Richard K. Baer, MD, is a Healthcare Coverage consultant with over 20 years of experience in medical director roles for the Medicare Administrative Contractor (MAC), the Recovery Auditor (RAC), and regional home health and hospice contractors. He most recently served as the Medical Director for the RAC, Region A, in the northeast US.

    Dr. Baer is a Distinguished Life Fellow of the American Psychiatric Association, and a member of numerous state and national medical societies. He served as President of the Illinois Psychiatric Society, Editor of its newsletter, and Chairman of its Ethics Committee.

    During his tenure with the Medicare program, Dr. Baer authored several hundred Local Coverage Determinations (LCDs) and other medical review policy articles and documents for new technologies, pharmaceuticals, and highly utilized services covering millions of Medicare beneficiaries. He has provided medical policy assistance to CMS on national coverage issues, and has been involved in federal investigations and audits of Medicare improper payments and fraud matters for a variety of health care providers.

    Litigation Support - Dr. Baer has extensive experience consulting and testifying for the United States Department of Justice in Medicare criminal and civil fraud trials and other civil proceedings. He provides expert medical consultation on Payer Coverage Requirements for the Medical Device Industry.

    Areas of Expertise:
    • Medical Devices
    • Medical Device Design
    • Medicare Rules
    • Medicare Regulation Compliance
  • RAC Audits
  • Medical Billing
  • Medical Coding
  • Pharmaceutical Compliance
  • View Dr. Baer's Consulting Profile.
    Richard Baer, MD
    A Doctor’s Harrowing Story of Treating a Woman with 17 personalities.
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    Daniel Rapperport
    8 Wallis Court
    Lexington MA 02421
    phone: 781-862-9001 or 339-222-2822
    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.


    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
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    T. Kim Parnell, PhD, PE
    1150 Kelsey Dr.
    Sunnyvale CA 94087
    phone: 408-203-9443

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

    Kim Parnell Mechanical Engineer Expert PhotoT. Kim Parnell, PhD, PE is a Professional Mechanical Engineering consultant with strong experience in a number of technology areas. He holds PhD and MSME degrees from Stanford University in Mechanical Engineering and a BES from Georgia Tech. He specializes in the mechanical engineering design and behavior of Biomedical Devices, Superelastic and Shape Memory Metals (Nitinol), Bioabsorbable Polymers, Composites, Fiber-Reinforced Materials, Electronics, and Consumer Products. Dr. Parnell consults actively in these areas using finite element analysis and other advanced technologies to improve designs, to perform failure analysis, and to improve reliability.

    Dr. Parnell served on the Mechanical Engineering faculty at Santa Clara University from 2010-2012 and was previously a Visiting Associate Professor at Stanford University. He lectured in the Stanford Composites Design Program, and is a coach and mentor for the innovative Stanford Biodesign Program. He has worked for companies including MSC Software, Rubicor Medical, Exponent Failure Analysis Associates, SST Systems, ATT Bell Laboratories, Stanford University, and General Motors.

    Dr. Kim Parnell has experience as a medical device patent litigation expert, as an expert in product liability matters (including heavy truck crashworthiness), and frequently serves as an expert witness and litigation consultant. He has testified in both trial and deposition, and has also authored expert reports. Dr. Parnell's litigation support services are available to attorneys for both plaintiff and defense.

    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.
    Rail residual stress distributions can be complex and variable in nature, as different manufacturing techniques produce varying stress magnitudes and distributions. To evaluate the effect of residual stresses on rail integrity, an analysis technique was sought that could quantify the effect of these stresses on web crack propagation.

    The computer program LS-DYNA3D was used to simulate the behavior of a specific, though representative, heavy truck cab-over tractor-trailer vehicle during a full 180° rollover event. These simulations provide a key component in the development of a physical testing procedure for evaluating structural integrity and occupant crash protection system designs in heavy trucks.

    2/18/2014 · Medical
    The United States Food & Drug Administration (FDA) requirements for Class III implantable medical devices requires a 10 year life, or approximately 400 million cycles of service.

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    Ade Akande, MD, MBA
    11315 Catherines Mine Circle
    Charlotte NC 28277
    phone: 704-293-7728
    Adewunmi Akande, MD., MBA, is Board Certified in Internal Medicine, Anesthesiology, and Pain Medicine. He has 24 years of experience specializing in Interventional and Non Interventional Pain Management and Pain Medicine.

    Dr. Akande is the Founder and President of Charlotte Pain Associates, PA, a private practice pain management specialty with four regional satellite offices in North and South Carolina. The practice offers consultation, diagnosis, and treatment of all Chronic Pain conditions. The practice has a volume of greater than 1,200 consultations, 10,000 office visits, and 2,000 outpatients interventional procedures annually.

    Dr. Akande is also the Founder and Chairman of Nead Medical, PC, and outpatient JCAHO certified single specialty surgical suite for interventional pain management. The surgical suite handles a volume of greater than 1,300 cases of various types of complex interventional pain management procedures annually.

    Litigation Support: Dr. Akande provides expert witness services in cases involving complications with Anesthesia and Pain Medicine. He has testified 10 times in the past several years. Dr. Akande's services are available to attorneys representing both plaintiff and defendant and include medical record review, written reports, depositions, and trial testimony as needed.

    Areas of Expertise:
    • Spinal Anesthesia
    • Epidural Hematoma
    • Intrathecal Catheter
    • Opioid Therapy
    • Opioid Overdose
    • Pain Medicine Complications
    • Narcotic Use / Abuse
    • Facet Rhizotomy
  • Facet Injection
  • Cervical Epidural
  • Epidural Abscess
  • Nerve Root Block
  • Epidural Adhesions
  • Spinal Injections
  • Spinal Catheter
  • Blood Thinner
  • Education:
    • Internal Medicine Residency - Columbia University College of Physicians and Surgeons, New York, NY
    • Anesthesiology Residency and Pain Management, Fellowship - Brigham and Women's Hospital (Harvard Medical School, Boston, Mass)
    • Interventional Pain Management Fellowship-University of Medicine and Dentistry of New Jersey. Newark, NJ
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    Rod O'Connor
    1287 n. Tustin Ave.
    Anaheim CA 92807
    phone: 714-635-2650
    fax: 714-635-0223
    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).
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    Mari S. Truman, PE
    Principal Engineer
    221 N. Union St.
    Waraw IN 46580
    phone: 574-265-1726
    fax: 866-470-6125
    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.
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    Glenda Flemister MD, FACP, FCCP
    President/Medical Director
    21200 S. La Grange Road
    suite 273
    Frankfort Illinois 60423
    United States
    phone: 815.534.5677
    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.
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    George Yanulis, MEng, MS, DEng
    210 Ashley Run
    Voorhess NJ 08043
    phone: 216-571-1532
    George Yanulis, MEng, MS, DEng, is a nationally recognized Cardiovascular Device Product Development and Research Engineer and has conducted cardiovascular device research at the Cleveland Clinic Foundation. He has published in the areas of atrial fibrillation (AF), cardiac pacing, and congestive heart failure devices.

    Dr. Yanulis has a Doctorate in Engineering in a joint program between Cleveland State University and the Cleveland Clinic Foundation in Biomedical Engineering; a Master of Science from the University of Pittsburgh; and a Master of Engineering in Biomedical Engineering from the University of Virginia.

    Dr. Yanulis’ Medical technology experience has consisted of familiarity with the design, use, and applications associated with a variety of medical devices and software used for: cardiac pacing, ventricular assist, cardiac echocardiography and electrophysiology, vascular stents, physiological monitoring, medical imaging, neurological therapy, surgery, among others. He is currently teaching a cardiac device course in Temple’s Bioengineering Department and has been involved in research and development of cardiac pacing systems at the Cleveland Clinic.

    Litigation Support - Dr. Yanulis has provided testimony in 6 depositions in the last 4 years (without a Daubert Challenge) and has been an Expert Witness and medical device consultant for 10 years and has been involved in numerous medical device liability and patent infringement cases for both the Plaintiff and the Defendant sides. He has been involved in cases involving:
    • Implantable Cardiac Defibrillator (ICD) Device Systems
    • ICD Lead Design and Failures (including the St. Jude medical Riata leads)
    • Cardiac Pacemaker Systems Research and Development
    • Cardiac Pacing Lead Design and Development
    • Cardiac Pacing Lead Failures
    • Heart Failure Therapy Devices
    • Cardiovascular Imaging (including cardiac echo and MRI system design and maintenance)
    • Atrial Fibrillation Therapy Device Systems
    • Ventricular Assist Devices: Cardiac Stents; and Cardiac Valves
    View Dr. Yanulis' Consulting Profile.
    7/12/2017 · Failure Analysis
    Plaintiff was admitted to a health care facility with ventricular tachycardia (VT). He had a normal coronary angiography with moderate left ventricular (LV) function and was referred for an implantable cardiac defibrillator (ICD) implant procedure. A diagnosis of right ventricular outflow tract tachycardia was made. He was then admitted for an ablation procedure in March 2005, which was successful. In April 2005, he was readmitted with a further occurrence of tachycardia which required emergency cardio version due to hemodynamic compromise and a temporary pacing wire was placed. There was a further attempt at ablation that was again successful and the LV function noted now to have deteriorated and was noted as having poor functioning. On this basis he was considered a candidate for an ICD implant. There was a further reoccurrence of an episode of ventricular tachycardia (VT) in March and April 2006 which was treated medically and he was discharged.

    6/13/2017 · Medical
    The Medtronic's Enpulse Model E2DR21P Serial number PMU411109 as well as the Atrial Lead (model #496525, SN: LBT042477R-Epicardial Unipolar and the Ventricular Lead (model #496525, SN: LEN036731R- Bipolar Epicardial had been used to continually pace patient in the DDD pacing mode during patient's lifetime. The expert referred to all Medtronic specifications; warnings; and advisories relevant to both the pacemaker and pacing leads used for pacing this completely pacemaker dependent patient).

    8/30/2012 · Medicine
    Protocols for producing experimental heart failure by rapid ventricular pacing are well established [1]; however, for safety reasons, commonly used clinical pacemakers do not allow pacing rates that are sufficient to induce either heart failure (HF) or atrial fibrillation (AF).

    6/27/2012 · Medical
    Cardiac resynchronization therapy (CRT) has been shown to improve symptoms and survival in patients with systolic dysfunction and prolonged ventricular depolarization (wide QRS).1-8 However, atrial fibrillation (AF) may cause significant problems in these patients, particularly when the ventricular rate exceeds the device programmable rate.

    4/23/2012 · Medical
    Recent studies have demonstrated that ventricular rate control is a viable treatment strategy for patients in atrial fibrillation (AF). The purpose of this study was to determine whether or not the benefits of coupled pacing (ie, a proposed rate control therapy) could be used during persistent AF.

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    Alan Schwartz
    Executive VP
    55 Northern Blvd.
    Great Neck NY 11021
    phone: 516-482-9001
    fax: 516-482-0186
    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.


    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)
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    Lawrence S. Mayer
    MD, PhD
    3607 N. 55th Pl
    Phoenix AZ 85018
    phone: 410-336-2100 or 602-549-4885
    fax: 480-247-4989
    Dr. Mayer is a full-time professor of biostatistics, epidemiology, biomedical informatics, public health and psychiatry. He splits his time between Annapolis/DC and Scottsdale, AZ. He does a limited amount of consulting in epidemiology and biostatistics.

    He focuses on evaluating data, methods and models used in assessing risks. Over several decades he has worked equally for plaintiffs and defense. He trained as a physician epidemiologist and then as a statistician and biostatistician.

    Prides himself on being able to communicate complex ideas in simple language. Prefers problems in which the medical and epidemiological/statistical issues are complex, the methods and models are varied and the data are of limited quality or controversial.

    Has worked on problems in drug and device development, testing and regulation, product liability, patent disputes, occupational and environmental exposures, and medical malpractice.

    Has given about 100 depositions over the last 30 years in a variety of cases ranging from major federal litigation to state personal injury and malpractice cases.
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    Kurt D. Humphrey
    Managing Director, Principal Technologist
    3780 Masters Drive
    Colorado Springs CO 80907
    phone: 719-331-9788
    Kurt D. Humphrey has over 30 years of commercial Microelectronics and High-Tech Materials Design and Process Development, Corporate R&D Project Management, Reverse Engineering / Failure Analysis, and Patent / SME Consulting experience. With access to the best research tools, databases, labs and test equipment available, he is able to solve the most complex Intellectual Property technology issues.

    An accomplished inventor, Mr. Humphrey holds patents in the areas of oxygen sensors, MEMS, and semiconductor process technology as a result of his innovative work with General Motors Corporation, United Technologies, and Rockwell Science Center. Before launching his own IP and patent technical consulting business, he served as Director of Engineering Programs at TAEUS International managing numerous patent evaluation and product investigation projects for several Global 25 high-tech companies in the U.S., Europe, Japan, and Korea.

    Litigation Support - Kurt Humphrey offers forensic engineering and SME services to attorneys representing both Plaintiff and Defendant. His expertise is called upon for infringement litigation, IPR/PGR petitions and responses, expert reports and testimony, prior art, invalidity and FTO searches, product investigations and reverse engineering, claim charting and proof packages, and failure analysis.

    Mr. Humphrey's expert witness experience includes infringement analysis, expert reports, and testimony on behalf of Hewlett-Packard in an ITC patent infringement case, HP v. Acer, involving microprocessor architecture and operation, and failure / forensic analysis and expert trial testimony for the Houston Rockets (Plaintiff) in the LED lighting product failure / liability case, Clutch City Sports v. iLight Technologies in 2012.

    Areas of Expertise:
    • Advanced Wireless and Cellular Telecommunications Networks
    • Micro / nano-electronics, Ics, MEMS, Sensors, Imagers, Photovoltaics, LEDs, Packaging
    • Automotive Electronics and Systems, Smart Batteries
    • Flat Panel Displays: LCD / LED / OLED / E-ink, Plasma, and LED
    • Mobile Devices: Smartphones, Tablets, GPS, Wearables, etc.
    • Networks and Storage, Optical Networking, Opto-electronics /Photonics
    • Silicon and III-V Integrated Circuits/Devices: Digital, Analog, Mixed Signal, DRAM and NV Memory, Microprocessors, Smart Power
    • Biomedical Devices
    • Chemicals, Organic and Inorganic Technical Materials: Bulk, Films, and Coatings
    View Kurt Humphrey's Consulting Profile.
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    Edward E. Elson, MSME, MA MANGT
    4356 E Claytor Circle
    Anaheim CA 92807
    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.

    • 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
    • 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
    • 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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