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Medical Equipment Expert Witnesses

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Georgia J. Persky, RN, MBA, PhD, CLNC
Legal Nurse Consultant and Healthcare Executive
Harrison New York USA
phone: 914-552-2277
fax: 914-921-6467
Georgia-Persky-Consulting-Logo.jpg
Georgia Persky Legal Nurse Consultant Expert PhotoGeorgia J. Persky RN, MBA, PhD, CLNC, is a Columbia University trained nurse researcher with over 40 years of broad Clinical Nursing experience and 25 years of senior leadership in healthcare organizations. She has 20 years of Surgical Nursing and Operating Room experience. Dr. Persky has expertise in the micro issues in adult patient care and the broad management, quality, and regulatory issues in hospitals.

Background Experience - Dr. Persky served as Vice-President of Nursing and Patient Care Services for New York Presbyterian Hospital at Columbia University Medical Center. For nine years, she was responsible for Patient Care Services, Risk and Quality Management and Patient Satisfaction for a 750 bed academic hospital. She directed a $200 million budget with 33 patient services units and Care Management, Respiratory Therapy, Social Work and Admitting Departments with 9 direct reports and 2,000 patient services FTEs.

Litigation Support - As a Certified Legal Nurse Consultant and Quality Reviewer, Dr. Persky has investigated hundreds of Malpractice and Injury cases as a quality reviewer and can assist in legal case review with chronologies, timelines, and evidence based reports. She has testifying experience with human resource and employee discrimination cases with ability to attest to standards of care in clinical litigation. Dr. Persky's services are available to attorneys for plaintiff and defense seeking an expert in nursing and patient care with a strong understanding of how hospitals work.

Areas of Expertise:
  • Nursing Standards of Care
  • Surgical and Perioperative Nursing
  • Quality and Risk Management
  • Fall and Pressure Ulcer Prevention
  • Medical Device Safety
  • HIPPA
  • Hospital Policy and Procedure
  • Medication Safety
  • Nursing Informatics
  • Hospital Administration
  • State, Federal, Joint Commission Regulatory Compliance
  • View Dr. Persky's Consulting Profile.
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    Karl R. Leinsing, MSME, PE
    77 Spur Rd.
    Dover NH 03820
    USA
    phone: 603-203-0365
    fax: 603-749-0079
    Karl-Leinsing-Medical-Device-Expert.jpg
    Karl R. Leinsing, MSME, PE, President of ATech Designs, Inc., is a Professional Mechanical Engineer who specializes in Medical Device Product Development from concept to production.

    Mr. Leinsing has been granted over 20 patents (needle free IV valves, laparoscopic devices, needlescopic devices, suture lockers, catheters, mitral valve repair devices, knitting machines) and excels in solving the most complicated problems and design challenges. His company has a fully equipped medical lab with calibrated measurement and test equipment and all is fully documented with high quality reports with pictures and video to provide credible results and easy to understand compelling data.

    The winner of five design awards, Mr. Leinsing is recognized as one of the top 100 medical device professionals in the nation by MD&DI. For dedication to his industry, he was made the 2014 Chairman of the Medical Device and Manufacturing Conference in Anaheim, CA. Mr. Leinsing has also been acknowledged for his work in a publication by Life Magazine.

    Mr. Leinsing offers litigation support services to the legal community. He has extensive experience with Patent and Product Liability cases including report writing, depositions, and testimony.

    Areas of Expertise:
    • Intravenous (IV) Systems & Disposables
    • Hernia Repair
    • Endometrial Ablation
    • Laparoscopic Instruments
    • Injection Ports
    • Catheters
    • Heart Valve Repair / Replacement
    • Subcutaneous Ports
  • Bed Rails
  • Cervical Screws
  • Syringes
  • IV / Insulin Pumps
  • Glucose Monitors
  • Peritoneal Dialysis Pumps
  • Abdominal Aortic Aneurysm (AAA) Repair
  • Sleep Apnea Devices (CPAP)
  • View Karl Leinsing's Consulting Profile.
    6/24/2014 · Expert Witnessing
    Experienced Medical Device Experts can assist with a case in many different ways. First, they have industry knowledge of the medical device industry and can assist with prior art in patent litigation cases for example. They understand the technology and how claim terms are understood for one skilled in the art of medical device design, testing, and manufacturing. This firsthand information can then assist with proper claim construction and infringement analysis. Experience with medical devices product development can also assist in determining what is obvious in the field and what is not as it pertains to patent validation.

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    John D. Baker, MD, FACC, FACP, FSCAI
    4790 Irvine Blvd. #105-141
    Irvine CA 92620-1973
    USA
    phone: 877- 924-9009
    John-Baker-Cardiovascular-Expert-Witness-Photo.jpg
    John D. Baker, MD, FACC, FACP, FSCAI, is dual Board Certified in Cardiology and Interventional Cardiology by the American Board of Internal Medicine. Actively practicing, he has over 20 years of experience in Cardiology, Invasive and Interventional Cardiology.. Dr. Baker previously served as Co- Chair of the American College Of Cardiology Cardiovascular Care Team and Section, and he also served as the Director of Cardiac Catheterization Laboratories and Invasive/Interventional Cardiology for Anaheim Regional Medical Center.

    Dr. Baker provides evidence based opinions regarding the medical facts of each case, for attorneys representing both Plaintiff and Defense. His services include medical record review for causation, angiogram review, depositions, expert testimony, written reports with writing including statements of merit, case summary opinions, and affidavits.

    Dr. Baker also has extensive experience in peer review, in his capacities as prior Chair of Invasive Cardiology, organizing and maintaining high quality accurate peer review for Anaheim Memorial Medical Center, and redesigning the process to meet the Joint Commission's (JCAHO) Standards. He performs guideline and evidence-based reviews and depositions in all areas of Cardiology nationwide.

    Areas of Expertise:
    • Medical Malpractice
    • Coronary Heart Disease
    • Stents
    • PTCA
    • Pacemakers
    • Angioplasty
  • Myocardial Infarction
  • Radiation Safety
  • Congestive Heart Failure
  • Fluoroscopy
  • Rotablators
  • Laser Atherectomy
  • View Dr. Baker's Consulting Profile.
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    Dr. Richard Collins
    440 Monmouth Drive
    Cranberry Township PA 16066-5756
    USA
    phone: 724-742-0414
    Dr. Richard Collins, Former University Professor of Biomedical and Human Factors Engineering, Professor of Medicine, Professor of Mechanical and Aerospace Engineering. Dr. Collins has Demonstrated Accuracy in Research and Scientific Analysis in Mechanical and Biomechanical Engineering and Regulatory Assessments.

    His work has been Extensively Published in National and International peer-reviewed Literature. He is an Internationally recognized engineering and medical expert, having earned his Ph.D. from the University of California, Berkeley. Dr. Collins is qualified as an expert witness in civil and criminal courts.

    Areas of Specialization:
  • Wrongful Death, Medical Malpractice, Medical Device / Product Liability
  • Head and Spine Injury Cases in Motorcycle, Bicycle Collisions, Protective Helmet Liability
  • Accident Reconstruction / Failure Analysis - Serious Personal Injury and Trauma
  • Analysis / Injury Biomechanics: Automotive, Traffic Safety, Aircraft Crashes, Train Crashes, Forklift Turnovers, Elevator Failures, Sports Impacts, Sports, Recreational and Safety Equipment, Sports and Industrial Injuries, Ergonomics, Repetitive Stress Cases, Slips and Falls
  • 9/10/2008 · Medical
    Blunt impact to the thorax often results in traumatic rupture of the aorta, leading to immediate exsanguination. Current interest in the mechanisms of this failure is great (Roberts and Beckman, 1970), particularly with regard to vehicular fatilities in which passengers are subjected to high levels of deceleration

    9/10/2008 · Medical
    The lung constitutes a highly complex and selfregulating system for oxygenating man’s blood and removing its waste materials. It is at the alveolar level that the respiratory and circulatory functions interact and the important exchange processes occur

    9/10/2008 · Medical
    THE NUMBER of fatalities due to automobile collisions in the United States has reached an annual level of 55,000, according to the statistics of the National Safety Council. Of these, 16 per cent have been estimated by Greendyke (1966) to be due to traumatic rupture of the aorta, on the basis of a sample of 1253 automobile fatalities in Monroe County, N.Y., over a four year perio

    9/10/2008 · Medical
    The uptake of particulate matter by inhalation leads to complex transport processes influenced by unsteady convection through a non-dichotomously branching network of conducting conduits (airways)

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    J. Marcus Hollis, PhD, PE
    8418 East Bay Blvd.
    Navarre FL 32566
    USA
    phone: 850-292-4780
    J-Marcus-Hollis-Biomechanical-Engineering-Expert-Photo.jpg
    J. Marcus Hollis, PhD, PE, is a Bio-Mechanical Engineer specializing in biomechanics, injury causation, and seat belt effectiveness, and medical device design review.

    Dr. Hollis analyzes how the human body reacts to forces generated from an accident in order to determine if the injuries are consistent with the accident event. Dr. Hollis utilizes a robust 3-dimensional simulation program to determine how an occupant moves in a particular collision, what the occupant collides with, the forces that are generated, and whether seat belt use would have prevented the reported injuries.

    Dr. Hollis is currently an Adjunct Assistant Professor in the Department of Orthopaedic Surgery at the University of South Alabama. Dr. Hollis has earned 8 United States patents in the field of Bio-Mechanics.

    Litigation Support - Dr. Hollis has testified as an expert witness in various cases on behalf of both plaintiffs and defendants. His services include medical record review, written reports, computer animation, computer simulation, deposition, and trial testimony as needed.

    Areas of Expertise:
    • Medical Device Design Review
    • Product Testing
    • Bio-mechanical Analysis of Injury
    • Product Prototype Fabrication
    • Medical Product Design
    • Bio-medical Implant Testing
  • Medical Device Testing
  • Product Liability
  • Sports Injury
  • Orthopedic Bio-mechanics
  • Patent Application Assistance
  • Patent Infringement and Validity
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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 30 years experience in Managing Medical Technologies from Pre-Purchasing Evaluation phase, to Installation, Training, Servicing and Incidents Investigation. His expertise includes wide variety of medical devices and accessories including infusion pump, laser, electrosurgery unit, monitors, X-ray, defibrillators, implantable, surgical instruments and catheters. Dr. David is also an expert in Electromagnetic interferences (EMI) with medical devices and in Telemedicine and TeleHealth systems. His experience also includes review and analysis of IP infringements allegation and patent validity.

    Dr. David serves a Consultant for industry and institutions including the Food and Drug Administration (FDA), 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.He authored manuscripts, chapters and books.
    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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    John F. Norris, MD, FACC, FHRS
    516 Lakeview Road, Villa 5
    Clearwater FL 33756
    USA
    phone: 727-559-8785
    John-Norris-Cardiology-Expert-Photo.jpg
    John F. Norris, MD, FACC, FHRS is a multiply board certified Cardiologist and Cardiac Electrophysiologist who trained under Douglas P. Zipes, MD, at Indiana University School of Medicine. He has practiced cardiac electrophysiology for more than 20 years in Clearwater, FL and has specialized in the treatment of Atrial Fibrillation and Stroke Prevention.

    Background - Dr. Norris has lectured extensively in Florida and as far away as Macedonia on the utilization of catheter ablation, device therapy and newer medications for the management of atrial fibrillation. He is a Fellow of the American College of Cardiology and the Heart Rhythm Society and spends most of his time in clinical practice as the head of Pinellas Arrhythmia Associates, PA. Dr. Norris has been extensively involved in the American Heart Association “Get With the Guidelines-Atrial Fibrillation” initiative.

    Dr. Norris has lectured extensively in Florida and as far away as Macedonia on the utilization of catheter ablation, device therapy, and anticoagulant medications for the management of atrial fibrillation.

    Litigation Support Dr. Norris offers complete Medical-Legal consulting services for cases involving Cardiovascular Disease, Cardiovascular Medicine, and Medical Devices. His services include comprehensive medical summary reporting, standard of care reporting, and expert witness testimony, and are available to attorneys representing both plaintiff and defendant.

    Areas of Expertise:
    • Atrial Fibrillation
    • Stroke
    • Sudden Death
    • Catheter Ablation
    • Medical Device Therapy
    • Coumadin
    • Eliquis
  • Pradaxa
  • Warfarin
  • Xarelto
  • Cardiology
  • Electrophysiology
  • Pacemakers
  • Implantable Defibrillators and AEDs
  • View Dr. Norris' Consulting Profile.
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    Don Skaff
    Managing Director
    Worldwide Availability. Offices in Singapore & UK
    111 Deer Lake Rd, Suite 100
    Deerfield IL 60015
    USA
    phone: 888 782-3473 and Local 847-559-3000
    fax: 847-559-3010
    Envista-Logo.gif
    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 served the insurance, legal and risk management industries for over 25 years. Their Experts travel globally from 19 offices located across the U.S., Canada, the U.K. 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. LWG Consulting 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.
    2/18/2014 · Medical
    All is quiet at 10:30 pm until a nurse notices water on the 2nd floor hallway. Building maintenance is called and discovers a ruptured pipe fitting in a bathroom on the 2nd floor. The water is shut off at 10:45 pm but unfortunately the damage has been done. It is later discovered that water penetrated through perforations in the ceiling in the CT suite on the 1st floor exposing the 16-slice CT gantry and patient table to water.

    1/14/2014 · Machinery
    The role that water plays in our existence is well understood. Without it, most living things will rapidly wither and die. Equally catastrophic of course, are the consequences of too much water. Not only to living things, in terms of widespread flooding, but also in terms of damage to machinery and equipment from exposure to water.

    Is it possible to differentiate between lightning related surges and artificially generated electrical surges?

    E-Discovery is the process of collecting and exchanging electronically stored information (ESI) that is requested during the discovery phase in civil litigation.

    3/14/2013 · Corrosion
    An ominous cloud of smoke continues to billow as the sprinklers rain water throughout the facility. The production manager's mechanical and electrical equipment is rapidly deteriorating, and within hours, the previously pristine equipment normally used to manufacture precision circuit boards will have a thin coating of flash rust with further damage forthcoming.

    1/25/2013 · Damages
    Doctors and nurses need to make quick, educated decisions to minimize the impact of difficult situations. These decisions are based on the practitioner's years of experience, their education, the science and technology available, and with the assistance of critical analytical and diagnostic equipment.

    11/19/2012 · Damages
    A water pipe breaks in a healthcare provider's facility, saturating an MRI control cabinet. The manufacturer is called in and spends $200,000 on attempted repairs. The unit still doesn't work. The manufacturer says the entire unit needs to be replaced, at a cost of $240,000.

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    Rochester Hills MI USA
    phone: 248-464-7852
    Rabbie-Hanna-Gynecologic-Ocology-Expert.jpg
    Rabbie K. Hanna, MD, specializes in Gynecologic Oncology. Dr. Hanna is certified by the American Board of Obstetrics and Gynecology in both Obstetrics and Gynecology and Gynecologic Oncology. He has special expertise in Robotic-assisted Surgery.

    Licensed to practice in Michigan, Dr. Hanna is a Member of the Society of Gynecologic Oncology, American Society of Clinical Oncology (ASCO) and the American College of Obstetrics and Gynecology (ACOG), among others. He is currently a Clinical Assistant Professor in Obstetrics and Gynecology at Wayne State University, Detroit, MI.

    Dr. Hanna is an attending physician of Gynecologic Oncology at the Henry Ford Health System in Detroit, Michigan, in addition to Genesys Health System in Grand Blanc, MI and Hurley Medical Center in Flint, MI.

    Areas of Specialization:
    • Gynecologic Cancer
    • Minimally Invasive Surgery
    • Robotic Surgery
    • Gynecologic Surgery
    • Endometrial Cancer
    • Ovarian Cancer
    • Fallopian Tube Cancer
    • Primary Peritoneal Cancer
  • Cervical Cancer
  • Vulvar Cancer
  • Vaginal Cancer
  • Laparoscopically Assisted Vaginal Hysterectomy
  • Robotic Hysterectomy
  • Endometrial Biopsy
  • Leiomyoma
  • Ovarian Cancer
  • Author - Dr. Hanna has published numerous book chapters, peer-reviewed articles, and abstracts on topics within his expertise.

    Speaker - Dr. Hanna has delivered Gynecologic Oncology seminars and presentations around the nation to such entities as the Society of Gynecologic Oncology and others.

    Honors and Awards - Throughout the years, Dr. Hanna has been recognized for his outstanding achievement and ability. Among many include the 2015 nomination for membership into the Gold Humanism Honor Society. In 2012, he was honored with the “Outstanding Teaching Award” presented by the Henry Ford Hospital/Wayne State University Obstetrics and Gynecology Residents and other teaching awards.
    3/2/2016 · Medical
    The primary management of hydatidiform moles remains surgical evacuation followed by human chorionic gonadotropin level monitoring. Although suction dilatation and evacuation is the most frequent technique for molar evacuation, hysterectomy is a viable option in older patients who do not wish to preserve fertility. Despite advances in chemotherapy regimens for treating malignant gestational trophoblastic neoplasia, hysterectomy and other extirpative procedures continue to play a role in the management of patients with both lowrisk and high-risk gestational trophoblastic neoplasia.

    Abstract Aim: To evaluate clinical outcomes and identify factors predictive for recurrence in patients with 1988 (FIGO) stage IA uterine endometrioid carcinoma. Patients and Methods: Patients who underwent hysterectomy for stage IA carcinoma were identified in our database. Fisher's exact and ?2 tests were used to identify factors that influenced outcome. Survival plots were generated according to Kaplan-Meier product-limit method and the log-rank test was used to determine significance. Results: A total of 121 patients were identified.

    Purpose Uterine clear-cell carcinoma (UCCC) is a rare subset of type II endometrial carcinoma with a poor prognosis relative to the most common type of endometrioid carcinoma. Due to its rarity, there has been limited direct evidence of the efficacy of specific adjuvant therapy posthysterectomy in women with UCCC. We present a review of current literature regarding adjuvant therapy of uterine clear cell carcinoma.

    OBJECTIVE: To report on the perioperative outcomes after robotically assisted total hysterectomy for benign indications in a large patient population with predominantly complex pathology.

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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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    Alan Schwartz
    Executive VP
    55 Northern Blvd.
    Great Neck NY 11021
    USA
    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.

    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)
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    George Yanulis, MEng, MS, DEng
    210 Ashley Run
    Voorhess NJ 08043
    USA
    phone: 216-571-1532
    George-Yanulis-medical-device-engineer-Photo.jpg
    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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    Mari S. Truman, PE
    Principal Engineer
    221 N. Union St.
    Waraw IN 46580
    USA
    phone: 574-265-1726
    fax: 866-470-6125
    Mari-Truman-Orthopedic-Biomechanics-Expert-Photo.jpg
    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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    Ade Akande, MD, MBA
    11315 Catherines Mine Circle
    Charlotte NC 28277
    USA
    phone: 704-293-7728
    Ade-Akande-Anesthesiology-Pain-Management-Expert-Photo.jpg
    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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