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Medical Equipment Consultants

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5380 Old Bullard Rd
Suite 600-326
Tyler TX 75703
USA
phone: 414-218-4310
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Seth Womack Emergency Medicine Expert PhotoSeth P. Womack, MD, FAAEM, is Board Certified in Emergency Medicine by the American Board of Emergency Medicine. A fellow of the American Academy of Emergency Medicine, Dr. Womack is recognized for his expertise in pediatric, trauma, neurological, and cardiac resuscitation. Dr. Womack is also ATLS (Advanced Trauma Life Support) certified and has completed the Difficult Airway Course: Emergency ™. He is currently licensed to practice in Louisiana, Texas, and Wisconsin.

With an undergraduate Degree, Magna Cum Laude, in Biomedical Engineering, Dr. Womack is an experienced flight physician, skilled in the utilization of video laryngoscopy for emergency airway management and bedside ultrasound procedures. He has treated over 25,000 patients over the course of his medical career.

Litigation Support - Dr. Womack is highly experienced and able to serve as an Emergency Medicine expert witness. His case review services are available to counsel representing both Plaintiff and Defense. Dr. Womack works on cases involving an alleged breach of the standard of care committed by an emergency room physician. The issues he may be called upon to address include standard of care, breach, and causation.

Areas of Expertise:
  • Heart Attacks
  • Myocardial Infarction
  • Strokes
  • Pulmonary Embolism
  • Airway Management
  • Appendicitis
  • Ectopic Pregnancy
  • Pneumonia
  • Aneurysm Trauma
  • Testicular Torsion
  • Mental Health / Suicide
  • Sepsis
  • Airway Management
  • Central Line Placement
  • CASE: 43-year-old male presents to the ER with chief complaint of vomiting blood and epigastric (upper stomach) pain. Approximately 1 hour prior to presenting to the ER, he finished dinner with his family of 5; became nauseated and sweaty; and vomited his meal mixed with a large amount of dark red blood. His wife states that it seemed "like a gallon!" Pertinent past history included weekly ibuprofen use for chronic knee pain and alcohol use consisting of beer only on the weekends when he is not working.

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    Amitkumar Dharia, PhD
    8418 Sterling St., Suite A
    Irving Texas 75063
    USA
    phone: 972-915-0516
    fax: 972-915-0518
    Amit-Dharia-Plastics-Polymers-Expert-Photo.jpg
    Transmit Technology Group, LLC was founded in 1999 to assist small and medium size Plastics Industries and sole proprietors in their day to day problem solving and short –term product and process development needs.

    Clients come to Transmit Technology Group, LLC from a broad range of plastic industries (Fortune 500 to sole proprietors) and job functions including process engineers, QA/QC professionals, CTOs, CEOs of start-up companies, individual inventors, production managers, corporate marketing managers, lawyers, and R&D specialists.

    Transmit Technology Group, LLC is an independent laboratory which provides a wide range of services, including:
    • Plastic Testing
    • Polymer Analysis
    • Failure Analysis
    • Product Development
    • Contract Research and Development
    • Technical Marketing
  • IP Development
  • Equipment Modifications / Process Modifications
  • Competitive Advantage
  • Raw Material / Equipment Sourcing
  • Ideation or conceptualizing
  • Technical Representation
  • Principal, 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.

    View Dr. Dharia's Expert Witness Profile.
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    Joahnna D. Songer Budge RN, CCRN, CLNC
    Medical-Legal Case Consultant, Expert Witness
    Offices in Saratoga Springs, UT and Kerman, CA
    CA, UT USA
    phone: 559-741-3054
    fax: 559-553-8880
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    California Office
    15662 Orchard Way
    Kerman, CA 93630
    Utah Office
    186 Cove Road
    Saratoga Springs, UT 84045
    Songer, Evans & Associates, Legal Nurse Consultants are actively practicing Registered Nurses / Legal Nurse Consultants. As LNCs, they assist attorneys, insurance companies and health care facilities on medical-legal and medical record case issues. With over 35 years of combined clinical experience, they work as an extension of the attorney's education and thought processes. Their goal is for the attorney to be fully informed and prepared on the medical issues of a case for negotiating and litigating.

    As Consulting Experts, Songer, Evans & Associates work behind the scenes, providing essential organization and analysis of medical records, analysis of medical testimony, case strategy development, and medical record/testimony/case reports provided in the format of the attorney’s choosing. Songer, Evans & Associates, Legal Nurse Consultants, offers medical literature research relevant to case strategy, and medical demonstrative evidence preparation. For nearly 20 years, they have acted as collaborators and strategists, offering support in medically-related litigation and other medical-legal matters in the a variety of practice areas including the following:
    • Personal injury
    • Product liability
    • Medical malpractice
    • Workers' compensation
    • Toxic torts
    • Risk management
    • Medical licensure investigation
    • Fraud and abuse, compliance
    • Criminal law
    • Elder law
    View Expert Witness Profile.
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    Prosthetics and Orthotics Expert Witness and Consultant
    792 Eastern Point Road
    Annapolis MD 21401
    USA
    phone: 410-533-1960
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    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 knowledgeable in prosthetic and orthotic clinical practice and management, component prescription recommendation, and selection and utilization for all patient ages and levels of function make him an excellent expert witness resource. His services are available to attorneys representing plaintiff and defendant and include medical record review, second opinions, written reports, depositions, and trial testimony.

    Areas of Expertise:
    • Appropriate Prosthetic / Orthotic Component Selection Recommendation
    • Utilization and Failures Due to Improper Manufacturing Processes
    • Prescription Appropriateness
    • Clinical Applications and Negligence Directly Related to Limb Weakness and Loss
    • Spinal Cord Injury and Treatment
    • Wrongful Death Investigation and Determination
    • Limb Damage and Loss in Diabetics as Related to Footwear
    • LifeCare Plan Consultation and Preparation as Related to Orthotics and Prosthetics
    Education:
    • New York University Medical School Orthotics and Prosthetics Certificate Program, Certification as Certified Prosthetist, 1973
    • Northwestern University Medical School Orthotics and Prosthetics Certificate Program, Certification as Certified Orthotist, 1973
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    Richard K. Baer, MD
    2727 N Lakewood Ave
    Chicago IL 60614
    USA
    phone: 773-477-0201
    fax: 773-477-0202
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    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.

    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. Originally trained in psychiatry, 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. Dr. Baer provides Consulting Services on Medical Policy, Compliance, Billing, and Documentation and ICD-10 for Government and private payers, industry and providers. This includes:
    • Clinical Trials
    • Medical Billing Compliance
    • Medical Documentation Compliance
    • Medical Device and Drug Marketing
  • Coverage Expertise
  • ICD-10 Readiness
  • Medical Claims Processing Automation
  • Medical Claims Data Analysis
  • Dr. Baer also provides expert medical consultation on payer coverage requirements for the Medical Device Industry. His services include:
    • Review of new technologies to propose clinical study design to ensure post-approval coverage
    • Strategy to seek specific device coverage or overturn non-coverage decisions for government and commercial payers
    • Review of clinical data to make recommendations to strengthen coverage and payment positions
    View Dr. Baer's Expert Witness Profile.
    Richard Baer, MD
    A Doctor’s Harrowing Story of Treating a Woman with 17 personalities.
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    John F. Norris, MD, FACC, FHRS
    516 Lakeview Road, Villa 5
    Clearwater FL 33756
    USA
    phone: 727-587-6999
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    Pinellas Arrhythmia Associates (PAA) is a leader in comprehensive monitoring, diagnosis & treatment of Cardiac Electrophysiology problems. PAA, located in Clearwater-St./ Pete area, currently provides the full array of modern electrophysiology diagnostics, treatments, and technologies, which include:
    • Expert EKG Interpretation
    • Holter Monitoring & Interpretation
    • Loop Recording & Interpretation
    • Electrophysiology Studies
    • T-Wave Alternans Testing
    • Tilt-Table Tests
    • Antiarrhythmic Drug Therapy
    • Follow-up for Pacemakers & Implantable Cardioverter-Defibrillators (ICD Treatment)
    • Cardiac Resynchronization Therapy (Biventricular Pacing) for Heart Failure management
    • Catheter Ablation for Atrial Fibrillation
    • Hybrid Surgical CONVERGENT Ablation for Longstanding Atrial Fibrillation
    • Catheter Ablation Procedures for all Types of Cardiac Arrhythmias
    • Watchman Implantation
    Founder and President, 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.

    View Dr. Norris' Expert Witness Profile.
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    T. Kim Parnell, PhD, PE
    Principal
    1150 Kelsey Dr.
    Sunnyvale CA 94087
    USA
    phone: 408-203-9443
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    Medical Device, Biotech, Failure Analysis, Mechanical Eng, Materials, Design, Reliability, Consultant

    Kim Parnell Mechanical Engineer Expert PhotoParnell Engineering & Consulting (PEC) is a high-tech Mechanical Engineering Consultancy located in the heart of Silicon Valley. PEC focuses on providing technical support for early stage medical device and technology companies nationally and internationally.

    T. Kim Parnell, PhD, PE, Principal and Founder of PEC, is a Mechanical Engineering consultant with strong experience in a number of technology areas. Dr. Parnell 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.

    Areas of Expertise:
    • Medical Device / Biotechnology - Cardiovascular, Orthopedic, Orthodontic
    • Patents & Intellectual Property
    • Plastics, Molding, & Manufacturing
    • Composite Materials Design & Damage
    • Materials & Metallurgy
    • Failure Analysis & Reliability
    • Fracture & Fatigue
    • System Specifications & Test Procedures
    • Telephone Set Design; Keypads
    • User Experience & System Interaction
    • User Interface Design
    • Software Design, Development, QA
    • Green Energy: Wind Energy, Electric Vehicles, Battery technology, Solar
    • Structural Mechanics, Fluid Mechanics, Heat Transfer, & Thermodynamics
    • Finite Element Analysis of Structures and Fluid / Heat Transfer (FEA/CFD)
    • Piezoelectric components
    • Transducers, Accelerometers, MEMs
    • Vehicle & Heavy Truck Crash Worthiness
    • Shock & Vibration Sensitivity
    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 Expert Witness 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
    USA
    phone: 704-293-7728
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    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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    Glenda Flemister MD, FACP, FCCP
    President/Medical Director
    21200 S La Grange Road
    Suite 273
    Frankfort Illinois 60423
    United States
    phone: 815.534.5677
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    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.

    Currently the Executive Medical Director for Medical Health Solutions,a company involved in predicting trends to optimize healthcare at an affordable and sustainable rate, Dr. Flemister provides education, consultation, and resources to the medical industry, medical providers, and managed care organizations regarding:
    • Technology & Devices
    • Pharmaceutical Issues / Pharmacy Genomics
    • Health Care Standards
    • New Legislation concerning Health Care and Best Healthcare Outcomes
    Prior to Medical Health Solutions, Dr. Flemister served as the Mid America Medical Director for Aetna where she provided clinical leadership for the utilization management process of all ages, including pre-authorization, denials and appeals, specialty and sub-specialty reviews with medical determinations using nationally published and recognized clinical guidelines. Utilization reviews included evaluation of the health history, diagnosis, pharmaceutical utilization, and medical device review for appropriateness of medical services.

    Dr. Flemister delivers educational lectures and seminars on topics within her expertise including HIV and Aids, Asthma Control, Ventilator Management, Chronic Obstructive Lung Diseases, (demographics, treatment strategy, outcomes, projected cost etc), Medical Genomics, and Medical Devices Strategies.

    View Dr. Flemister's Expert Witness Profile.
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    George Yanulis, MEng, MS, DEng
    210 Ashley Run
    Voorhess NJ 08043
    USA
    phone: 216-571-1532
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    Medical Device Consulting, LLC provides Biomedical, Clinical, and Forensic Engineering services to hospital systems, medical device companies, insurance carriers, and legal practitioners in both medical device liability and patent cases.

    Medical Device Consulting, LLC offers Medical Device Research and Development and Clinical Engineering Consulting Services for medical instrumentation devices including:
    • Cardiovascular and neurological device design issuesIntellectual property related to medical devices and imaging systems
    • FDA medical device regulatory compliance controls
    • FDA regulatory issues of medical devices
    • FDA device verification and validation
    Principal, 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.

    View Dr. Yanulis' Expert Witness 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
    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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    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 Lipschultz, PE, CCE, CSP, CPPS
    11420 Strand Drive, #306
    North Bethesda MD 20852
    USA
    phone: 302-584-1050
    HealthCare Technology Consulting, LLC provides technical assistance to regulators, manufacturers, user facilities, and users of Medical Devices. The president of HealthCare Technology Consulting, Alan Lipschultz, PE, CCE, CSP, CPPS, is a nationally recognized expert in Clinical Engineering and Healthcare Technology Management. He has almost 40 years of professional experience in the healthcare industry serving as Director of Clinical Engineering at two major institutions. He is the recipient of the Marv Shepherd Patient Safety Award in 2012 and the Association for the Advancement of Medical Instrumentation (AAMI) Clinical / Biomedical Engineering Achievement Award in 2006.

    Consulting Services:
    • Clinical Engineering - Help in making sound economic decisions regarding purchasing, implementation, and management of processes surrounding medical devices.
    • Forensic Engineering - Analyze the failure of medical devices.
    • Patient Safety and Risk - Work with healthcare providers, manufacturers, and independent test labs to mitigate risks before they create hazards.
    • Systems Integration - Help; link devices together to technologically improve the practice and economics of healthcare.
    • Medical Device Improvement - Advise on design concepts or NFPA-99 compliance prior to sale and for existing products.
    View Alan Lipschultz's Expert Witness Profile.
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    Rochester Hills MI USA
    phone: 248-464-7852
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    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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    Jon M. Crate, President & Chief Executive Officer
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    FAI Materials Testing Laboratory, Inc. (FAI) is a full service Analytical, Failure Analysis, and Materials Testing laboratory that provides clients with the best explanation about why their materials, products, and components perform the way they do.

    FAI is comprised of professional scientists, chemists, and engineers with decades of experience solving problems in a host of industries including Aerospace/Aviation, Automotive/Vehicle, Biomedical Device, Construction, Energy/Power, Manufacturing, Marine & Offshore, and Mining & Metals.

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    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 consultnat who 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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