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Biotechnology Expert Witnesses

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William Acorn, P.E., FASHRAE
Principal
10617 N Hayden Rd, Suite B-108
Scottsdale AZ 85260
USA
phone: (602) 888-7250
fax: 520-577-0851
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William Acorn Technology Analysis ExpertWilliam R. Acorn, P.E., FASHRAE, is principal and founder of Acorn Consulting Services, LLC (ACS). For over 35 years, he has been involved in the Engineering Analysis and Design of hundreds of projects ranging from Institutional Laboratories to Cleanroom Facilities for the semiconductor industry.

Mr. Acorn has significant experience as an Expert Analyst of System Design, System Failures, Code Compliance issues and Cause/Effect relationships of problems related to the built environment. Mr. Acorn has received numerous awards for technical excellence and is recognized for his technical achievements, innovation and foresight by peers, associates and clients in the advanced technology industry.

Mr. Acorn is an Adjunct Professor at Arizona State University; the author of the book Code Compliance for Advanced Technology Facilities; and a frequent lecturer to the industry and academia on a variety of technical topics related to building and cleanroom design, construction and project management.

Mr. Acorn is registered as a Professional Mechanical Engineer in the States of Arizona, California, Colorado, Illinois, New Mexico, New York, Nevada, Oregon, Texas and Utah. He is also registered with the National Council of Examiners for Engineering and Surveying.

Forensic & Litigation Consulting

Analysis and evaluation of losses related to failed systems or other facility performance issues is provided on behalf of owners or attorneys. These services are provided with regard to deficiencies in HVAC Systems, Cleanrooms, Piping Systems, Refrigeration Systems, Construction Claims, Building and Fire Codes:
  • Litigation Consulting
  • Technical Analysis and Investigation
  • Claims Preparation and Analysis
  • Expert Testimony
  • Project Consulting

    ACS assists their clients to optimize the outcome of new and retrofit facilities by providing a range of high level services including:
  • Strategic Planning: Conceptual Design; Feasibility Studies & Evaluations; Value Engineering
  • Facility Retrofit and Renovation Strategies
  • Program Management: Project Delivery Strategies; Selection of Design and Construction Teams
  • Design Consulting and Design Review
  • Code Compliance Analysis and Negotiation
  • 4/11/2005 · Construction
    Introduction: In our first Volume of the Forensic Exchanger, we discussed some of the all too many reasons why HVAC systems fail. If you missed that edition and are interested in that topic e-mail us and we will gladly send it to you. We will follow up with more discussion of that important topic in later editions

    William R. Acorn
    Facilities which utilize hazardous liquids and gases represent a significant potential liability to the owner, operator, and general public in terms of personnel safety and preservation of assets. It is obvious that a catastrophic incident or loss of property or personnel is to be avoided at all costs. This book was conceived to give the reader a guide to understanding the requirements of the various codes and regulations that apply to the design, construction, and operation of facilities utilizing hazardous materials in their processes.
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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
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    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.
    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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    Dr. Bruce C. Hemming
    PhD, President/CEO
    See Multiple Addresses Below
    St. Louis MO 63119-3421
    USA
    phone: 314-645-2177 or 800-688-9144
    fax: 314-645-2544
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    Dr. Bruce C. Hemming, PhD - President & CEO of Microbe Inotech Laboratories, Inc. (The MiL, Inc.) is an accomplished science and business professional with over 30 years of real-world experience in Microbiology and its practical applications. Dr. Hemming and his staff perform rapid microbial identifications, confirmations, and contaminant sourcing, of all pathogenic, indicator, and spoilage organisms (bacterial, yeasts and molds, and other fungi) using the latest genetic (DNA) and instrumental technologies.

    Dr. Hemming provides litigation support services to attorneys representing both Plaintiff and Defense. He brings with him The MiL advantage of:
    • Proprietary, microbial kinetic and endpoint assays
    • Microbial databases which contain profiles of over 3,000 species of microbes
    • Microbial diagnostics research
    • Product development capabilities
    • Specialized skills in using automated, microbial characterization, identification tools
    Areas of Expertise
    • Food Safety & Nutrition - Spoilage
    • Environmental Sampling
    • Biomedical - Pharmaceutical
    • Industrial Hygiene
    Helix Center (Core Lab)
    1100 Corporate Square Drive, Ste. 225
    St. Louis, MO 63132
    Telephone: 800-688-9144
    Microbe Scan, LLC
    1100 Corporate Square Drive, Ste. 224
    St. Louis, MO 63132
    Telephone: 800-688-9144


    View Dr. Hemming's Consulting Profile.
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    Michael F. Arrigo
    620 Newport Center Drive
    Suite 1100
    Newport Beach CA 92662
    USA
    phone: 949-335-5580 x101
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    Michael F. Arrigo, CPHIT, CPEMR, is Managing Partner of No World Borders works with health systems, health IT companies, and health plans and provides opinions in compliance with Rule 702 based on his knowledge, skill, training, education and experience based on facts in the case, and application of testable principle and methods.

    Professional Summary:
    • Expert for work with health system, health IT company, and insurance firm in landmark federal trade commission case
    • Quoted in Wall Street Journal, New York Times; regular speaker, published as expert in the field
    • Clinician, coder, medical billing, claims, E.H.R, practice management software, and regulatory usual, customary and reasonable (UCR) medical and prescription charges experience
    Litigation Support - Mr. Arrigo provides expert opinions in matters at county, state, and federal levels. He has worked on cases regarding individual plaintiffs and defendants, city governments, law enforcement agencies, insurance firms, and hospital systems and physician groups, as well as class action law suits with tens of thousands of members throughout the U.S.

    Mr. Arrigo has the ability to explain complex concepts such as HIPAA EDI, claims, payor-provider contracting and resultant reimbursement, and other processes to lay-persons and the Court in expert reports, depositions and at trial. He has balanced plaintiff / defendant law firm engagement experience.

    Education:

    Currently studying at Stanford Medical School in biomedical informatics, business degree from University of Southern California, studies in economics, computer science and statistics at the University of California Irvine.

    Areas of Expertise:

  • Affordable Care Act
  • Coding & Billing
  • Health Care Administration
  • Health Care Finance
  • Health Care Policy & Procedures
  • Health Care Regulations
  • Insurance Laws and Regulations
  • HIPAA Privacy & Security
  • HITECH Act
  • HMO / Managed Care
  • Hospital Records
  • ICD-10
  • Insurance Claims
  • Insurance Compliance
  • Insurance Fraud
  • Medicare
  • Meaningful Use of Electronic Health Records
  • Medicaid
  • MRI, CT Scans
  • Medical Records Review
  • Regulatory Issues
  • Cost Benefit Analysis
  • Online Privacy & Security
  • Usual, Customary & Reasonable (UCR) Medical Costs


  • View Michael Arrigo's Consulting 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 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.