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

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

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

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

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

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

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

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

    View BHBA's Consulting Profile.
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    Uwe G. Goehlert, MD
    President
    150 Dorset Street
    PMB 201
    South Burlington VT 05403-6256
    USA
    phone: 802-578-8179
    fax: 802-713-1002
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    Uwe Goehlert Health care Expert PhotoUwe Gustav Goehlert, MD, CM, MPH, MBA, FAAFP, FAEP, FACFEI, CHCQM, FAIHQ is Board Certified in Family Practice, Emergency Medicine, Forensic Medicine, Quality Assurance and Utilization Review, Managed Care Medicine, and eligible in Preventive Medicine and Public Health. Dr. Goehlert has been practicing medicine for more than 30 years. He has extensive “hands on” clinical and administrative experience in multiple primary care settings. His broad expertise is in Ambulatory Emergency and Urgent Care Medicine for all age groups.

    Dr. Goehlert has particular interest and expertise in Managed Care Quality and Utilization Management for out of network and out of geographic area benefits. Efficiency of appropriate health care delivery using cutting edge biotechnology and medical informatics technology are his particular emphasis. He continues active clinical practice, administration, medical legal and insurance consulting and teaching. He is currently and actively engaged in medical legal ethics and peer review activities. His engagements include medical legal, insurance, educational, and managed care entities.

    Dr. Goehlert provides Medical-legal and Insurance Review Services to attorneys for both Plaintiff and Defense. His services include document review and second opinion to detailed ongoing litigation support / expert consulting.

    Areas of Expertise:
    • Ambulatory Care
    • Urgent Care
    • Emergency Medicine
    • Insurance Appeals
    • Utilization Reviews
  • Peer Reviews
  • Pre-authorizations
  • Medical Necessity Reviews
  • Travel Medicine
  • Medical Ethics
  • Education: Education: MPH, Johns Hopkins, Baltimore, MD. USA; MSc, MD, CM, McGill University, Montreal, CANADA; MBA, Loyola College, Baltimore, MD. USA

    Memberships and Associations (Selected):
    • American Medical Association
    • American Academy of Family Physicians
    • American College of Emergency Physicians
    • American Board Of Quality Assurance and Utilization Review Physicians
    • American College of Managed Care Medicine
    • American Academy of Urgent Care Medicine
    • American Public Health Association
    • International Society of Travel Medicine
    • American College of Forensic Examiners
    • American College of Physician Executives
    • American College of Legal Medicine
    • American College of Forensic Examiners Institute
    View Dr. Goehlert's Consulting Profile.
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    Kurt D. Humphrey
    Managing Director, Principal Technologist
    3780 Masters Drive
    Colorado Springs CO 80907
    USA
    phone: 719-331-9788
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    Kurt D. Humphrey has over 30 years of commercial Microelectronics and High-Tech Materials Design and Process Development, Corporate R&D Project Management, Reverse Engineering / Failure Analysis, and Patent / SME Consulting experience. With access to the best research tools, databases, labs and test equipment available, he is able to solve the most complex Intellectual Property technology issues.

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

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

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

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