John B. Everlove, Paramedic, BA has over 25 years of experience providing Emergency Medical Services. Currently licensed and practicing in California, Mr. Everlove has the following licenses and credentials:
Litigation Support - Mr. Everlove provides dependable and professional litigation and support services for both plaintiffs and defendants. As a Supervisor and Clinical Manager for an organization of 150 employees, he conducted numerous investigations related to all aspects of Pre-Hospital Emergency Care from inception, to final review and root cause analysis. Mr. Everlove has participated in the research, development and implementation of clinical care equipment, policy and procedure design and implementation, as well as clinical educational services for Paramedics and EMTs. Areas of Expertise:
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 34 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.
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Peter A. Crosby has over 35 years experience in the Medical Devices Industry. He has been the CEO of six medical device companies (public and private) in four countries, and has been a member of the board (including chairman of the board) of over 10 companies.
Mr. Crosby is an accomplished entrepreneur and company builder, and has brought many medical device products to the world market. In 2017, he retired as CEO from Mainstay Medical, after spending over 8 years as the founding CEO, doing several rounds of financing, taking the company public in Europe, and bringing Mainstay’s ReActiv8 to market in Europe. Although he continues to work with the company on a consulting basis, he has shifted his focus to helping other companies grow, as a board member, advisor, and in interim management.
With a university education in Biomedical Engineering, Mr. Crosby is the inventor on over 30 US patents and applications pending. He has managed the intellectual property portfolio of several companies. His clinical domain experience includes ophthalmology, otolaryngology, cardiology, cardiac surgery, orthopedics, pain management, anesthesia, and intensive care.
Litigation Support - Mr. Crosby has served as an expert witness in many cases including product liability, intellectual property (patent disputes), and commercial contracts disputes. He has testified in three cases in which the outcome hinged on interpretation of “commercially reasonable efforts.” Mr. Crosby's services are available to attorneys representing plaintiff and defendant.
Dr. Yadin B. David has over 35 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, implants, monitors, warmers, surgical instruments and catheters. Dr. David is also an expert in Electromagnetic interferences (EMI) medical devices and in Telemedicine and TeleHealth systems. His experience includes review and analysis of patent infringements allegation and validity. Dr. David serves a Consultant for industry and institutions including the Food and Drug Administration (FDA), General Hospital and Personal Use Devices Panels, World health Organization (WHO)and medical devices manufacturers. His services include testing, adverse events investigation, engineering reports, equipment management 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.
Mary B. Gloeckner, RN, MS, APN, is a Medical-Surgical Clinical Nurse Specialist who specializes in Wound Care and Ostomy Nursing. She has been a nursing consultant at Trinity Medical Center in Rock Island, Illinois, a 500 Bed hospital, for over 36 years. Ms. Gloeckner started the Wound & Ostomy Clinic (WOC) program at Trinity when she began there in 1983. She served on 2 National Boards, the WOC Certification Board, and the Friends of Ostomates Worldwide. Ms. Gloeckner was also elected to sit on the International Board(ISTAP) on Skin Tears, which she still currently serves on. She was honored with receiving the 2011 Iowa Affiliate Wound, Ostomy and Continence Nurses Society's (WOCN) Nurse of the Year Award and the 2016 USA WOC Nurse of the Year Award. Ms. Gloeckner provides litigation support service to attorneys for Plaintiff and Defense. Her cases include issues related to Wound Care and Colon and Rectal Surgery. Ms. Gloeckner is available to review medical records for standard of care and causation. Areas of Expertise and Consultation:
Lloyd Marks, MD, MBA, FACC, is an MIT trained Electrical Engineer, Johns Hopkins trained Pediatric Cardiologist, and Inventor. Always active in both medicine and medical engineering, Dr. Marks has been granted 22 Medical Device Patents. He currently gives advice to academic institutions, investors, and corporations regarding the commercialization of medical technology.
Background Experience - Dr. Marks was in academic medicine for 15 years, as the Director of the Cardiac Cath Lab at St. Christopher's Hospital for Children and the Division Chief of Pediatric Cardiology at the Children's Hospital of New Jersey. He was then in private practice for 18 years. In 1997 he opened his clinical practice, specializing in Pediatric and Adult Congenital Heart Disease, where he provided clinical evaluation, electrocardiography, echocardiography, stress testing, Holter/event monitoring, diagnostic cardiac catheterization, and interventional cardiac catheterization.
After closing his clinical practice in 2015, Dr. Marks went to business school and obtained an MBA from the Haslam School of Business, University of Tennessee. While there, he wrote a business plan with financial projections for his startup company, MGI Medical, LLC, commercializing a non-invasive patient monitor for the detection of post-operative bleeding. Dr. Marks has successfully licensed 9 of his inventions to industry and assigned 8 to MGI.
Litigation Support - With his unique background in the field of medical device commercialization, Dr. Marks has been involved in protracted Patent Infringement litigation with a successful outcome. He is adept at explaining to a jury in lay terms complex medical technology and terminology, ranging from MRI readings to the difference between "clinical" and "statistical" significance. Dr. Marks' cases include all matters pertaining to:
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John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies.
Mr. Stevens has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices.
Litigation Support - An FDA expert and seasoned business professional, Mr. Stevens is uniquely qualified to opine on cases involving the FDA's regulation of medical devices. He has served as an expert witness for over 10 court cases involving the FDA regulation of medical device firms. His services include thorough reporting, depositions, and trial testimony.
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T. Kim Parnell, PhD, PE is a Professional Mechanical Engineering consultant and is Principal & Founder of Parnell Engineering & Consulting (PEC). Dr. Parnell holds PhD and MSME degrees in Mechanical Engineering from Stanford University, a BES from Georgia Tech, and is a registered Professional Mechanical Engineer (PE) in the State of California. He is an ASME Fellow, an IEEE Senior Member, and a Member of ASM and SAE. Dr. Parnell is Past-Chair of the IEEE Santa Clara Valley Section (IEEE-SCV) (over 12,000 members) and Past-Chair/Board Member of the IEEE Consultants' Network of Silicon Valley (IEEE-CNSV). Dr.Parnell is an experienced Expert Witness, has provided testimony in both trial and deposition, and has authored numerous expert reports and IPR declarations. He has worked extensively as an expert in medical devices, patents, product failure, product liability, and personal injury. Dr. Parnell has been retained in medical device litigation cases that are in the news and adjudicated in MDLs. Products include IVC Filters (Inferior Vena Cava Filters), Pelvic Mesh, Transvaginal Mesh, Intragastric Abdominal Balloon Weight Loss Systems, Back Pain Reduction Systems, and others. Dr.Parnell brings both breadth and depth of experience to clients. He has over 34 years of professional consulting experience, has taught both graduate and undergraduate University classes (Visiting Professor at Stanford University & Adjunct Professor at Santa Clara University), and has also worked in industry. His industrial positions include sectors such as software, hardware, medical devices, and telecommunications equipment. He has extensive experience in areas including patents, medical devices, Nitinol shape memory alloy material, mechanical failure of products or equipment, and material failure by fracture or fatigue. Dr.Parnell frequently works with early-stage companies as both a technical consultant and a business advisor in sectors including medical devices and flash memory technology.
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Georgia J. Persky RN, MBA, PhD, CLNC, CNOR is a Columbia University trained nurse researcher with over 40 years of broad Clinical Nursing experience and 25 years of senior leadership in Hospitals, Nursing Homes and Home Health organizations. She also has 20 years of Surgical Nursing and Operating Room experience. Dr. Persky has expertise in the micro issues in nursing for 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 the past 25 years and most recently at New York Presbyterian Hospital/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 care units and Care Management, Respiratory Therapy, Social Work and Admitting Departments with 9 direct reports and 2,000 patient care employees.
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 in malpractice and personal injury cases, as well as, with human resource and employee discrimination with an ability to attest to standards of care in clinical litigation. Dr. Persky's services are available to attorneys for the plaintiff and defense seeking an expert in nursing and patient care with a strong understanding of how heath care organizations work.
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Richard A. Lazar is the nation’s leading Automated External Defibrillator (AED) Program Compliance Expert. He and his company, Readiness Systems, design and document complete AED programs, remotely monitor AEDs, provide AED law and public policy resources and publish industry standards
An AED program consists of a design and supporting set of policies and practices that ready an organization for Sudden Cardiac Arrest (SCA) emergencies, suggest what actions should be taken if SCA is encountered and help manage the legal risks that come with owning AEDs. Industry standards and AED laws guide what to include in an AED program’s policies and practices.
Background Experience: For over 25 years, Mr. Lazar has designed and documented AED programs for AED programs nationwide. Examples include Microsoft, the Federal Aviation Administration, 24 Hour Fitness among many others. Earlier in his career, he practiced emergency medical services law, designed emergency medical services (EMS) systems, served as an EMS system administrator, and was an emergency medical technician. He also holds a law degree from Lewis & Clark School of Law and a Bachelor of Science degree in Public Affairs from the University of Oregon.
Mr. Lazar develops and publishes national AED Program Design Guidelines that describe industry standards for AED programs and the AED Law Center, the only comprehensive online information resource that helps AED owners learn about the AED laws for every state, understand the AED laws in plain English, and stay informed about pending AED legislation nationwide.
Litigation Support: As the leader in his industry, Mr. Lazar has provided both consulting and testifying expert services to lawyers in a variety of cases around the U.S. involving sudden cardiac arrest response in workplace and community (non-medical) settings. His deep understanding of AED programs has led him to testify before the U.S. Congress in support of the Cardiac Arrest Survival Act, the FDA on AED over-the-counter and reclassification issues, and numerous state legislatures on AED public policy issues and immunity laws.
Christopher M. Daft, PhD, is an award winning, Oxford Educated Materials Scientist whose areas of expertise include medical imaging, electronics, semiconductors, medical devices, sensors, MEMS, signal processing, and image processing. A serial inventor who holds 23 United States Patents with several pending, Dr. Daft has diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung, and Siemens as well as several start-ups. He is a well-published winner of grants from the National Institute of Health. Dr. Daft has been an Institute of Electrical and Electronic Engineers (IEEE ) Senior Member since 2004. He has three years of experience teaching electrical and computer engineering at the University of Illinois. Dr. Daft holds a BA and MA in Physics from Oxford University as well as Doctorate from Oxford in Materials Science.
Litigation Support - Dr. Daft provides litigation support in the areas of Intellectual Property and Medical Devices including Imaging, particularly Medical, Patents, Minimally Invasive Surgical Guidance, and more. His experience includes a variety of cases in the areas of wearable electronics, imaging systems, and surgical technology. Dr. Daft has extensive deposition and trial testimony experience.
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