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.
Vikas Aggarwal, MD, MPH, is a Board-certified Interventional and General Cardiologist with additional specialization in Vascular Disease and Pulmonary Embolism. He has vast tertiary care experience in the medical management of cardiovascular conditions as well as interventional techniques such as coronary and peripheral vascular interventions, pulmonary vascular intervention, mechanical circulatory support, and structural heart interventions.
Dr. Aggarwal holds certifications in Peripheral Vascular Ultrasound Interpretation (ARDMS) and Adult Comprehensive Echocardiography. He has extensive academic and teaching experience in the areas of interventional cardiology, cardiology, and vascular disease. He is a frequent invited lecturer and presenter at noted universities and cardiovascular institutions around the world.
Litigation Support: Dr. Aggarwal has extensive experience as an expert medical witness having completed more than 50 case reviews and depositions over the past 3 years. His cardiology and vascular disease services are available to attorneys for both plaintiff and defense, and include medical review, thorough reports, deposition, and trial testimony as needed.
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Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 35 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials.
As a consultant in his own pharmaceutical development advisory firm for over 23 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services are furnished to institutional investors.
Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.
Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more
Litigation Support - Mr. Anderson has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness and consultant to litigation in the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Anti-trust, Patent, and Product Liability.
Steven Burres has over 30 years of experience in the practice of Facial Plastic and Reconstructive Surgery. Dr. Burres provides all aspects of care including surgery, evaluation, treatment, and complications. He specializes in:
Dr. Burres' ear nose and throat experience includes broken noses and other facial fractures, hearing loss, vertigo, dizziness, smell, taste, nasal obstruction, sinusitis, tinnitus, hoarseness, GERD, sleep apnea, cancer, headaches, TMJ, skin disorders, facial nerve, and allergy.
Dr. Burres also has expertise in medical manufacturing having creative from concept-to-sales two medical businesses, one an injectable filler and the second a set of ear cleaning tools sold at major retailers.
Litigation Support - Dr. Burres has 20 years of experience serving as an expert witness and evaluator. He is a licensed QME/IME in California. His services are available to attorneys representing plaintiff and defendant for any medical legal matter including personal injury, workman's compensation, QME, IME, medical malpractice, or other medical manufacturing issues.
Education / Training:
Tobias A. Mattei, MD, is a academic Neurosurgeon specialized in Complex Spine / Deformity Surgery. Dr. Mattei is currently practices as an Assistant Professor of the Division of Neurosurgery of St. Louis University. He has been an active member of the North American Spine Society, American Association of Neurological Surgeons, Congress of Neurological Surgeons, World Federation of Neurosurgical Societies, as well as many other international societies.
Dr. Mattei is a member of the editorial board of The Spine Journal and Deputy Editor of the North American Spine Society Journal, the new open access initiative of the North American Spine Society. He is an active reviewer of several other neurosurgical journals including World Neurosurgery, Clinical Neurology & Neurosurgery, Journal of Clinical Neuroscience, Osteoarthritis & Cartilage, Journal of Engineering in Medicine: Part H, British Journal of Neurosurgery and Neurological Sciences.
As a researcher, Dr. Mattei has published more than 130 original research articles, having been cited more than 1400 times. He holds an unrestricted medical license in the states of Ohio, Missouri, New York, and Maine, and has never been submitted to any sanction or disciplinary action by any medical boards.
Litigation Support: Dr. Mattei provides expert witness services in the field of Spine Surgery, Spinal Care, and Neurosurgery. He has provided expert review services for several scientific funding agencies in the U.S. (including the NIH Panel for Clinical Neurophysiology, Devices, Neuroprosthetics, and Biosensors) as well as abroad (including the Innovation and Technology Commission/ Hong Kong SAR Government and The Brain Tumor Charity - New Ideas Award/UK).
Dr. Mattei's litigation support services are available to attorneys for plaintiff and defense and include review of hospital records, medical reports, imaging results, operative reports, patient's evolution, depositions, and trial testimony.
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Robert M. Stark, MD, has 40 years of experience practicing Internal Medicine, Cardiology, and Preventive Medicine. A graduate of Harvard Medical School, he is in full-time practice in cardiology and internal medicine.
Dr. Stark is past-president of the Connecticut Society of Internal Medicine. He serves as Adjunct Clinical Professor of Medicine at New York Medical College. and Director of his hospital’s Cardiovascular Prevention Program. Dr. Stark teaches residents and medical students as Adjunct Clinical Professor of Medicine. He also speaks frequently on cardiovascular topics for lay and professional groups as well as the media.
Litigation Support: Dr. Stark has 20 years of litigation experience in state and federal jurisdictions. He has served as a senior member of his state’s Medical Malpractice Claims Review Panel, where he helped determine the defensibility of cases on behalf of malpractice insurers and individual law firms. He also had responsibility for advising on defensibility of cases for Aetna Life & Casualty and CNA Insurance, as well as for individual law firms.
Dr. has given deposition and trial testimony in over 125 cases. He specializes in reviewing and explaining medical treatments and potential complications of cardiac conditions, and in evaluating medical treatments for standard of care. Dr. Stark provides summaries and reports that are cogent and complete. He firmly believes that the ability to communicate effectively is as essential to medicolegal work as it is to quality patient care.
Cardiovascular Disease and Internal Medicine Expertise:
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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|Failure Analysis||Accident Reconstruction|
|Fire & Explosion Analysis||........Safety|
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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Selected Professional Memberships:
Rod O'Connor, C.P.O. has over 30 years experience with Prosthetic and Orthotic Devices. His company has been Orange Countie's premiere Orthotic and Prosthetic supplier. After almost three decades of excellence, Mr. O'Connor sees client’s from around the globe including Spain, Iran, Japan, and more. He uses a combination of tried and true techniques combined with cutting-edge technology to tailor each device to the client’s needs.
O’Connor Orthopedic is the first orthotics and prosthetics clinic in Southern California to incorporate 3d printing and scanning into our everyday practice. Patients will see a reduction in the time it takes them to get their device and also a vast increase in the comfort due to the precision fit they can offer.
Litigation Support - Mr. O'Connor is available for consulting, expert witness services, forensic work, case viability and second opinions. He is certified by the American Board for Certification in Orthotics & Prosthetics. He has expertise in all types of artificial limbs and orthopedic appliances (braces).
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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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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