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.
National Expert Witness And
Consulting Service For Attorneys
KHB CONSULTING SERVICES provides research, consulting and expert witness services to the legal profession for cases involving:
The primary areas of expertise are:
Dr. Ewen Todd is a Food Safety Expert with over 45 years of experience in the reporting and surveillance of Foodborne Disease, as well as development of analytical methods for identifying foodborne pathogens. As a result of his knowledge of foodborne disease and work researching different pathogens and toxins, Dr. Todd has influenced research programs and regulatory approaches taken by the Health Protection Branch of Health Canada. In the US, he held the position of Director of the National Food Safety and Toxicology Center and the Food Safety Policy Center at Michigan State University.
A leader in microbial research, foodborne disease surveillance, costing of outbreaks, food safety policy, seafood toxins, standard-setting, risk assessment, risk management and risk communication, his presentations and food safety programs have been influential in many countries including China, Cambodia, Japan, United Arab Emirates, Lebanon, Kuwait, Saudi Arabia, Europe, as well as Canada, and the USA. Dr. Todd has delivered over 400 presentations and posters at national and international meetings, with over 200 invitations to speak and teach workshops.
An acclaimed author in the field of Foodborne Illness, he has written 109 research papers, 16 reviews, 36 book chapters and booklets, 40 departmental publications, 37 conference proceedings, 9 laboratory methods, 56 investigational and editorial articles, 90 published abstracts, and 3 editings of proceedings or books. Dr. Todd has received 20 appointments and awards, including the Excellence in Science Award for 1998, the first to be awarded by Health Canada. He is a Fellow of the American Association for the Advancement of Science, the International Association for Food Protection and MSU University Outreach and Engagement as well as Editor in Chief for the Elsevier Encyclopaedia of Food Safety.
Dr. Todd's Consulting services are available to businesses and governments internationally. He responds to telephone calls, emails, and written requests for information on food and waterborne disease.
Consulting Services Include
One Way Consulting, LLC, is a Medical Device Consulting firm whose mission is to help get your device to the market sooner, to assure your quality systems meet FDA requirements, and solve any FDA issues in a timely and successful manner.
Principal, 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.
Tracy L. Skaer, PharmD, FASHP, FASCP is a Professor Emeritus of Pharmacotherapy with over 30 years of pharmaceutical experience. Dr. Skaer's research and professional experience include pharmacy practice, chronic pain, mental health, substance abuse, and complementary and alternative medicine. She is licensed pharmacist in California, Idaho, and Washington.
Dr. Skaer’s current research involves the use of mindfulness and multiple family group problem solving for the Treatment of Chronic Pain in those with high risk of Opioid Use. Her plans are to expand this intervention to manage chronic insomnia and post-traumatic stress disorder in children and adolescents, American Indians, veterans, and other populations. Other research interests include chronic pain, comorbid mental illness in chronic disease, depression, anxiety disorders, insomnia, mindfulness, complementary and alternative medicine, and pharamcoeconomics and pharmacoepidemiology. Her research has been supported by over $3.2 million in grants from foundations and pharmaceutical industry.
Dr. Skaer has published 110 professional abstracts, 82 research papers, 43 review articles, and 6 book chapters. She serves on the editorial boards of 3 medical professional journals, Clinical Therapeutics, Journal of Sleep Medicine and Disorders, and Pain Studies and Treatment. Dr. Skaer's publications have appeared in numerous journals including, Drugs, Clinical Drug Investigation, PharmacoEconomics, Journal of Clinical Pharmacy & Therapeutics, American Journal of Medicine, Harvard Review of Psychiatry, and the New England Journal of Medicine among others.