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.
Dr. Ewen Todd is a Food Safety Expert with over 45 years of knowledge and experience in general food safety and Food Microbiology Issues. Specifically, he has extensive 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 work with the industry and his knowledge of foodborne disease, 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. He has worked in numerous countries educating and training, and collaborating to set up surveillance systems, food safety policies, regulations, and HACCP and other control strategies, including China, Cambodia, Japan, United Arab Emirates, Lebanon, Kuwait, Saudi Arabia, and Europe, as well as Canada and the USA. He is also familiar with food defense and food fraud issues, and waterborne disease. He is familiar with the US and Canadian food industry, both foodservice and food processing, HACCP, disease investigation, food, and equipment contamination.
Since leaving the Canadian government and entering academia and as a consultant, he has been an expert witness in 25 cases in both the U.S. and Canada where foodborne illnesses have occurred. He has testified on the behalf of plaintiffs who suffered from E. coli O157:H7, Campylobacter, Salmonella, ciguatoxin fish poisoning, yeast, and unknown agents. He has also represented defendants in two illness cases. Therefore, his litigation services are available for both Plaintiff and Defense.
Areas of Expertise
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.
Areas of Expertise:
Tracy L. Skaer, PharmD, FASHP, FASCP is a Professor Emeritus of Pharmacotherapy with over 30 years of pharmaceutical experience; 5 years as an expert witness. She is a licensed pharmacist in California, Idaho, and Washington. Dr. Skaer is a Fellow of the American Society of Health-Systems Pharmacists, the American Society of Consultant Pharmacist, and a Member of the American College of Clinical Pharmacist's (ACCP) Pain and Palliative Care Practice and Research Network (PRN).
Dr. Skaer's 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.
Litigation Support - Dr. Skaer has completed several expert cases across the United States. Her services are available to attorneys representing plaintiff and defendant and include record review, written reports, deposition, and trial testimony. Dr. Skaer's cases involve: