Medical Product Liability: Was It the Device, the Doctor, or the Disease?

Dr. Laurens is a highly credentialed biomedical engineer and expert in FDA regulation, compliance, and product liability for medical devices and biologics. She provides expert witness services to both plaintiff and defense counsel in litigation involving medical device and biologics FDA approval and clearance, labeling and warnings, quality systems, adverse event reporting, clinical trials, and post-market surveillance. Dr. Laurens brings over 20 years of combined industry, research, and regulatory experience. She has led regulatory and quality efforts across the entire medical device lifecycle, from concept through commercialization, supporting product development, regulatory submissions, and quality compliance for a wide range of technologies, including cranial and orthopedic implants, spinal and neural devices, tissue engineered-biologics and combination products, hydrogel biomaterials, as well as pediatric and women’s health innovations, among others. As founder of Genius Shield, Dr. Laurens provides regulatory and quality support to medical technology companies and investors, including due diligence assessments, and compliance strategies across U.S. and EU markets. She has helped numerous clients achieve FDA clearance/approval, mitigate product risks, and strengthen quality management systems in line with ISO 13485 and 21 CFR Part 820. Earlier in her career, Dr. Laurens held leadership roles at a Fortune 500 medical device manufacturer, where she led cross-functional teams in the development and successful commercialization of Class II and III implantable products. Her name appears on multiple patents, and her contributions have won patent innovation award and driven multimillion-dollar product launches.

Dr. Stein is board certified in both Emergency Medicine and Internal Medicine and subspecialty certified in Neurocritical Care. After Medical School at Vanderbilt University, Dr. Stein completed Residency at the University of Kentucky Medical Center and at Washington University Jewish Hospital. He has practiced Emergency Medicine for 29 years and Critical Care / Intensive Care Medicine for 27 years. Professional association memberships include the American Association of Physician Specialties, the Society of Critical Care Medicine, and the American College of Chest Physicians. Dr. Stein is an expert witness for both plaintiff and defense in cases involving emergency medicine, critical care and internal medicine, including damages & causation in personal injury and wrongful death cases.