Lynn Bailey is a Principal Consultant at CardioMed Device Consultants with more than 35 years of experience in preclinical research, specializing in cardiovascular and vascular medical devices. She brings extensive expertise in preclinical animal study design, Good Laboratory Practice (GLP) studies, interventional procedures, and regulatory testing. Her experience helps medical device manufacturers develop effective preclinical testing strategies, select appropriate animal models, and generate high-quality safety and performance data to support FDA regulatory submissions.
Experience
Ms. Bailey has directed hundreds of regulatory preclinical studies evaluating coronary and peripheral vascular stents, drug-coated balloons, atherectomy and thrombectomy devices, and intravascular imaging technologies, including OCT, IVUS, and near-infrared spectroscopy. As an experienced research interventionalist, she has performed thousands of complex catheter-based procedures and developed animal models for myocardial infarction, aneurysms, thrombectomy, and in-stent restenosis.
Throughout her career, Ms. Bailey has held leadership positions at several prominent research institutions, including Director of Interventional Services at the Center for Biomedical Sciences and Emerging Technologies (CBSET), Managing Director of the Interventional Cardiology Research Laboratory at Stanford University, and leadership of the preclinical catheterization laboratory at the Cardiovascular Research Foundation. She began her research career at Walter Reed Army Medical Center in 1987.
At CardioMed, Ms. Bailey advises manufacturers on preclinical study design, animal model selection, GLP study execution, protocol development, and regulatory study reports. She works closely with research teams, veterinarians, pathologists, and quality assurance professionals to support the generation of reliable preclinical evidence for medical device development and FDA submissions. She has authored and coauthored numerous scientific abstracts and peer-reviewed publications.