Background
Ethan has extensive experience in medical device regulation, biomedical engineering, and leadership. He brings expertise in managing complex regulatory programs and cross-functional teams. At the FDA, he led the review of hundreds of spinal device submissions including 510(k)s, IDEs, PMAs, HDEs, and Q-Submissions – while serving as a primary industry contact and developing cohesive regulatory strategies for novel technologies. Ethan has broad knowledge of spinal devices, including regulatory precedents, clinical relevance, product classification and jurisdiction, and regulatory pathways.
Education
Ethan received his Master of Science in Biomedical Engineering from Johns Hopkins University and his Bachelor of Science in Biochemistry from Indiana Wesleyan University.
Experience
Prior to joining MCRA in November of 2025, Ethan worked for nearly 6 years at the FDA in Division of Spinal Devices under the Office of Orthopedic Devices. He served as the Assistant Director of the Non-Fusion Spinal Devices team, Policy Analyst in 510(k) Staff office, and Lead Reviewer in the Intracolumnar Devices team.
Overview
As Vice President, Spine Regulatory Affairs, Ethan Naylor leads MCRA’s spine team in the development of regulatory submissions, medical and regulatory writing, review and analysis of pre-clinical and clinical data, design of clinical trials, regulatory review of marketing materials, and regulatory strategy for medical devices.