Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, Empirical Technologies has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, mechanical and packaging testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Since Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio. She is a member of the ODT Editorial Advisory Board and frequent speaker at industry events and trade shows.