The Entrepreneurs-in-Residence Program (EIR), a program at the Center for Devices and Radiological Health (CDRH), brings entrepreneurs, innovators, and government employees to combine the principles of lean engineering in rapidly testing, validating and scaling new approaches to the development in areas that impact innovation with the goal of delivering transformational change. This change, specifically in the medical device arena of public heath, would provide patients in the U.S. to high-quality, safe, and effective devices quicker.