Implementing Agile in an FDA Regulated Environment

Developing medical devices that are subject to FDA approval has traditionally followed the waterfall methodology, largely due to the structure of the regulations that govern development practices. But we know from myriad case studies in different industries that agile methodologies are far superior in providing the highest value to customers in the shortest time to market. Neal Herman shares how one developer of complex medical devices embraced agile software development practices and proved that it could not only develop software faster with higher quality but also meet all regulatory requirements. Convincing the internal quality management, systems engineering, and regulatory departments was difficult, but the software department was able to overcome these obstacles and fundamentally change the company’s philosophy on product development. Since 2012, software development productivity is up 100 percent, and quality is up 200 percent. Now, after seeing these gains from the software department, agile is being rolled out to all areas of R&D including hardware.