There has been a dramatic increase in the use of connected systems in our daily lives. This trend is starting to make its way into the medical device realm as users are able to collect more and more data about themselves through devices like Apple Watch and Fitbit. This presentation will provide information into the approaches and strategies that Lilly used while creating an Open Loop medical device system consisting of a mobile application, connected insulin pen, and a cloud that provides the backend to store all of the information that is generated. In the creation of this innovative system, Lilly needed to learn and implement best practices around medical device development, regulatory interactions, cybersecurity, and accounting for real world use of these devices. As a result of this session/presentation, participants will learn about what Lilly did to design, develop, verify, and validate the mobile app and connected insulin pen; the cybersecurity activities for the overall system; and challenges the team had to overcome while trying to achieve digital speed in traditional Pharma, including quality and regulatory hurdles.