Zero-downtime clinical backend migration
SetPoint Medical, a Class III medical device manufacturer, encountered a significant infrastructure challenge when its backend platform provider announced it would cease operations. At the time, SetPoint was conducting a crucial clinical trial under stringent FDA regulations, which prohibited modifications to its current system or the expedited deployment of an internally developed replacement. To address this, SetPoint enlisted Resolute Software to manage the backend and facilitate a migration of the system without altering its functionality. Timeliness was vital; it was necessary to maintain consistency for users and APIs, adhere to regulatory standards, and ensure that patients would continue receiving their treatments without interruption. The challenge was to execute this migration while keeping therapy delivery continuous during the active clinical trials and without modifying the existing system. The solution involved creating an identical copy of the system, preserving all existing functionalities while taking over operations, security updates, and infrastructure management within strict compliance guidelines. As a result, the transition was successfully completed ahead of the service discontinuation deadline, with no downtime or changes visible to users. This ensured the continuity of the clinical trial, full regulatory compliance, and uninterrupted therapy for patients, thereby avoiding a potentially irreparable delay to the company’s approval process and commercialization strategy.