The adoption of Agile Software approaches is not new, but it’s fit within a robust and risk focused formative evaluation plan is often lacking. Last month (March 2024) Ian Culverhouse attended HFES Healthcare Symposium 2024 in Chicago and presented a poster on the development of an Agile Formative Framework.  The poster discussed the remarkable surge in the integration of internet-connected technologies, including connected drug delivery devices, real-time diagnostic devices, and companion apps. This shift toward widespread incorporation of digital interfaces into medical devices has brought with it a growing adoption of Agile development methodologies, leveraging tools and approaches commonly seen in the software development realm.

While this approach can expedite development, there often exists a noticeable disconnect between the pace of Agile software development and the rigor and control typically observed in medical device development processes. When developing a connected device, scheduling and conducting sprints too rapidly can lead to inadequate integration with essential use-related risk activities, potentially neglecting critical safety and effectiveness aspects. Moreover, rapid sprints may compromise traceability and fall short of regulatory expectations for general design controls.

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