Presentation
MDD14 - Developing an Agile Framework, grounded in use-related risk, to support accelerated, iterative formative usability evaluations
DescriptionThe proliferation of connected technologies in medical devices has fundamentally transformed the healthcare industry. Over the last decade, there has been a 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.
In Agile software development, efforts are commonly divided into short, frequent iterations known as sprints. Usability testing is seamlessly integrated into each sprint, allowing for continuous feedback and adjustments. The underlying principle is that each sprint facilitates the early identification and resolution of usability issues, reducing costs and efforts.
Each sprint typically focuses on specific features or portions of a user interface, often resulting in parallel teams working simultaneously on different elements of the system's UI. While this approach can expedite development, it may introduce inconsistencies and conflicts between different elements, potentially leading to suboptimal UI integration downstream.
Additionally, 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. For instance, outside the medical device realm, sprints usually last 2-4 weeks, encompassing user research, development, and testing. In contrast, a typical formative evaluation in medical device development may span 8-12 weeks, not to mention the months required for design and engineering efforts between testing cycles.
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.
Rebus Medical's team has extensive experience collaborating with some of the world's largest pharmaceutical and medical device companies on various connected device projects. Rebus has pioneered and trialed a framework that allows development teams to leverage Agile methodologies while maintaining robust connections with use-related risk and minimizing the perceived documentation burden between cycles.
This oral presentation will address common pitfalls associated with applying Agile methodologies to medical devices and introduce a framework for development teams to effectively integrate sprints into a risk-based design process.
In Agile software development, efforts are commonly divided into short, frequent iterations known as sprints. Usability testing is seamlessly integrated into each sprint, allowing for continuous feedback and adjustments. The underlying principle is that each sprint facilitates the early identification and resolution of usability issues, reducing costs and efforts.
Each sprint typically focuses on specific features or portions of a user interface, often resulting in parallel teams working simultaneously on different elements of the system's UI. While this approach can expedite development, it may introduce inconsistencies and conflicts between different elements, potentially leading to suboptimal UI integration downstream.
Additionally, 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. For instance, outside the medical device realm, sprints usually last 2-4 weeks, encompassing user research, development, and testing. In contrast, a typical formative evaluation in medical device development may span 8-12 weeks, not to mention the months required for design and engineering efforts between testing cycles.
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.
Rebus Medical's team has extensive experience collaborating with some of the world's largest pharmaceutical and medical device companies on various connected device projects. Rebus has pioneered and trialed a framework that allows development teams to leverage Agile methodologies while maintaining robust connections with use-related risk and minimizing the perceived documentation burden between cycles.
This oral presentation will address common pitfalls associated with applying Agile methodologies to medical devices and introduce a framework for development teams to effectively integrate sprints into a risk-based design process.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives