Presentation
MDD4 - Adopting Agile Methodology to IFU Design and Formative Testing
SessionPoster Session 2
DescriptionAgile Methodology is a common practice used in software development that emphasizes flexibility, continuous improvement, and rapid response to change. This approach is not only applicable during the early feasibility phase of medical device design, but also throughout the entire development process. By applying Agile principles to the formative usability testing of the instructions for use (IFU) for medical devices, manufacturers can enhance device usability and safety during later stages of the medical device development process while also significantly decreasing time and resources needed for multiple formative evaluations.
Formative usability testing of a medical device is a critical step that involves evaluating the device’s user interface, including its packaging and labeling, with potential users to identify usability issues before the device is finalized. Best practice suggests that any identified usability issues, depending on potential harm severity, should be designed out of the device. However, if a use issue is discovered late in the development process, there may be constraints that limit the ability to modify the physical components of the device’s user interface. In this case, a manufacturer may rely on labeling, specifically the IFU, as a control measure to reduce use-related risk. This makes formative testing of the IFU paramount in evaluating the effectiveness of the visual communication of the intended use and safety of the medical device. By integrating Agile into this process, medical device manufacturers can adopt a more dynamic and rigorous approach to usability testing, focusing on the effectiveness of the IFU’s design. Instead of a linear, one-time evaluation, an Agile approach to formative testing can evaluate multiple IFU revisions in order to quickly determine usability performance of each.
This presentation provides details of a case study implementing an Agile approach to the design and formative evaluation of the IFU and packaging for a combination product. Following the initial design of the preliminary IFU, a series of "rapid formatives" (or “sprints”) were conducted, focusing on the device, its labeling, and packaging. The primary goal of these rapid formative was to quickly iterate based on real-time feedback, addressing any use errors identified and implementing necessary mitigations promptly, allowing for the evaluation and refinement of several revisions of the IFU, packaging, and labeling within a remarkably short timeframe. Each iteration was analyzed and refined based on user interactions and feedback, ensuring that each subsequent version addressed the shortcomings of the previous user interface components. This iterative process not only streamlined the development cycle but also effectively enhanced the usability and user safety of the final product within the shortened timeframe.
The application of Agile in this context demonstrates its viability beyond software development, highlighting its potential to improve medical device development processes. Attendees of this presentation will gain insights into the practical implementation of Agile practices in the rigorous field of medical device usability testing, offering an alternative framework that can lead to effective visual communication in IFU development.
Formative usability testing of a medical device is a critical step that involves evaluating the device’s user interface, including its packaging and labeling, with potential users to identify usability issues before the device is finalized. Best practice suggests that any identified usability issues, depending on potential harm severity, should be designed out of the device. However, if a use issue is discovered late in the development process, there may be constraints that limit the ability to modify the physical components of the device’s user interface. In this case, a manufacturer may rely on labeling, specifically the IFU, as a control measure to reduce use-related risk. This makes formative testing of the IFU paramount in evaluating the effectiveness of the visual communication of the intended use and safety of the medical device. By integrating Agile into this process, medical device manufacturers can adopt a more dynamic and rigorous approach to usability testing, focusing on the effectiveness of the IFU’s design. Instead of a linear, one-time evaluation, an Agile approach to formative testing can evaluate multiple IFU revisions in order to quickly determine usability performance of each.
This presentation provides details of a case study implementing an Agile approach to the design and formative evaluation of the IFU and packaging for a combination product. Following the initial design of the preliminary IFU, a series of "rapid formatives" (or “sprints”) were conducted, focusing on the device, its labeling, and packaging. The primary goal of these rapid formative was to quickly iterate based on real-time feedback, addressing any use errors identified and implementing necessary mitigations promptly, allowing for the evaluation and refinement of several revisions of the IFU, packaging, and labeling within a remarkably short timeframe. Each iteration was analyzed and refined based on user interactions and feedback, ensuring that each subsequent version addressed the shortcomings of the previous user interface components. This iterative process not only streamlined the development cycle but also effectively enhanced the usability and user safety of the final product within the shortened timeframe.
The application of Agile in this context demonstrates its viability beyond software development, highlighting its potential to improve medical device development processes. Attendees of this presentation will gain insights into the practical implementation of Agile practices in the rigorous field of medical device usability testing, offering an alternative framework that can lead to effective visual communication in IFU development.
Event Type
Poster Presentation
TimeTuesday, April 14:45pm - 6:15pm EDT
LocationFrontenac Foyer