Designing The Total User Interface: How Devices, Instructions, And Packaging Work Together To Improve Safety

When developing a medical device, the user interface extends beyond the device itself to encompass the entire product system, including packaging, labeling, and Instructions for Use (IFU). This total interface must work together cohesively to support clear understanding, correct action, and safe, effective use. While device design often takes center stage, these other components—particularly the IFU and packaging—function as essential risk controls for mitigating use errors that can't be eliminated through device design alone.

The total user interface involves key components like the physical device design, on-device labeling, carton and primary packaging, IFUs, and visual/tactile cues. Human factors engineering standards require that the entire user interface is considered during usability testing. Case studies show that targeted improvements to packaging and labeling can effectively resolve usability issues, such as partial dosing or incorrect opening, without having to redesign the device. By integrating the testing of these elements early and using agile, iterative methods, development teams can accelerate design refinement, validate risk mitigation, and enhance regulatory defensibility.

A safe and effective medical device depends on a coordinated system. Learn how to leverage the entire user interface to reinforce safe use and minimize real-world errors.