Graphical User Interface in Medical Device Design: Do It Early

By Christina Vivona, Software Quality Engineer

These days, the medical device industry is developing more devices with software or graphical user interfaces (GUI) than ever before. In my experience, the interface features are often considered too late in the process, rather than early and iteratively throughout the development cycle.

As with all tools, GUIs must meet actual users’ needs in the context of real-time use. And a good tool is transparent to the work it facilitates —it makes the job easier.

The complex nature of many GUIs drives this point home. How many of us have experienced a system that is frustrating, confusing, or takes a long time to learn?

Much of the interaction that users have with GUIs is cognitive. So you need a solid understanding of the users’ mental models and perceptions to design one that will feel intuitive and safe. The only way to ensure you’re developing a tool that people will really use is by asking them and involving them in the process early and often. This structured, iterative approach will:
In short, it leads to a better product.

• Reduce risk to the development cycle, time to market, and project budget
• Optimize the design based on real user observations and feedback, driving product adoption and increasing sales
• Illuminate potential use errors through early usability analysis and testing, allowing timely mitigation leading to a safer design and regulatory approval
• Delight users, enhance brand perception, and create loyalty, as well as continuity across multiple platforms

But this isn’t to say it’s all going to be very easy. Designing an optimal interface involves a host of functions, including:
While there’s a lot to consider, it’s well worth it. Incorporating GUI design techniques early and throughout the development process results in safer, more efficient, relevant, and successful medical devices.

• Researching published literature and technologies
• Conducting voice of the customer interviews, focus groups, contextual observation, and ethnographic observations to determine actual user needs
• Understanding the relative importance of user needs and how they may be distributed differently across various user groups
• Generating and refining concepts that translate research and insight into concrete solutions
• Performing usability assessments to examine how users interact with a system or prototype
• Refining concepts into increasingly more detailed designs and testable prototypes
• Creating documentation and implementation to incorporate risk management and user feedback to optimize design and safety
• And finally, verifying and validating to ensure that the delivered product meets the original design intent and supports marketing claims