Beyond Software: How Agile Methodology Improves Human Factors Testing

What if the same agile methods that revolutionized software development could make medical device instructions safer and easier to use? In an industry where usability and compliance go hand in hand, that’s more than an intriguing idea. It’s a practical shift that can transform how Instructions for Use (IFUs) and other elements of the user interface are developed. 

Applying Agile Thinking to Medical Device IFU Design 

Instructions for Use (IFUs) are a critical but often underestimated part of medical device design. They bridge the gap between engineering intent and real-world use, guiding clinicians and patients through essential steps that safeguard both performance and safety. When design flaws or potential use errors can’t be fully engineered out of a product, IFUs become one of the most powerful tools manufacturers have to reduce risk and support safe, effective operation. 

Because IFUs are typically developed near the end of the device design process—after the form and function of the product are locked down—there’s often little time to test and refine them. That means, in a traditional design process, there may be only one or two opportunities for user feedback and testing before finalizing the design. That can make it difficult to uncover and address subtle usability issues without delaying launch. What’s needed is a faster, more flexible way to gather and apply user data, so teams can iterate efficiently, validate effectiveness and move forward with confidence that their IFU supports safe, correct use. 

That’s where agile methodology comes in. Battelle is applying agile principles—long proven in software development—to the challenge of designing and validating medical device instructions. The goal is to make the IFU development process faster, more responsive and more effective, without compromising safety or compliance. 

In a traditional development process, IFUs are often created in a straight line: drafted, tested once or twice, revised and finalized. Because usability testing typically happens near the end of the device timeline, any major findings can trigger costly rework or delays. When issues surface late—such as unclear steps, overlooked warnings or user confusion—there’s rarely time or budget for multiple rounds of improvement. The result is a missed opportunity to optimize instructions that are vital to safe, correct device use. 

Agile changes that. Instead of a single, linear study, Battelle’s approach divides IFU development into a series of short, focused “sprints,” each targeting a specific aspect of the design (such as layout, visual communication or risk messaging). Each round builds on the insights of the one before, creating a continuous loop of testing, feedback and refinement—all within a single formative study.  

This iterative process gives teams multiple opportunities to uncover and address usability issues early, improve clarity step by step and strengthen the final design, without adding cost, delay or regulatory complexity. 

Agile in Action: Nasal Spray Drug Delivery Device  

A medical device manufacturer came to Battelle with a usability challenge: users were missing key safety information and a critical dosing step for a combination drug-delivery device. The product was designed to deliver a single dose in two sprays (one in each nostril), but early testing showed that many participants stopped after the first. Some also overlooked important warnings hidden by the folding layout of the IFU. These misunderstandings had the potential to compromise both safety and treatment efficacy. 

Using an agile framework, Battelle’s Human-Centered Design and Human Factors Engineering teams structured the IFU development into three rapid sprints, each focused on a different design element. In the first, testing revealed that the folding pattern obscured critical safety information. After revising the layout, the second sprint uncovered a new problem: users were still misinterpreting the dosing steps because the repeated visuals made the process appear redundant. In the third, the team refined the graphics and reorganized the content into two clearly distinct stages, improving comprehension and dosing accuracy. 

The result was an IFU that users could follow easily and confidently, without confusion or error. By applying agile principles, the manufacturer achieved a safer, more effective design within a single formative study, saving time and cost. The iterative documentation also created a stronger regulatory story, demonstrating a systematic, user-centered process of risk identification, mitigation, and validation. 

The Agile Advantage: Designing for Real People 

Agile methodology isn’t new, but applying it to medical device development can transform how teams approach human factors and usability. At its core, agile is about iteration, collaboration and rapid learning. Instead of waiting until the end of a project to find out what works, agile invites user feedback early and often, allowing teams to adapt quickly and refine designs step by step. 

This flexibility is especially valuable for elements that directly shape the user experience but are often finalized late in the development process. When design changes are no longer feasible, IFUs, labeling, packaging and training materials become critical tools for reducing risk and ensuring safe, correct use. By applying agile principles, these components can be tested, refined and validated more efficiently, so teams gain confidence that users understand exactly how to interact with the device. The result is a development process that’s faster, smarter and more responsive, without sacrificing safety, compliance or quality.