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The First Five Things You Need to Know About Human Factors Validation Testing with Staci Miller

4 days ago
4 min read

Human factors validation testing can feel like one more hurdle on the long road to bringing a medical device to market. But according to Staci, a human factors expert with nearly 15 years of experience, the validation study itself is only one part of a much larger process. The real work starts much earlier, with understanding users, identifying risks, defining critical tasks, and building a study designed to determine whether a product can be used safely in its intended environment.


Start With the Risk Documents

The first, and perhaps most important, thing to know is that the validation study doesn't start with the validation study. According to Staci, the use-related risk assessment (URRA) and use specification are foundational documents for developing the validation study. The URRA identifies the tasks users perform, how they interact with the system, and the risks associated with those interactions. The use specification defines who the users are, what they do, and how they interact with the system.


Together, these documents establish the foundation for the validation protocol and help determine who needs to participate in the study. This has practical implications beyond regulatory compliance. For startups especially, understanding user groups and testing requirements early can help teams anticipate recruitment needs, timelines, and costs well before reaching verification and validation.


Critical Tasks Define What You Test

The second key takeaway is that critical and essential tasks aren't simply another piece of documentation. They form the baseline for the human factors validation process. Critical tasks identified in the URRA ultimately help define what must be tested and establish the success criteria for the study. The use specification also identifies the different user groups who interact with the product and their respective roles. Understanding those distinctions matters because different users may interact with different parts of a system, and may therefore have different testing requirements.


A Task Sheet Is Not the Same as Leading

One of the most easily misunderstood aspects of validation testing is the difference between giving participants a task and telling them how to complete it. A scenario task sheet provides enough context for a participant to understand what they need to accomplish without telling them exactly how to do it. For example, a participant might be asked to prepare an infusion pump and administer medication according to a physician's orders.


That's fundamentally different from telling the participant which button to press, what sequence to follow, or exactly what information to enter. The distinction is critical because validation testing is intended to evaluate whether users can safely interact with the system, not whether they can successfully follow a moderator's instructions.


Validation Is Not Exploration

Another important distinction is between formative research and validation. User research, market research, and formative studies are exploratory. They help teams understand how people interact with a product, identify opportunities for improvement, and uncover potential problems. Validation has a different purpose. As Staci explains, “Validations are not exploration studies.”


The goal is to determine whether the system can be safely used by its intended users, for its intended uses, in its intended environments. That means the study is focused on defined data points such as task success, use errors, use difficulties, and close calls. If a participant struggles, the team isn't simply collecting an interesting observation. The finding needs to be evaluated and, where appropriate, root-caused. That distinction helps ensure the validation study stays focused on demonstrating safety rather than becoming another round of product discovery.


Keep the Final Report Clear and Concise

Finally, Staci offers advice that applies well beyond human factors: make the report clear, readable, and succinct. Validation reports can become enormous when teams attempt to document every observation or conversation from a study. But more information doesn't necessarily mean a better submission. The purpose of the report is to communicate whether the system is safe for its intended users, uses, and environments, not to retell every detail of the study.


Staci's preferred approach is to incorporate validation results into a broader human factors engineering report that tells the story from the beginning of the development process through validation. This creates a more holistic view while reducing duplication and giving reviewers a single, coherent document.


Why This Matters

Human factors validation shouldn't be treated as a box to check at the end of development. The strongest validation processes are built on decisions made much earlier, particularly around risk, users, tasks, and intended use. For medtech startups, that means thinking about human factors early can do more than support regulatory requirements. It can help teams understand what they need to test, who they need to recruit, what those studies may cost, and ultimately whether their product is designed to be used safely and effectively. The bigger lesson? A successful validation study starts long before the first participant enters the room.


What to Watch

As medical devices become more sophisticated, the interactions between users, technology, and clinical environments become increasingly important. Human factors validation provides a structured way to ensure those interactions support safe and effective use. For companies preparing for validation, Staci's first five points offer a useful framework: build from your risk documents, clearly define your users and critical tasks, distinguish task-based testing from leading, understand that validation is not exploration, and communicate your findings clearly.


To hear the full conversation and dive deeper into human factors validation testing, listen to the latest episode of the Project Medtech Podcast featuring Staci: https://www.projectmedtech.com/projectmedtechpodcast/episode/1ad97734/episode-278-staci-miller-founder-of-gen-ux-consulting-the-first-five-things-you-need-to-know-about-human-factors-validation-testing



Podcast promo for Project Medtech: Staci Miller, Episode 278, on human factors validation testing, with her portrait and sponsor logos.

 
 
 

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