Whether you’re preparing for a Human Factors Validation under FDA guidance or a Summative Evaluation according to IEC 62366-1 (for EU MDR compliance), the path to a successful usability validation is more complex than it appears. And it starts earlier than most teams expect.
We often work with companies who realize far too late in the process: “We still need to run a usability validation!” The result? Last-minute stress, scheduling chaos, and the risk of not meeting regulatory expectations.
But there are clear warning signs that your timeline may already be heading off track. Here are five of them — and what to do about it.
1. There’s no structured timeline for the validation
It may sound basic, but we see it all the time: Human Factors Validation gets penciled in somewhere between verification and submission — with no clear dependencies, and often no clear ownership.
A successful study needs to be planned like any other major project milestone. Device readiness (including IFU and training), participant recruitment, internal alignment, and risk documentation all require lead time. What’s more, few studies go perfectly — and most will require some level of residual risk analysis or follow-up documentation.
Our tip: Integrate the Human Factors Validation or Summative Evaluation early into your milestone roadmap — and assign clear responsibilities.
2. Your documentation is outdated — especially your use-related risks
Both FDA and MDR expect that the scope and content of your usability validation are derived directly from your risk analysis. If your hazard-related use scenarios or your dedicated use-related risk analysis (URRA) are incomplete or outdated, your validation will lack regulatory credibility — and may be rejected outright.
This means your risk analysis needs to be current, traceable, and aligned with your test protocol. Realizing this a few weeks before your study starts is a recipe for delay, especially when multiple teams or departments are involved.
Our tip: Keep your risk analysis, use specification, and task list in sync — or allow time in your planning to update them properly.
3. Recruitment isn’t treated as a top priority
Recruiting participants for usability studies is almost always more time-consuming than expected — especially for studies involving healthcare professionals. If you wait until after your test protocol is finalized to think about recruitment channels or screening criteria, you may lose weeks — or be forced to delay a booked study.
In the U.S. and Europe, an IRB or ethics review may also be required if the study could place participants at risk. This adds prep time, submission time, and potentially revision time.
Our tip: Don’t treat recruitment as an afterthought. Make it one of your first operational steps — whether you’re planning a formative or validation study.
4. The product release date is fixed — but the test-ready device isn’t
“We’re launching in October — so we’ll run the usability validation in August.” Sounds fine. But it only works if you’ll have a product-equivalent device ready in time, complete with finalized IFU and training materials.
In practice, product development often slips — especially for embedded systems that rely on multiple teams delivering at once. We frequently see rushed, low-quality IFUs prepared at the last minute, which leads to predictable outcomes: test participants struggle, and the study has to be repeated.
Our tip: Closely align development timelines with validation planning. Make sure your IFU, training, and hardware/software are all test-ready — and build in a buffer.
5. There’s no dry run scheduled
If you haven’t conducted recent formative testing — or your design has changed significantly — a dry run is a critical safety net. Think of it as a full rehearsal: testing your planned scenarios, training, and materials with real users from each target group.
This pre-test (or pre-summative) helps uncover usability issues or procedural flaws before your official validation begins. Skipping this step puts your entire data set at risk.
Our tip: Schedule a dry run on purpose. It’s often your last opportunity to course-correct before your validation counts.
Bottom line: Plan early or pay later
A successful Human Factors Validation or Summative Evaluation doesn’t happen by accident — it’s the result of solid preparation. If any of these warning signs feel familiar, now is the time to realign your project.
To help you plan proactively, we’ve created a focused, practical webinar:
Your Perfect Timeline for Summative Evaluations & Human Factors Validation Testings
In this session, you’ll learn what to consider in your planning process — plus realistic timelines for each phase based on real-world experience.
Register here to build a timeline that actually works for your project.
