Human Factors and Usability Validation Report: Why You (& the FDA) Need a Good One

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The last thing a medical device manufacturer wants to receive in response to their FDA filing is a “request for additional information.” It’s usually not a deal killer, but at the very least it’s going to delay the approval process and ultimately your product launch.

Delays mean substantial, increased development costs outside of planned budgets. Also the hard-to-calculate impact of missed sales opportunities and revenue.

One way to avoid this is by submitting a really good human factors engineering and usability (HFE/UE) validation report. It’s one of the most important documents you’ll submit to the FDA and one of the most highly scrutinized.

There’s a common misconception among medical device makers that the HFE/UE validation report simply summarizes the final summative usability validation testing. The truth is it’s way more than that. Not understanding this document’s importance gets a lot of companies in hot water.

FDA Expectations for Your Device’s Report

In February 2016, the FDA issued the guidance document Applying Human Factors and Usability Engineering to Medical Devices. Its purpose was to communicate the expectations for human factors engineering that the FDA expects medical device makers to follow. The FDA’s overall goal is to improve the usability of medical devices and reduce the frequency of use errors and injuries.

These are the eight sections of the the human factors report, in order, that the FDA expects to receive from you:

1. Conclusion

2. Descriptions of intended device users, uses, use environments, and training

3. Description of device user interface

4. Summary of known use problems

5. Analysis of hazards and risks associated with use of the device

6. Summary of preliminary analyses and evaluations

7. Description and categorization of critical tasks

8. Details of human factors validation testing

You’ll notice that the report starts with the conclusion. Here, the FDA expects to see this exact statement: “[Device Name] has been found to be safe and effective for the intended users, uses, and use environments.” Like a defense attorney in a jury trial, your job is to use the rest of the report to present evidence that supports your claim and proves your case to the prosecutor, or in this case the FDA reviewer.

The validation report needs to tell a comprehensive and thorough story about your entire HFE program, not just the final validation testing. It needs to contain actual data, results, and evidence as opposed to simply referencing that information found in other documents. It’s not uncommon for a validation report to range anywhere from 50 to 150 pages. Expect to write more a book than a story!

A robust HFE validation report in most cases indicates a robust HFE program was followed. A weak report will cast doubts about your entire HFE process and prompt the FDA reviewer to question everything.

Best Practices for Writing a Successful HFE/UE Validation Report

1) Begin writing the report early in product development, not at the end.

It’s very typical for companies to call us a few weeks before their submission is due and request help in writing their HFE/UE validation report. Often we find that they are missing information or worse yet, failed to complete a required task. That’s certainly not a position anyone wants to be in on the eve of submitting an FDA filing.

Starting earlier will help you avoid the burden of writing at the last minute while you’re trying to focus on wrapping up the validation testing. Use the report outline as a tool to identify gaps in your human factors plan early and as a compass to guide your team.

2) Take a team approach to writing it, with your human factors engineer serving as the team leader.

Have everyone who was involved contribute to the report. Thinking about sections and writing them as you go in this way will increase the chances that you do everything that the FDA expects without missing anything.

Follow these suggestions and you’ll reduce a source of stress from the FDA application process. As your submission deadline approaches, proceeding in this way should give you a sense that the report practically wrote itself.

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