Human Factors Validation Testing
If you are a medical device manufacturer, or a pharmaceutical producing a drug delivery system such as an injector or inhaler, you will need to conduct human factors validation testing to satisfy the FDA’s concerns about safety. The requirements for testing were outlined in the recent FDA Draft Guidance Applying Human Factors and Usability Engineering to Optimize Medical Device Design. You can read a synopsis of the guidance here.
What Is Human Factors Validation Testing
For most device manufacturers, human factors validation testing requires conducting a simulated-use test, in which a minimum of 15 prospective users for each distinct user population are asked to operate the device in a meaningful way, in a realistic, but simulated environment. The test should be structured to mimic actual use, utilize a production version of the device, and be sufficiently sensitive to capture use-related problems, if they exist. This means test participants must be representative of actual users; the testing must be focused on the highest-priority tasks or use scenarios; and environmental and situational factors that can affect performance must be incorporated into the test environment (e.g., dim lighting, multiple alarms, distractions). The test should monitor participant performance for evidence of use errors and engage participants (after all test scenarios have been completed) in assessing any use issues that arose during testing.
Finally, test participants must be Americans. The FDA is responsible to US consumers. Rather than entertain arguments from foreign manufacturers about why Canadians or English-speaking Europeans are adequate surrogates, the Agency now requires that testing be done in the United States.
We begin by reviewing your Use Error Analysis. If you haven’t completed a Use Error Analysis, we will work with you to do so. This includes reviewing publicly available databases for reports of use issues with similar devices already on the market, documenting user interactions with your device, identifying what can go wrong, evaluating the potential for harm if something does go wrong, and identifying critical and essential user-device interactions (those interactions that must be performed well to ensure safe and effective use). Based on the Use Error Analysis, we’ll draft a Human Factors Validation Testing Protocol. We encourage clients to submit the protocol to the FDA for review and will participate (at your request) in interactions with the Agency during the review process. When you are ready to proceed, we will obtain Independent Review Board Approval, recruit prospective users of your device, and set up a suitable simulated-use environment for testing. We will conduct the testing, compile the results and present key findings. The results will be summarized in a Human Factors Validation Test Report suitable for submission to the FDA as part of your Human Factors Engineering Report (a summary of your human factors activities during the development of your product now required by the FDA).
Use Error Analysis, Independent Review Board approval, Test Session Videos and Completed Data Recording Forms, Key Findings Presentation, written Human Factors Validation Test Results Report.