What is human factors validation testing?
Medical device regulators in the U.S., EU, U.K., China and other countries require human factors (HF) validation testing (summative usability testing) that aligns with the International Electrochemical Commission (IEC) 62366-1 standard. Testing provides regulatory bodies such as the U.S. Food and Drug Administration (FDA) with data demonstrating intended users’ ability to interact with a given product via simulated use scenarios and knowledge tasks to decide if a product meets safety and effectiveness requirements.
Considerations for human factors validation testing
Human factors validation testing is a pivotal, high-stakes evaluation that can make or break a regulatory submission. Determining the scope and methodology for testing involves several nuanced and strategic considerations, including:
- User group definition and sample size selection.
- Critical task identification.
- Logistics of simulated use and the simulated use environment.
- The product’s use-related risk profile.
- Representative training program and decay period selection.
- Participant recruitment and facility procurement.
- Data collection and analysis techniques.
- Reporting structure and approach.
Our experience conducting human factors validation tests
Emergo by UL has conducted hundreds of human factors validation tests of medical devices, pharmaceutical combination products, in vitro diagnostic devices and software as a medical device (SaMD). Products have ranged in size and complexity from insulin pen injectors to heart-lung machines and robotic-assisted surgical systems. Testing has included participants with varied demographics, including pediatric and adult laypeople, physicians, surgeons, nurses, laboratory technicians, biomedical engineers and other specialized healthcare professionals.
We collaborate closely with medical device developers to produce final testing strategies that match the product’s intended use, user base, use-related risk profile and target markets.
Frequently asked questions (FAQs) about human factors validation tests
- How long does it take to conduct a human factors validation test?
The scope of testing varies widely based on the medical product and its intended users and use environments. We advise customers to plan the test well ahead of the projected start date, primarily because we often advise customers to pre-submit their protocol to the FDA (when planning a subsequent FDA submission) for review before test execution, which can require several months.
Recruiting participants might take two to three weeks, and the test duration depends on the test session length and participant sample size. For example, some test sessions may last 30 minutes, and there might be 15 sessions. In other cases, a single test session might last 3 hours, and there may be 60 total sessions. In either case, human factors validation tests often comprise one or more weeks of test conduct, whereas formative testing is typically shorter — more often days rather than weeks.
- I want to bring my product to market in the U.S. and EU. Do I have to conduct a human factors validation or summative usability test in both regions?
For human factors validation testing or summative usability testing, the ultimate strategy will depend on myriad factors, such as the intended users, the intended use environment and the product’s risk profile. At a minimum, you will need to conduct a human factors validation test in the U.S. with U.S. residents, per FDA’s guidelines. We might then be able to leverage this data for a regulatory submission to a European Notified Body with a proper justification. We would be pleased to discuss your project in greater depth to see how we can help apply a robust, streamlined and cost-effective approach to your HF validation efforts.
- Can Emergo by UL plan a human factors validation test and review the test report, leaving the customer to conduct the test, analyze the data and prepare the report?
We can. We are pleased to offer a customized scope of support for HF validation testing — or any of our services. We can fulfill a more advisory role, providing guidance on strategy and key activities, or have a more hands-on approach to complete some or all parts of the activity. Our services allow customers to benefit from their internal capacity and competencies, combining your team’s expertise with our proven methodologies for efficient, high-quality testing.
Navigate human factors validation testing with Emergo by UL
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