A Human Factors Engineering (HFE) Perspective on Supplemental FDA Human Factors Guidance.

As a Human Factors engineer, staying informed about the latest developments in FDA Human Factors guidance is critical for success when designing and implementing new and modified medical devices and combination products. In recent years, the US Food and Drug Administration (FDA) has released several sets of supplemental guidance documents, most recently in December 2022 (medical device marketing submissions), formalized draft guidance clarifying the Human Factors information they expect to see based on whether the device is new to the world or a modified existing device. This blog post explores the implications of the FDA’s most recently proposed supplementary recommendations from an HFE viewpoint, focusing on how they impact the amount of work required by Human Factors Engineers for submission.

The FDA reviewers constantly face a daunting challenge – the volume of submissions to review far outweighs the available resources. Their goal is to maintain their effectiveness and regulatory standards while handling the ever-increasing submissions. It is an uphill task that demands continuous improvement and efficiency within their reviewing processes. In addition, medical device manufacturers’ regulatory submissions typically include either insufficient or too much information. It is another reason why the FDA wants to optimize the time its professionals have available for reviewing submissions and maximize the number of submissions they can review in their available time. To do this, the FDA recently put out a draft guidance document clarifying the Human Factors information they expect to see based on whether a device is new or modified.

According to the draft guidance, “Including appropriate Human Factors information may improve the efficiency of FDA review by reducing the number of requests for additional information.” HFE practitioners benefit from updated FDA guidance documents just as much as the FDA’s professionals do. It helps HFE practitioners to be efficient and optimize their time (i.e., not doing the full HFE process when the FDA doesn’t need nor want to review unnecessary information) and clarifies what information is required if it’s not the full HFE process. Stated differently, receiving additional clarification on what is expected in the submission takes the guesswork out of the HFE submission process. Time is saved in the submission preparation process as HFE professionals do not have to ascertain what is needed in the submission, which means that they may be implementing a scaled-down HFE process — yet another time-saver and efficiency-enhancer.

Key Points of the Updated FDA Human Factors Guidance

The FDA updates its guidance on medical devices for many reasons. For example, the FDA might be issuing new FDA Human Factors guidance because of advancements in technology, new safety concerns, changes in industry practices, feedback from stakeholders, changes in regulatory requirements, or some combination of the above catalysts. Or when it is evident through enough reviewed submissions that the existing guidance doesn’t provide enough specificity, new FDA Human Factors guidance needs to be created.

1) Evaluate use and usability contextually

The FDA provides guidance on what to consider and how to think about changes made to devices (i.e., Human Factors practitioners should not evaluate the change in a vacuum, rather they should understand how the change will impact the overall use of the device and its usability — by use, we mean, how the user interacts with the devices changes, and by usability, we mean adhering to good design and usability principles). An incremental change by itself may seem benign. However, in the overall context of the use of the device, it may mean, for example, degrading the clarity of the navigation of the device user interface to a sub-optimal level or adding an additional menu item that confuses intended users when in situ with other items it shares within the menu, thus, impacting usability and the information that needs to be submitted to the FDA. Although you are applying a scaled-back version of the HFE process to evaluate the changes made to a device, you still need to do appropriate due diligence and consider whether there are changes to the user interface, intended users, the intended medical device use, planned use environment(s), training, or labeling. If there are, you need to take a risk-based approach to evaluate the impact of those changes and, thus, what kind of information you need to submit to the FDA. 

2) Make risk-based evaluations to changes

The FDA requires medical device manufacturers and HFE to make risk-based evaluations of changes for several reasons. Because medical devices are used to treat, diagnose, and prevent diseases, all changes to their materials, design, intended uses, and manufacturing processes can affect the efficacy and safety of the devices, which is why potential risks must be evaluated, and the appropriate changes must be made to ensure safety and effectiveness. Consider the overall environment and context of device use and usability as you document your assessment and the portion of the risk analysis that contributed to the assessment of use-related impact. It helps to have a record of the assessment so you remember why you assessed it as such, and even if the FDA doesn’t require the information, it may be required by quality regulation (e.g., 21 CFR 820). 

3) Refer to the FDA’s tables

In the draft FDA Human Factors guidance, the FDA presents a couple of tables showing HFE professionals and device manufacturers what their reviewers expect to see for use-related risk analysis and to show the changes made to an existing device with a rationale of whether usability is impacted. This drastically reduces the guesswork involved in the process. 

Final thoughts

We urge you to leverage the structure for your HF Summary / HFE reports that the FDA recommends because they directly communicate how they want to see the information presented to their reviewers. When your document aligns with their expectations, it allows them to review the information they need the way they want to see it more quickly. It’s a win-win!

At THRIVE, we are fully committed to enriching lives through better device design, which includes a passion for the correct application of Human Factors Engineering as a vital part of making this happen. Contact THRIVE today for a free consultation on your Human Factors Engineering needs. With years of experience, our Human Factors experts can help you develop a repeatable human-centered design approach that meets the requirements of the FDA and other regulatory bodies to keep your business thriving today and long into the future.

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SOURCE: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissions

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ABOUT THRIVE

THRIVE’s Human Factors professionals have decades of experience applying Human Factors to products ranging from medical devices used by specialized healthcare professionals in clinical environments to combination products used by laypeople in the home.

If it’s your first time applying Human Factors and you need a comprehensive end-to-end Human Factors program, we’ll scope out the program and conduct the activities on your behalf, leaving you time and resources to focus elsewhere. If you’re a resource constrained HFE professional, we’ll step in, providing the teamwork, collaboration, and support to help you meet your goals. Or, if you just want a final sanity check to ensure you’ve met the latest and greatest expectations, we’ll do that too.

Contact us today at 404.228.7342 or email [email protected] to get the conversation started.

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People Also Ask These Questions About FDA Human Factors Guidance

Q: When is human factors/usability testing required?

• A: Human Factors/Usability testing is required (at a minimum) to identify use errors that result from the user’s interactions with the device and for those use errors that could lead to severe clinical consequences for the patient and/or user, validating that the design of a medical device has effectively mitigated those use errors. That said, we often advocate for conducting human factors and usability tests throughout the design process to identify potential usability challenges and opportunities to improve the user experience and identify use-related risks that may need further mitigation. Formative studies are prime opportunities for learning about your users and how they will use your medical device. Incorporating these learnings early into the design process will enable your design and development team to make changes at a time when they are not expensive from a time and budget perspective and will help to ensure that your device is safe and effective for use!

Q: What does the FDA human factors guidance document include?

• A: Several FDA guidance documents pertain to human factors work. All are intended to provide insight into the FDA’s thinking on appropriately applying human factors and usability engineering to ensure the design of a safe and effective medical device use. The documents include definitions to enable FDA and industry practitioners to speak in everyday terms, a description of the human factors and usability engineering activities to conduct with considerations for designing and evaluating medical devices, the FDA’s expectations for conducting these activities, and helpful resources.

Q: How do you conduct human factors testing?

• A: Human factors testing may look different depending on the purpose for conducting the test, the objectives and scope of the test, and the type of medical device being designed. Testing ranges from internal assessments, such as expert and heuristic analyses, during which a human factors practitioner assesses the design of the medical device against a set of relevant heuristics, a clinical expert’s judgment, or their expertise in designing and evaluating medical devices, to external evaluations, such as simulated use formative studies, in which human factors practitioners observe representative end users interact with a medical device design and ask questions to learn about the user and how the medical device may be used in the actual use environment. The approach for these is different; some are more appropriate for particular testing objectives than others.

Q: What are the requirements for human factors submissions to the FDA?

• A: The FDA requires medical device manufacturers to submit a Human Factors Engineering/Usability Engineering Report, otherwise referred to as a Summary Report, that summarizes the human factors activities that were conducted on a medical device to ensure it is safe and effective for use by the intended users, for the intended uses, and in the intended use environments. The information that should be included is provided in the FDA Guidance document “Applying Human Factors and Usability Engineering to Medical Devices” and is further clarified in the draft guidance “Content of Human Factors Information in Medical Device Marketing Submissions,” providing specific guidance for information based on the device’s submission category. 

Q: How does the FDA evaluate human factors in device approval?

• A: The FDA reviews the human factors and usability engineering information provided in the marketing submission to determine whether the use-related risk of a medical device has been adequately mitigated and evaluated. The FDA will look for evidence that the needs of the intended users were considered in the device design and that the device is safe and effective for the intended users, use, and use environments. This evidence includes information about the device’s critical tasks, validation of the effectiveness of risk mitigations, and a discussion of residual risk.

Q: What are the common pitfalls in human factors submissions?

• A: Submissions fail to provide the required human factors information, including a discussion of critical tasks associated with the medical device, evidence through appropriate validation strategies that the risk mitigations are effective, and a discussion of residual risk. To circumvent these pitfalls, the FDA provided draft guidance (Content of Human Factors Information in Medical Device Marketing Submissions) on the human factors information that they expect to see based on the classification of the medical device using a risk-based approach.

Q: How has FDA human factors guidance evolved?

• A: The FDA guidance for human factors activities has become more specific with respect to how to conduct human factors and usability engineering processes, clarifying the FDA’s expectations concerning information that needs to be submitted for medical device approval. The latest draft guidance on human factors information is specific regarding exactly how a device needs to be evaluated and precisely what information needs to be sent to the FDA in the marketing submission. The clarifications and specificity were driven by industry questions, confusion, and feedback regarding how to apply the HF/UE process, as well as its experience reviewing the HF information provided in marketing submissions.