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Formative & Summative Human Factors Evaluations: Your Ticket to Successful FDA Clearance

You’ve spent a lot of time and budget developing a revolutionary new medical device. You’ve designed, verified, and prepared your DHF. Now it’s time for the moment of truth: the FDA submission.

Not passing the FDA submission process could mean costly, potentially extensive redesigns. A simple way to increase your chances of getting FDA clearance the first time is by incorporating formative and summative human factors evaluations into your medical device development process. These evaluations allow you to make informed decisions during the design process, leading to a better medical device that is easier to use, prevents potentially fatal use errors, and has a higher chance of first-pass FDA clearance. ALTEN Technology can serve as your engineering partner to help you reap these benefits.

When you apply for FDA clearance, the FDA will inspect your medical device submission for proof of human factors testing, done both formally and informally, to confirm your device is safe and simple to use. While this may seem straightforward, there are many ways even simple medical devices can be used incorrectly. Medical device use errors constitute 28.1% of adverse-event medical device reports labeled with problem codes in the FDA’s online database, Manufacturer and User Facility Experience (MAUDE). These errors have the potential to result in both deadly consequences for end users and inefficient use of health care system resources. Proving that your medical device will not contribute to medical errors is vital to end users as well as the FDA.

At the end of 2022 the FDA released a draft guidance document to help inform developers of what human factors information it commonly expects to be included in a medical device submission. However, FDA guidance documents are generally loosely worded to give developers the necessary room to make the optimal benefit decisions for their products. That means that even with the guidance and reference to ANSI/AAMI/IEC 62366-1:2015/(R)2021+AMD 1:2020; Medical devices—Part 1: Application of usability engineering to medical devices + Amendment 1, many device developers are still unsure how to realize the benefits of human factors and usability engineering in their designs.

Lines 39 to 45 of the FDA guidance document state, “The marketing submission should, where appropriate, demonstrate 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, uses, and use environments. Thus, marketing submissions should include, where appropriate, information that explains the presence or absence of critical tasks, validation testing for risk mitigation strategies, and a description of residual risks. Including appropriate human factors information may improve the efficiency of FDA review by reducing the number of requests for additional information.”

How can you demonstrate these items and include the appropriate human factors information? Let’s talk about the two types of human factors and user experience (HF/UX) evaluations. Formative evaluations are informal use-scenario experiments that provide crucial design decision information and user feedback to developers throughout the early- and mid-development stages. Because these are informal, they may be as casual as asking a coworker to go through the motions of using a Styrofoam mockup of the device being developed. While you don’t submit the results of formative evaluations to the FDA, they’re key to improving the usability of devices by discovering and enabling the correction of issues early in the design process. Summative evaluations, conversely, are formal studies designed to observe real users in real-life situations. The goal of these evaluations is to confirm that the medical device can be successfully used without critical errors or delays in use-case environments. Unlike informal formative evaluations, summative evaluations ask intended users to trial a completed device in a simulated use-case environment with replicated lighting, noises, and other key factors.

If you’re new to incorporating formative and summative human factors evaluations into your development or simply don’t have the resources or bandwidth to perform them, partnering with an engineering services company can help you reap the benefits they offer. ALTEN Technology can help your team plan and perform formative HF/UX evaluations throughout the early product development phases and interpret and incorporate the feedback into design decisions, guiding engineers to design products that are intuitive and simple for end users. Critical task analysis, a fundamental tool of human factors engineering, is performed throughout operational scenarios and informs both user studies and risk analysis to improve upon pivotal actions throughout the design. This ensures your design develops with end users in mind, rather than requiring costly redesigns later.

After verification activities, the design team at ALTEN Technology will help plan a summative test, work with recruitment agencies to fill the roster with qualified test participants, and complete formal testing to prove your final product is safe and effective to use. This data, incorporated and highlighted in your FDA submission packet, will provide confidence in your device’s success to both your stakeholders and the regulatory council and increase your likelihood of clearance. If the FDA reviewers have questions, we’ll be right beside you to answer them clearly, referring to the testing that’s already been successfully completed.

Get in touch with our medtech team to talk about how we can leverage formative and summative human factors evaluations and our other industry expertise to support your project.

Meghan Kern

Meghan Kern

Systems Engineer II

Meghan Kern is a systems engineer at ALTEN Technology, where she and her team support medical device and aerospace developers in solving tomorrow’s engineering and innovation challenges. She has worked within three medical device companies, in over five positions, and on more than a dozen projects spanning from design and development, testing, and production through post-market vigilance and failure investigation. Meghan’s passion lies in using systems engineering and human factors/usability engineering to guide design teams to the most suitable design solutions for their end users. Meghan received her biomedical engineering bachelor’s degree from the University of California, Davis.

Rachel Sellers

Rachel Sellers

Marketing Content Writer

Rachel Sellers is a marketing content writer at ALTEN Technology on a mission to make technical content that’s clear and easy to understand. In her eight-plus years of creating content that distills complex ideas, she has partnered with numerous subject-matter experts to create actionable content for several industries, including aerospace, medtech, UAV, and automotive. Rachel has a bachelor of arts from Regis University.