Healthcare Human Factors Engineering
Human Factors Engineering focuses on designing products that match human capabilities and account for human limitations, thus making products easier to use, more effective, and safer. This is critical when designing medical products such as medical devices, combination products, and in-vitro diagnostics. Products with inadequate human factors engineering can lead to use error — situations in which users make mistakes due to bad design. In many cases, these use errors can cause complications, injury, or even death. Indeed, several Healthcare Human Factors studies demonstrate that medical error is the third-leading cause of death in the United States, with similar percentages around the world. A significant number of these preventable deaths are caused by use error.
You may have detected an important distinction here. Note, that we use the term “use error” rather than “user error.” This simple change in terminology highlights that a product’s design can make errors more likely if the designer failed to consider the capabilities and limitations of the user. It also removes the shame and blame from the user who made the mistake. Typically, the error is not caused by incompetence, malpractice, or malice, but simply by a disconnect between the capabilities of the user and the requirements of the design.
FDA Human Factors Submissions
Recognizing this problem, the Food and Drug Administration (FDA) now requires manufacturers of medical devices and combination products to provide Human Factors Engineering analyses in their regulatory submissions. The studies are intended to reduce use errors and demonstrate that the products can be used safely and effectively. What’s more, these requirements apply to not only the product itself, but to packaging, labeling, training, and instructions as well.
The submissions illustrate exactly how the Human Factors Engineering issues have been considered, and how the corresponding activities have been conducted, throughout the entire design cycle. They further show how problems were identified and mitigated, and how the design improved. Addressing these components is no small feat, but with some smart planning, it is achievable.
Why Hire a Human Factors Expert
You might wonder, “Can’t we just do this in-house? After all, we have a regulatory consultant and a quality engineering group. Perhaps they can follow FDA’s Human Factors Guidance and save money on outside resources.” Of course, this sentiment is understandable. Product development is expensive, and it can be tempting to try to save money by conducting Human Factors research on your own. In fact, that is exactly what many of our clients originally thought. The fact is that we are retained by many clients only after they have been rejected by the FDA the first time around.
Unfortunately, many of them learned the hard way that this requirement should not be taken lightly. Regulatory submission is not the time to take chances by pinching pennies. If Human Factors activities are conducted inappropriately, or the report is confusing, the FDA can delay or even prevent approval. They may request additional analyses or require additional usability testing. This is not only frustrating, but is also exceedingly expensive. During this time, when you are trying to recoup research and development costs, you cannot sell your product directly, resulting in investors losing confidence and stock prices dropping.
Sadly, the FDA Human Factors submissions record is atrocious, with fewer than 10% of those reviewed being successful on the first try. One FDA Human Factors reviewer put it plainly: “This is pretty sad, I can tell you.” This low acceptance rate for submissions can be attributed to a host of factors ranging from a missing or incorrectly developed use-risk analysis to conducting the usability testing incorrectly. More specifically, there may be issues associated with the user groups, the selection of research participants, or the research procedure. Other times, there have been no usability activities done at all.
Although these results are disappointing, they are not surprising, as these requirements and analyses are still foreign to many companies. At Research Collective, our experience has been just the opposite. Throughout our dozens of submissions, we have never had an FDA Human Factors submission rejected.
Recently, we interviewed several clients to understand why they prefer to hire a Human Factors Expert when seeking FDA medical product approval. We then categorized their responses to better comprehend the big picture. Here is what they told us.
The most common reason for hiring a human factors expert had to do with the ability to provide strategic guidance. This guidance can help determine exactly which human factors activities are required for your specific product and your specific situation. Sometimes, for example, when there are no critical tasks, you do not need to conduct usability testing at all. In that case, you might still choose to do usability testing to improve your design, but it may not be required for the FDA submission. This is an important distinction. For example, one client reminded us about a Class 1 device project in which a regulatory consultant told him it required usability testing. We did a quick use-related risk analysis and found that no serious harm could result from misuse. As a result, usability testing was not necessary for the FDA submission. This discovery saved that client a sizable amount of money and time.
The second reason for hiring a human factors expert is efficiency. A specialized team with M.S. and Ph.D. degrees in Human Factors enables you to move quickly and with confidence. They have most likely seen the challenge you are experiencing several times over and know how to address it.
In addition to this, human factors experts stay current on recent developments, concerns, and areas of focus within the FDA. Their training and experience prepare them to draft reports specifically directed to Human Factors Engineers, such as those at the FDA, by crafting word responses and formatting reports that highlight the most important issues. In fact, one client, who previously served as an FDA reviewer, engaged our services recently. She contacted us because she found our “FDA submissions were so well organized and easy to read. They highlighted just the right information and answered just the right questions. I did not have to dig around to find what I was looking for.” That is what happens when Human Factors Experts write reports for other Human Factors experts.
The third reason is speed. An external human factors expert can simply do the work faster. One long-term client pointed out that a good external consultant can conduct twice the work in half the time of an internal resource. This is often because the external expert does not need to attend all-hands meetings, get pulled into politics, or conduct various kinds of company-required training. The external resource has one job: to get work done. Because external Human Factors Engineers do this work all the time, they are fast. In many cases, an external human factors expert has developed dozens, if not hundreds, of use-risk analyses, user profiles, and environmental profiles throughout their career.
The resources available to an external Human Factors Engineer when conducting usability testing also enable work to be done more rapidly and efficiently. Some examples of this come in the form of recruiting, where experience conducting usability testing creates relationships with trusted vendors or allows for an extensive participant recruitment database to be accessed. External human factors engineers also utilize their expertise in not so obvious ways, such as knowing the going compensation rate for participants depending on varying demographics or being knowledgeable of documentation required based on new legislation, such as the Sunshine Act. This speeds up the whole process.
At Research Collective, we work with companies to walk them through each step of the FDA submission process, making sure to highlight all of the benefits of giving us the responsibility to complete the process. Whether it be to save time, money, or stress, or to make sure your product is easy to use, we will be the Human Factors Experts who will utilize our years of knowledge and expertise to get your FDA submission approved.
Contact us to learn how our human factors engineering experts can help you expedite approval of your FDA submission.