The Hippocratic Oath and its famous dictum, “First, do no harm” (primum non nocere), have been part of the medical world for centuries, a telling sign of medicine’s long-standing commitment to prioritizing the welfare of the patient.
But what it meant to “first, do no harm” back in the day when care was dictated almost entirely by physicians is very different from today’s world where patients themselves play an active role in managing their health, taking advantage of advanced devices, and very often using those devices in ways that, yes, can result in real harm.
The medical device industry learned this the hard way in the early 2000s when a series of high-profile product misfires showed how even solutions that were well-engineered from a technical point of view (i.e., fully capable of doing what they were designed to do) could completely fail in the hands of their intended users.
Both the industry and the FDA soon realized that traditional compliance testing that focused on technical functionality all-by-itself wasn’t enough. You also needed to consider the almost inevitable “usability gaps,” the common mistakes that people make when these devices get used in the real world.
This led the FDA to begin requiring manufacturers to conduct human factors engineering (HFE) studies. In effect, the FDA called upon the medical device industry to expand the principle of “do no harm” and make it “do no harm knowing that in the real world your device will get used in ways very different from what was anticipated in the product engineering lab.”
At Suntra, we’ve been involved in HFE studies for a wide variety of medical products including ones that are highly sensitive to FDA regulations, such as insulin management systems, infusion pumps and dialysis machines. Through that experience, we’ve developed a comprehensive process encompassing risk analysis, industrial design, UX/UI design and regulatory/compliance documentation. You can get a quick overview of our approach to HFE here.
A big challenge in HFE is that how you go about evaluating usability can vary widely based on the device in question. The human factors involved in the use of a large MRI machine will be very different from those of a small, wearable glucose monitor. However, it’s a mistake to assume that the glucose monitor, because its primary user is a consumer, has more usability issues than the MRI, which is likely to never be operated by anyone other than trained personnel. After all, the operator of the MRI machine is a human being too and equally capable of becoming distracted, fatigued, confused and making mistakes.
Another common error is to assume that usability testing is all about cosmetic issues and can be deprioritized until near the end of product development. We structure our HFE work to spend significant time upfront (before engineering begins) fully understanding the role of the end user and also making it a point to introduce realistic prototypes early on. This helps ensure that HFE has a continuous part to play throughout the product development lifecycle, not just at final validation.
We find this approach not only enhances usability, but it can also pay for itself through reduced rework, broader commercial adoption, reduced training and fewer post-market issues (e.g., expensive recalls).
Want to dig deeper into what it takes to orchestrate a successful human factors usability study? Here’s a good overview. And here’s a look at some industry best practices. Finally, if you want to nerd out completely, here is a great podcast interview with Nicholas Lesniewski-Laas, Suntra’s Sr. Director of Software and Systems. Nick plunges deeply into what it means to address user needs versus requirements versus actual mandated FDA requirements and much more. Check it out.
HFE is now well established. It’s also about to undergo big changes, for example, by taking into account devices designed to integrate dynamic, AI-driven behavior. Consider, for example, the insulin pump that uses AI to predict the correct dosage by reading real-time sensor data. Human-factors specialists will need to address how the infrastructure behind that pump addresses issues such as data governance and trust calibration. Or take the case of nanotech medical devices (e.g., smart implants) that operate with no real user interface. Among other things, HFE studies will need to focus on how patients understand and trust devices they cannot see or feel.
Usability will become a question not just of how people use devices but how do people, data and autonomous systems, collaborate and learn from one another in effective ways.
And, of course, how do they do all of that and deliver great care…without first doing any harm. It all starts with focusing on the user.
Nick brings over a decade of experience solving complex technical challenges through his deep expertise in microelectronics, electrical design, and software development. At Suntra (formerly Sunrise Labs), he collaborates closely with the Engineering and Quality teams to oversee and optimize Systems Engineering processes, ensuring their efficient application across projects. In addition to his leadership role, […]
