Kathryn Rieger has been studying usability and human factors for over two decades. Now, she brings her expertise and compassion to the world of minimally invasive care, driving innovation in a field that helps save lives.
When I tell people about the Human Factors team at Intuitive, I start with this: We’re the usability people—we make things that matter easy to use. Of course, when it comes to medical devices, usability is critical because any misstep could have dire consequences. The providers using our surgical systems trust us to deeply understand their every move, so they can focus on what matters most—the patient.
Most manufacturers focus on human factors at the end of the design process when the Food and Drug Administration (FDA) requires usability testing. At Intuitive, our goal is to get that input at the earliest stages of the product development lifecycle. As part of the R&D team, we begin by helping to identify user needs and contextualizing the opportunity space; we then complete research and rigorous testing as our engineers and designers add new features to our products. We study the physical, perceptual, and cognitive aspects of humans, as well as the environmental, social, and organizational factors that might influence a surgeon’s behavior. For example, we observe the workflow of how a surgeon may reach for this knob or that button in a certain order. We measure perspiration, heart rate, and the time between movements. We run electroencephalogram (EEG) tests and track pupillometry to measure brain activity; we use inertial measurement units (IMUs) and motion capture to assess ergonomics and postural movements. All of this gives us a comprehensive picture of how a surgeon uses our tools.
We use all of this data to inform usability validation and complete the required regulatory documentation about safety and effectiveness and usability risk with confidence—and that’s of course hugely important. But that is just the baseline. What we’re really trying to do is drive desirability and positive emotion in our users—because we know positive emotion leads to better performance. As we collaborate with teams across Intuitive and surgeons and care teams themselves, the goal is usability that is natural and seamless.
Meeting care teams where they are
As our team grew and we began testing more products, we needed to expand the scope of the surgeons and OR staff who test them and make it easier to reach them where they are. Gaining varied perspectives helps ensure we don’t miss anything. Plus, if someone has seen a previous iteration of a device, their experience becomes biased. And requesting that whole care teams travel to our headquarters in Sunnyvale, Calif., was a big ask. So, we needed to reach more people more conveniently.
The solution? A mobile lab. We envisioned a big roving OR truck that we could park outside a hospital for surgeons and care teams to come out and use on a lunch break. We could travel to wherever the participants are, carry out the study for an hour, and be done. I had my doubts at first about the logistics, but we pulled it off: We're able to reach many more study participants, and the customers love it. Now I’m a total truck convert.
The truck has two sides: A lab to run our simulated use studies and a conference room where we can sit with providers to review their experiences. We outfitted the inside so we can run full-scale, high-fidelity studies required by FDA. These days, we try to run multiplier events with the truck, which means we can join our commercial team at an event where they might be bringing in a group of potential customers. That gives us a nice pool of folks to choose from and gives Intuitive the chance to introduce more people to our solutions. And while we still rely heavily on fixed labs that are somewhat more sophisticated than the truck lab, I believe the truck will continue to be useful for us. The more interactions we have with potential users, the more we learn.
Setting the standard
Intuitive has a responsibility to the industry. We’re setting the standards for what usability looks like in robotic surgical care—and we take that responsibility seriously. Car manufacturing is a good analogy: At some point someone decided to put the gas pedal on the right and the brake on the left. That’s where Intuitive is positioned in the world of minimally invasive care—we’ve helped build the foundation of a whole industry. And right now, we're optimizing the fundamental tools in the field while also innovating new solutions.
Striking that balance is an incredibly motivating challenge for me as a leader. As we continue in our journey to collaborate earlier in the production cycle, my team gets to dig in and innovate. Every person on my team has a voice in building the future of our products. They’re all leaders.
We’re now working with our advanced product development teams, as well as with our new product development teams, to bring our expertise to the entire process. This more holistic approach to human factors allows us to ask big, hard questions. For example, we’re asking ourselves if good usability means reducing surgical times or increasing autonomy, or how much control a surgeon may want versus what’s automated. And as Intuitive continues to expand its global presence, our focus is increasingly international: We’re learning how hospital systems in other countries function differently than those in the U.S. and adjusting our research accordingly.
Human factors testing is a crucial contributing factor to product design—and to our mission of helping providers change people’s lives. That’s why I got into medical devices all those years ago, and the passion to help people drives everyone on my team.