While uncertainty reigns in the medtech industry under the Affordable Care Act (ACA), one thing is clear: The ability to improve outcomes and reduce healthcare costs will determine the fate of medtech companies in this new era of value-based healthcare. And central to increasing patient compliance, developing disruptive technologies, and, ultimately, improving outcomes, is the effective application of user-centered design, according to Chicago-based consulting firm Insight Product Development.
“User-centered design is a tool companies can use to help combat these pressures,” Craig Scherer, Insight PD senior partner and cofounder, said during an interview at MD&M East last week. “User-centered design focuses on the end-user, which in many cases is the patient. They're at the center, but it's very important to understand that there is a whole ecosystem of relevant stakeholders—clinicians, anyone in the supply chain or the hospital environment. You have to understand all environments of use for these products and the workflows themselves.”
There are two main steps to gaining this holistic understanding of the product’s journey, according to Scherer: conducting in-context research and creating a platform for applying disruptive technologies in appropriate ways.
The Impact of Disruptive Technologies
Aside from being a trendy term, disruptive innovation can comply with the basic tenets of the ACA by providing better outcomes and reducing system costs. But it has to be applied appropriately, support these goals, and cater to a concrete clinical need, Scherer said.
To illustrate this point, Scherer recounted how Insight PD developed an innovative imaging technology to address a clinical need in endoscopic sinus surgery. Hospital staff will typically take a patient to radiology prior to sinus surgery, perform a CT scan, conduct the entire procedure, and then take the patient back to radiology to image the area and ensure that the surgery was properly performed.
This approach is inefficient, to say the least. If a problem isn’t observed until the post-op scan, as Scherer pointed out, the patient may have to undergo a second procedure, which can wreak havoc on the schedule and may present reimbursement challenges.
To address this issue, Insight PD set about gaining a deeper understanding of the workflow and goals in order to develop a mobile imaging unit for real-time imaging feedback right in the OR. Developed using a user-centered design approach, the finished product cost 20% of the full-size unit, streamlined the overall workflow, and yielded better outcomes as a result of the real-time imaging capability, according to Scherer.
The Importance of In-Context Research
The second part of the equation, extensive in-context research allows designers to observe how the product is used, who comes into contact with the product, current inefficiencies, and challenges. “The repeatability and predictability of outcome is very important, so that has to be supported by a well-designed product but also [requires] a really good understanding of the environment and the steps of the workflow,” Scherer noted.
Researchers, according to Scherer, should observe as much as they listen when conducting in-context research. They should listen to the end-user, but also observe his or her actions and compare the two for a better understanding of the environment, workflows, needs, and end goal. Paying attention to end-users’ facial expressions can provide additional valuable insight that may not be verbally expressed.
Another best practice for in-context research is to take a step back and consider the entire product journey, according to Mark Tunkel, partner and director of business development at Insight PD. “If you're liberal when defining all of your stakeholders, you're going to see all of these interrelationships and you'll see cause and effect you might not normally get if you're just focused on the surgical procedure,” he said. “But if you back up, [you might] realize there's a dynamic with the way a particular device was prepped that's leading to difficulty in administration of the procedure. And beyond the OR: How does equipment come out of central supply and get taken to the room?”
In the diabetes space, for example, in-context research as part of a user-centered design methodology would center on observing how the patient managed his or her disease and interacted with the device in the normal use environment outside of the clinic. The focus would be to figure out how to improve compliance in order to achieve better outcomes.
But the research shouldn’t start and end with the patient because other stakeholders may influence product use, compliance, and outcomes, according to Tunkel. “[Devices are] ultimately used in the home, but in the case of diabetes, patients are trained in the clinical environment; a nurse educator is critically important to how adherent that patient is,” he said. “We think understanding all of these things is not only going to reduce costs, it's an opportunity for differentiation; there's a business element, too. Missed doses means missed revenue.”
Designers can leverage these extensive in-context observations of a range of stakeholders to craft a detailed task map prior to the design phase. This “systematic dissection of tasks” associated with the procedure allows designers to examine whether there is an opportunity for improving or streamlining the procedure—or even creating a new product.
This approach, Scherer noted, can be easier and more manageable than tackling the potentially daunting challenge of improving the whole workflow in one fell swoop. Of course, designers ultimately have to confirm that modifications to tasks still allow for a seamless overall workflow.
In the end, though, it’s important not to lose sight of the overall goal of the procedure or product, Tunkel commented. “A task is a means to an end; maybe there are too many tasks to get to the goal,” he said. “If we can better understand the goal, that's the foundation we can use to disrupt because we understand the job to be done.”