How to Design Patient-Centric Medical Devices

A design expert identifies the major consumer trends that are influencing medical device design and how device makers can embrace patient-centric design.

A design expert identifies the major consumer trends that are influencing medical device design and how device makers can embrace patient-centric design.

Yuhgo Yamaguchi, principal design strategist at Continuum, thinks deeply about how patients and caregivers use a health product and how design choices can improve those devices.

MD+DI spoke with Yamaguchi to learn more about the process he uses to design a human-centered medical device. Read on to find out why he believes the context of use matters so much and what he thinks is the best way for a medical device maker to get in the patient-centric design mindset.

This Q&A has been edited slightly for clarity and brevity.

Hear Yamaguchi present the Express Workshop, "Now Trending--Leapfrog Your Competition by Applying Consumer Trends to Device Design" at the MD&M East Conference in New York City, June 14-16. 

MD+DI: Why does a human-centered approach to designing medical products matter?

Yuhgo Yamaguchi: It matters from a couple of perspectives. I'll talk about the functional and emotional connection that people have to devices. With the functional, you have to understand how people use things, in terms of the jobs that they need to get done. When we think about medical devices--the safety, the consistency, the accuracy, making sure that the device works in the manner in which it's supposed to to deliver the results that are expected--these are clear and obvious parts of why you should design in a human-centered way. If people can't achieve those results due to some barrier or due to some design issue or flaw, then that's obviously going to have a clinical impact. From a functional standpoint, understanding how people use things really does matter. This is where engineering and design need to work hand in hand to understand both of those components. When they don't work together, you can run into problems.

It's important to consider human emotions as well when designing medical products, or any product for that matter. If you're a surgeon and the pressure is high--your stress levels are elevated, perhaps you're working in a confined space, maybe you're working in a place that is not your hospital--maybe you're working with Doctors Without Borders in Sub-Saharan Africa. The context of use matters and how that impacts what I'm trying to do as a surgeon, as a nurse, as anyone who is providing care really matters as well. Products and the associated services need to deliver on that in order to be successful. Often it's not necessarily just the clinical outcomes that drive use, but it's the emotional connections that people have in terms of the design language, the form, the weight and how it feels . . . that make people gravitate toward certain devices versus others.

MD+DI: Can you tell me about two or three key consumer trends that are applicable to medical devices?

YY: A trend like quantified self--the idea that people want to track their own health for preventive reasons and just out of curiosity--is a consumer trend in health that we see being applicable to medical devices in the future.

The point of care is changing as well. Things are moving out of centralized locations like hospitals to places where we live and work. That really changes the context of use, and when you change that context of use, you can't necessarily just use the same devices and have the same services. It may even just be the places in between, if we're talking about mobile.

One more [trend] I'll throw out there is the idea that having global views and perspectives matters. I think about companies like Mint that give someone a more comprehensive view of his financial situation by aggregating information from a lot of different sources. Healthcare needs to have those same types of services in order to give people a comprehensive view of their health and wellness. That's a trend that we see as a consumer trend that will impact medical devices in the future.

MD+DI: So, it's just a matter of time until we expect the same things from our healthcare, right?

YY: Yes, there are EHRs and EMRs out there that are providing that level of visibility for hospital systems and we are starting to see some interconnectivity between systems, but could improve and it isn't consumer-facing. That is all content that's really for clinicians to control and share with patients as they permit.

Will that change? People want to own their financial information today, but didn't 30 or 40 years ago. That was something handled by a broker. But now, people own their own financial information and want to know what's going on and make decisions based on it, or at least understand what's going on. I think that same idea will happen in healthcare, where we start to be more curious and we want to have a better, clearer view of our total picture when it comes to health.

MD+DI: Can you offer any real-life examples/observations of the benefits connected medical devices offer? Have you observed any drawbacks?

YY: Jana Care is a company that comes to mind. They do blood glucose and diabetes monitoring, making sure that people in India can monitor their blood glucose. The idea of continuous blood glucose monitoring is not new, but making it digital by having a device that connects to smart phones through the audio plug jack and enables people to more consistently measure their blood sugar and monitor it--that's where we see the connection between clinical benefit as well as, how you make that action a habit for people. It's something that we see as very beneficial, particularly when those devices were not necessarily readily available in certain parts of the world. 

I think the positive side of this movement is that you have that trend line of your own blood glucose measurements. Point measurements can be helpful, but patterns matter. When we have more of that information, we can monitor not only people who have diabetes, but also populations who are pre-diabetic. We can start to see whether or not they should be receiving some treatment or education around diabetes, so that they can avoid being sick in the future. So, having this information at hand and easily accessible and usable is something where we see a benefit from connected medical devices.

You also asked about drawbacks. I think a drawback when you're collecting more data is if you can't turn that data into actionable information, then you've just proliferated data. That's not necessarily beneficial and it actually just worsens the signal-to-noise ratio. That's not helpful to any clinician who is trying to make decisions about care. That's one negative about connected devices.

I read an article a while ago with a provocative title, "Guess what? Doctors don't care about your Fitbit data."  A doctor's perspective might be, "Okay, that's interesting, but what is it doing to your blood sugar levels, what is it doing to your blood panel that I need to understand? If it impacts that, then I want to know about it, but simply giving me the data feed isn't really helping me as a clinician." I think that is one downside to connected medical devices.

MD+DI: What is the best way for medical device designers to adopt a patient-centric approach to design?

YY: This sounds like too simple an answer, but you have to spend time with patients in context. That is something that, in design thinking and innovation, it's one of the foundations of the work that we do. If we don't know what's happening on the ground, then how can we possibly design for it? Again, sounds obvious, but that's really important because if you're simply using responses from people and not understanding the context of use, you'll see a disconnect there. That will be obvious from the very first time you spend time patients, physicians, nurses or any care provider.

People are not necessarily good at articulating what's difficult for them; they're so used to their workflow that it's difficult to imagine how it could change. Looking at the problem through the eyes of someone who thinks about human-centered design for a living really does start to highlight opportunities much faster, and that can be much more effective than simply relying on the responses to surveys and focus group questions. Spending time with people in the context of use is a really important step in the design process.

See where the device is used today and then, the other part that I think is really important is, patient centricity is not just about designing for today, but designing for tomorrow. You have to imagine the ways in which the device might be used in the future. That's why at Continuum we think a lot about not just the work that we do in healthcare, but we think about the work we do in financial services, in hospitality, in retail, and other industries. These are all areas where we can pull design elements to create a better experience that isn't necessarily just healthcare-focused. Sometimes innovation can just be about applying existing tools or frameworks to new contexts of use.

Once we understand the context and we start to think about where the future is headed, then it's also about understanding what the value of those spaces are to people. When someone gets care in a hospital versus a home--those are two places where there are beds that you can lie down in and perhaps get treatment--but I don't think anyone would argue that those two places feel the same. You need to understand that from the patient's perspective in order to design the right experience for each of those places.

It's not just patients. Patient centricity really needs to take into account caregivers as well. These are the people that support patients as they go through chemotherapy or whatever illness they're going through, be it a spouse, a daughter, a son, or a neighbor. They are the unsung heroes of our healthcare system, and understanding how to support them is also something that we should think about as device designers. They're the ones that live with the disease and with the patient every day. 

MD+DI: Some health-related companies with tools or devices attempt to target a consumer audience instead of medical audience in order to avoid stringent regulatory requirements. What advice, if any, do you have for companies unsure if their device is best suited for a consumer audience or medical audience?

YY: Our first bias there is to get concepts in the hands of people first. Period. A company likely will work squarely toward launching a regulated device or a consumer product--but those lines are blurring. Some wearable-makers may start in the consumer space, where they can gather a large dataset from a consumer user base, then make a play for the regulated market.

But ultimately, any medical device manufacturer is going to have to work through FDA requirements in order to get their device exposed to clinical settings. That obviously takes time and effort, but it's critical to get devices in the field as quickly as possible because there is a lot of learning that happens when you put the device in the hands of people that are just things you would not expect. New contexts of use, there are so many things that are out there that were created for one market but ended up being more valuable to a different market. When we think about that potential, getting it in the hands of people is really where you can learn a lot.

Once you see how people use a device, you can start to iterate it or develop it for the particular users that you are thinking about in a clinical setting. Is this for a surgeon who works in a large university hospital and has all of the support needed to do their work, or for EMTs out in the field, or people that work in remote areas? All very different contexts of use even though they're providing healthcare. When you get it into the hands of different types of people, you start to see what design opportunities exist when designing something new.

MD+DI: We've observed on the consumer side that people get tired of wearing some fitness trackers after three to six months. Is there a way medical device designers can increase adherence and make patients stick around?

YY: Gamification is one of the first things that comes to mind when I think about how to keep people engaged with something. The gamification may be for competition with yourself or competition with others, but when you start to connect socially with what you're doing, adherence can go up. It started in consumer, but even in the healthcare space we can see that as beneficial.

Also, sticking with something that really matters when it comes to, "Am I seeing a benefit to me?" I wore a Nike FuelBand for a couple of years and one of the first things that I noticed is that my curiosity kept me going in the beginning. That's the first wave of it. I just had no idea that I was taking this few steps or this many steps or earned that many Fuel points when I ran 3 miles. Once you start to build that trend line, it really helps you see, "Oh, I'm less active in the winter, more active in the spring and summer." You start to see that seasonal pattern. What are the activities that are driving my behavior? That's the first wave.

Once you start to understand that . . . then it's really about competition with yourself. Is this driving me in terms of weight loss, the number of workouts I do a week, motivating me to go out for a 20-minute walk instead of going home and watching television? Will I reach my goals? Those are the things that I think these health and wellness companies are hoping for, that it's actually going to drive some behavior. If you can use it to do that, you can start to see some benefit. However, many people don't, and their curiosity after that first wave fades and they don't really see that device motivating them to do more.

I think you can combine the idea of gamification with, "Is this improving my life or can this improve my life, and can I see those results?" Those are two ways to get people to stick with it. 

[Image courtesy of GRAUR RAZVAN IONUT/FREEDIGITALPHOTOS.NET]

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