It’s Time to Meet the Users of Medical Devices

A half-day workshop at MD&M West will give attendees the chance to interact with both patients and new technologies. The session can help designers and engineers rapidly understand user needs and how empathy and co-creation can occur even within compressed schedules.

Stuart Karten, principal of Karten Design, will lead a workshop for medical device designers and engineers that will allow them to co-create and co-design with patients. 

In the last five years, design has taken on a larger and more focused role in medtech, said Stuart Karten, principal of Karten Design. Such a trend has been driven in part by the consumerization of healthcare, he explained. “Many more devices that would have been in a clinical setting are now being pushed into patients and other users' hands. It all ties back to the Affordable Care Act and getting hospitals penalized for readmissions. Patients have become more empowered in the actual execution of their healthcare.”

To help medical device companies meet the needs of this changing market, Karten and his team members will be leading a new half-day design workshop at MD&M West 2019 on February 7 called “Creative Velocity.” He and other members of Karten Design have spoken at MD&M West in years past in an effort to bring more awareness around the role that design plays in medical device development, specifically in upfront early stages, but this year they’ll be offering attendees something different.

The idea for the workshop is “rooted in the frustration that I’ve had and seen with other workshops where you bring people in and you give them a mock situation: ‘Imagine if this happened, or imagine a clinician wants this...’” Karten said. “We want to put people through a real learning experience where they can truly gain an understanding of the value of empathy. Empathy should always be at the center of medtech design. How can we understand true empathy and have it be a guiding force in medtech?”

The half-day workshop will involve working with actual patients. “We're going to bring in five e-patients. E-patients are individuals who are equipped, enabled, empowered, and engaged in their health and healthcare decisions. Since we are in the New Technologies track, we're going to make a list of new technologies, such as Artificial Intelligence, Virtual Reality, Augmented Reality, and some others. Then we are going to break people into groups facilitated by team members from Karten Design. Therefore, if a workshop participant will be leveraging augmented reality to help a patient who suffers from rheumatoid arthritis, the participant will get to first understand what the patient's challenges are. Then the workshop attendee will start to connect the dots on the patient's needs on augmented reality and generate concepts around how augmented reality can help somebody with rheumatoid arthritis. Instead of design thinking, this will be design doing in real-time, with a real patient. We're going to guide participants in how to do research and think about product design. At the end of the workshop, we will see the different solutions and share them with the group. We want them to use empathy to drive ideation.”

The workshop’s structure should help participants “understand true empathy because they will be in front of a patient and be in the unique position to partner with, co-generate ideas, and listen to people suffering from a chronic disease,” said Karten. “Device designers and engineers rarely get this sort of access. They typically receive delivered specifications, and then they’re designing against specifications. It’s a very linear process. This workshop will allow them to focus on the challenges that are important without getting bogged down in classic engineering aspects, such as material specs, how much will it cost to make, and other engineering-centric concerns. The opportunity to co-create and co-design will enrich both ‘sides.’ ”

While sometimes overlooked, empathy is important for medical device development and engineering. "With development teams their primary focus is the device—how to build it, how to mold it, and make it. They want to make sure it lasts, that it passes regulatory tests. There are so many engineering concerns,” he explained. “It's important to also understand the ultimate goal of the product, to create an extraordinary experience. So this will be an amazing opportunity to put the patient in the middle of the design process. In our experience with a lot of clients, it's not often that development teams are taken into people's homes or taken in the field to see the challenges people experience when managing their health, what it means to their emotions, what it means to their families and their unpaid caregivers.”

Development teams still do need to understand that design is not only important but critical for the success of a product, Karten said. “There are those who have been enlightened and have worked closely with designers in the early stages of a product and have been able to go through the full product development to really understand that it's not just about delivering functionality—it’s about delivering engagement. At Karten Design we say, ‘It’s about delivering an emotional connection.’ We want to make things seamlessly easy to use. We’ve moved to a point in medtech design in which product development teams want to engage patients [and] they want to provide true value by creating a much higher emotional connection. But how do we do that? The only way for medtech products to succeed is to take a path that includes understanding theneeds of the patient and engaging people. The most successful companies right now are executing on patient-centric design. While companies want to develop patient-centric products, they often don't know how to proceed. We're not there yet, and that's why this workshop is so important."

Design can also provide a competitive advantage. “The clients we have worked with—who really understand its value—call it their secret weapon. Do we still have to convince some clients about its worth? Yes, but we've seen a change for the better. When potential clients understand the power of design, there can be incredible success, such as our recent work with Axonics.”

Co-creation is also an important part of medical device design and engineering and will be highlighted during the workshop. “Co-creators in this workshop will be the attendees, mostly device designers and engineers, and then they'll be Karten Design designers and actual patients,” he said. “We will take all of those multidisciplinary people and put them in one room and get them to interact. I think this dialogue, this co-creation, will be part of what's going to make the workshop exciting. It will be true co-creation. I've seen many incidents in which someone falls in love with a product idea for technology sake without it actually having a resonance with a patient.”

Co-creation can link to typical Design Controls processes. “At KD, we call this type of project ‘Pre-stage Gate,’ meaning it’s before the client gets into the very formal process of rules and regs of how to develop a product under design control,” he said. “This is work that's done upstream from that. Therefore, by the time you get to the Stage Gate process, you're already prevalidated. It’s much better if you can say you've already spoken to patients, already shown them something, and have confidence that patients are going to be interested in this based on X, Y, and Z. If a company has already gone through ‘Pre-Stage Gate,’ they are prepared to develop a real product and start putting it under the formality of design controls. By going through this process, the client will save time down the road because they’ll already have a comprehensive look of the users. All of this won't be accomplished in the workshop, but it will be a microcosm of what would happen if you hired a design firm with this sort of training in medtech. While often overlooked, it is really important to spend time with patients in their context, such as in their homes or wherever they're utilizing the device. When you're actually iterating the product with them to get to the point where people are saying, ‘Wow, if I had that, I would love that—I really want that!" Then you have created this higher level confidence that once you take it and you put it through the design control process that there is more likelihood that there'll be uptake and engagement.”

Co-creation also allows interaction with users to begin before human factors or usability studies. “Human factors is a box that needs to be checked. There's formative and summative and we are doing work pre-formative: we call it discovery research,” Karten said. “Once it enters the Stage Gate process then we begin the process of putting it through formative, which is the early stage testing. The earlier than all of that—the Pre-stage Gate—is when you want to start the work to understand what you might be developing and what the product needs to be to use that to inform specifications. And then the second and third round of iterations with users would be the formative stage. We want to make sure we’re getting good validation and that these are actually things that users want. As it moves further through the process, summative is the ultimate check to make sure that you have everything built in that you need.”

The workshop may also help medical device innovators come up with initial ideas. Attendees “will see how to create a framework to go through the ideation process,” he said. “They might not accomplish everything in four hours, but they'll get a taste of all the elements of what it means to actually come up with initial ideas (with the patient front and center) and they can work in a ‘specification-free zone.’ The workshop is meant to be aspirational. Because the ePatients will be equal participants in the co-creation, the workshop will be innovative, unique, and valuable. So if you come to the workshop, you might be freaked out that there's actually a client across the table that’s going to call you out on whether or not your ideas are good or bad. But having that feedback loop is super valuable. It makes it very real. Here is a chance to dream about what would be the best, the most aspirational version of a product.”

And the workshop isn’t just preaching innovation. “Innovation is a crazily overused word,” Karten said. “People think it's all about going into a room with bean bag chair, putting up some whiteboards and brainstorming. That’s too simplistic. And I've actually seen many companies do that with no success at all.”

Instead, when asked what he hopes medical device designers and engineers do differently after attending the workshop, he said: “I want them to meet the people who are users of the product. I also want them to understand the ecosystem: look at the surrounding players; it’s very rarely one person in medical device design: there are caregivers, unpaid caregivers, clinicians, patients, and others. I want them to understand the value of going out and looking at the ecosystem. At Karten Design, we call it understanding the Voice of the Ecosystem. I think they'll come out of this workshop with an understanding of the KD framework of how to actually drive innovation. They're going to come out of this workshop with tangible skills and then hopefully go back to their companies or their startups and understand the worth of listening to patients, clinicians and others before designing products. We've gone through this process with dozens of clients. They often tell us that it's important to have an outside perspective. They are often super-biased about what they think, and an outside perspective creates a lot of value.”

Please join Karten at MD&M West 2019 on February 7 for the design workshop, “Creative Velocity.”

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

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