Medgaget recently had the chance to interview Stuart Karten, the noted founder of Karten Design, a design consultancy that has worked on numerous medical device projects. Among the projects Karten has worked on is the Zon hearing aid from Starkey Laboratories, which won the 2008 People’s Design Award from the Cooper Hewitt National Design Museum. Additionally, Karten’s design firm received the 2008 North American Services Medical Devices Healthcare Innovation Award.
In this exclusive interview, Karten shares his thoughts on his history designing devices, the highlights of his career, and where he thinks medical devices are headed.
Medgadget: How did Karten Design get involved doing medical projects?
Stuart Karten: I started my career designing medical devices for Baxter and Gould Medical. It was at Baxter, while designing a disposable bone marrow biopsy needle, that I had an enlightening experience. I saw that doctors would wad up cotton pads into their hand to prevent themselves from getting hurt as they pressed the plastic needle into the bone. I started looking at the form factor and the forces at work and redesigned it to be safer and easier for the doctor to use. I really felt like I made a difference.
I’ve maintained a specialty in medical devices after founding Karten Design. For the last 27 years, medical device design has comprised about 30% of our work. In Southern California, where medical devices are a major industry, I’ve never found a shortage of opportunity. Our early partners included many start-up companies, which would come to Karten Design with proprietary technologies and prototypes. We would commercialize that technology in a way that’s suited to its users and its environment.
For example, Irvine-based start-up SenoRx had a breast biopsy system that uses a proprietary cutting method to remove a sample with minimal trauma, replacing surgical biopsies. Karten Design transformed a rough engineering prototype into a patient-friendly device. We observed that the waiting rooms at breast clinics contrast starkly with the sterility and technology of the treatment rooms and we sought to narrow the gap, choosing forms and materials that would soften the aesthetics and assuage patients’ fears. This work has significant psychic income. It’s work that I feel good about because we’re empowering people to save lives and improving patients’ ability to heal.
Medgadget: Which medical device projects that you’ve worked on are you the most proud of? Why?
Karten: I’m most proud of Karten Design’s recent work for Starkey, a company that makes some of the world’s most technologically advanced hearing aids. When Starkey came to Karten Design, its behind the ear (BTE) hearing aids still looked like the typical beige, organic objects that no one wants.
Starkey’s CEO realized the advantage that design could provide and partnered with Karten Design to address the design and user experience of its hearing aids. Before developing a single product, we had the opportunity to spend months in the field with stakeholders, from the audiologists and dispensers who fit patients with hearing aids to the end users themselves. We came to internalize the challenges that hearing aid users face. First we recognized a significant emotional stigma. People with hearing loss live in denial for five to nine years before getting their first hearing aid because they associate traditional hearing aids with age, disability and weakness. In response, Karten Design developed a new design language for Starkey’s hearing aids, inspired by modern architecture and automotive design. This sophisticated design language, introduced in the Zon hearing aid in 2008 and continued through future products, helps to remove the stigma.
Secondly, we observed some functional challenges with hearing aids. Their tiny battery doors, control switches and dials were not designed with the needs of elderly users in mind. Those with conditions such as arthritis, diminished dexterity and poor vision have a difficult time changing their hearing aid batteries (something that must be done approximately once a week) and adjusting volume. Karten Design introduced functional innovations into Starkey’s hearing aids, starting with a large push-button control and a side-loading battery compartment in the Zon that could be placed on the table for added stability. 
As we approached next-generation hearing aids, Karten Design tested and refined the use of discrete gestures to control hearing aid volume and settings. This effort lead to the S Series with Sweep Technology—the first hearing aid to use gestures and touch control to make it easier for users to adjust their hearing aids. Our partnership with Starkey is currently entering its fifth year and, during that time, we’ve engaged with Starkey across the company’s entire product roadmap, looking for ways to improve the user experience through multiple generations of hearing aids and accessories. Most recently we worked with Starkey on a device that streams content directly from a television to a hearing aid, and a customizable remote control that helps hearing aid users or caregivers discretely make adjustments to their devices.
Medgadget: How is the realm of consumer products influencing medical device design?
Karten: As design has become so noticeable in consumer products, it’s changed people’s expectations, both as consumers and professionals. People now expect the same attention to detail—the same high-level fit and finish—in their medical devices as they see in their cars or their electronics. It used to be that device manufacturers only emphasized design in consumer-facing products. Now companies realize the advantage that attention to form, color, material and construction strategy can provide for B2B devices.
Consumer electronics have popularized some new habits and ceremonies in the public consciousness, such as touch screens and gesture control, which have changed the ways that people interact with technology. Those of us designing medical devices have the opportunity to reference the positive feelings around such new interfaces to make medical products, from hearing aids to hospital monitors, easier to use.
Medgadget: How difficult it is it to be innovative when designing medical products—in light of regulatory and other requirements?
Karten: It’s not difficult at all. I find that constraints force us to be more creative. Being familiar with regulatory requirements means we know how to innovate within that framework. Here’s one example: we’ve designed several automated external defibrillators (AEDs), which are highly regulated products. One of the regulations specifies that the defibrillator be labeled in a certain way. We embraced that requirement and developed a label that became a teaching tool. An AED is seldom used, but it’s always visible. We wanted to encourage a higher level of interaction between the product and its users to make sure that potential rescuers were educated and ready to spring confidently into action in the event of a sudden cardiac arrest.
Medgadget: What are the most-exciting trends you see in medical devices?
Karten: For years I’ve followed the trend of individuals being able to take ownership of their health as care moves from hospital-based reactive treatment to home-based proactive care. This is really coming to a head with Wireless Health. Medical product manufacturers are taking advantage of wireless, connective technology to empower doctors, patients and caregivers to manage their health proactively throughout their daily lives. From telemedicine to “body computing,” wireless health is changing the healthcare delivery model. Some companies are now marketing wirelessly-enabled health products directly to consumers. This is a growing market. Consumers today are used to collecting and analyzing data. Many want to collect data from their own bodies and use that data to inform their decision-making and behavior. Design research and product design is more important than ever in this context. Mainstream consumers will not adopt new technologies unless they meet a real need and are packaged in a way that’s attractive and easy to use. Karten Design recently became a founding member of the USC Center for Body Computing—a hub for Wireless Health in Southern California—to help develop new technologies and prototypes.
Looking further out into the future, I have my eye on the Facebook generation. Accustomed to information on demand, this young cohort has vastly different attitudes toward privacy, efficiency and personal engagement. It will be interesting to see what kinds of industry changes result as Millennials come into power.
Link: Karten Design…
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