Stuart Karten, founder and principal at Karten Design (Marina del Rey, CA) as well as a juror for this year's Medical Design Excellence Awards, recently spoke with MPMN about the changing landscape of medical device design, emerging trends, the meaning of innovation, and the power of the first impression. Karten Design focuses on design strategy and research, industrial design, and mechanical engineering disciplines throughout every phase of the product development process in order to maintain a continuous focus on the end-user's needs and desires.

MPMN: What steps or types of research do you think are critical to optimizing medical device design?

Karten: Medical device designers should be inspired by the needs of all product stakeholders--not just the end-user, but everyone who interacts with a product, including doctors, nurses, technicians, mechanics, patients, and their caregivers. It's important for researchers to go into the context of use and speak with and observe these people. After all, good research looks holistically at the physical and emotional interactions between people and products, including such functional aspects as users' ceremonies, habits, and rituals around the product. When a product is designed to blend in with users' habitual work process, it is more likely to promote safer use. Understanding stakeholders' emotional experiences with a product allows designers to improve the user experience, developing features and visual cues that empower and delight.

A step that many people forget in their research, however, is the translation phase. Research can be thorough and complete, but unless it's presented to designers in a way that they can internalize, you're not getting the maximum impact. My team of researchers and designers at Karten Design, for example, has developed strategies for making research actionable, such as making information visual and establishing a shared framework. Collaboration between researchers and the designers implementing the device is critical; so many opportunities are found in translation.

MPMN: Which design elements, features, or needs are currently often overlooked by medical device manufacturers?

Karten: Few medical device manufacturers truly realize the power of the first impression. Consumer companies like Procter and Gamble have coined the term "First Moment of Truth" (F.M.O.T.) to describe the split-second emotional reaction that occurs during the important first moments of interaction between a person and a product. If it's a positive interaction, if forms the basis of a good relationship. It's no different with medical products. Patients and medical professionals are first and foremost people. In the long run, they're impressed by improved device functionality, but during the first few moments of interaction with a product, their interest is aroused by appearance. Thus, a product design that leverages color, form, and materials to maximum advantage can draw people in and communicate a complex product's function and purpose in a single glance. F.M.O.T. makes a product intriguing yet accessible. It doesn't just improve the experience for medical professionals, but for patients and their loved ones as well. A product's aesthetics can inspire confidence or introduce softer forms and finishes that put patients at ease.

MPMN: In the age of the iPad and other such popular consumer products, end-users are becoming increasingly vocal and have higher expectations than they used to in terms of the look, feel, and features of a medical device. How are medical device companies addressing this trend?

Karten: The iPad is setting a new bar for user experience. Just as high-end imported cars set a new bar for quality years ago by raising consumers' expectations, the iPad has raised people's expectations about user interfaces. Companies are making efforts to meet this demand with simple, more-graphic user interfaces that are more intuitive to navigate. Because of the intricate link between device and interface, hardware and software are being developed simultaneously to complement each other.

MPMN: On a related note, patients are taking a more-active role in managing their health. As a result, devices that were historically employed in the clinical setting are now shifting to the home and are being employed by novice users. How has this impacted medical device design in recent years and what do you see happening in this area moving forward?

Karten: Simplicity is more important than ever these days. The intuitive user interfaces of many consumer electronic products are training people for that style of interface, establishing new use habits. Medical products must match or exceed that level of ease. This goal will likely require some products to have multiple interface layers with functionality tailored toward the needs of distinct user groups such as patients, caregivers, and medical professionals with different levels of control and information display.

MPMN: What are some of the most significant emerging trends that you see impacting medical device design in the next few years?

Karten: I believe that connected health is a trend that will only grow. There will continue to be a convergence of devices as medical functionality becomes available on personal consumer electronic devices used in the home. This will pose challenges for FDA regulations, requiring designers to focus more than ever on developing simple, error-proof products. It will also open up new opportunities for aesthetics and interfaces not usually found in the traditional medical device industry. Many of my medical device clients today come to Karten Design because we have experience in consumer electronics as well as medical devices. They're looking for consumer-inspired cross-pollination.

Democratization of healthcare is another driving trend. People want control over their own technology. This means that data will need to be collected, analyzed, and presented in a way that's clear and actionable-- not just providing information, but suggesting solutions.

MPMN: Finally, how would you define innovative medical device design?

Karten: Truly innovative medical device design not only leads to positive health outcomes, it creates a positive experience for its users. It introduces new technology, deployed in a meaningful way. This philosophy means that the design visually communicates the functionality and newness of the technology inside, making it visually compelling. But the device must go beyond a positive first impression to make a real difference in the user's life. It must be easy to use, integrating with their behaviors and ceremonies and becoming an integral part of their lives to empower users to improve health outcomes.