The Role of Human-Centered Design in Insulin Pen Innovation and the Future of Insulin Delivery

Abstract

Insulin pens have made a dramatic impact on diabetes care, with evidence suggesting that they promote performance of self-care and reduce negative health outcomes for people with diabetes. Human-centered design (HCD), practiced by IDEO for over 40 years and together with Eli Lilly for over 15 years, has helped to design insulin pens that evolved with the needs of people with diabetes. HCD employs unique methods that help to uncover people’s needs and design with them in mind. The future of diabetes care is bright with the ongoing application of HCD methodology in this space.

Introduction

The development of insulin pens has made a significant impact on diabetes care, making management easier, improving performance of self-care, and reducing negative health outcomes. Much of this success is attributable to the use of human-centered design (HCD) methodology, which starts with first uncovering people’s needs, and then designing products that address those needs.

IDEO, a global design and innovation company, worked closely with Eli Lilly for over 15 years to continually improve the design of their insulin pens, drawing on insights from people with diabetes. This Commentary does not provide a comprehensive history of all successful insulin pens developed over the last decades, such as those created by Novo Nordisk, Sanofi, and Owen Mumford, ¹ but instead focuses mostly on those developed by Eli Lilly and IDEO, due to the authors’ richer knowledge about them.

Through the ongoing application of HCD methodology to the development of products for diabetes management, we can continue to improve health outcomes for people with diabetes.

The Impact of Insulin Pens on Diabetes Care Outcomes

In 1921, insulin was discovered and first used as a treatment for diabetes, revolutionizing care for people with the condition. Prior to 1921, it was rare for a child with type I diabetes to live past the age of two. ² By the 1950s, insulin was delivered widely to patients as the most effective antihyperglycemic agent, which it remains to this day. Despite being a critical therapy for diabetes, a vial and syringe was the only delivery method available for insulin for decades. It was not until 1985, with the first manufactured insulin pen, NovoPen, that new insulin delivery methods started to emerge. ¹

Following the publication of two major trials in the 1990s,^3,4 diabetes experts began to highly emphasize the importance of treating hyperglycemia. New and more user-friendly insulin delivery tools, like insulin pens, afforded patients many advantages to the vial and syringe method. Insulin pens have been found to be more accurate, ⁵ quicker to prepare, and easier to use ⁶ when compared to a vial and syringe. Further, many patients report insulin pens as “more socially acceptable” than a vial and syringe, often leading to improved performance of self-care. ⁷

Studies continue to show that switching patients from vial and syringe therapy to an insulin pen is associated with improved self-care medication behaviors, fewer emergency visits, and a significant reduction in health care cost.^8,9 However, much of this positive health impact relies on designing a tool with the patient’s needs in mind.

How Human-Centered Design Leads to More Effective Health Products and Services

In a technologically oriented society, it can be all too easy to jump to a “solution,” without considering how and by whom innovations will be used. The consequences of creating new health technologies, without accounting for the nuances of human behavior, can be disappointing—leading to issues like low adoption or inconsistent use, and ultimately creating minimal health benefit, or even harm.

HCD, also often referred to as “design thinking,” proposes that true innovation occurs at the intersection of what is viable, feasible, and desirable—and starts first with people (Figure 1). For example, when designing an insulin pen, if technology were the prime consideration, we might have created a device with a large reservoir for insulin and requiring firm injection force to simplify internal mechanisms. However, once we learn from people with diabetes about their experiences of peripheral neuropathy, and their desire for discretion when using insulin out in public, designing a smaller pen that requires less hand strength and dexterity to operate becomes important.

Figure 1.

IDEO’s human-centered design (or design thinking) approach.

HCD employs specific methodology to better understand people’s needs and desires, creating the opportunity for better health products and interventions. The following section outlines some of the methods employed by HCD teams.

HCD methodology relies on in-depth, in-context qualitative design research. HCD begins with people: we observe what they say and do, to try and understand what they think and feel. This research usually involves triangulation—not only listening to what people say, but also observing their behavior to uncover inconsistencies. It also usually takes place in-context, where we can observe “hacks” people might use to get around products that are not designed for them. For example, consider the case of a design team visiting a woman with rheumatoid arthritis in her home, where she was asked if she had any trouble opening her medication bottles. She said no and, when asked how she does it, she led the team to her kitchen and used a deli meat slicer to remove the cap.

Another method used in HCD is analogous experiences, which provide teams with inspiration from other industries or fields. For example, when designing an injection pen, one IDEO team went to a toy store, a cosmetic store, and a hardware store to explore other hand-held tools. They also observed a tattoo artist, for inspiration from someone who uses a hand-held device with needles for hours every day.

HCD teams also build empathy and understanding by simulating the end user’s experience. For example, an IDEO team designing a new insulin pump wore a commercially available insulin pump continuously for multiple days to understand better what it felt like. They experienced first-hand what it was like to be limited to sleeping on one side of their body, and how frustrating it was when the adhesive began to peel off before it was time to remove the pump. We do these activities knowing that we can’t fully live the lives of those we are designing for, but getting a taste can inspire innovation.

HCD also recruits different research participants than many other types of research. Often, the insights gained from design research can be greater by examining the amplified needs of people with more extreme attitudes or behaviors, as opposed to the “average” person that is often sought in market or scientific research. On the insulin pump project, the design team spoke with people with very active lifestyles and people with disabilities that limited their activity. The team heard about how physical buttons are easier to interact with than a touchscreen—both for a triathlete, and for a woman who is blind and partially deaf. Learning from people with more amplified needs often leads to better designs that also benefit the “average” person.

Another key method of HCD is prototyping and testing. Developing early, low-fidelity prototypes and getting them into people’s hands ensures that we learn quickly and can rapidly abandon or improve designs before investing major resources in something that will ultimately fail. HCD teams often go through many prototypes of varying fidelity over the course of a project. In early design research on the now-ubiquitous defibrillator, the team found that people wanted clear instructions on the specific placement of each pad on the body, despite the fact that they are interchangeable. Prototype testing with real end-users led to the ultimate design with audio prompts and clear, three-step instructions.

The use of these HCD methods leads to important breakthroughs in our understanding of people’s needs and our ability to design health products and interventions that can make a true impact on health outcomes.

How Human-Centered Design Contributed to the Evolution of Insulin Pens

HCD has played a key role in the design and evolution of insulin pens since the 1990s. IDEO contributed to these innovations, working together with Eli Lilly to ensure that insulin pens meet the real needs of people living with diabetes. Some of the insulin pens designed by Eli Lilly and IDEO can be seen in Figure 2.

Figure 2.

Eli Lilly insulin pens, designed in partnership with IDEO.

Clockwise, from top left: Disposable Humulin insulin pen (1999), HumaPen LUXURA insulin pen (2002), KwikPen insulin pen (2008), HumaPen SAVVIO insulin pens (2013).

Initially, Eli Lilly and IDEO collaborated on the design of the Humalog/Humulin insulin pen, which was the first disposable pen to offer single-unit doses. Doses were dialed in, using a single, large knob. Design research for this pen uncovered the need for a device that allowed insulin injections to be quick and unobtrusive, and the resulting pen-like device could be kept for up to a month in a pocket or purse.

Around the same time, IDEO also worked with Eli Lilly on the design of the HumaPen Ergo insulin pen, which was a refillable pen. Research uncovered the importance of considering that many people with diabetes have limited tactile sense and dexterity due to neuropathy, reduced vision, and low hand strength. Therefore, the pen was designed to minimize injection force, thumb extension, and pen diameter, while also ensuring doses were easy to read and dial.

IDEO’s next collaboration with Eli Lilly was the LUXURA insulin pen, which first came to market in 2002. After learning from people with diabetes that they often had to waste insulin if they accidentally dialed too far, this pen was designed to make it possible to dial backwards if you accidentally passed your dose. It also was designed to look “dressier” and even less like a medical device than previous pens, to promote greater comfort when dosing in public.

The next major insulin pen innovation by Eli Lilly, Battelle Medical Device Solutions, and IDEO was the MEMOIR insulin pen. This pen, which was launched in 2007, recorded the last 16 insulin doses that were delivered. This helped people with diabetes to better track their insulin doses, and reduced the mental burden that many people with diabetes experience. During design research with people with diabetes, our teams have frequently heard about how mentally exhausting managing diabetes can be—keeping track of carbohydrate intake, insulin dosage, blood sugar, exercise, and many other details, all day, every day is a significant burden, and this pen design aimed to reduce that.

In 2008, Eli Lilly launched the Kwikpen, which was also designed in partnership with IDEO. The pre-filled pen was designed to be as small as possible at 5.7 inches, in line with people with diabetes’ preference for smaller pens that were easier to carry and more discrete.

Finally, IDEO and Eli Lilly collaborated on the HumaPen Savvio, which came to market in 2013. Through design research in several countries, the IDEO team uncovered the insight that people with diabetes want to be valued as unique people, not as generic patients. They described other personal non-medical objects that they carried with them daily, like tubes of lipstick, and this led to the design of the pen to look more like a personal accessory and less like a medical device. It also inspired the decision to make the Savvio Pen available in six colors, allowing for personalization and choice.

IDEO’s partnership with Eli Lilly and use of HCD methodology led to advancements in insulin pen technology that evolved with the needs of people with diabetes. It is important to note that, while we have focused this section on our experience with insulin pens designed by IDEO and Eli Lilly, other companies also made significant advancements in insulin pen technology over this period as well. For example, the Novo Nordisk’s FlexPen evolved to require a lower injection force while maintaining dose accuracy when compared with the older, original FlexPen. ¹ Novo Nordisk’s NovoPen Junior also allows the dose to be adjusted in half-unit increments, like Eli Lilly’s HumaPen LUXURA HD, which is especially important for pediatric patients. ¹ Novartis also developed the NovoPen 3 PenMate to hide the needle from view, for patients with a fear of needles, and found a reduction in patients’ perceptions of pain when using the PenMate. ¹⁰ Many pens currently on the market from all manufacturers now have features described above, such as disposable prefilled pens (which may be considered more convenient by patients) and backward dialing to correct misdialed doses. ¹ More recently, smart insulin pens have also been developed and have the potential to reduce the cognitive load for people with diabetes, as well as to improve self-care behaviors and insulin dosing accuracy.^11,12

How Human-Centered Design Can Contribute to Future Innovation in Insulin Delivery, and Beyond

In recent research, design teams have heard that some people with diabetes hesitate to use (or use as prescribed) today’s insulin pens, due to the stigma associated with the recognizable form or the obvious and sometimes scary “stabbing” motions required to use them. These insights helped to identify an opportunity to either make the form and interaction more discrete, or to “hide it in plain sight” by integrating into another familiar non-medical form. To illustrate how HCD can fuel future innovation from an insight like this, we asked a multidisciplinary team of designers at IDEO to brainstorm ideas, responding to the question, “How might we design an insulin delivery device for intermittent use that is discreet and reliable?” In brainstorms, we strive for quantity over quality, avoid critiquing, and encourage wild ideas. We avoid applying any constraints at this early stage to push the boundaries of what is possible and to fuel creativity, as even “impossible” ideas can be the inspiration for new solutions that are feasible. Figure 3 shows the output of this brainstorm. As a next step, we could take some of these early ideas to people with diabetes to hear their reactions and learn about their priorities. We often call these provocations or early ideas “sacrificial concepts” and they are a common research tool in HCD. This quick brainstorm illustrates how we begin to move from an insight about user needs to early ideas and inspiration, and then back to users for their ongoing input. This same process can also be applied to spark new ideas in any other area of diabetes care.

Figure 3.

Intermittent insulin delivery provocations, or “sacrificial concepts.”

Conclusion

Over the last two decades—alongside other major advancements in the field of diabetes care, due to the work of competitors and collaborators—IDEO and Eli Lilly contributed to advancements in insulin pen technology that evolved with the needs of people with diabetes. HCD methods—such as in-context design research, analogous inspiration, and prototyping—help to ensure that we put people’s needs at the forefront when making design decisions, thus leading to the creation of more effective health products and interventions.

Future technology developments—higher concentration insulin, more precise dosing mechanisms, easier integration with digital platforms, and closed-loop glucose monitoring and insulin delivery systems—will make new designs in diabetes care possible. The greatest design gains will be made by applying the tools of HCD to interpret how these new developments can be made most useful to people, satisfying human needs that are as-yet insufficiently met. We are excited to see what new, human-centered innovations will emerge in the future to improve the lives of people with diabetes.