This article originally appeared e + f: engineering the future, a CUES publication April 2006.
How does a medical device company create a new product for a well-established market when a handful of competitors seem to have sewn it up? This was the problem facing Smiths Medical MD, (Minneapolis USA) who had recently successfully entered the diabetes market with an insulin pump and were looking to create a new infusion set for the same market. How could this new infusion set be made compelling enough to move customers entrenched with the competitive offerings over to a new product?
The Smiths Medical Cleo Insulin Infusion Set
This article uses the case study of the design of this infusion set to illustrate how designers and engineers can best refine their design process to create new products that both benefit consumers and make their companies more competitive in the global marketplace. Although it is focused on a new medical device,the design process described here can be used across many product types that have a high degree of human interaction, ranging from consumer and automotive through a wide variety of industrial and scientific equipment markets, ensuring that a product is beneficial for users without sacrificing the company’s competitiveness.
Living with Diabetes
To understand this product challenge it is necessary to understand how patients currently manage their diabetes. Type 1 diabetes, also previously referred to as juvenile or child onset diabetes, is a condition where people stop producing their own insulin. Insulin is a hormone that controls humans’ ability to regulate the flow of glucose in their blood. If a person looses this control, their blood sugar oscillates wildly according to many factors including what they eat, how they exercise and if they are sick. Such a lack of control over blood glucose leads to many life threatening complications such as loss of limbs and sight, and leads to shorter life expectancy for the millions of people with diabetes. Although much research is centered on finding one, there is currently no cure available. In the meantime people with diabetes have to control their blood sugar by taking regular doses of insulin, often in the form of multiple daily injections using simple hypodermic syringes.
What is an Insulin Infusion Set?
Increasingly, diabetes professionals and patients are recognizing the value of using a small programmable pump to infuse regular amounts of insulin directly.The programmability of the pump and the user’s ability to routinely adjust, or titrate, the dose of insulin allows people much greater control over their blood glucose levels. It also has the added advantage that users do not have to stick themselves multiple times with a needle. Instead they insert a small plastic tube, known as a cannula, into the midriff region of their bodies and let the insulin be pumped in exactly when needed. This connection, known as an infusion set, is typically worn 24 hours a day held on by an adhesive patch, and is disposable, with changes necessary about every 3 days. The cannula has to be introduced into the body with a small needle to help it reach the region of fat just beneath the skin (known as subcutaneous fat). After insertion the needle is withdrawn and disposed of. A thin plastic tube then connects this infusion site with the pump.
As readers will see from the above explanation, diabetes is not much fun to live with. Patients have to suffer multiple insults to their body, including pricking their fingers for testing blood every few hours as well as sticking themselves to get the insulin in. Infusion sets and insulin pumps help, but as designers and engineers what can we do to make life easier for these people?
How can we make the new product compelling?
To really cater to a user, you have to understand exactly what it is like to live with the disease. This is the premise with which Smiths approached the design of their infusion set. They asked the question “How could this new infusion set be made compelling enough to move customers entrenched with competitive offerings over to a new product?” Just doing a “me-too” product in the £XM diabetes infusion set market was not likely to win customers over or help the management at Smiths justify the significant R&D expense of a new offering.
Smiths immediately set about creating a small core team of about eight people to begin the development. This was a cross-functional team with mechanical and manufacturing engineers as well as product marketing people. Smiths medical also partnered with an industrial design firm, Bridge Design, at the very beginning of the project to ensure the team was rounded out and to take advantage of Bridge’s previous experience with developing Smiths market winning Insulin pump (Cozmo). The project started with all members on board and a team leader, Tim Bresina, who, although from a manufacturing engineering background, had a broad perspective on what it takes to develop successful medical devices and a real appreciation for what the various disciplines in his charge could do collectively to allow innovation to flourish. Team members often bring preconceptions or pet solutions to the problem they are trying to solve. This is inevitable, but before any serious work began on this project the team set about calibrating their understanding of two crucial things; what diabetics want and to benchmark the competitive landscape.
The “Deep Dive” into the Customers Mindset
To understand users, Smiths had three exploratory submarines in its fleet, all of which were important in taking a “deep dive” into the customer’s mindset. Firstly, its connection and understanding of its present customers was a valuable data point. Smiths had a nascent Diabetes business and a maturing understanding of its customers that were currently buying an OEM infusion set that Smiths branded and sold. The marketing people on the team normally worked in this marketplace, and were thus able to bring this perspective. Secondly, Smiths had assembled a couple of external advisory boards consisting of various types of healthcare professionals such as Endocrinologists (the medical doctor specialists for Diabetes) and Certified Diabetes Educators (CDEs) who are the nurse practitioners who work directly with patients to help them get better control of their blood glucose levels. Regular meetings with these advisory panels helped the team understand emerging trends, providing a forum for rapid feedback on product development ideas. With a patient’s purchasing decision influenced by a mix of doctor, CDE and peer referral, as well as the medical insurers or healthcare systems willingness to cover the cost of specific products, the market for infusion sets is complex. As Smiths was targeting a global market, they used ethnographic research to “get under the skin” of what people with diabetes really desired in the ideal infusion set –and this proved extremely important. Ethnographic research is a technique of observing and interacting with people to gain a deep understanding of their needs, including needs that the users might have a hard time articulating. There are many ways of doing this research and they vary according the nature of the problem. Smiths enlisted the industrial designers from Bridge Design to do the ethnographic research for Cleo but also made a point of sending along a few of their engineers and marketing people to observe. Bridge recruited about 50 people with diabetes of various backgrounds and ages all of whom were currently using infusion sets. To ensure a good spread of feedback three different geographic regions of the USA were chosen.
Once the participants were identified they were briefed about the team’s interest in better understanding what it is like to live with the current infusion sets on the market. Disposable cameras were sent out ahead of our interviews and two weeks later we met with them. Fortunately, our subjects were highly enthusiastic about it, and willingly told us what it is like to live with infusion sets, sharing photographs of their infusion routines and in some cases showing us where they were wearing them in the actual interview sessions. Of course, the interviewing process had to be conducted very carefully, with the risk that, if it was too structured, it could have prevented us from pursuing interesting lines of questioning. In practice it is best to have interviewers who bring very few preconceptions to the session but who have a significant understanding of the issues. For instance, participants will often tell little white lies about some of their routines because they know that they are “supposed to do it like this”. In doing this research there are of course no right or wrong answers, so the role of the interviewer is to make subjects feel comfortable about being honest in their responses and to probe areas where there is concern that actual practice may differ from what is recommended.
Briefing the Team – Getting the Voice of the Customer into the product design process
A few core members of the team then set about preparing for an intense two day team briefing and brainstorming session where about eight team members from all the different disciplines would meet off-site for focused idea generating sessions. The focus of the sessions was not on solving a narrow set of technical issues. Instead it was on understanding the users’ needs for the product and using that insight to focus the whole group on a series of questions that were carefully crafted to elicit design ideas that attempted to meet those user needs.
Prior to the two-day session, various team members also did some preliminary brainstorming around a sub-set of technical issues. The mechanical engineers from Smiths developed some interesting ideas for sprung mechanisms to assist with extracting the needle from the cannula after it is inserted through the skin.
Bridge Design went out and did some shopping for the project, spending about a day scouring the aisles of supermarkets, drug stores, toy emporiums etc. The designers found many interesting products that could be used in the brainstorming to stimulate the team. Bridge design hosted the meeting in San Francisco and compiled a two-hour briefing presentation for the team. This briefing gathered all the research, including the ethnographies, benchmarking of competitive products and inputs from marketing and the advisory boards. All team members were encouraged to contribute their own experiences and research to the briefing–exposing the entire team to diverse opinions and interpretations of what the customers wanted. However, with a large patent estate already surrounding infusion technology, the team also had to consider what solutions would be out-of-bounds due to pre-existing intellectual property.
The team then set about debating what the customer requirements were. It is important to understand that users will not always articulate fully their hopes for what a new product might be like. People are very good at judging products and solutions that are already created; they are not good at imagining “What could be”. Therefore in debating the customer requirements the group was trying to get to the very basics of what customers want as well as what they need, which is why it was so important to involve a diverse group who had all had some kind of customer contact. In the case of a medical product, such as the Cleo, the customer is broader then just a typical user, as the opinions of healthcare and insurance professionals also need to be considered.
To organize and prioritize the list of requirements, which were deliberately stated very simply, a scoring system of 1, 3 or 9 points was used. This scoring system was set up to polarize the scores around some big number differences as arguing about whether a feature merits a score of 4 or 5 does not force a team to make bold decisions about what really matters to the users.
The team also debated other factors such as the users’ current satisfaction with these types of products and the potential impact of meeting a particular requirement to improving sales. For instance users expect a medical product to be reliable so this would have a neutral effect on sales, whereas creating a highly integrated device (insertion, adhesion, needle safety etc) would be a big plus for sales so is scored more highly. The purpose of the customer requirement ranking exercise was not to get the scoring ‘exactly right’. Instead it is an exercise that takes about two hours and is about the team debating,arguing and reaching an understanding of what these requirements actually mean to users.
This technique is a highly simplified adaptation of a system for product development known as QFD (Quality Function Deployment) that is often used in six-sigma types of product development environments. In practice this author feels that although QFD may be of value on very complex product development processes it is too cumbersome and frankly a very boring way of getting a development team excited about the product possibilities. But stealing a few of its techniques and simplifying them are useful.
What the team learned from users was that they valued good old convenience and reduction in the steps to use the product. Children and some adults also expressed a dislike of handling the needles required to help insert the set. The requirements in this chart capture the essence of what the team felt customers wanted and importantly give some dimensions to the criteria rather than just blandly stating things like “convenient to use”. This is a much more useful place to launch into a creative brainstorming session than trying to plough through a detailed 50 page customer requirements document.
Setting up the Brainstorming Questions
Next the team set about creating a very pointed group of about six questions that would be used to focus the idea creation process. This is a skilled task as the questions have to highlight the customer needs without limit or suggesting possible solutions.
The brainstorming itself consisted of about six half hour intense ideation sessions spread over nearly a whole day. Each mini-brainstorm was structured around a particular question centered on an essential customer requirement; ie “How can we reduce & speed steps in the insertion process?” The whole process of being immersed in the design issues off-site over a two-day period really focused the team’s efforts. Keeping the actual sessions as short sharp bursts of creative energy with rest periods of at least ten minutes between sessions also helped keep the team fresh. Rather than using large white boards or cumbersome flip charts the group used small easily manageable “idea sheets” to sketch or write down their ideas and share them with the team before posting them on the wall. All the usual rules of brainstorming were applied and the team was encouraged to turn any critical thoughts they may have into new insights, building on both other team members’ ideas as well as generating new ones.
One Idea a Minute
The result was that the team created about 200 idea sheets with innovative solutions focused by the careful preparation. The Smiths engineers shared mechanism ideas with the team and it further stimulated ways of using the mechanisms with a very user-centric appeal. A smaller group of designers at Bridge Design then took the group’s efforts and sorted the ideas into three categories – Hot, Maybe and Not. As many readers are aware, successful brainstorming tends to focus on creating a large number of ideas rather than fewer higher quality suggestions. This session produced a solid collection of ideas that were truly “Hot” with an equal number that were mediocre. Once the best ideas were sorted through it became clear that there were a number of innovative solutions that could be synthesized into different product concepts.
The Whole is Greater than the sum of the parts
In all, about 6 different concepts were explored and the one that offered the most advantages was pursued and engineered by the Smiths team. The design attributes are:
- Users told us that step reduction was an important goal so the final product is the first all-inone system: sterile packaging, inserter and needle safe disposal container and reduces the insertion steps from about 15 to only 3. The adhesive patch does not require stripping as it is protected inside the disposable. The user simply unscrews the cap and gently presses the unit into their skin at a speed convenient to them. At the end of the insertion stroke, a spring returns the insertion needle up inside the container into a needle safe location.
- Cleo hides the needle from sight for ease of mind and perceived pain reduction.
- The “on-body” part was made smaller and adjustable to fit any infusion or pump location.
- Cleo is a discreet non-medical looking product that uses a classis bottle “rip-top” appearance to help cue users that this is a disposable product.
- It met the intellectual property goals of creating technology unique to Smiths.
Often engineering education focuses on the functional aspects of a product. In medical product design this is often thought of as how medically efficacious the product is. Unfortunately, in practice this view tends to disregard a broader user perspective – “How can you make this product easier for me to use”. In this context “easier” can mean many things. New medical procedures often require users to change their habits, ergonomics and visual cues, instead of making a new procedure seem like a logical progression from something that they are already familiar with, which can really make adoption easier. An attractive product which appears non-threatening is also effective when trying to help children better manage diseases like diabetes. The process that Smiths adopted for Cleo was really focused on getting these softer, user desired qualities into the product. It is possible to go back through the project history and see user comments that asked for certain attributes and then follow a trail through the design process to see how those insights really motivated the team to turn their technical skills in the most useful direction. It is also possible to say that everyone on the team contributed to the design. Ideas were built upon; inspiring technical solutions came from the process. And, if a technical block was met along the path to implementation, the engineers at Smiths were highly motivated to overcome them as they had a good understanding of what their customers wanted, providing them with a sense of satisfaction of knowing that when they got the job done they would have made diabetes just that little bit easier to live with! Left: Cleo with the cap removed and ready for insertion. (Note that the adhesive requires no manual stripping.) Right: After insertion with the needle safely retracted.