Bridge Design

Finally our new web site is up and running – thanks to considerable efforts by our ID Director Matt Presta and our Marketing Assistant Caitlin Clarke.  We should also thank our web developer and host Level9. The new site will allow us to update and add new projects much more easily as it has the latest in content management systems to make this easier.  Thanks for visiting and come back as we will be adding new content regularly.

Bill Evans President Bridge Design

One of the larger trends we are seeing is that some of the thinking behind what makes a great consumer product is finding its way into forming medical products, especially those that are very patient-centric in their use.  Nowhere is this more obvious than in application specific products where we have an opportunity to design for a much more specific group of users, the product can be designed for a much better patient experience without the need to be all-things to all users like many of the general medical products out there.  To give an example of this trend and be able to show it now the Bridge ID team designed our interpretation of what an ultrasound device could be like in the near future.  Our press release below.

San Francisco – April 6, 2009 – Bridge Design, Inc. - Portability is the fastest growing segment in the ultrasound market. Imagine fast-forwarding a few years when technology becomes less expensive and more powerful and compact. What would a birthing-specific ultrasound, designed specifically for the mother–to-be, look like?San Francisco-based Bridge Design has come up with an innovative, mother-centric device that focuses on making the ultrasound experience pleasant and hassle-free. The Stork provides a number of features not yet on the market, including a second display so the mother won’t have to strain her neck to look at the screen. It also allows the mother to email electronic images directly to family and friends from the device instead of receiving paper printouts. Unlike the average ultrasound machine, the Stork is unintimidating, even playful, with a flip screen and basket-like portability which contains “cup holders” for probe and gel. The Stork’s color, materials, and finishes forgo the clinical white and gray palette for a much more soothing birthing experience.Bridge’s Director of Industrial Design, Matt Presta, who also happens to be a parent, explains:“Any mother who has had an ultrasound is familiar with the cart of equipment, probes, gels, screens, printouts, and everything else that comes with it. And although the experience is necessary for clinical reasons, many parents just want to see their baby. For years, Bridge has observed trends clearly pointing towards designing for the patient’s experience. Since we’re still a few years away from seeing the tipping point of the patient-centric trend in health care, we wanted to provide a glimpse into the future based on what we’re seeing happening in the industry.”It’s worth noting that although this device has not yet been manufactured it reflects a trend that Bridge sees growing, with more application-specific medical products likely to appear at healthcare facilities in the not-too-distant future. “As a given technology matures, its cost and size typically shrinks. This opens up exciting possibilities to those forward-thinking medical equipment manufacturers who understand that if you change your design thinking to be more user and patient-centric, then new market opportunities can be created. Addressing baseline functionality and reliability at low cost is not enough to stay ahead of the game in mature markets,” says Presta.

A description of services can be found at http://www.bridgedesign.com.  SOURCE Bridge Design, Inc.  Contact Matt Presta of Bridge Design, Inc. +1-415-487-7100, ext 300, mpresta@bridgedesign.com

This article was originally published in MDDI on August 2008.

The green writing is on the wall: it is time for medical manufacturers to consider the sustainability of their products, packaging, and production processes.  In the consumer world, Wal-Mart is undergoing a major effort to adopt sustainability and even hired the ex-head of the Sierra Club as a consultant on this topic. Clorox recently announced its Green Works line of greener household cleaning products.  Companies with a strong presence in the medical field like Kimberly-Clarkand Philips have long been addressing the problem.

Even if you are not doing something about getting greener, your customers are. Alegent Health, a company with nine hospitals and 8600 employees, has recently named a vice president of sustainability.  When faced with a choice of medical products of similar cost and efficacy, it is likely that customers will purchase the greener product, especially if manufacturers have added green to their brand attributes in a way that customers see has real meaning.

Sustainability broadly means considering the environmental effect of a product throughout its life cycle, not just in its creation and initial use. And it is a daunting topic for the uninitiated.  Although RoHS and other legislation in Europe have brought some sustainability issues to the forefront, it is understandable that many medical manufacturers have been reluctant to embrace sustainability. The device industry is notoriously slow to make changes. In addition, the industry is sometimes exempted from the legislative restrictions required in the consumer marketplace and is therefore less likely to pursue such change. Further, sustainability has an image of increasing costs.

Start Here: Map the Product Life Cycle
Understanding how manufacturers can use sustainability requires mapping a product’slife cycle. This includes raw material extraction; all processing and manufacturing; actual use; and disposal, reuse, or recycling.

Creating a sustainable product is an attempt to reduce the environmental footprint at each stage with some kind of change. Changes do not have to be massive to have a positive effect. For instance, Philips Healthcare considers a product a Green Flagship if it achieves 10% improvement over its predecessor or competitor. A review of Philips products with such status indicates that most achieved improvements in the 25–35% range.

OEMs usually focus on improving efficacy and usability, and minimizing trauma and cost. Like these factors, sustainability has the biggest influence at a product’s conception.  Many sustainable qualities of a product are baked in during the innovation and design stage.  

For medical products, the business model is also important. For example, a one-time-use disposable consumes more resources than a reusable product. Of course there may be clinical, product, or sterility issues that require disposability. Because of such factors, the approaches to sustainability from the general consumer or industrial world do not always translate well to medical products.

Quantifying Design Alternatives

Once a specific device’s life cycle is understood, an OEM can begin identifying the places to lower its environmental impact. The team should quantify the effects of various choices.

One way of enumerating a particular design’s effect is to use software such as Life Cycle Assessment (LCA). This software draws on carefully researched databases, allowing manufacturers to estimate the effect of one type of plastic over another, the weight and material type of packaging, or shipping options.  Leaders in LCA software are European companies with products such as SimaPro and GaBi. 

Although large companies may already own such software or think nothing of purchasing it and training people on how to use it, the software may not be the right place for most device manufacturers to start.

Hans van der Wel, Philips Healthcare’s manager of ecodesign and sustainability, helps run its Green Flagship program. He says the best method for starting out is to “keep it simple. Start with a spreadsheet based on simple indicators. We call ours green focal areas [and] include qualities like the amount of materials, energy, and hazardous substances used.” He says it took Philips 10 years to get to its Green Flagships program.

Example: An RF Surgical Tool

An example product demonstrates how device designers might approach sustainability. A product system includes a disposable and an energy-supplying console.  The following section explores the effects of changing these system elements, which are typical to many medical products.

In evaluating the effect of the various components that make up the whole product, designers need to use real impact data. The LCA software makesfinding data easy. It is probably the best long-term tool, but it requires a commitment of money and training that might slow initial efforts. Alternatively, the Okala Guide is inexpensive ($12) and has a useful table of impact factors that covers common materials and processes. It is used in this example.  The Okala guide combined with a simple spreadsheet may be good tools to get started.

To make this example easy to understand and illustrative of the kinds of improvements possible, not every material or process is compared. In some places, system elements are combined and given overall numbers to ease the reading of the tables.

The analysis focuses on areas in which manufacturers can have the most influence.  In practice, when you consider the whole product, the actual impact reduction achieved might be lower than the numbers shown here. However, on an established product, an overall 20–30% reduction is relatively easy to achieve.

Product Description. A hypothetical radio-frequency (RF) tool for clamping and cauterizing surgical wounds is being considered for redesign. The company hopes to improve sustainability.  The product is a system consisting of a disposable handpiece and an RF energy generator and controller.

The Disposable Handpiece: Consists of a plastic-and-metal handle with integrated mechanisms that provide mechanical advantage to the surgeon’s grip during the procedure, and a wiring harness to connect to the console. The handle is currently single-use (all parts) and is contained in sterile packaging.  It is manufactured at one location but used in all major global markets.

RF Energy Generator and Controller: Consists of a piece of capital equipment that is a power and control source for the disposable. It is based on five-year old electronics and display technology, has no field-upgradable features, and is intended to last five years. The console is built into its own hospital cart.

Two levels of improvement are considered: first, a few options f or redesign of the disposable, and second, a redesign of the reusable energy-generating console. To begin, readers should understand the existing product’s ecological footprint to accurately compare new design approaches.

Calculating the Footprint.

Everything that is used to make, use, or dispose of a product is scored based on its environmental effect. This is calculated using a rating called impact factor.  Impact factor numbers have been gathered or researched and reduced to a standardized unit by an agency such as the makers of LCA software or compiled in resources such as the Okala guide used here. This factor is based on how the particular parameter is used in the product (e.g., per lb material, kWh of energy, tn/miles of transportation, etc.). Totaling the scores yields an overall product rating. In this example, units are in Okala milli points. Impact factor units must be the same for all contributors. Values from sources that do not share units cannot be mingled.

The RF device example looks at the effect for the entire life of the product—about five years. During this time a typical user buys one console and uses 10 disposables per week, yielding a use of 2600 disposables per console lifetime. This means that of the roughly 212,000 impact points, the 2600 disposables used over the product life contribute about 196,000 points. It is important for designers to consider the overall system usage, not just individual parts, in evaluating and comparing the various redesign choices. With this calculation in mind, consider the following possible changes to the hypothetical product.

Scenario 1—Make the Disposable Part Weigh Less (console unaffected).  This scenario simply considers using improved design optimization tools such as finite-element analysis (FEA) to reduce the material needed for both the plastic and metal components (without compromising function).

A slight weight reduction has various virtuous effects. Less material is used, which reduces environmental impact.  In addition, lower material cost helps offset the increased design and validation costs of a lighter handpiece.  Packaging can also get a little lighter to reduce shipping cost and impact.

A modest change to the product, requiring no major changes to the way it is made or used, yields a small but meaningful 6% reduction in impact over the product’s life.

Scenario 2—Make the Disposable Weigh Less and Enable the Wiring Harness to Be Reusable 20 Times. The development team notices that almost half of the disposable’s impact comes from the copper wiring in the leads that connect it to the console. The leads are redesigned to be sterilized and used 20 times instead of just once. The copper content remains the same, but the insulation needs to be beefed up to make the parts rugged enough to withstand reuse.  Also, now they will not be packed with every disposable but instead be shipped one set per box of 20 hand pieces. Overall, the product and packaging are lighter, further reducing impact score. A factor must be added for the sterilization by the hospital. 

Reusing the wiring harness has a very significant effect. Now the impact is reduced 44% overall from the original product. This redesign does, however, require a change in how the product is sold (box of 20 handpieces with just one wiring harness enclosed) and in how it fits into the hospital’s overall workflow. Hospitals must sterilize, manage, and inventory a wiring harness for 20 uses. But copper is also expensive, so now the cost to provide the function of 20 handpieces has decreased. Such savings could be passed on to users in exchange for the task of sterilization, without negatively affecting the manufacturer’s profit per handpiece. It is a balancing act, because the cost of sterilizing at the hospital may outweigh any savings.

Although the market may not yet be ready to make such a change in how it handles wiring harnesses, the example shows how such a change contributes to making the overall system green.  As some large hospital groups become serious about being more sustainable, they may be prepared to make these kinds of changes in the near future.

Scenario 3—Build on Scenario 2 by Redesigning Electronics and Choosing Lighter Materials for the Enclosure.  Now the development team turns its attention to the console and notices that the energy used while the machine is on (usually for a four-hour procedure) affects every disposable. Modern electronics are not only RoHS compliant, but also offer a more efficient package in terms of PCB size. Furthermore, new electronics consume half the energy of older electronics (due to improved sleep modes between uses during the procedure).  Now that the console is smaller, it can be built into a lighter, portable enclosure, rather than integrated into a heavy cart. Such changes have a significant effect on both disposable and capital system elements, and yield an overall 52% reduction.  Notice that if further changes are made to the console electronics to reduce copper wiring by 20–50% (perhaps by some novel pulsing technique or a change in the frequency of the RF), it would further improve the product’s impact score.

A simple spreadsheet scenario like the tables allows a team to see possibilitiesfor redesign. This is obviously a highly generalized example. Only your technical and marketing teams know where the opportunities lie for your specific product in its clinical efficacy and marketing acceptability.

The Disposable Matters More
In this example, it is assumed that 10 disposables are used per week per console—not an unreasonable assumption for this kind of surgical tool. As noted, this means that over a five-year design life, 2600 disposables are used.  Therefore, even a small improvement in the disposable has a magnified effect.  By contrast, if the design team halves the impact of the console it hardly reduces the system’s overall impact. Designers must consider the effect of the whole system’s use.

Although the case study shows that focusing the redesign effort on the disposable has the most affect on environment, there are still things the manufacturer can do to the reusable portion of the product that can further reduce its impact. In the example, 50% more efficient electronics in the RF energy generator lowered the energy portion of the product’s impact 2600 times because each use of the disposable cost 50% less energy.

Conclusion
This exercise shows how changes such as lowering energy use through a better sleep mode for the console can have a greener consequence than, say, using a lighter plastic on the enclosure.  It’s not always the obvious changes that have the most benefit, and unfortunately, finding the changes that have the greatest potential are not formulaic. Each product will have very different aspects that must be rethought.

Perhaps as an industry we need to reconsider what it means to be green.  As Wendy Jedlicka, a sustainable packaging expert, puts it, “The idea that you have to wholly embrace eco like a religion is shortsighted and frankly not sustainable. We need to get everybody doing a little bit of something to mitigate what we are doing right now; then we can keep improving.”


Reference
1. Philips Medical Green Flagships [online] (Amsterdam [cited 28 May, 2008]); available from Internet: www.medical.philips.com/main/company/sustainability/
green_flagships. 

These trends are exactly that trendy. Like any new method, they go out of fashion after a time. Sometimes it ’s for a good reason, but occasionally they are wrongfully discarded for the next new thing. Although many aspects of these trends have something to offer, the biggest improvement will come from taking a more-holistic view of innovation by focusing on three core areas of a business: culture, process, and resources. Try introducing six sigma into the wrong culture and it is bound to fail. Pour resources into a development program with a bad process and it is unlikely to create breakthrough products. This article provides insight into the aspects of company culture that make many successful innovations possible.

The trick is to experience failures quickly. Test ideas in the first months of the development project, way before any serious engineering has been done.  Use every trick in the book to visualize the product and get it in front of customers.  Show sketches, prototypes, and simple foam models. Cheat prototypes into existence by cobbling together existing products or hijacking technology from other industries.  Show early ideas to potential customers.  Get ideas out in the open for people to criticize, but do it as soon as possible.

Paradoxically, teams that learn to be good at failing quickly often learn to become better at succeeding quickly.  To encourage risk, and hence innovation, all team members must become comfortable with this paradox and adjust their expectations as a project moves from concept to refinement.  Taking risks early is inexpensive and potentially rewarding. Taking risks later in a project is much less desirable.  Then, the die has been cast, and linear, predictable behaviors are essential.  This takes almost superhuman management abilities, because unpredictable behaviors must be encouraged early on, but later, when the project progresses or employee reviews come along, the same manager must hold employees accountable to their management by objectives. Or the managers must account for the team’s progress to an upper management that is more skilled at counting beans than at growing them.

A project leader with great interpersonal skills as well as technical chops is key to a successful team. But people are not born this way—they are cultivated.  Along with the top leader, every significant project should have submanagers who are being mentored to take the leadership position on future programs.  Train for the soft people skills as well as the technical know how to cultivate a team.

Project leaders need to be supported by upper management with realistic budget and scheduling that has contingency built in. The entire team does not need to know exactly how much contingency there is; instead, the leader listens to each subteam’s needs and allots it some of the scarce resources.  Other team members must quickly learn the reasons for the allotment so that it is understood that there is sound logic behind it.

But even without a contingency, the schedule needs to be plausible. There is nothing less motivating to a team than shooting at a target that is hopelessly out of range. Obviously, there is never enough time to get every detail of a p roject perfect.

It is inevitable that a team leader will ask for a few miracles and, as the joke goes, these will take a little longer. But when the entire team understands the bigger project goals both technically and from a business perspective, and it is plausible that with a little extra effort these goals can be grasped, people rally to meet the objective.

But in subtle ways, such situations can come up all over an organization as a project unfolds. Sarcastic comments around the water cooler about nascent ideas or overheard phone conversations that poke fun at a part of a project that failed puts innovation in a straitjacket.

Experience often gets in the way of new thinking, but it is an important partner in making things actually happen. Therefore, the entire team needs to encourage a democracy of ideas, especially in the early concept stage.

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?

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. (For a more detailed explanation of this brainstorming process see the article “Beyond Brainstorming” on http://www.devicelink.com/mddi/archive/04/09/013.html)

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.

You can view a short video of the insertion process here. You can find more consumer information about the Cleo here.  

Conclusions

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.