Bridge Design

The CADD-Solis pump is a patient-controlled analgesia (or PCA) pump that lets clinicians and patients administer pain medication within pre-programmed, patient-specific, safe limits. The CADD-Solis System advances "smart" medication delivery; the user interface was designed by Bridge and Smiths Medical to help reduce medication delivery errors.

The medications PCA pumps deliver can harm patients if programming errors are made. CADD-Solis provides a system designed to help reduce these errors. Using software, the hospital builds a library of safe treatment protocols that are downloaded to the pumps.  To program a pump, a user steps through a sequence of three simple questions relating to observable conditions, such as patient age or route of medication delivery. Only a limited set of safe choices are available at each step.  Once a protocol is selected, the user can adjust delivery parameters only within predetermined safe limits.

CADD-Solis demonstrates the value of design research in focusing the team’s design efforts. Insights gained about the system-wide issues faced by stakeholders—from risk managers to floor nurses—enabled Bridge and Smiths Medical to develop a truly innovative approach, designed to help reduce medication delivery errors, ease the burden of set-up for nurses and dosing for patients.

To appreciate the design challenges CADD-Solis has solved, it’s necessary to understand the complex topic of safe pain medication delivery. After their invention in the 1970s, PCA pumps gradually became more sophisticated in their programming of doses and limits. Multiple routes of administration were developed (intravenous, epidural, and peripheral nerve block), and the number of available drugs and concentrations proliferated.  By the early 2000’s, regulatory groups such as JCAHO (the US Hospital auditing body) and watchdog organizations such as ISMP (Institute for Safe Medical Practices) noted a significant number of safety incidents with PCA pumps. They identified a set of contributing factors, which included many relating to the design and programming of the pumps. These included drug labeling and concentration mix-ups, pump mis-programming, incorrect route of delivery (a safe dose intravenously can be fatal epidurally), incorrect transcription of prescriptions into pharmacy computers, and calculation errors when determining the patient's dose or rate of infusion.

From these safety reviews and the information gathered from the stakeholders--including pharmacists, hospital administrators, pain doctors and nurses, and ward nurses--it was clear that to improve safety, the whole system would have to be tackled. How can the pump that is just on the delivery end achieve this? The design solution was to treat the pump and its programming as just one piece of a medication error reduction system and create a new systematic approach to PCA medication safety.

In addition to the medication delivery system overhaul, Bridge made key design improvements from the prior generation, such as:

• An improved remote dose cord ergonomically designed to sit much more comfortably in the hand of a potentially sleepy patient. It also offers greater ease-of-use for those patients who cannot comfortably use their hands. (See Exhibits yy and zz.)
• A medication cassette which can now be changed using only one hand, instead of two hands as was previously required. (See video.)

CADD-Solis also has built-in USB and infrared ports. As the number of hospitals using more advanced information systems grows, the company will be able to offer appropriate server-based software to connect CADD-Solis to these systems.

Insulin-dependent diabetics may opt for an insulin pump rather than injections. A pump provides much tighter control of the disease, more flexible eating habits, and lower risk of complications. Insulin pumps rely on disposable infusion sets to deliver insulin to the body. Inserting a set means driving its soft, hollow plastic cannula into the skin with a needle that is then withdrawn; the cannula is affixed to the skin with an adhesive patch and connected via tubing to the pump. Given the development cost (and risk) of designing and producing their own infusion set, Smiths challenged Bridge to help them create a product with significant user benefits over existing designs.

Cleo's overarching mission was to make infusion sets easier to live with, from purchase to insertion to disposal. The result of a customer-focused, research-oriented process was a uniquely all-in-one infusion set that's radically different from any competitors': it's an integral sturdy sterile package, easy-to-use insertion tool, comfortable and secure on-body device, and an automatic, needle-safe disposal container. Cleo's unique design and its host of new features reduce complexity, maximize comfort, and ensure safety. A truly collaborative effort between Smiths' engineers and Bridge's industrial designers and researchers, the result exceeded expectations. In an informal race, one user was able to install 10 Cleo's in the time it took his opponent to insert one competitor's set!
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Most companies do at least some kind of market research before designing or redesigning their products. This research may be informal, such as input from the sales team on what customers want, or formal, quantitative research, often conducted in focus groups or as part of a larger Six Sigma process. Design research is a fundamentally different way of approaching the innovation process.

Design research means Bridge's designers get immersed in the problem by direct and personal contact and observation of the intended user group. Because we are designers we see issues in a fundamentally different way than market researchers. We are much more interested in "What could be" rather than "What has been". We are not looking to have our users design the product for us by listing out the shortcomings of existing products or suggesting incremental improvements. Instead we are experts at finding out what users really want by understanding the context of how they want the product to fit into their lives. This is how Bridge's designers worked with the engineers at Smiths Medical to create this groundbreaking product.

Although Bridge already had extensive experience in this area, having designed the CoZmo™ insulin pump, it was important to go back out into the field to confirm or disprove existing theories specific to infusion sets this time. The designers, using a special blend of design research techniques, began immersive research by observing and interviewing dozens of insulin pumpers to learn all the details of how they live with their infusion sets. Disposable cameras and journals sent out in advance allowed the participants to document and ponder their daily routines, giving Bridge unique insight into the nuances of their lives, especially in areas that users have a difficult time articulating. Group and one-on-one interviews followed where Bridge designers discussed, in a structured but flexible format, issues that spanned a wide range of topics (some planned and some serendipitous): education, installation frustrations, pain, infection, scar tissue, fat, clothing, sex, swimming, insurance, general hopes and desires. After several days of videotaped interviews, it became clear that although users can't design their own infusion sets, they do know what they want. They want fast, simple, and foolproof insertion and long-wearing comfort all in a compact design.

Through years of experience we have observed that better briefed teams are much more innovative, contrary to popular belief that the best ideas will come from people who are unclouded by existing practice. Bridge hosted a briefing session based on our user research, helping Smiths understand and rank customer requirements until the whole team had a deep feel for what users really wanted and needed. The project team (which included people representing an assortment of ranks and roles from both Bridge and Smiths) brainstormed in a series of short "mini-brainstorm" sessions over 2 days. Each mini-brainstorm was structured around a particular question centered on an essential customer desire; ie "How can we reduce & speed steps in the insertion process?"

Hundreds of brainstorm ideas, from silly to sublime, were documented, ranked for potential, and sorted by Bridge. With more interpretation, thought, and sketching, Bridge designers generated a set of about a half-dozen possible product concepts synthesizing the best of the brainstorm ideas. After a presentation of each concept and discussions about its particular goals, strong points and failings, inherent issues and possible solutions, the team selected the top ideas for further development. The all-in-one set was a clear winner, and happily dovetailed well with an integral inserter tool already underway in Smiths' engineering department.

As Smiths engineered Cleo's mechanism and detailed parts for production, Bridge provided design guidance to be sure "softer" user needs were represented in every detail of the design. We helped refine the fastener that locks the infusion set onto the cannula, keeping in mind that people with diabetes may well have impaired manual dexterity. We suggested and detailed the knurled texture of the product's triple-duty sterile packaging/inserter tool/needle-safe container so that it provided a good grippy surface and conveyed a soft drink level of disposability -"twist me open and throw me away". And we guided the overall look of the product, which had to a walk a line between trust-inspiring solidity and guilt-free disposability - with flair and consumer appeal that never announces its user has a medical condition.

The Detector is an injection port detection system for reconstructive surgical breast implants. Doctors use the Detector to find the re-sealable port on the surgical implant in order to inject a saline solution into the implant. By gradually stretching the patient’s skin, the implant is inflated with a saline solution. Every few weeks for up to 6 months a hypodermic needle and syringe are used to pump saline through the re-sealable injection port that contains a stainless steel disc. The detector makes finding this port an easy and accurate job for the health care professional.  To appreciate the new design it is important to understand the previous product that Mentor had developed prior to Bridge’s involvement.

A single sensor embedded in the probe looked for a peak signal. This older product required four steps:

• It must be tuned
• It must then be calibrated by sweeping it across the chest
• The chest is slowly scanned until the device peaks as the two upper green LEDs come on, indicating the port location
• A pen is then passed through a narrow hole in the center to mark the skin                                        

Not surprisingly, many users had trouble following these steps accurately, leaving a large margin for error.

The design challenge was to develop a much more user-friendly and reliable way to detect and mark the port, so the needle could accurately find its target up to 2” beneath the skin.  Mentor’s original attempt at designing the detector was complex to use, requiring a particular pen to mark the skin, needing specific attention not to angle the detector on the skin surface and repeated runs to confirm locations which at times still proved to be incorrect. The consequences of a missed port could mean minor surgery to remove a burst implant - so the design stakes were quite high.
The design challenges were:

• To greatly simplify the device and win back the customers with a product that gave great confidence to users
• To devise a more reliable system for locating the port 
• To make it easy to mark the port after it was found
• To make the device’s operation easy and self-evident without complex calibration issues
• To bring visual appeal and ergonomic comfort to the design
• To package the detector’s components compactly in a hand-held unit
• To create a detector that would be centered in the palm of the hand instead of having a “bicycle hand grip style” handle that introduced angular inaccuracy
• To make a product that would encourage doctors to use Mentor’s implant system rather than discouraging them

To re-design the product the designers started with the user interface. If detection was to be improved, we needed to create a new way of scanning the breast area. Mentor was reluctant to spend too much money on a more sophisticated interface without knowing it would be successful. To answer this question Bridge created an interactive computer model of a number of different approaches to port detection, with varying degrees of change to the detection and interface electronics.  This was like a video game –it randomized where the port was buried on an outline of a chest.  
Bridge then asked a number of potential users to try out the interface and see how good they were at finding the port.  Concept 1 (in the Flash demo here) is closest to the old product, and showed how hard it was to detect the port with only the limited “peak” information. Try detecting the port yourself by clicking on this window.
Bridge created other ideas including Concept 2 (in the Flash demo here) which was the favored idea for the new user interface.  Here the user gets clear directional information (arrows indicate which way to move to find the port) and a positive signal (all arrows go green) when they are over the target. However, it did require that the unit had three sensors to give this information instead of one. But it was so strongly preferred and better understood by users that it was the clear winner and was therefore implemented in the product, even though it cost a little more.

The design of the detector had to satisfy two divergent criteria: it needed to appeal to doctors and reassure patients.  For patients it was desirable that the units have a soft and friendly feel, as it is used intimately across the skin of women who have already seen many medical instruments and unpleasant procedures.  For doctors, with whom the detector itself is a sales tool for the implant procedure, the unit should look sophisticated, technical, and precise.

The solution shown here was a greatly simplified user interface that did not require any training or confusing calibration. Simple arrows direct the user to the port.
When the port is found, a well-placed plunger is depressed to gently mark the skin with a temporary dimple. Soft rubberized grips help make it a  palmable, soft, friendly-looking product with superb ambidextrous ergonomics that both doctors and patients love. User feedback is that this product is far easier and more intuitive to use when compared to the old product.

The Stork 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.

From Bridge’s vantage point of spending a great deal of time in the field and always working on the next great medical product that’s two to five years away from release, we have an interesting relationship to medical product design trends.  On the one hand we help establish the trends with the products we design. On other hand we observe changing cultural trends and incorporate those into our design thinking.

One of the larger trends we’re seeing is that some of the thinking behind what makes a great consumer product is finding its way into designing medical products, especially those that are patient-centric.  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 better patient experience without the need to be all things to all users like many of the general medical products out there.
 
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.
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