Originally Published MDDI May 2004

Alden

May 1, 2004

23 Min Read
The Lessons of Winning Design

Originally Published MDDI May 2004

An MD&DI Roundtable



The winners of the 2004 Medical Design Excellence Awards represent the best of the medical industry. Four members of the awards panel share their insights into what makes these products stand out.

BiteStrip disposable bruxism test, manufactured by SLP Ltd. (Tel Aviv, Israel).“The BiteStrip has good visual design, good functional design, and a real understanding of how to take a process out of the sleep lab and into the patient population.”—Dale Bevington

To reflect on some of the design lessons that may be learned from the 2004 MDEA winners, announced in last month's issue, MD&DI invited four of the judges to participate in a telephone roundtable discussion. 

The roundtable was organized with the assistance of MD&DI contributing editor Michael Wiklund, who served on this year's jury. Wiklund is vice president in charge of the Human Factors Research and Design Group at the American Institutes for Research (Concord, MA). Participating with him were Stephen Wilcox, founder and principal of Design Science Consulting Inc. (Philadelphia); Dale Bevington, cofounder of Product Innovation Partners (London); and Tor Alden, principal at HS Design Inc. (Gladstone, NJ).

Were there any particular design trends among the products that were submitted for the MDEA competition this year?

Wilcox: What was particularly striking is how sophisticated medical devices are becoming. The entries seemed just a little more sophisticated this year, both clinically and in terms of design and usability.

Wiklund: More medical device manufacturers are embracing simplicity to reduce the amount of work clinicians need to go through to accomplish a task. Likewise, they are trying to reduce complexity so there is less of a chance of use error. There are a couple of products that I would cite as good examples of that. 

A good example is the BiteStrip bruxism test. It has been reduced down to something you press and apply to the jaw. I could imagine a less appealing product that would have lots of wires running to controllers and recorders. 

Another good example is the Dermabond topical adhesive ProPen XL. This product is something like a marker pen. You pick it up and you apply adhesive by squeezing the device rather than having to mix a two-part adhesive in a separate tray. 
These two examples are certainly indications that device makers are thinking about how to reduce clinician work loads and to cut down the likelihood of use error.

Bevington: One of the things I saw was a move to designing products for use in outpatient settings rather than the hospital. I believe this will be a growing trend across the medical market. 

Alden: Yes, over-the-counter products and blood glucose meters are definitely picking up on trends in the consumer product industry. We are seeing a lot more two-shot molding and other more-sophisticated manufacturing processes. When people are getting released to their homes quicker and the products are following them into their homes, these products are in essence becoming consumer products, in that they have to be intuitive. They have to be more robust, more like consumer products in their features. 

Wiklund: On the other hand, a number of entries we admired did not reflect that level of refinement. Instead, the devices looked like they had been recently conceived in a lab or machine shop and brought to market fairly quickly, perhaps without passing through a design-refinement phase. For example, some of the rehab products had characteristics we would not necessarily associate with a successful consumer product.

Wilcox: There was something of a trade-off between clinical innovation and design sophistication. It seems like small, innovative companies are really the ones coming up with radical new ideas, but at the same time, they do not have the design and engineering horsepower to refine a product to the extent that a large company does.

Bevington: Companies coming to market and needing to create revenue rapidly face the costs of more-sophisticated design, engineering, and distribution. Some of the things that were not particularly visually sophisticated showed sophistication in intent or sophistication in terms of innovation. In that case, you have to refrain somewhat from questioning draft angles and presentations, bearing in mind that the product concepts are quite revolutionary. 

Wiklund: When a product does the job but does not have the styling or the impressive refinement that we might look for, who is to say that that is a problem? Maybe it brings a needed product to market at a lower price point.

Bevington: I agree. I do not think there is a direct correlation either in terms of revenue or benefits to patients with spending tons of money at the beginning stages of new product concepts to get them absolutely right. It really is important that products get to market, create benefits, and then move towards a more-sophisticated presentation. I do not think there is a simple answer. When you do have limitations, the limitations are going to come financially or through a lack of the necessary expertise in the companies. Such companies have to get somewhere first in order to become more sophisticated in due course.

Wiklund: But from an ergonomic, end-user point of view, you have to get some of that right the first time to avoid use errors that could place patients at risk.

Bevington: Yes, you cannot place the patients at risk. The designer has an overriding responsibility to the patients. Ultimately, if you make clinicians do odd things in order to help the patients, you can actually make them do the wrong thing. But there is a point of trade-off, where you have to get as much right as you possibly can given the size of your business.

Did any MDEA winners stand out as models for excellent medical device design? Among those products, did you notice any common trends in how they were designed?

Storm Series TDX5 power wheelchair, manufactured by Invacare Inc. (Elyria, OH). “The center-wheel drive on the wheelchair clearly is an innovation. It is responding to the need for people to turn on a dime.” —Michael Wiklund 

Alden: You have to look at that by category. For critical care, you could look at the LifePort kidney transporter. The BiteStrip from the dental category and the Dermabond topical adhesive ProPen XL from the finished packaging category are designed for their industry appropriately, and I think that is the key when you talk about design excellence. You have to look at the perception of the product, its aesthetics, its usability, the value of its deliverable, and its price point. Some of the general hospital devices are extremely expensive systems, so you would expect more in terms of design. But I do not know that you can group them all together and say, “I like this one the best.” 

Wiklund: I think highly of the Storm Series TDX5 wheelchair and the Diego powered dissector. Both reflect intensive attention to ergonomics. Both have been resolved to a fine level of detail. All the touch points seem very well thought through. When I look at how these products are designed, I think that the users are going to be quite satisfied. They will be able to operate the devices safely and accomplish tasks more efficiently. I would credit these impressions to the design research that came before the products were produced. The center-wheel drive on the wheelchair clearly is an innovation. It is responding to the need for people in wheelchairs to turn on a dime rather than having to cope with a wide turning radius. In the case of the Diego powered dissector entry, the design was strongly influenced by observational studies involving clinicians performing sinus surgery. The developers spoke about their desire to enable surgeons to maintain a neutral wrist position while operating the device.

Diego powered dissector, manufactured by Gyrus ENT LLC (Bartlett, TN). “The design was strongly influenced by observational studies involving clinicians performing surgery.” —Michael Wiklund

Bevington: In terms of human factors, what did you think about the MicroTargeting platform for use in cranial neurosurgery?

Alden: I thought it was excellent. It is total function, but it is a simple invention that is so needed. It really did not have anything to judge in terms of aesthetics.

Wiklund: What is interesting is that you do not see everything behind the product in terms of the scanners and the fabrication machines it uses to make a stereotactic fiture. The platform seems to promise usability and speed in the surgical setting. Yet many hours could go into preparing things. 

Bevington: This product comes very close to the idea of mass customization that has been bandied about for many years. We have the tools now to make custom products, and I thought this was an extremely interesting example of how they can be used. You would think that rapid prototyping tools, the component cost of which is dropping rapidly, should lead to more such customization.

Wilcox: One other product that really stood out was the Partner Rhythm Assistant. It is one of the most radical products we saw. It represents a totally different approach to cardiac rhythm management, but at the same time, it is very well designed.

Bevington: I agree. It has two buttons to do everything. Amazing stuff. The back of it had understandable and accessible graphics that people could understand. The company is very clever on the marketing side, showing actual users with it in their hands. It is simple, straightforward, and stylish. 

Wilcox: The idea that the end-user or patient is the one controlling the treatment is something that will move to the forefront of device design, partly because of the increase in outpatient treatment. Consequently, the interface design and the entire product design are going to be predicated on amateurs using sophisticated equipment. It has to be simple and understandable.

Alden: It underscores the notion of the device as consumer product in the home. The packaging, manufacturing, and graphics are getting so sophisticated that the tooling and manufacturing process are becoming very similar to consumer products. Along that same line, I think we have to give credit to the Syndeo patient-controlled analgesic syringe pump. It brings the product back to the patient, with a simplified user interface and robust design.

MicroTargeting Platform System, manufactured by FHC Inc. (Bowdoinham, ME). “The MicroTargeting platform is a simple invention that is so needed.” —Tor Alden 

Wiklund: I agree. In this country, more and more people who work with medical products are familiar with good design in the consumer product world. This means that clinicians might observe, “Why can't the products I use every day be as good as the ones I find at Circuit City?,” thereby increasing the demand for better medical devices.


What other design trends do you see in the MDEA products?

Wilcox: There is a turn toward wireless products. Several of the winners were wireless. Some were basically redesigns to incorporate Bluetooth, but such a redesign changes the product dramatically. In other cases, the products themselves were more radical. But even getting rid of the wires is a plus, particularly if it is a hospital product. 

Alden: I noticed that a lot of these devices are using touch screen and flat-panel graphics, which are encroaching on the actual overall design look and feel. It is very important that you have the proper user-interface design. 

One system that I thought deserved credit is the System 100 fluid removal system. It has a very simple and intuitive approach to putting on and off the disposables, to the point  where you could actually do it without even looking at a manual. It is very 
straightforward. 

Another entry that impressed me was the HealthWear weight-loss system. It broke a stereotype regarding people who are conscientious about monitoring their intake. The designers made it into more of a sports endeavor.

Based on your experience in judging these products, what would you say are the key elements of great design?

mddi0311p50a.jpg

In this country, more and more people 
who work with medical products are 
familiar with good design in the consumer product world.
—Michael Wiklund 

Wiklund: I look to see whether a product has a task-oriented quality to it, whether it is oriented toward helping the clinician or the patient at home accomplish their key tasks. I also look for well-developed touch points, the places where a person comes into contact with a product, whether they are visual, audible, or tactile. I look to see whether those touch points are well developed, so that people can use the product with satisfaction and without hindrance.

Alden: When I look at products like these, I take a three-step process. The first involves perception, what the product looks like. Is it appropriate? Does it look friendly? Is it approachable? The next step I take is experiential. Does the product do what it looks like it is supposed to do? The third and most important consideration is strategic value. Does it solve the problem that it started out to solve? 

I think it is very important for medical equipment to have the appropriate look and feel. For example, when we considered the Hand Mentor rehabilitation system, there was a debate about whether we were rewarding engineering or design excellence. I think ultimately we have to take an integrated view.

Wiklund: I have heard several of you suggest that with more money to invest in design, some entrants could have taken their products further. Undoubtedly that is true. But it raises in my mind the question of what you can do with a small investment. Can't you invest 20% of the ideal resources and get 80% of the benefit? 

Syndeo patient-controlled analgesia syringe pump, manufactured by Baxter Healthcare Corp. (Round Lake, IL). “The Syndeo patient-controlled analgesic pump brings the product back to the patient, with a simplified user interface and robust design.” —Tor Alden

Alden: I think so. If you have a competent design firm working on a product like that, you are going to find ways to make parts cheaper and manufacturing simpler. You can go all the way through the life cycle of the cost of the product and you will find out that the design costs pay for themselves. A properly designed product will cost less over the course of its life than one that is not well designed.

Wiklund: This points to the core issue of how a product emerges. Was it a technological process where somebody had a breakthrough idea or discovered a new technology, created the product, and then saw how well it worked for people? Or was it the polar opposite, where a company conducted research about problems and needs people have and then envisioned a product to fulfill those needs?

Are there surefire ways to distinguish design from engineering, and if so, what advice would you give to smaller device companies, or any device company, as to how to apply that for practical purposes?

Wilcox: I think we would all agree that any decent product design, in this day and age, requires an integrated team that consists of both engineers and designers. 

Bevington: There has to be a balance. Some products require a lot of industrial design and some do not. Some require tons of engineering and some do not. I do not think we should be unhappy about that. What we have to be unhappy about is people not realizing that there are huge benefits to be gained by taking an open-minded attitude to whatever it is you are doing in the development sense.

Wilcox: What used to happen in the past was that design engineering was not integrated, so the designer would conceive something and the engineer would be expected to implement it. Or, alternatively, the engineer would show up with a working breadboard and ask the designer to skin it. I think those days are long gone in the better companies. But if you find a company where the engineers and designers are not working in an integrated fashion, chances are they are pumping out products that have usability problems. 

How do you define excellence, and what examples really showed it? 

Hand Mentor rehabilitation system, manufactured by Kinetic Muscles Inc. (Tempe, AZ). “When we considered the Hand 
Mentor rehabilitation system, there was a debate about whether we were rewarding engineering or design excellence.”
—Tor Alden

Bevington: A good example to my mind is the BiteStrip. I think it has good visual design, good functional design, and a real understanding of how to take a process out of the sleep lab and into the patient population. It has so many benefits at that level. It is simple. It is cheap. It looks good for what it is. I think that is something that hooks a lot of things together in one hit. 
The Partner Rhythm Assistant is another example. You know that when you look at it you are going to understand it. 

Wiklund: They are two products that fit in your hand and have minimal user interfaces. 

Bevington: I like the ThinPrep imaging system for much the same reason. Its designers made up a brand new language, but put it in the ambience of desktop products. The system is very cleverly designed. It does a lot of things right and makes use of a lot of things that hospitals have around. Again, it is welding together all the different strands in product development and coming up with something solid.

Wilcox: The LifePort kidney transporter is another example. It has a very clear clinical value, lengthening the life of a kidney for a transplant. At the same time, it shows evidence of a lot of attention to detail.

Alden: It also shows how the value of design contributes to excellence. Somebody could have easily made that without any thought of design. It could have been just a black box with sharp corners. But while it might have had the exact same functional outcome—doubling the life of a kidney—it would have made it so much harder for the users to maintain it. The whole life cycle of the product would be affected.

Small, innovative companies are really the ones coming up with radical new ideas, but they don't have the design and engineering horsepower to refine a product to the 
extent that a large company does.
—Stephen Wilcox

Wiklund: It is a product that stands out because it is so obviously needed but has never existed before. It makes you ask, “Why didn't anybody else think about that?” The BiteStrip is like that. The solution seems obvious, but no one came up with it before. The Partner Rhythm Assistant is, as well. People who experience atrial fibrillation can now do something about it without having to go to the hospital. 

Alden: Another good example is the Dermabond topical adhesive pen, because of its sheer strategic value, how it solves a problem. Before that pen was invented, people had to mix solutions outside of the operating room, then carry them in. There were several steps. There were a lot of disposables. A lot of things could go wrong. This product solves these problems in a very simple way. Engineering was involved in combining the two adhesive components into something that could be put into a single vial. Design was involved in coming up with an intuitive way to apply the adhesive. It is a perfect fit.

What is most important: styling, ergonomics, or ease of use? What constitutes excellence in these areas?

Alden: Ease of use is the quintessential aspect of how you should evaluate a product's excellence. If it is not easy to use, no matter how valuable it is to a doctor or nurse, it will not win an award.

Wiklund: Usability is a natural result of ergonomic design. Ergonomics, usability, and to some degree styling, all overlap in terms of their contribution to user satisfaction and functional effectiveness. There are things you can do in terms of styling that make the proper operation of a particular control more intuitive. Or, you might use styling to draw attention to something that needs to receive the user's attention. Lousy styling can interfere with usability. 

ThinPrep imaging system, manufactured by Cytyc Corp. (Boxborough, MA). “The ThinPrep imaging system makes use of a lot of things that hospitals have around. It is welding together all the different strands in product development and coming up with something solid.” —Dale Bevington

Alden: It is not even that black and white, depending on the class of instrument or the complexity of the task. Products may require training. But if the design is done right, the user can adapt more quickly.

Wiklund: The Paradigm Link blood glucose meter is a good example of the convergence of styling, ergonomics, and usability. It looks appropriate. It takes styling cues from the consumer product industry. It has good ergonomics in terms of how it fits the hand. It can give results in seconds.

Wilcox: It is also wireless, so it incorporates some new technologies.

Wiklund: I do not know that I would separate any of those attributes to say that one thing is more important than the other. They all come together in a synergistic way to make a really good product.

Wilcox: I agree. I do not think you can really say that one dimension is inherently more important than the next. It all forms a foundation where, if you are missing any of it, it is just not a decent product. 

There are other industries that are very sophisticated in design. Do you think there are any specifically that the device industry could learn from, or that it is currently learning from?

Wilcox: The medical world could learn from industries where data are handled better, like process control or warehouse management. In warehouses, when they do inventories, everything is digitized and sent wirelessly to a central computer. In a hospital just recently, I saw somebody writing the numbers down off the computer screen into the patient file. That happens all the time. There is improvement in this area, but it is happening in a surprisingly slow manner.

Things that are not fundamental to the function of the product can result in a product of value to the end-user. This is where I see the medical device industry shifting very rapidly. —Dale Bevington

Wiklund: I think you have to cite the software and consumer product industry as the leaders when it comes to investing in usability. Consider software companies like Microsoft or Oracle. They employ hundreds of people who focus on the usability of their products. In the consumer world, you have companies like Kodak, which is working hard to differentiate its products as the most user-friendly. You see companies that try to make design and usability part of their brand identity, Apple Computers being a prime example. I think medical companies that try to do the same thing have been quite successful. We did not see any entries from them this year, but I know that Phillips Medical has put a lot of energy into the visual appeal, usability, and ergonomics of their imaging systems.

Wilcox: GE, Siemens, and Ethicon are other good examples of companies investing in design.

Wiklund: Web site design is certainly influencing medical device design. When you think about where people's computer-interaction proficiencies are coming from, it is from browsing the Web to order clothes from Land's End. So if you develop software for a blood testing machine that has a Web-like user interface, you are presenting people with something that seems familiar and may also be easier to use from the start. 

Is the medical device industry investing enough in human factors and industrial design?

Wilcox: In-house human factors people are still very rare in medical companies. There is something funny about that. It just does not seem quite right.

Alden: I think we have a long way to go. Even though there are a number of large companies in the medical device industry, there are not a lot of in-house design groups. 

Ease of use is the quintessential aspect of how you evaluate a product's excellence. If it is not easy to use, no matter how valuable it is to a doctor, it will not win an award. —Tor Alden

Bevington: I think there has been massive sea change in this area. Companies are recognizing the competitive advantage here. I think we saw it in the blood glucose meters, where the designers clearly asked questions that were sensitive to the end-users. How can we take the least possible blood? How can we minimize damage to the skin? These things are not fundamental to the function of the product, but they can result in a product that will sell and be of value to the end-user. This is where I see the medical device industry shifting very rapidly. A lot of products are technologically mature, so the advances are in usability.

Wiklund: The medical industry is like a dark forest where every once in a while you see a campfire burning brightly. There have been some companies that have invested a lot in human factors. They have internal human factors and industrial design groups that do great work. 

But you often see those groups burn out like a campfire that it is deprived of fresh logs. When companies become strapped for resources, management teams often view design as a value-added rather than an essential ingredient. So the jury is still out on whether the industry has fully embraced design. The more companies make a big deal out of winning design awards, and the more they promote design excellence in their marketing materials, the more the industry as a whole may embrace design. 

If I were a clinician, I would be encouraged to know that there is a Medical Design Excellence Awards program. I would be pleased to see an industry serving my needs aspiring to design excellence. There are all kinds of award programs, and it nice that there is one that focuses strictly on medical products. 

Copyright ©2004 Medical Device & Diagnostic Industry

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