Medical Device Link.

The same pattern is emerging in the medical device industry. Medical instruments that used to look as though they were designed by and for engineers are assuming more user-friendly forms as well as delivering improved ease of use. Better-designed medical devices are enhancing the performance of physicians, technicians, therapists, and other medical workers by reducing the chance that they will make a mistake and by saving them time. "Design is no longer considered a styling option or frill for medical products. It is understood to be an authentic expression of the technology and use of most medical instrumentation," says Jack Harkins, medical section chair of the Industrial Designers Society of America (Great Falls, VA) and president of Roche Harkins Design (Hollis, NH).

Better designs are giving device manufacturers a competitive edge while simultaneously decreasing customer support requirements, helping to secure regulatory approval, and reducing exposure to product liability claims. "The medical device industry acknowledges design's contribution to competitiveness more today than ever before," says Stuart Karten, who began his career in medical technology at a branch of Baxter Healthcare (Glendale, CA) before opening his own firm, Stuart Karten Design (Marina del Rey, CA).

Better design is also bringing device manufacturers recognition in the form of an awards program dedicated to honoring excellence in medical design. In June 2001, Canon Communications (Los Angeles) will announce the winners of its fourth annual Medical Design Excellence Awards (MDEA) competition, celebrating new heights in the design of products that serve user needs and help development companies thrive.

According to Michael Wiklund, a human factors engineer at American Institutes for Research (Concord, MA) and chair of this year's MDEA jury, "Common characteristics among winning designs over the past few years, following the trend in consumer products, have included increased attention to ergonomics and usability. Due to competitive pressures, heightened customer awareness of user-friendly designs, and FDA's regulatory mandates, medical device companies are investing more resources into understanding and meeting user needs." Wiklund points to the large community of product-development consulting firms as a key force in the movement toward user-centered design in medical devices.

In addition to seeking outside user research and testing expertise, device manufacturers are increasingly supplementing their core competencies and relying on design and development firms to provide support in areas such as industrial design, prototyping, mechanical engineering, design for manufacture, design planning, and branding. Investment in such services can result in faster times to market, avoidance of inappropriate product solutions, greater ease of use, and improved functionality.

Unquestionably, there is a significant learning curve when it comes to medical design efforts. "Designing a medical product involves knowing a lot of information that's outside the normal boundaries of what we'd expect from our staff, such as a familiarity with the business landscape for healthcare, reimbursement, physiology, and clinical practice patterns," says Tad Simons, health industry director at IDEO (Palo Alto, CA), a design firm that provides services to medical device manufacturers. Although the high learning curve in the medtech industry may present a challenge for many design firms, it clearly isn't a problem across the board. In fact, the top design and development firms have become attuned to the specific needs of medical device manufacturers and have developed an appreciation for industry issues such as the importance of ergonomics and usability, healthcare economics, and the regulatory environment.

Adding Value Through Design

According to Bill Evans of Bridge Design (San Francisco), some manufacturers are moving away from developing devices that require a significant capital investment because of the tight reimbursement environment and the demands of the stock market. Instead, more and more device manufacturers are focusing on developing products with quicker returns, such as disposables. In such highly competitive areas, design can play a significant role in a product's success. "Often, there's an opportunity for the second or third player in a market to use design to bring their product to the next level," says Evans. "It's not unusual for someone to call and say, 'We're number two in this market, we've got a single-digit share versus a significant double-digit share, and we're looking to use design to leapfrog our competitor.'"

Doug Hiemstra, president and CEO of Hiemstra Product Development (San Francisco), says that product design firms "add a tremendous amount of value when a company needs to create a unique device that requires aesthetic differentiation, to deal with human factors or ergonomic considerations, or to make use of some innovative thinking about high- or low-volume mechanism design or injection molding."

For more-mature markets, the competitive edge often lies in improving a product's interaction with users. "There is a general pattern that when new technologies are developed and introduced, competition is at first based upon differences in the technology," says Stephen Wilcox, principal of Design Science (Philadelphia). "Then the technology matures and the differences between competitive products converge. At this point, ease of use becomes a key differentiator."

In addition, by bringing a fresh perspective on design for manufacture, product designers can bring new approaches to highly cost-constrained design efforts. "Medical products need to convey sophistication in relatively low production volumes relative to goods such as consumer electronic products. Meeting this challenge presents every medical device company with an opportunity to gain market share," says Harkins of Roche Harkins Design.

Picturing the State of the Art

The reimbursement environment continues to be a strong driver of innovation, which is why designers are working on more devices for minimally invasive procedures and products for the management of chronic diseases such as diabetes. The latter area is likely to spur the development of a variety of lifestyle-related medical devices that require the designer to match a technology with the way a patient wants to live with that product, says Evans.

Designers are also being sought to provide solutions for the increasing migration of devices to less-expensive use environments. Products such as bone-density measurement devices that were once found only in labs are being repackaged as desktop units for doctors' offices, and more and more products are being redesigned for less-skilled caregiver operation in the home environment. "Lately, we have become more involved in developing home-healthcare products that are prescribed for the end-user," says Lars Runquist, principal of redgroup (Minneapolis). "Because the products are being sold and used differently now, the overall perception of what the product should be has shifted as well."

On the technology end, miniaturization continues to create new design challenges. "Microelectromechanical systems (MEMS) are opening up new areas of opportunity in diagnostics, and very small mechanical devices that challenge the meaning of ergonomics," says Bert Heinzelman, CEO of RefacDesign (Edgewater, NJ), formerly Human Factors-ID. "We are exploring ways to leverage this new technology, which resides at subhuman scale, and to introduce handling and delivery devices that bridge the gap in physical size. This type of development, which marries integrated-circuit manufacturing technology with physical design, is very exciting."

Increasing sophistication in laboratory instruments is another growing area when it comes to design considerations. "The miniaturization of components has certainly played a huge role," says Steve Hauser, president of Hauser Inc. (Westlake Village, CA). "This can be seen in blood analyzers, laboratory instruments, and glucose readers."

Sticking with What You Know

The growing participation of design firms in medical device development efforts may be a reflection of manufacturers recognizing their core competencies and venturing outside for all other needs. When properly coordinated, this approach can result in significant cost and time savings and, some would argue, better products. With today's highly specialized and diverse design and development firms, companies can outsource virtually any service they need. "Pharmaceutical companies focus on molecules and formulations, but they turn to us to help with delivery systems for these drugs," says Simons of IDEO.

Whereas device companies may have expertise in manufacturing, regulatory approval, and innovative technology, Eric Park, program director at Ziba Design (Portland, OR), says, "They often miss the mark in translating these assets into a positive user experience that is on target and truly addresses an unmet need. That is why they come to us."

Doug Hiemstra says that his 10-person firm does about 85% of its work with medical device companies, most of which are start-ups. "For good reason, most of our clients focus their engineering efforts on their core technology," he notes. "They have the internal resources to get the device to work clinically, but they don't want to worry about ergonomics or manufacturability that early in the process. Once they are confident that the device works, our client may not have the in-house expertise, interest, or available resources to create the production design. Generally, I've found that our clients are very good at making prototypes and will rely on us to create the refined design for volume production."

With a strong focus on problem solving, design and development firms can also bring a valuable solutions-driven approach to a development effort. "We offer clients an objective perspective on their product development projects by frequently challenging their givens," says Wayne Booker, director of business development at Product Genesis (Cambridge, MA). "We leverage the combined expertise, experience, and knowledge of our company and the client's to solve their business questions. The solution is based upon the goals of the business, the needs of their target market, the technical solution, and the needs of the end-user."

The task of understanding and evaluating the needs of the user is often outsourced. "Device companies tend to be focused on the technology end of the equation and look to us to connect that technology with users and patients in meaningful ways," says John Edson, president of Lunar Design (San Francisco). "This process can include developing the product experience, visual product positioning, and the design for brand messaging. In terms of the product experience, we often act as integrators of all the different user voices, including doctors, technicians, service personnel, and patients."

Sometimes outside design and development skills are sought to solve a very specific problem. "We are often brought in on a case-by-case basis to solve particular problems that clients can't support internally," Edson says. "For example, Lunar has designed individual handpieces and reengineered laser-aiming systems in more-focused programs."

In-House versus Outsourcing

With design being hailed as such an important element, why aren't more device companies investing in in-house design and development expertise? The answer has to do in part with economics. "Manufacturers are starting to realize that research, industrial design, and mechanical engineering should be variable expenses. Many device companies develop a new product every few years at most, so they do not need a full staff of designers and engineers," says Runquist of redgroup.

The answer may also be rooted in the nature of the relationship between designers and the corporate culture of device companies. As Evans of Bridge Design explains, "The natural habitat of the industrial designer is in the consulting environment. Designers typically thrive on variety and stimulating settings, and there's tremendous cross-fertilization in the consulting environment. Even in a relatively small consulting firm, designers aren't just going to work on ergonomic handpieces for dental work or consoles for x-ray imaging equipment. Companies should only consider setting up in-house industrial design teams if they really have enough work to allow their designers that kind of variety and they think they can pull off that kind of atmosphere within the corporate culture."

Len Czuba, director of the medical sector at Herbst LaZar Bell (Chicago), adds, "Rather than work for the traditional firms in corporate America where their projects may revolve around a single product category, today's best talent craves change and constant creative challenge."

This range of multiindustry experience is having a significant impact on medical device design. Increasingly, designers are introducing solutions from other industries into their work with medical devices. "Technology advances in fields such as computer science are providing a means to advance medical devices and instrumentation," says Booker of Product Genesis. "Because we have a broader approach to development, we have the ability to be objective and serve as a generalist for our clients. For example, when we were designing a steerable catheter for a medical device client, we drew from our past experience in designing a cable-driven system for NASA."

As Czuba notes, "The latest design-for-manufacturing idea that solved a high-speed production problem in the automotive industry has the potential to radically reduce the costs of a new medical device. Also, the increased automation and reduced handling capabilities developed for a home appliance can have direct bearing on reducing the handling contamination that caused previous medical devices to need cleaning before assembly and packaging."

Meeting User Expectations

With heightened user expectations being driven in large part by consumer products, it makes sense that consumer product designers are also designing medical devices. Stuart Karten's 15-member design team works on consumer products and toys in addition to medical devices. "I've noticed that our work in consumer products is playing a stronger role in our design approach to medical instrumentation," Karten says. "In a market proliferated with beautifully designed stereo equipment, kitchen appliances, and household electronics, it's only natural for medical practitioners to want the same level of design sophistication in the instruments that they operate at work. In terms of form, color, graphical user interface, and ergonomic considerations, medical design now has to match the sophistication of high-end consumer products."

"Increasingly, the users we interview don't distinguish between the control panels on their cars, their stereos, or on a piece of medical equipment in their offices," says Evans of Bridge Design. "People are becoming more and more critical as they are asked to switch gears between all the different disciplines and the things they use. You can sit in any car anywhere in the world, and with no printed instructions on any of the controls, you can drive off in two minutes flat. When was the last time you sat down with a piece of medical equipment that you could operate in such a short amount of time?"

End-users have similar high expectations. Evans continues, "Users ask questions such as, 'Why is my glucose monitor so hard to use, yet the interface on my cell phone so easy to figure out?' This is especially the case if the devices have screens that are the same size and have the same number of buttons."

The Importance of Early Involvement

A focus on the needs and expectations of end-users—both clinicians and patients—is the current driving factor behind most product development efforts. Designers and engineers emphasize the importance of high-quality user testing and user feedback at various points in the development cycle. While device companies may be embracing human factors programs in large part to fulfill regulatory requirements, often they find that these exercises can turn up some important and sometimes even surprising results.

"All human beings, including product developers, tend to underestimate the degree to which other people differ from them," says Wilcox of Design Science. "Some of our designers are trained in cultural anthropology, which is all about understanding the point of view of people who are radically different from the observer. The same skills that apply to understanding South Sea Islanders apply to understanding product users. We develop and test user interfaces that are based upon our research into user needs. Our clients are not typically skilled in these areas, but they recognize the need, particularly in light of the new FDA human factors requirements."

According to Simons of IDEO, however, normal intuition does not always apply to a design solution for healthcare. He cites the recent development effort of a public-access automatic defibrillator for Heartstream (Seattle). In an early iteration of the design, the two electrodes meant to be positioned on the chest were the same and could be placed interchangeably on either side. Through user testing, IDEO's human factors specialists quickly discovered that people were confused by the similarity of the electrodes and were concerned about making a mistake. As Simons explains, "We had to go back and label them with clear illustrations and make them different so that people didn't spend time worrying about it. That's an example of how intuition can fail you and why user observations are a critical part of the design process. We made those two electrodes with different part numbers and labels in order to get around a problem that we originally thought we wouldn't have to face."

Simons's example underscores the value of design firm involvement early in the development of a medical device. But a design firm's early involvement can do more than help the manufacturer to avoid user problems. It can also allow the manufacturer freedom to experiment with a variety of approaches, which could be risky at a later stage. "If you really want to innovate, you've got to be prepared to take risks," says Evans. "You've got to break the mold and think outside the box, but you've got to do it early enough in the cycle so that you have ample time to get feedback to correct any problems. Design is very well placed in helping device companies create tools early in the product development stage to make these different ideas manifest."

Some of the greatest and most creative benefits from design and engineering can be derived in the planning stages of products, says Edson of Lunar Design. He explains, "The advantages for medical device manufacturers in creating an early design vision include quicker development time, better manufacturability, holistically designed products that meet a full range of needs, and products that are better coordinated with the company's brand message." Greg Volan, principal of Volan Design (Boulder, CO), adds, "The most significant contributions of the designer are usually made during the earliest stages of the development process. Bringing in a design firm late in the process tends to relegate the design work to the status of superficial or cosmetic design."

Another advantage of early involvement of design expertise can be cost reduction. Sometimes device companies will formulate a niche technology and explore its progress internally to make a case to management for further development. Simons notes, "I've seen companies spend one or two full-time equivalents to noodle around concepts instead of launching the technology with the help of a design firm, which would take them directly to the users. Usually, design firms' fees are comparable to this type of investment, which means that many of our clients could get much higher leverage from their development dollars by approaching us at the right time."

Collaborative versus Turnkey Teams

The ways in which medical device manufacturers use design and development services vary widely. Some manufacturers create collaborative teams composed of staff members from both companies, while others look to outsource all aspects of a design effort, and still others fall somewhere in the middle. "We interact with our clients on several levels—as strategic advisers and implementers, as turnkey product developers, and as an integrated part of their team," says Eric Park of Ziba Design. "The client's in-house engineering team is usually focused on technology development, and we support them in product development."

The team structure may change over time as the company's needs change. Wayne Booker explains Product Genesis's approach: "In our relationship with a client, we jointly identify what disciplines a project will require and evaluate the client's in-house resources accordingly. We partition work responsibilities based on the experience and core competencies of each member of the team. Often, we will alter the structure during the development stages. For example, one client came to us requesting only industrial design and product strategy services, and by the end of the project we were managing the entire development effort. It can work in reverse as well."

Conclusion

For medical device manufacturers, investment in design and development services varies as widely as device complexity. Astute manufacturers typically view the cost of design services in the context of project goals, realizing that effective product design can mean such benefits as reduced user error, faster time to market, or increased market share.

Some design firms focus specifically on user research and user interface design. According to Wilcox of Design Science, these areas are a relatively small percentage of a given project but crucial to product success. "This means that the cost of our services is seldom an issue," he says. "A typical program for a moderately complex device ranges from $300,000 to $500,000 from beginning to end, including discovery research, human factors consideration, interface design, and usability testing."

Jack Harkins of Roche Harkins Design gauges the cost of industrial design with related engineering for an electronic device such as a patient monitor to run from $250,000 to $500,000, plus the cost of prototypes. Add-ons for this effort could include another $150,000 for human factors, plus the costs of international travel and testing. For complex medical devices, Stuart Karten estimates that a development effort of 9–12 months involving eight specialists can range from $750,000 to $1.5 million.

However, outsourcing design and development is not simply about the cost of the effort. It may be more about the cost of not investing in an appropriate design effort. A company such as IDEO, which has been involved in thousands of design and development efforts, clearly understands that speed to market can make or break a product. "It seems like we cost a lot," says Tad Simons, "but we'll have the product out much sooner."

With medical device design quickly reaching the usability sophistication of products in the consumer marketplace, everyone stands to gain. Device companies are finding new opportunities, healthcare professionals have access to more ergonomic and easy-to-use tools, and most importantly, patients are reaping the benefits as recipients of less-invasive and more-cost-efficient procedures and simpler self-care products.

Technology Watch Doug Hiemstra According to medical device designers, many of today's advances in technology are being strongly influenced by the changing needs of users and the different environments in which medical care is now being delivered. A growing number of treatments and procedures are now possible in the home, doctor's office, or clinic, in part because of the latest advances in computer technologies. "Today's advances in information management, wireless technologies, and hardware and software are defining the state of the art," says Doug Hiemstra, president and CEO of Hiemstra Product Development (San Francisco). Ultimately, today's intense focus on changing user needs and use environments plays well in the global marketplace. Following are some areas generating excitement in the design community. Tad Simons Redefinition of Users and Use Environments. More and more, medical devices are being used by those with widely different cognitive and physical abilities—physicians, clinical technicians, patients, and caregivers. Cost-containment efforts are continuing to influence the shift of devices into less-expensive use environments, which requires equipment that can be operated by less-skilled caregivers. "Many products are migrating from professional-use settings to home use by patients themselves and a wide variety of caregivers," says Tad Simons, health industry director at IDEO (Palo Alto, CA). "Products that can be designed to make this transition help to fulfill the need to offer uncompromised patient care while containing healthcare costs." Even in the hospital setting, issues such as minimizing the time required for operator training are dictating that devices be highly intuitive to use. "In hospitals and clinics, users are faced with ever-increasing interaction with technology," says Jack Harkins, president of Roche Harkins Design (Hollis, NH). "Technology is also being pushed downstream to less-skilled hospital personnel, which is a factor that designers and engineers must consider." With medical device use taking place in an ever-increasing variety of environments, communication and data collection are more important than ever. The ability of a medical device to document its status, interface with other associated products, and be monitored from a remote source are a few characteristics that are becoming state of the art. "Based on this premise, medical devices now have to be designed and developed in a systems mentality," says Lars Runquist, principal of redgroup (Minneapolis). Bill Evans Management of Chronic Diseases. Healthcare payers and policymakers are focusing on improved management of chronic diseases such as asthma, diabetes, and heart disease as a way to control costs. As a result, there is a greater demand for devices that can aid in management and improve patient compliance. Bill Evans of Bridge Design (San Francisco) says that "a big area of growth is in lifestyle-related medical devices, where you're trying to match a technology with the way a patient wants to live with that product." The focus on chronic-disease management is also leading to more customization of devices and therapy regimens. Simons explains that there is an "emerging need to tailor a therapeutic protocol to an individual, which is a response to a mixture of new diagnostic and pharmaceutical tools and patient preferences. Every patient has a slightly different path in congestive heart failure, for example, and we are seeing a desire to custom-tailor products to meet the differing needs of those patients." Len Czuba Globalization of Design. Companies are also designing with increased sensitivity to the world market for medical products, thereby driving interfaces to a more user-friendly position. One example of designing for the global marketplace is the development and adoption of universal symbols that can be understood by a disparate group of users. "There has been a shift in the symbology used with controls." says Len Czuba, director of the medical sector at Herbst LaZar Bell (Chicago). "For example, test-based labeling is no longer enough, especially as medical devices are now being designed for markets outside the United States. Multiple-language labels are being replaced with universally understood visual icons, and we will soon see a transition to icon messaging, where the icon will no longer be a single image, but a series of images demonstrating the function of the button." As Wayne Booker, director of business development at Product Genesis (Cambridge, MA), sums it up, "Medical products can no longer be designed only for right-handed North Americans."

Amy Allen is a Web-content manager and freelance writer based in Concord, MA.

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