BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Medical device companies in all sectors are facing increasingly crowded marketplaces. Thus, many industry players are paying added attention to product design as a means of differentiating their products in the face of potential commoditization. And in their drive to enhance the usability, aesthetics, and functionality of their products, device manufacturers are increasingly turning to outside partners for assistance in developing, designing, and validating their technologies.

In this article, product design and development firms with expertise in the medtech realm take a look at recent trends in medical device development and share examples of products that have achieved success through improved design.

Design Evolution

The complexity of medical devices has increased over the past decade, most notably evidenced by the advent of combination devices such as drug-eluting stents, orthobiological implants, and drug-delivery devices, says Randall Sword, vice president of GEN3 Partners (Boston). "This is a typical progression of technology and indicates a logical maturation of device technologies," he says. "Reviewing the natural evolution of technologies and referencing other technology-driven industries suggests many device technologies will transition to new engineering systems in the near term.

"At the same time, funding this transition will be expensive and will occur as the economics of the medical device industry are beginning to change," he adds. "Today, reimbursement risks steer investments toward projects with short regulatory and reimbursement cycles. While the regulatory process has become more transparent over the past few years, winning approval for reimbursement remains less clear—and it is not likely to improve soon. What is clear is the economics of healthcare will be the most important driver for innovation and device design moving forward. They will force companies to refocus their business models and learn to compete in new ways."

One way of competing more effectively is to gain a greater understanding of customer needs. Stephen B. Wilcox, PhD, principal of Design Science (Philadelphia), says device manufacturers have become considerably more sophisticated with regard to addressing the needs of end-users. He says that manufacturers have enhanced their product development processes in recent years by conducting more field research to see how devices are actually used, performing careful usability testing, using more-sophisticated and faster prototyping software and hardware, paying closer attention to risk analysis, and increasingly incorporating user-related issues into risk analysis.

"These changes are being driven by FDA's increased focus on human factors, new human factors and risk analysis standards, and a convergence of technology in many product areas that causes more focus on the user interface to provide differentiation that can no longer be achieved with technology alone," he says.

Marc Piel, founder and CEO of InterDesign (Paris), agrees. He says that in past years, technology drove product design. Today, however, design concepts are often driven by the goal of simplicity of use. "The role of electronics and automatic detection is becoming increasingly significant in making products more user-friendly, with little or no learning curve," Piel says.

In addition, medical device manufacturers are also looking to compete more effectively by improving their time-to-market metrics. Therefore, medical device development timelines have become much more aggressive in recent years, says Cary Chow, vice president of Nectar Product Development (Long Beach, CA). "Where multiyear development schedules were common for medical device companies several years ago, time-to-market has become one of the most important parameters for recent programs," Chow says. "Six-month to one-year development schedules have become common in an effort to beat the competition to the marketplace."

Mimicking Consumer Products

Healthcare product customers today expect medical devices to mimic the trend in the consumer products industry toward sleek and efficient design. "We were beginning to see this trend at the turn of the century and now it is growing, driven partly by significant ease-of-use improvements in everyday consumer products like TiVo—replacing the blinking clock of our old VCRs—and computers," says Bill Evans, founder and president of Bridge Design (San Francisco). "Healthcare customers are asking, 'Why isn't this product as easy to use as an iPod?'

"This trend of consumer-product design culture infecting medical product design has extended into the areas of branding and design languages," Evans adds. "As competition has heated up in the last 10 years, medical original equipment manufacturers have looked over to the consumer world and noted how effective brand-building strategies have been there. They have tried to emulate this in the medical world with a consistent and visually appealing approach to applying a brand to products and using the power of a family look to their product offerings—often referred to as a design language—to reinforce their brand presence."

James Toleman, principal of James Toleman Industrial Design (Puget Ville, France) says there are many examples of technology transfer from the consumer world to medical products. In fact, medical devices that were previously exclusive to healthcare settings are increasingly cropping up in the consumer arena. "In the not-too-distant future, we will see consumer medical products appearing more and more," he says. "These personal products will cater to a new, more health-conscious and aware public—which will have an ever-increasing expectation for products offering self-diagnosis in the privacy of the home."

Stuart Karten, principal of Stuart Karten Design (Marina del Rey, CA), agrees that many principles of medical device design are being driven by the trend toward home healthcare products. "As people are increasingly asked to take their healthcare into their own hands, we are completing more life-style medical projects, designed for the lay user," he says. "These patients and users are facing many new burdens. They are being asked to fit new devices and equipment into their homes, use unfamiliar and often intimidating products, change their habits and routines, and spend large sums of money on home healthcare products."

Thus, product designers are challenged to ease these burdens through clever design.

Focus on User Interfaces

Medical device manufacturers' emphasis on enhanced usability and aesthetics is evident in the sophisticated yet elegant user interfaces that are hitting the medtech market. However, some manufacturers have yet to give this design element the attention it deserves.

"Medical professionals are overworked, multitasking individuals who need to be brought up to speed quickly through readings from multiple devices—devices that they may use daily, or maybe only a couple of times a year," says Christian Trifilio, director of research and design for Worrell Inc. (Minneapolis). "That said, the interface is key."

Inexpensive color screens and increasing processing power are quickly changing the look of medical user interfaces, Evans says. "This presents a design challenge to the industry, as not all manufacturers have yet woken up to the reality of the challenges as well as opportunities that this kind of user interface offers," he says. "For instance, adding color and gee-whiz graphics to a user interaction method that is not well thought out just adds colorful confusion, when before it was black-and-white confusion."

Michael Wiklund, president of Wiklund Research & Design Inc. (Concord, MA), says many medical devices are now substituting software user interfaces for traditional push buttons, rotary knobs, and LED readouts. "This shift has been made possible by the reduced cost of microprocessors, computer memory, and displays," he says. "Optimally, manufacturers will follow a user-centered design approach that bases design solutions on an orderly process of defining user needs, applying human factors principles for user interface design, conducting iterative usability tests to identify opportunities for refinement, and then validating the design. However, not all manufacturers do this. So the industry is seeing a raft of use errors associated with software user interface complexities.

"Along with the proliferation of software user interfaces has come an array of cursor-control devices enabling navigation through options and selections," Wiklund says. "At best, these devices provide rapid access to functions and displays. At worst, they hinder task efficiency. There's nothing quite as efficient as pushing a dedicated push button. To exaggerate the point, few nurses would choose to silence a blaring alarm by using a rotary encoder to select 'menu,' then select 'alarms,' then select 'heart rate alarm,' and finally select 'silence.' So, manufacturers need to avoid going overboard in minimizing their hardware costs and making almost all functions software-based."

Incorporating Information Technologies

The healthcare market is increasingly being driven by the need for connectivity. Thus, device manufacturers are increasingly looking to incorporate advanced information technologies into their products.

"One of the most exciting and challenging changes that we have encountered over the past few years is the integration of wireless technologies into medical devices in and out of the hospital environment," says Fernando Raimi, director of new business development for GadShaananDesign (La Jolla, CA).

According to Craig Scherer, a senior partner at Insight Product Development (Chicago), technology convergence is enabling companies to expand their product and service offerings. And at the same time, it is forcing them to expand beyond their core competencies. "For instance, device manufacturers trying to develop in-home remote-care products must now account for wireless data transfer and networked information management solutions in addition to providing clinical benefits," he says.

"With the advent of centralized and automated information systems in hospitals, clinical users have much higher expectations for connectivity and integration of devices across their network," Scherer adds. "Therefore, medical products now require a more fluid, seamless flow of information across systems, from product to product and from clinician to clinician. For example, electronic medical records (EMRs) have become a key tool for managing patients, especially because they provide an integrated view of patient comorbidities. Therefore, devices must be able to port information into EMRs."

Evans says that the potential to improve the delivery of healthcare using hospital information management systems is only just beginning to be realized by the vast majority of medtech players. "Over the past five years, I have seen a considerable awakening among some device manufacturers that are grappling with how to rise to this challenge," he says. "For now, the lack of standards and low utilization are hampering the potential for new products that ultimately will have the smarts to act in interesting new ways to improve patient outcomes."

Conclusion

Although there's no doubt that the medical device industry will continue to produce breakthrough products that dramatically change the face of healthcare, much of the industry's progress will continue to be generated through an iterative process in which existing device concepts are refined and reenvisioned to improve usability, functionality, and aesthetics. In identifying enhancements that will differentiate a device within a crowded marketplace, manufacturers and their product design partners rely heavily on input from end-users--both practitioners and patients. Devices that respond to the needs of the healthcare market while taking into consideration broader regulatory and consumer product trends will find greater acceptance among both medical professionals and the growing legion of home healthcare consumers.

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