Benchmarking Medical Product Design 4288

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, partly driven 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."

Toleman says that product development and design capabilities must evolve to meet the demands raised by the emerging trend of consumer medical products. "It is no longer acceptable to provide simply a traditional industrial design service," he says. "A thorough knowledge and understanding of the human aspects—user psychology, ergonomics, interaction, and environment—is now a must for the development of medical products for the future."

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. "We aim to create products that blend seamlessly with users' environments, lifestyles, and expectations, and are easy to use with minimal training," Karten says. "Design research is the key to discovering what users' real needs are in each area and developing a product that meets each need."

As technology, ergonomics, and user-friendliness become industry standards, aesthetics are increasingly being seen as a key differentiator among medical products, Karten says. "Manufacturers are finding that aesthetics give their products a big competitive edge with users who have come to expect design in every element of their lives," he says. "Many of our projects involve an intensive aesthetic exploration, informed by design research findings."

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. The point is not to turn a user interface into a Christmas tree of color, and some manufacturers need to ask for more design help to get these interfaces working well and not just looking fancier. An added bonus is that better-thought-through interfaces are usually safer."

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."

Efficiency and Environmental Considerations

Medical device firms looking to increase the efficiency of their products have a wide range of options that weren't available just five or 10 years ago.

"Technology has given product developers the opportunity to work with electronics that are more energy efficient and have lower power requirements than in the past," says Rex Bare, president of Omnica Corp. (Irvine, CA). "We also have access to batteries that have a greater power density that can be used to power those components. The net effect is that we are seeing more money being spent on portable medical devices that take advantage of these advances."

In addition, an environmental consciousness is taking root in the design community, says Matt Duncan, president of Morphix Design Inc. (San Clemente, CA). "The Industrial Designers Society of America has partnered with the Environmental Protection Agency and formed an ecodesign section to promote a practice of design that considers the entire life cycle of a product—including ecological impact and material separation and reuse," he says. "These are important issues to consider in medical product design when sterility requirements traditionally point the way to disposables and single-use devices."

Harnessing External Resources

The medical device industry is no stranger to outsourcing. Depending on the scope of a company's core competencies, firms may look to outside partners for assistance in everything from product design and manufacturing to regulatory consulting and distribution. However, in recent years, many manufacturers have started to look for outsourcing partners that can provide a wide array of specialized services under one roof.

David Robson, development director for Ximedica LLC (Providence, RI), says that design-to-supply outsourcing is more common than ever across all business categories and company sizes. "This includes regulatory strategy and submissions, development engineering, verification and validation testing and documentation, design transfer, production, distribution, and product life cycle tracking," he says.

Similarly, Jerome Jackson, vice president of research and development for Stellartech Research Corp. (Sunnyvale, CA), says that the major shift his firm has seen in its relationships with medical device clients in recent years is an expansion in scope. "Our clients—primarily venture capital partners and entrepreneurs—increasingly contract with us to act in the capacity of a virtual company," he says. "This model uses our facilities, personnel, quality system, regulatory status, and other business infrastructure to achieve rapid development progress while minimizing capitalization requirements. It also requires that we become involved at the concept stage, performing all services through design and development to commercial manufacturing. There seems to be a growing recognition of the synergies that can be achieved by having design and manufacturing under one roof."

Robert Andrews, medical division manager for Foster-Miller Inc. (Waltham, MA), says that in years past, his firm was commonly approached by medical device makers that were seeking help in addressing a specific problem or creating a partial product design solution. "Today it is more common to be contacted to work on projects from start to finish, as customers are seeking full product design solutions," he says. "We are more frequently involved in the entire research and development process, from technology forecasting through manufacturing equipment design and manufacturing.

"We have also seen a growing interest in outsourcing R&D from start-up companies, as they particularly benefit from avoiding the risk and costs associated with hiring full-time internal engineering employees," he adds. "We expect this trend to continue in the next few years."

Risk is another consideration that device manufacturers are now taking into consideration earlier in their product design cycles. "Manufacturers are increasingly focusing on investigating risk analysis before the formal development process begins and are defining regulatory specifications up front," says Andrews. "This growing trend saves the client time and money later on in the process by uncovering potential pitfalls earlier in the timeline.

"Device manufacturers realize that it is important in this competitive market to ensure that the concept fits the market need and answers the end-user challenges," he adds. "Other issues that clients recognize are critical in the early stages include potential development costs, design for manufacturing, the regulatory pathway, and having a reimbursement strategy."

In addition to the expanded scope of many product development partnerships, product design firms are being approached by a wider array of medical device companies. In years past, Wiklund says, most of his firm's projects were for companies developing complex devices that incorporated a software user interface. "Today, we continue to work on products of similar complexity, but we also work on less technically complex devices, such as surgical instruments, drug-delivery devices, and disposable items, which still benefit from human-factors engineering," he says.

Doug Hiemstra, president of Hiemstra Product Development LLC (San Francisco), says he has also seen a shift in the types of devices with which medtech manufacturers are approaching his firm. "There is more activity in the orthopedics and spine sectors than there was six years ago," he says. "There also continues to be more and more activity in the diabetes market. But fundamentally, the big clinical markets are still the same: cardiac, cardiology, urology, and diabetes."

In addition to working with a widening array of device functions and complexities, product design firms are now being approached by manufacturers of every size and stage. Jack Harkins, cofounder and president of Farm Design Inc. (Hollis, NH), says his company's client base of medical device firms has become polarized over the past few years. "We're working for Fortune 100 companies as well as venture-funded start-ups," he says. "And they need quite different services. The larger companies have many of their needs covered internally. Thus, they may require a focused effort on ideation to create some unique intellectual property. Alternately, they may just need voice-of-the-customer work to help write design inputs, or perhaps they need an engineering service such as finite element analysis.

"The start-ups don't have the infrastructure in place yet so they generally need soup-to-nuts—everything from user research at the front end through manufacturing transfer, including design history file and device master record," Harkins adds.

Christian Peclat, PhD, senior vice president of Helbling Technik Bern AG (Liebefeld, Switzerland), says his firm's customer base has also shifted from large medical device manufacturers to a mix of start-ups financed by venture capital—or even inventors financed by angels—and established companies.

"The size and duration of projects are clearly increasing," he says. "On one hand, this is linked to the growing complexity of active medical devices comprising many hardware and software functions. On the other hand, it also seems to be a result of the increasing complexity of quality and risk management systems, partly induced by regulatory requirements."

Enhanced Tools

Refined product design tools are enabling the development of more-sophisticated medical devices. In addition, such tools are aiding in the development of products that can be rapidly prototyped and tested, ultimately reducing the time to market for new medical technologies.

"There has been a very interesting duality with the use of both high-tech and low-tech tools and processes over the past few years," says Insight's Scherer. "The focus on frequent and rich interactions with end-users has driven more iteration early with low-investment tools like scenario boards for new systems or paper prototypes for interfaces. It also has driven the utilization of technology-based tools to provide much higher-resolution deliverables in a short amount of time."

Rapid Prototyping. Stellartech's Jackson says that medical product design and development have been dramatically influenced in recent years by a suite of tools intended to facilitate creation, analysis, and realization of a physical model. He says that less than a decade ago, most designers were using 2-dimensional computer-aided design (CAD) tools.

"Three-dimensional CAD systems were available, but they were technically difficult to use and required a commitment to finicky software packages," he says. "When it came time to translate a 2-D concept into a product mock-up, all the component and assembly interactions had to be worked out. Required design elements could easily be left out and much iteration was necessary to yield a workable design. Now, most engineers design in 3-D during the entire process. Component parts and assemblies are created using 3-D platforms that are easy to use and automatically keep track of the design elements necessary for these parts to fit together and work."

Scherer says his firm used to rely on carefully sculpted foam models that were produced by designers in his company's shop. "We learned a lot from the models, but the process was very time-consuming and hard to transition to production, and it was difficult to make small tweaks and adjustments based on user feedback," he says. "Now we have a variety of in-house rapid tooling methodologies that we can use to create physical models. The cost of the capital equipment has decreased enough that every designer and engineer has access to create 3-D physical models in a matter of hours. The models can then be quickly evaluated, refined, and rerun."

Phillip M. Leopold, president of Medical Murray Inc. (North Barrington, IL) says his firm continues to increase its investment in equipment that enables the in-house fabrication of prototypes to reduce the time for development. "This equipment expansion enables us to control and adapt the process to the product being developed," he says. "Examples are injection molding machines, silicone rubber molding, laser welding and cutting, heat treating, and braiding. Many times we are required to develop the process or machine required to make a special device."

Jackson also notes that rapid-prototyping techniques have vastly improved in recent years. "Several years ago, there were rapid-prototyping methods available, but the equipment was expensive, the materials selections were very limited, and the parts were costly and fragile," he says. "Now, many manufacturers sell rapid-prototyping equipment that is easily affordable by small engineering firms, putting this capability in the hands of many more engineers."

In addition to the enhancement of sophisticated design systems, Jackson points to a basic technology tool that has dramatically boosted product design and development efficiency: the Internet. "It's easier to share materials properties, communicate designs across large distances, and even work with suppliers to fabricate parts and subassemblies without ever having to leave one's home office," he says. "This reduces R&D costs and also speeds the development process.

Understanding Users. In addition to advanced CAD and prototyping systems, new tools focused on incorporating end-user insights into the design process have also become increasingly important to the product development process, says Tad Simons, leader of the healthcare practice at IDEO (Palo Alto, CA). "A new demand from all our medtech clients is to look at larger solutions—to look more deeply into user needs and values, and to try to imbue greater value and better outcomes in every solution we craft," he says. "This requires skills that are deeper and broader than engineering prowess. So we have sharpened our technical skills and augmented our skills to synthesize user-centered information.

"We are trying to bring the perspective of real value into designs from the beginning, and we are incorporating a wider audience of inputs into design," he adds. "Our tools now include methods to include users in the design process—rather than seeking their blessing at different stages."

Similarly, Scherer says his firm's research methods have grown to include consideration of the emotive aspects of the products his company develops. "Utilizing a quantitative research process, we can identify the best solutions that meet the emotional needs of the end-users," he says. "This quantification also supports various regulatory requirements as input points to the submission process."

In addition, biomechanics continues to play a major role in design, says Daniel Formosa, PhD, a design consultant with Smart Design (New York City). "Sensors and other monitoring equipment enable us to quantitatively evaluate the physical abilities of people and product performance—and design accordingly," he says. "The ability to understand and visualize information quickly feeds our design work and leads to innovative ideas. With tools like this, the process of innovating and developing products continues to become more fluid.

"It is impossible in many products to separate physical factors from perception," he adds. "To address this, we have developed ways to quantify consumer perceptions." Furthermore, advanced software and computer processing power enable his firm to continually refine its system for mapping perceptions about products, Formosa says.

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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