Paying attention to today's medical device design and development trends can help executives produce breakthrough technology success
Medical technology innovation today is more critical than ever. Breakthrough technologies can lead to a higher level of patient care at a lower cost. For medical device companies, advancing the commercialization of innovative products can lead to higher profit or greater share of a hot market segment.
According to a recent U.S. public opinion survey on innovation, most Americans are optimistic about the positive results of new technology, while experts urge more caution.1 The survey also found that 80% of Americans believe that the country is prepared, scientifically and technologically, to ensure their personal safety, health, and well-being. Likewise, 80% of Americans are optimistic about how science and technology will affect their future.
Medical device experts may urge caution because of the pitfalls typically associated with growing innovation, including rising costs of product development, regulatory hurdles, and reimbursement concerns.
According to FDA, the path to new product development is critical. A recent report by the agency said, "The medical product development process is no longer able to keep pace with basic scientific innovation. Only a concerted effort to apply the new biomedical science to medical product development will succeed in modernizing the critical path." At the same time, FDA noted that scientists in academia, government, and industry are working on these challenges and that there has been success in recent years. "Directing research not only to new medical breakthroughs, but also to breakthrough tools for developing new treatments, is an essential step in providing patients with more timely, affordable, and predictable access to new therapies. FDA is confident that, with effective collaboration among government, academia, and the private sector, these goals can be achieved," the report said.
All aspects of growing innovation, from the birth of a technology's idea and the source of its funding to the technology's design, development, and marketing, are necessary components to ensure commercial success. Medical device company executives must examine market, design, and development trends to cultivate a strategy for strong medtech innovation.
Sources of Innovation Innovative medical product ideas often arise from a variety of sources, including academia, technology development firms, design firms, and finished-product manufacturers. These sources may also interact to generate the best idea.
Today, a significant amount of medical device innovation is coming from small start-up companies, says Sheila Zelinger, associate partner for the health and life science industry at Accenture (Palo Alto, CA). "There are many partnerships in the product design and development area, where large companies are strategically partnering with or making acquisitions of small technology-based companies," she says. "With in vitro diagnostics, intellectual property (IP) licensing is an increasing trend."
Gerald Loeb, professor of biomedical engineering at the University of Southern California (USC, Los Angeles), takes a different view. "Truly innovative ideas are still coming from academia rather than industry, but the effort to translate them into products requires more financing and creative input from industry as the complexity of those products increases," says Loeb, who is also director of the medical device development facility of the A. E. Mann Institute for Biomedical Engineering at USC.
Within industry, however, small companies are typically more likely to grow innovation than large companies.
"There are huge barriers to entry for start-up companies—including regulatory, reimbursement, and marketing challenges—but they still flourish because they are more adept at thinking out of the box," says Loeb. "In reality, though, most start-up companies are counting on a buyout exit strategy, which just reinforces the tendency of large companies to let the start-ups assume the risks of innovation."
Relationships between large and small companies can take several forms, says Zelinger, including partnerships in which both parties work closely together to develop and commercialize the product; agreements where IP is licensed from one company but the commercialization resides internally with the licensor; acquisition; and equity investment, where the relationship between the companies is managed through milestone-based funding.
"Large companies support start-up companies for very specific reasons," says Zelinger. "They want access to innovative technology that is likely to prove technically feasible in the near to medium term, and they want the technology to result in a new product that they can market and sell to their current customer base—or that will allow them to enter into a new therapeutic area that has significant market potential."
Today, the number of strategic partnerships and acquisitions between large and small companies is increasing, says Zelinger. "The main benefit is time-to-market with a new innovation. In the next 2–3 years, companies are expecting to reduce the time from an idea's conceptualization to a development commitment by nearly 50%, and strategic partnerships are likely to play a significant role in achieving this reduction."
Role of Incubators Incubators are often a key source for supporting early-stage medtech companies. Through various means of assistance—including funding, infrastructure aid, and a collaborative environment—incubators can nurture a start-up company to grow beyond its initial stages. Incubators may take the form of business parks or programs established by universities, large companies, or government entities.
For a large company, there are different structures and governance models to incubate early-stage innovative ideas, says Zelinger. "A large company may start up a separate division or business unit that is solely focused on incubating new technologies in the research stage. With this structure, the company provides the facilities, communication, and research infrastructure for inventors—either internal or external—to design, develop, and test the technical feasibility of their innovations," she says. "Alternatively, a large company may create a division that is focused on taking an innovation through development and launch. Strategic partnerships or networks of alliances are often used in these situations. A third option is for a large company to fund innovation through equity investments.
"The value of incubators is that they enable innovations, which by definition are higher risk, to be developed outside of the more risk-averse mainstream business," says Zelinger. "The real challenge or limitation is how that idea or concept gets commercialized. Innovators must ask, 'Will another company find value in the innovation?' 'How much will they want to pay for it, given the amount of money required for commercialization?' Even when an incubator resides within a large company, there are challenges in integrating new technologies into on-going operations. Should the product development teams merge or stay separate? How will the other functions be resourced to support the new innovation?"
Finding a source of funding can be a crucial link on the path to development, adds Loeb.
"Today, areas like tissue engineering are benefiting from a lot of government funding," says Loeb, "but the path to commercial products is much longer and more uncertain than scientists and venture capitalists recognize or want to admit."
Design and Development Trends Whether the new product incorporates innovative materials, information technology capabilities, miniaturization, or consumer-oriented design elements, patients and practitioners are likely to benefit from design and development trends.
Consumer Awareness. One movement in particular—attention to consumers—is on the upswing, experts say. "Industry's greater awareness of the end-user during the last five years has brought about significant changes," says Stuart Karten, founder of Stuart Karten Design (SKD; Marina del Rey, CA). "There is an increased level of interest in usability and human factors. Manufacturers are more willing to fund user research and to establish design specifications in the early stages of product development that address intuitive interfaces, cognitive and physical ease of use, and user safety. This has resulted in manufacturers' greater insight into the needs and wants of users, and an emphasis on resolving product inadequacies and providing a better user experience."
For example, the SenoCor 360 breast biopsy system by SenoRx Inc. (Aliso Viejo, CA) epitomizes the focus on the end-user's perception, says Karten. "In the early stages of product development, SKD conducted a great deal of research into the concerns of breast cancer patients and physicians that led directly to materials, form, and color choices. The resulting product featured forms with rounded corners, soft materials, and colors that were carefully selected to be soothing and reassuring for the patient while durable and easy to read for the physician."
Manufacturers are taking cues from consumer product industries and applying them to medical devices, says Aaron Oppenheimer, principal product behaviorist at Design Continuum (Boston). "Since more medical devices are being sold over the counter, it has become important for manufacturers to understand how to create products that resonate with the lives and life-styles of patients. Manufacturers can achieve this by using design to communicate not only appropriate medical messages (e.g., "This is a high-tech device to help manage a disease") but also appropriate life-style messages (e.g., "I'm taking care of my health"). Sometimes design wants a product to send the messsage, 'I'm not a medical device,' as with the Accu-Chek Compact blood glucose meter by Roche Diagnostics (Indianapolis)."
"Medical device manufacturers now understand that more time should be devoted to researching users' needs and defining products rather than obsessing about features and technological prowess," says Bill Evans, founder of Bridge Design Inc. (San Francisco). "Also, new products must appeal to a broader audience than ever before. This is especially true for surgical tools, where in the past, companies have focused on research from elite groups of surgeons and failed to get market share."
Technology. The addition of breakthrough technology to a product can be a strong asset, offering services to patients and physicians that were previously not available. "Technology continues to create consumer benefits," says Oppenheimer. "For example, diabetes products that connect to personal computers to help evaluate a patient's management of disease are a terrific enhancement that provide undeniable benefits." On the flip side, Oppenheimer says, the addition of more technology does not guarantee that a product will be better. "Because technology can be inexpensive to incorporate, there is a temptation to simply shovel in dubious features. Manufacturers need to understand which features are truly valuable and which are better left out of a product."
Craig Scherer, cofounder and senior partner at Insight Product Development LLC (Chicago), says that wireless technologies have affected industry in recent years. "The ability for devices to wirelessly communicate with each other creates an opportunity to completely rethink established product lines and features," he says.
Product development experienced a renaissance in recent years that paralleled the dot-com boom, says Korhan Tekin, founder and principal of Damgudesign Inc. (Los Angeles). "The Internet era accelerated communications and proliferated information. This brought closer synchronization between the various disciplines and more-thoroughly integrated products. Instead of disparate, isolated devices that fail to conform to their environments or users, there are more-fully-integrated systems of intelligent components that communicate with one another and accomplish tasks more efficiently—in less space, and with reduced expense and improved reliability. Consequently, product and end-user experience greater intimacy than ever before."
Industry Influence. Many of the same trends driving industry at large—increasing medical and insurance costs, and decreased reimbursement levels—are also creating major shifts in medical device development, says Robert Howard, vice president of engineering for Lunar Design Inc. (Palo Alto, CA). "There is a drive to shift some of the healthcare system's burden to patients for managing their own diseases, including diabetes, hypertension, and asthma. This shift has created a host of 'consumerized,' portable medical devices that can easily absorb inexpensive, ubiquitous technology," he says. "Also, aging baby boomers play a more active role in making their healthcare decisions, and that will translate into an increased demand for devices that give data to people who understand its implications on their quality and length of life.
"Lunar is participating in a trend toward wearable technology in the medical diagnostic area," says Howard. "One of our collaborators is BioSentient Corp. (Houston), a company formed to commercialize NASA technology developed to help train astronauts to adapt to space and to avoid the symptoms of space sickness. The company's wearable sensor system and physiologic feedback approach promises to help sufferers of other automatic nervous system disorders, possibly including motion sickness and panic. In the future, wearable sensor systems will provide real-time feedback to patients, empowering them to manage their own treatment regimens, reducing doctor visits, and improving quality of care."
Design Aesthetics. "There is an increased acknowledgement of the value in developing emotionally rich medical products," says Kevin Young, principal industrial designer for Design Continuum. "Everything from lab equipment to surgical tools are benefiting from increased attention to design aesthetics. One reason for this shift is the realization that the users of these products—physicians—are consumers, too. And as consumers, they have emotional reactions to the tools they use. So it is equally important to design products to satisfy functional and ergonomic needs as well as emotional desires."
Consumers expect medical devices to be well designed just like automobiles, home entertainment systems, computers, and other appliances, says Scherer. "When conducting research at Insight, we often hear people say, 'This interface should work like my TV remote control,' or 'I want that product to look like my home computer,'" he says. "Consumers expect design that is visually appealing and that removes any intimidation factor. People want a design they enjoy interacting with."
Patient Safety, Usability, and Human Factors
For any person or company involved in developing an innovative product, patient safety, usability, and human factors are all important elements of the product's design and engineering. While most experts agree that patient safety is and has always been a priority, usability and human factors are now attracting more attention.
"Usability and human factor issues are becoming more visible to manufacturers as they realize that patients are consumers who are shopping for over-the-counter medical devices," says Oppenheimer. "The Internet allows patients and medical professionals to talk directly to each other and trade information, so even prescription devices are subject to comparison shopping."
Patient safety, usability, and human factors considerations must be at the core of any product development initiative, says David Robson, development director at Item New Product Development (Providence, RI). "Too often, companies focus on these concerns at the middle or latter stage of a project because the practical tendency is to first solve the technical challenges of making the product work. Addressing human factors at the outset is one of the hardest things to do, but the entire project will be meaningless unless the people for whom it's designed can use the product properly. Human factors and usability are also increasingly what drives commercial success.
"At Item, we make every attempt to quantify a product before it is designed. This entails making educated approximations and decisions based on experiences, surveys, and a deep understanding of the patient, manufacturer, and user," says Robson. "Smaller companies with limited resources, as well as large companies that are departmentalized, might be inclined to skip this step. That could put a project's success at risk."
"Usability and human factors are considerations that can play a role in safety," says Howard. "They also play an important part in the acceptance and adoption of medical products. Today, everyone interacts with machines and devices. After years of putting up with great technology but poor usability, people have come to demand that machines accommodate them—not the other way around."
Usability and human factors are the conduit whereby the full benefits of any given technology are delivered to the end-user or patient, says Tekin. However, they are also "considerations that are gaining prominence but still fail to convey the dazzling technological innovations of recent years," he says. "Compelling technology requires attentiveness to these values to realize full potential and achieve product excellence."
Manufacturers must look beyond efficacy and increase their products' usability or else they will not achieve significant market share, says Evans. "There is also increasing concern about medical error reduction by hospitals, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and FDA. There is potential regulatory interest in this matter that may call for usability tests of drug-delivery equipment to make sure human error is reduced through well-thought-out interfaces. Basically, as standards improve, FDA and JCAHO move their goal posts and ask for better human factors. This is a good thing that will motivate companies to act."
Consumer Design Sensitivities
No matter what the industry, the design requirements of product purchasers are what drives advances in engineering, says Howard. "One of the key reasons is that baby boomers have become accustomed to being picky shoppers—demanding design and features choices that meet their lifestyles.
"As advancements in medicine put more diagnostic tools in the hands of patients, designing these tools to fit people's lives is becoming an important differentiator for the companies that make them," says Howard. "For example, the blood glucose meter market has become saturated with competitive products that are separated by more than just differences in performance. Patient preference has driven the development of products that offer detailed feedback and minimize utility in favor of portability."
"Designers need to know how a patient feels about using a device in order to understand how it should operate and look," says Oppenheimer. "The device may take the role of a doctor, analyzing a patient's situation and making a recommendation; the role of a police officer, ordering a patient to use the device; or the role of a friend, helping a patient experiment with treatment."
Consumers read reviews and compare product features more than ever, says Karten. "This heightened awareness and competition pushes engineering to constantly increase product performance and reduce size and weight," he says. "Medical equipment has to be at the same level of design and technology as any other consumer product, and it is subject to similar short product life cycles."
When competing products are clinically on par and competitively priced, design becomes the critical differentiator, says Robson. "Investment in design gives a sales force leverage to demonstrate that they've taken all customer needs into consideration," he says.
Tekin believes that consumers are not always precisely aware of design sensitivities, but they sense a product's quirks and shortcomings and clearly have preferences. He points out that consumer design sensitivities are not the only values that affect commercial success. "Price, financing options, and advertising, among other factors, ultimately influence purchasing decisions," he says. "But setting marketing and financing influences aside, design becomes a primary determinant of market acceptance."
Functionality and Commercial Success
Well-engineered products operate on a different level than emotionally-targeted products, says Young. "Clearly, a product must perform; if it doesn't, consumers will find out," says Oppenheimer. "There are two types of features to note: those that deliver better results, and those that exist merely to differentiate a product. The latter features can be trivial and often muddy the waters rather than help the user. The hard part is understanding which features truly bring a benefit to a product and which ones only complicate it."
Great engineering is often hidden from the average product user through excellent usability features, software, and training, says Howard. "What's not hidden is the basic functionality offered by the product, and unless that is market driven, even the best technology won't find a home.
"Lunar Design has worked on many surgical products that offer a variety of functions in a single product," says Howard. "These types of products are designed to help practitioners easily leverage technology into a number of applications. The key principle for commercial success remains interface simplicity combined with powerful functionality."
"Design and engineering are the soft and hard disciplines of product development, respectively," says Tekin. "They go hand-in-hand and are necessary to one another. Without inspired design, experience of a product can be difficult, painful, frustrating, and ultimately displeasing. Without inventive engineering, the product will be unreliable, minimally functional, of low quality, and insubstantial. Ideally, devices should embody the complementary soft and hard values, and be ambitious in challenging the status quo of functionality."
