— Mitchell Kapor
Picture it: New Orleans, La., mid-March 2014. Ryan Estes is walking the exhibit floor at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, beholding all the science fiction-like technology and devices available to licensed practitioners. He slowly traverses through the throng of display booths assembled in half a dozen halls of the Morial Convention Center, a colossal building encompassing nearly 11 square blocks on the Mississippi River banks.
It’s Estes’ first time at the event and he’s eager to build new business partnerships as well as ascertain industry needs. Innovation literally surrounds him on the 582,000-square-foot exhibit floor, where “naturally” flexible artificial knees vie for dominance with ankle, wrist and hand clamps, titanium headless compression screws, disposable bone fixation templates, PEEK (polyetheretherketone) polymers, bone graft delivery systems, and spinal fixation solutions, among others. Amidst all the technological prowess, Estes spots some familiar items—relics really, compared to the breakthroughs being touted by the majority of exhibitors.
Estes immediately recognizes the products, verifying their identity from their signature bracket design, their material composition and silkscreen graphics. There’s no doubt in his mind: The sterilization cases and trays on display in the AAOS exhibit hall are stylistically synonymous with his company’s former models and, he would later learn, the same as those his father observed on the show floor in 1993.
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Picture it: Indianapolis, Ind., mid-2000s. Full-service sheet metal fabricator Estes Design and Manufacturing Inc. is entering its third decade of producing sterilization cases and trays. Little has changed since the company began making the products in 1983—the trays still feature an industry-standard bracket design, with the brackets themselves consisting of either anondized aluminum or nylon-coated stainless steel.
Same old design. Week after week, year after year.
A move, however, is underway to incorporate plastics in case and tray design, specifically high-performance, biocompatible materials that are reusable over many loads and resistant to the sterilization process for which they are specified. One such substance is polyphenylsulfone, a tough moldable polymer able to withstand more than 1,000 cycles of steam sterilization without any significant loss of properties.
Estes Design bigwigs are aware of the industry’s newfound penchant for plastics, but decide not to embrace it. They stick with the classic, tried-and-true metal bracket tray design, letting other companies risk the unknown.
Flash forward: Autumn 2008. The nation slips into a nasty recession, pushed to the brink by a toxic brew of bad mortgages, plummeting real estate values, failing investment banks, skyrocketing household debt and a monstrous trade imbalance. It’s the worst economic calamity since the 1930s and it wastes no time claiming victims. Within its relatively short lifetime, the Great Recession erases trillions of dollars of wealth, destroys 8 million U.S. jobs and robs an untold number of families of their homes.
America’s manufacturing sector is particularly hard-hit. Companies in all industries are struggling to survive amid rising energy costs and commodity prices, lower customer demand, and tightening credit. Estes Design is feeling the pinch, having weakened its core medical business by shunning plastic in its sterilization case/tray design.
“As a result of that decision, our medical business dropped off quite a bit. And the downturns in the economy hurt a little more without the strong medical work that was a bit more recession-resistant,” noted Ryan Estes, director of business development at the family-owned Estes Design, which offers engineering, design and manufacturing services to various industries, including medical equipment. “It especially hurt in 2008-2009. That was a real eye-opener for us.”
Vowing to stay true to their core competency, Estes bigwigs decide to return the firm’s medical business to its former glory. They enlist the help of an industrial designer—a creative “right-brainer,” as Ryan Estes put it—and spend the next several years developing a marketable redesign of sterilization cases and trays.
“We wanted to get back into the [medical] industry,” Ryan Estes told Medical Product Outsourcing. “And from a sterilization tray point of view, it was an industry with pretty stale designs. There isn’t a whole lot of new ideas or innovation—the trays and cases in use today are the same style as the ones we made 20 or 30 years ago. We really came at this with the idea of injecting new ideas into a stale industry. That’s what got the design side of things rolling again.”
Flash forward: Fall 2011. Estes debuts its redesigned sterilization cases/trays with a potential customer. The revamped product is lauded by executives for its simplicity, style and functionality, and touted as a radical departure from the current market standard. It consists of fewer components than most cases/trays (making assembly relatively quick and easy); it features aesthetically pleasing packaging (enhancing the product’s overall looks); and has ample open areas to aid the sterilization process and expedite dry times.
Estes boycotts plastics (again) in the redesign, choosing instead to manufacture its new cases and trays from stainless steel. This time, though, managers are rewarded for their decision—their material selection is becoming more popular with multinationals facing harsher sterilization equipment cleaning processes in Europe.
Estes’ potential client is among the converts. It likes the redesign, and negotiates a manufacturing/distribution agreement with Estes. Official production of the stainless steel cases and trays begins in the fall of 2013.
“Sterilization cases and trays tend to be an afterthought in the product development process,” noted Ryan Estes’ father Ron, vice president of operations. “When an OEM is preparing to launch a new system, trays are not on the priority list of new concepts. They tend to be addressed late in the game, often under the pressure of time. As a consequence, designs tend to revert back to tried-and-true basics that are not always current but have efficiencies that can be applied quickly. With the redesign, we didn’t want to be a ‘me too’ supplier. There are several big suppliers in the market that make [sterilization] trays, so for us to come in with the same thing would have been a tougher sell. Creative thinking is a big part of our culture. Whether it comes to equipment selection or design strategy, we cannot just follow the beaten path.”
Estes has plenty of company on the road less traveled. A growing number of contract manufacturers and medical device designers are blazing new trails to meet the needs of a rapidly evolving healthcare system. Though still guided by the basic principles of aesthetics, cost and improved outcomes, designs are now beginning to reflect the market shift towards value-based solutions, consumerism, and wellness/prevention programs.
A small cadre of companies have passionately been working to develop small, discreet devices that monitor health and wellness through such forms as temporary tattoos, band-aids and ingestible pills. MC10 Inc.’s Biostamp, for example, is thinner than a band-aid and the size of just two postage stamps. Affixable anywhere on the body, its sensors can monitor temperature, movement, heart rate, brain activity and ultraviolet radiation exposure, and transmit the data wirelessly back to patients and their clinicians. The Biostamp is expected to cost less than $10 per unit, and the Cambridge, Mass.-based startup is hoping to release a commercial version of the product in the next five years. In the meantime, MC10 has teamed up with Reebok on a memory card-sized head impact indicator. Released last year, the CheckLight measures athletes’ head movements during competitions to determine the severity of jolts. The system consists of a skullcap-imbedded body sensor and a small screen that lights up on impact: yellow for a moderate blow, red for more severe.
Another startup, Corventis Inc. (recently acquired by Medtronic Inc.), has designed a band-aid that detects cardiac arrhythmias, while Proteus Digital Health Inc. is gaining notoriety for its ingestible computer chip. The 1-square-millimeter device—roughly the size of a grain of sand—is imbedded in a capsule that is activated upon contact with stomach acid. Once ingested and dissolved, the chip’s sensors can report such physical parameters as time of ingestion, temperature, heart rate, body position and activity level. The sensor transmits that information through the skin to a stick-on patch, which in turn, sends the data to a mobile phone application or any other authorized devices.
Proteus’ “Ingestion Event Marker” received CE Mark approval in 2010 and the U.S. Food and Drug Administration’s (FDA) blessing in August 2012.
Indeed, technologies like ingestible computer chips, biometric skin patches and impact-measuring sensors can help clinicians and patients cost-effectively prevent, diagnose and monitor health conditions; manage treatment; and enable timely communication and intervention. But such forward-thinking solutions can be difficult to design and develop.
One of the most pressing challenges to wellness device design is the complexity of the solution. Most, if not all, products in this budding sector incorporate a medley of technologies, from electronics (sensors), miniaturization and data acquisition to cybersecurity and workflow automation. No company can possibly integrate all those features on its own.
Consequently, the effort requires intense collaboration between the consumer health and medtech industries, neither of which really understands the other.
“The market challenge today is you have very passionate consumer digital health/wellness type of activities going on in places like Apple, Samsung and Fitbit. People are adopting these technologies en masse but not getting relevant, actionable information from these devices. ‘I took so many steps today,’ or ‘My heart rate was this,’ just doesn’t provide the promising utility to users, “said Sean MacLeod, president of Stratos Product Development LLC, a Seattle, Wash.-based design and strategy consultancy specializing in medical product development and consumer electronic product design. The firm previously partnered with Proteus on its Ingestion Event Marker, designing, developing and testing its wearable hardware, and working on early generations of its product offerings.
“Most consumer digital health companies are not skilled in the art of determining how to create a device that has medical, actionable relevance for the user,” MacLeod continued. “On the other side of the fence are the people that develop traditional medical devices. They’re very keen on efficacy and how to meet the unmet needs in the regulated healthcare space, however, they don’t really have the consumer market savvy or usability understanding of how patients might interact with their technology and data daily to provide actionable guidance and wellness utility. They don’t really understand what that interaction model is in daily life. So, you put these two industries side by side and neither one understands enough about the other to be successful. The solution is also so broad, going from brand new sensor technology that might be implantable or ingestible to wearable technologies that need to be ruggedized and have interfaces to a mobile app. Success for these applications that will happen at these intersections will be very interesting and have very high-promise but will also be very complex. This complexity is hard to manage and hard to pull off in a way that any normal startup or major corporation may have done in the past.”
Product software also can complicate the design process. Even the simplest diagnostic and monitoring apps easily can become convoluted by software that wirelessly connects a medical device to the Cloud or other data storage systems. Issues such as branching, perpetual updating, failures occurring with little advance warning, and seemingly insignificant changes in code can create unexpected and significant problems in a software program. Thus, it is imperative that mobile medical app and device developers design their creations with patients in mind, paying particular attention to ways in which the software addresses human factors—including user error due to design.
An app for testing blood glucose levels, for example, would be useless, or at the very least, seriously flawed if patients cannot understand or interact with it. To ensure the design and later validation of a safe and effective mobile medical app, designs should take into account risk analysis; hardware; built-in error, alarm, and warning messages; communication links to the hardware and user; and security measures.
Designers should be cognizant of software updates or modifications and electronic component life cycles too, as both elements can entangle the product development process in bureaucratic red tape. Software revisions—whether from debugging, regulatory changes, design alterations or problem-solving—significantly can affect the function of a mobile medical app or device. Thus, the FDA and most international regulatory agencies require companies to revalidate updated software and computer systems to ensure changes are implemented correctly and, most importantly, do not adversely impact other parts of the software product.
Electronic components can be particularly problematic for designers due to their relatively short life spans (roughly two to three years). Electronic component manufacturers attempt to give customers 180 days notice before changing a part or marking the end of its life but unaddressed/unnoticed constituent changes or obsolescence can force companies to redesign a product and in many cases submit a 510(k) for that redesigned device.
Boston Engineering Corporation had to navigate through this precise scenario helping a client get its recalled device back on the market.
“As a designer, it’s really important to specify electrical components that are relatively early in their life cycles to mitigate the risk of obsolescence and the subsequent need for more regulatory filings,” explained Dave Jacobs, director of medical device development at Waltham, Mass.-based Boston Engineering, a product development consultancy. “We recently had to redesign a device that had been recalled and been off the market for several years. The client did all the work required to close the recall and wanted to reintroduce the product. But, they found that they could no longer build it because many of the components were now obsolete and couldn’t be found anywhere. So, we redesigned the device for manufacturability, replaced obsolete components with components that were relatively early in their life cycle and submitted a 510(k) for the redesigned product.”
“That was an extreme case though,” he continued. “And what made it even worse was from the time the company originally created the software, the FDA’s expectations for software verification and validation had changed. So, in addition to doing verification and validation on the code we changed, we also had to review the original software and document that review because the software validation and verification that had been done seven years before didn’t meet current requirements or the agency’s expectations. What had appeared to be a seemingly simple project did in fact became very complex. There’s no such thing as a simple project and if you think it’s simple you’re probably going to be proven wrong.”
Completely wrong. Product development is indeed a complex process and designers have perhaps the toughest job of all, juggling cost, engineering specifications, required features, user needs, reimbursement potential, electronic component life cycle and aesthetics when devising their medtech masterpieces. And each one of those elements carries its own set of challenges.
Consider aesthetics, for instance. All companies want their devices to look good, since visually appealing products can communicate certain meanings (e.g., prestige) through design, create a competitive advantage in the market and bolster the item’s chance of success. A great deal is decided by visual cues, experts claim, the strongest and most persuasive being color.
One of the most influential elements of a design, color, is used by medical device designers to increase functionality, making the product easier and more intuitive to use; encourage a certain emotional response in the patient and/or user; and reinforce brand recognition.
Designers can improve device functionality through contrasting values (dark vs. light) or color. Injecting color into various interface areas can help the user determine its functions and important controls (on/off switch, access port handling, luer attachments, etc.). Color also can create optical illusions: Light-colored objects appear to weigh less than their dark counterparts, while devices with black or darkly colored interiors appear smaller than those with light midsections.
Choosing an overall color is rarely as easy as it seems. Our emotional response to color is tied to the symbolism normally associated with each hue, though symbolic associations differ among cultures, emotional effects vary among individuals, and color psychology is not a definitive science. Nevertheless, most colors have specific connotations—white usually is affiliated with cleanliness/sterility and purity (appropriate for medical settings); blue is soothing; black conveys seriousness, sophistication and excellence (effective for laboratory products); red is energizing; pink is tranquil and is societally associated with the feminine; orange is happy yet oddly comforting; yellow is sunny, optimistic and friendly (ideal for pediatrics); and brown is both reliable and supportive, but its association with decay makes it a dubious choice for medical settings.
Looks aren’t everything, though. Even the prettiest of medical devices can be commercial failures if they are designed without a clear understanding of their intended use and target audience. Interaction design, however, can help product development teams decipher end-user needs and experiences. Interaction designers take a user-centered approach to design, focusing first on insights related to the patient’s or clinician’s desired experiences; these insights serve as the starting point for the design process. Designers then incorporate those desired experiences into product features, composition and specifications with the goal of improving end users’ interactions with technology. Interaction design not only improves interfaces—it also can provide a better overall user experience.
Royal Philips’ recent launch of its VISIQ tablet ultrasound is a prime example of the shift in design focus from technology to user interaction. Typical hospital ultrasound machines are heavy, cumbersome and unwieldy, but newer, more portable, compact systems have been introduced within the last decade to fulfill customer needs. VISIQ specifically addresses user demand, as it is designed for hospitals, physicians’ offices and remote healthcare settings.
Portability was not the sole design driver, though. VISIQ also facilitates user interaction: The tablet was specially designed to help doctors more easily share the screen and an image of the fetus at the patient’s bedside. The product also accommodates physicians’ various work environments, realizing that practitioners in remote areas with limited access to healthcare have different needs than those working in a traditional hospital.
Interaction design is bound to play an increasingly important role in future medical device design as companies pursue a better understanding of user wants, needs and experiences. Some experts, in fact, expect user-centered design to serve as the main point of departure for true innovation in medtech development.
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Regardless of its destiny, the design process undoubtedly will remain a complex beast, with its creative thinkers incorporating a host of factors into their final works of art. And while market trends are driving a shift toward user-centered design, medtech couturiers will not easily abandon the longtime fundamentals of cost, efficacy, aesthetics and intended purpose. Future designs are likely to be a mix of both—a low-cost, easy-to-use solution whose functional specifications are secondary to the experiential components.
As Dan Coppersmith, sales engineer with Phillipsburg, N.J.-based manufacturer Engineered Medical Solutions, noted: “Medical device design will always reflect the user-needs and requirements of the intended outcome. If there is a great demand to reinvent how procedures are performed, designs will change with the available technology. How designs are created rely on volumes and profit, but what it really comes down to is how to design a part in the simplest way that serves its purpose, has no wasted material, and is also practical in its use, while maintaining an aesthetic design. Today’s newer designs reflect the availability of plastics, electronics and robotic movements mainly because they are becoming more affordable, but basic designs and traditional techniques still control the majority of the market because they have been proven over time to be effective.”