Finding the Right Balance
More function, better looks, less cost: Medical device designers must merge aesthetics, performance and efficacy.
“A common mistake that people make when trying to design something completely foolproof is to underestimate the ingenuity of complete fools.” —Douglas Adams, an English writer best known for his book and radio comedy “The Hitchhiker's Guide to the Galaxy.”
While most healthcare providers certainly aren’t fools, few things in life are completely error-proof. Adams’ point is that you never know what might go wrong. The challenge with designing and manufacturing medical devices is that you’re striving for end products that are error-free and building in as many steps to design and test to ensure a device is effective before it gets into the hands of a physician.
Creating something from nothing is never easy. Add a life-or-death element to some products and the task becomes even more onerous. Medical device manufacturers traditionally kept this function in house, but increasingly are outsourcing more of the medical device design functions to trusted supplier partners.
“OEMs know more about what is being requested in clinical settings,” said Mike Cusack, business development manager for Tucson, Ariz.-based Xeridiem Medical Devices, a designer of single-use, minimally invasive medical devices. “They recognize the opportunity, do the market research, establish the business case and then outsource the development to companies like ours.”
OEMs are outsourcing medical device design for a number of reasons. First, the Great Recession was a knockout punch for innovation and research and development, leaving many engineers and designers out of work. Even though the economy is (somewhat) on the mend, many companies still are reluctant to rebuild their internal resources until the medical device industry is really back to normal.
More than ever before, speed to market often is the key competitive advantage for product launches—something that is difficult for scaled-back companies to accomplish without their full resources. The U.S. Food and Drug Administration (FDA) also steadily is raising the bar when it comes to design controls. When all these factors are combined with the fact that medical device design is becoming more complex and technologically challenging, it’s just easier for OEMs to outsource to fully compliant, cutting-edge contract manufacturers that have the services, technology and staff to design and build the medical devices their end users want.
Of course, in return, OEMs want higher-quality, functional, low-cost designs with faster delivery and low development costs. The best way for contract manufacturers to deliver on these expectations is by managing the complete product life cycle—and the first step in this process is working closely with the end users of the devices to determine their unmet needs.
“It all starts with the end user,” said Thomas Taylor, president of Roush Life Sciences in Salem, N.H., which specializes in product development for diagnostics, medical devices, drug delivery and laboratory products. “We look at the existing application and conduct observational studies to watch what the end user actually does. From these observations we develop new design ideas and subject them to focus groups to get valuable feedback. We may have to go through this process several times until we get the best possible design. Then we pull in the engineers and ask, ‘How do we make this?’”
Although OEMs still manufacture brand-new products, many of them are favoring incremental improvements in existing devices instead of developing revolutionary (high cost), game-changing technology.
“It’s another way to control costs, especially in an increasingly challenging regulatory environment,” said Steve Maguire, general manager for Orchid Design (a division of Orchid Orthopedic Solutions LLC), a Shelton, Conn.-based company that specializes in orthopedic implants and surgical instrumentation. “Incremental improvements tend to have lower regulatory hurdles and an already-approved design process in place. ‘Revolutionary’ designs tend to become expensive, clinical trial candidates.”
Incremental changes still can be highly challenging to design, however—customers want to enhance their competitive position by adding valuable features and benefits to further differentiate the product,
but without much additional cost or creating intellectual property (IP) challenges.
Tim Hopper, chief operating officer for Gilero LLC, a full-service medical device design and product development company in Research Triangle Park, N.C., has noticed the same trend.
“More of our clients are looking to ‘refresh’ an existing product within their offering,” he said. “These are products that create a good deal of cash for them, yet IP protection may be expiring and the threat of copycat knockoffs loom. Or it may be as simple as driving more user ergonomics and an updated look and feel into time-tested products. These already have regulatory approval, or at least the path for a modified submission is already known.”
Hopper indicated clients are outsourcing these redesigns because their own engineers are just too close to the product and a “new set of eyes really provides a different way of looking at things,” he added. “We’ve had projects that run up and down the challenge scale. In one recent project we came away with limited design changes because the original design was so well liked during our ‘voice of customer’ exercise, yet were able to add a very simple feature to the molded design of the product that gave it another use within a different market category all together. For another project we were able to conceptualize and then design into the device a new sensing technology that actually makes the new design less costly to produce and provides better overall accuracy, possibly even creating a new protective IP for the client.”
Another cost-control measure OEMs are taking is designing devices that share the same standard platform and application software across their product lines—saving money in the process and speeding up production, approvals and time to market.
“For example, they want to use the same liquid crystal display (LCD) and the same LCD driver printed circuit board assemblies (PCBA), etc.,” explained Scott Kellogg, business unit manager for Jabil Healthcare & Life Sciences, a division of Jabil Circuit Inc. based in St. Petersburg, Fla. “Now, industrial design is just having us do this instead of bringing us plans. More customers are also asking us to get involved with the graphic user interface and user interface. This affects our design process by getting us involved earlier in the design process. This is a plus, of course, and helps make a better design in the end.”
System Engineering
Over the last several years, there has been a significant increase in discussions between OEMs and contract manufacturers regarding the need for system engineering and “right-sizing” the product development process, especially for software.
“A number of manufacturers have hit some bumps in the road late in their product development cycle, resulting in cost and schedule overruns or releases with reduced feature sets,” said Tim Bosch, vice president of architecture and consulting and chief architect for Foliage, a medical device consulting and product development firm based in Burlington, Mass. “More than a few companies have been burned by cost and schedule overruns because they haven’t realized until late in the product development cycle that there are mismatches between hardware and software, or between electrical and mechanical design or that something like labeling that ends up beingtreated as an afterthought.
A good system engineering approach integrates all disciplines involved in product development, and drives the product from concept through to operation while considering the complete problem throughout.”
Human factor engineering and usability engineering are key components of system engineering and the subject of much stronger regulatory focus.
“Healthcare costs will be reduced by moving care to lower-skilled workers and even to patients,” said Maguire. “Medical devices must be designed with this in mind. Good design means intuitive user interfaces and robust designs that can handle more abuse and misuse, without compromising function and safety.”
Human factors should be addressed during all phases of development, from upfront research through design and verification—ideally using a multi-disciplinary approach that includes usability specialists, industrial designers and engineers.
“We find that a user-centered design approach actually increases our creativity, rather than limiting it,” said Darrin Manke, director and program manager at Farm Design Inc., a full-service product development firm in Hollis, N.H., that provides complete development services for medical, life sciences and consumer-health companies. “For example, ethnographic research uncovers unmet and unarticulated user needs leading to innovative solutions, and workflow analysis leads to opportunities for streamlining processes and improving existing products. This includes everything from hand-held surgical instruments to large diagnostic equipment with touch-screen user interfaces.”
The FDA’s “Medical Devices-Application of Usability Engineering to Medical Devices” (IEC 62366:2007) requires developers and manufacturers to involve users in all stages of research to determine usability requirements and validate inputs and needs. On June 22, the FDA issued the draft guidance document “Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety & Effectiveness in Design” for the medical device industry as well as FDA staff. This guidance document currently is being distributed for comment purposes, and a final version will eventually replace “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management,” which was issued in July 2000.
“In addition to IEC 62366:2007 becoming mandatory in 2010, both the FDA and AAMI (Association for the Advancement of Medical Instrumentation) have infusion device safety initiatives under way,” said Manke. “There is also a relatively new AAMI committee developing a standard for the design of medical devices used in the home. Another big development this year was the publication of the long-awaited standard ANSI/AAMI HE75:2009, a huge compendium of human factors design guidelines and best practices.”
New Materials
There always will be a need for higher-performing, lower-cost materials that improve quality, longevity and lower total costs. Smaller sizes and lighter weights will continue to be the main drivers in medical device product development for years to come. OEMs continuously ask for innovative materials that will make medical devices stronger, tougher and better-looking, as well as provide a competitive advantage, such as enhanced biocompatibility.
“Materials can greatly affect the design of any device, primarily due to the different material properties of each resin family,” said Tom O’Brien, market director for Pittsfield, Mass.-based SABIC Innovative Plastics, which produces high-performance polymers for medical device manufacturers. “For example, using one of our Lexan HPX resin grades of polycarbonate enables longer flow lengths with minimal loss of impact. What this means to a device manufacturer is the potential to thin down a wall, enabling the part to become smaller or lighter weight but still maintain the properties or strength needed. Another example is the use of a colorable material. By using a colorable material OEMs can color-match their company color (or chosen application color) into the resin, thus eliminating the need for painting the part. Plastic also gives customers the design freedom that other materials, such as metal, do not allow.”
SABIC Innovative Plastics recently introduced test results for Ultem HU1004 resin, a resin that meets a number of critical industry sterilization demands, including higher-temperature autoclaving, ethylene oxide, gamma and Sterrad radiation. During Sterrad radiation the material also maintains its ductility and color after many repeated sterilizations.
“We can now position this material for applications using all major sterilization types,” added O’Brien. “This lets our customers use one material for their device versus multiple materials, potentially enabling them to reduce the number of materials and parts on hand.”
Another relatively new material that is getting attention is cyclic olefin copolymer (COC), an amorphous polymer with a very low concentration of extractables that provides glass-like clarity. COC possesses good stiffness and chemical resistance, can be extruded or injection-molded and is compatible with all types of sterilization procedures. Healthcare applications include pre-filled syringes, vials and other medical devices, diagnostic and laboratory equipment, precision optical technologies and blister packaging.
The unique combination of shape memory, super-elastic properties and biocompatibility has made Nitinol a rising star for specific dental and medical applications, especially arterial stents. “Working with this material, however, requires a certain level of expertise,” noted Cusack. “Engineers and technicians need to know how to manipulate this material without degrading its qualities. There are lots of advances going on right now in material science and engineers must stay on top of these developments to provide the best possible solutions to their clients.”
Trends in the Marketplace
Miniaturization continues to be a hot trend in medical device design. The use of smaller flexible circuits and smaller electrical components requires smaller PCBAs. A major design challenge is integrating components, such as building more functions into one singular microprocessor or integrating mechanical and electrical functions into single components known as micro-electromechanical systems.
“Many small ‘on body’ devices are becoming conformable and/or disposable,” indicated Ralph Hugeneck, director of medical technology for Jabil Healthcare & Life Sciences in Vienna, Austria. “Design is being challenged by developing elastic—not just flexible—circuit boards and housing materials and driving costs down if parts are being disposed after some days of use. Expertise is increased by working on technology demonstrators, which leverage the newest technologies of Jabil’s internal material group and external key suppliers.”
The increase in the number of smaller, high-volume electronics devices being developed provides more design options for engineers.
“For example, a single-use—low-cost disposable—drug delivery device could use flexible microelectronics to power and control liquid drug delivery in a small comfortable package attached directly to the patient,” said Alan Morris, business development manager for Invetech Pty. Ltd., a company specializing in the design and engineering of innovative diagnostic instruments and devices based in Melbourne, Australia. “Along the same lines, a small and flexible physiological monitoring device could attach to a patient and use WiFi to transmit data to a central location. These devices will require small and flexible conductors while attaching to miniature silicon chip technology for the controlling and data gathering. Miniature power sources would also be needed to operate these devices. Microfluidics technology is also being used more and more in medical devices. The big design challenge here is pushing the envelope for higher quality, higher reliability, and more complex functionality at a continually lower cost expectation.”
Roush’s Taylor said that more medical plastic products are using in-mold labeling technologies. These processes attach paper or plastic labels to plastic components during the blow molding, injection molding or thermoforming of these parts for medical devices. The label becomes an integral part of the final product—a pre-decoration step that eliminates secondary operations, which reduces costs. The label and the part to which it adheres typically are made from the same materials and have the same melt indexes for complete bonding. However, a new process recently has been introduced that uses a micro-porous film for the label; the plastic melt fills the tiny holes in the film during extrusion, making a permanent bond that is not dependent on chemistry.
A few medical device manufacturers are moving toward remote real-time collaboration, especially regarding medical images/video sharing to provide live feed of procedures to specialists and others who are mentoring or monitoring the procedure, or in some cases directing the procedure remotely —“such as in the catheterization lab or electrophysiology lab,” said Bosch. “The goal is to leverage that specialist’s expertise without requiring them to be physically at the location where the procedure is taking place, but the challenge is how to manage non-deterministic aspects—network latency for instance—that are being added to something that may require a specific level of determinism. If real-time imaging is streaming from an ultrasound catheter, for example, and now you want to stream that over a network connection or more to a remote application or browser, you’re adding time delays to something that formerly didn’t have those delays.”
Influences from Consumer Electronics
Consumer electronics are evolving quickly—especially mobility and the simplicity in design and user interface. Medical device manufacturers are paying close attention and pondering how these advancements of design and usability can be integrated into their products. Consumer electronics also provide immediate access to results—both real-time and stored data—something even baby boomers have come to expect from the technologies they use.
“There is a great deal of convergence going on between consumer and biomedical markets,” said Morris. “Devices are becoming easier to use, yet capture more and more detailed, complex information and perform increasingly sophisticated tests and analyses.”
Smartphones such as Apple’s iPhone or the Droid from Motorola, for example, also have had a huge impact, changing the way every device with a touch screen manages the user interface.
“The idea of remotely accessing previously ‘closed’ systems and devices via a smartphone application or browser is now a standard part of every design discussion,” said Bosch.
Kellogg agreed: “There is definitely more focus on how iPhones and iPads can be integrated with medical devices. These are consumer devices, but we have several customers who are looking at how to validate their use within a medical device, or even as a medical device. This has not yet been accomplished, however.”
As healthcare becomes decentralized, more responsibility will be transferred to the clinic or patient’s home, away from the laboratory or hospital. Therefore the movement of devices will follow the same path from the clinical space to the consumer health and well-being environment, where patients will be able to purchase devices from the pharmacy, supermarket or online. Even though the robustness, usefulness, reliability, ease of use and breadth of testing capability are still critical features, consumers also will be motivated to purchase according to ease of use and appearance.
“There are definite design challenges in trying to balance the ability to capture and utilize extremely complex data with simplicity of use,” said Morris.
User-friendliness is absolutely essential for marketability; if patients are asked to use a device at home, it must be functional and easy to understand so they will be compelled to use it and stay in compliance. The device also must look appealing in order to complete the sale—“in many cases devices are considered ‘furniture’ where they are sitting on a nightstand or countertop and consumers want them to look good,” said O’Brien.
Medical OEMs increasingly are using color, texture and ergonomic designs in their medical devices, added Taylor.
“For example, manufacturers of blood glucose meters and lancing devices have now incorporated cell phone plastic technology and colors into their latest designs. A short time ago these devices were only available in standard hospital colors,” he said. “Now lance devices, for example, come in a variety of colors so female diabetic patients, if they choose, can purchase pink lancing devices. There is no question the decorative technologies of the electronics markets are coming to the medical device industry.”
The touch-screen interfaces of smartphones and the latest tablets have changed the way people interact with complex electronic devices. Navigation, data input and a myriad of other functions are becoming common practice through touch screens; healthcare professionals and patients alike are becoming increasingly comfortable with this method of interaction. There also has been an influx in the approach of medical devices communicating with smartphones, allowing physicians and nurses to receive patient data like heart rate, oxygen level, blood pressure, etc.
“This convergence is truly revolutionizing the medical device space and is a keen topic of discussion throughout the industry,” said Manke. “Some of our clients have been discussing potential ways to integrate these technologies into new and existing devices, but at this stage we are proceeding cautiously because there are so many challenges associated with incorporating this kind of emerging technology. That said, this is an exciting time for medical device designers and a great opportunity to design new medical devices and systems that improve ease of use and improve the overall effectiveness and functionality of healthcare.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders such as Kohler. He also writes a variety of feature articles for regional and national publications and is the author of five books. Contact him at mark.crawford@charter.net.