Designed to Sell
A User-Friendly Design Can Give Products an Edge in the Marketplace
By Stacey L. Bell
In Hollywood, you’re only as good as your most recent film. In the medical device industry, the same can be said about your latest product launch.
Even the most brilliant distribution and sales and marketing strategies will fall flat unless two core concepts shine through: the product meets a need in the marketplace, and it is designed to sell.
“Designed to sell is one of the few ways you’re going to be successful,” said Steve Maylish, director of business development for Aubrey Group, Inc. in Irvine, CA. “Industrial design has typically focused on the outside of the unit—its appearance and its ergonomics. The medical device industry’s definition of good design is more inclusive. Is the product easy to learn? Does it work well and reliably? Is it easy to service?”
As an example, Maylish noted, consider a sweet-looking sports car that comes with a 300,000-mile warranty. Drivers won’t care how high-tech the car is and how well it handles curves if they have to take it into the shop every three months for repairs, he said.
Certainly, safety and efficacy are foremost concerns when designing a medical device, but the product’s reliability, look, usability, manufacturability and a host of other factors also play key roles.
Experts say that designing medical devices today differs from the process used even a decade ago. Here’s why.
The Perfect Storm
The perfect storm is brewing in the US medical marketplace. An aging population is expected to increase the demand for surgery in numerous specialties by nearly 50% by 2020. As technology advances proliferate, more people are seeking minimally invasive surgeries as well as outpatient procedures and home care remedies. But even as the need for more medical care increases, there is a dwindling number of professionals available to oversee or render necessary care as more healthcare workers retire or shift into other, less stressful careers.
• A 2003 study by the University of California – Los Angeles predicts shortages for many surgical specialties by 2020.
• The American Medical Association says there is now a shortfall of physicians in some regions and specialties, with more significant scarcities projected for the future.
• The US Department of Health and Human Services’ Health Resources and Services Administration notes that 30 states had an insufficient number of registered nurses in 2000, and this number is expected to grow to 44 states and the District of Columbia by 2020. Stated another way, by 2012, there will be 1.1 million unfilled openings for RNs, according to the Bureau of Labor Statistics.
• Physical therapists, anesthesiologists and myriad other disciplines also are projected to experience shortfalls within the next decade.
Treating more patients with fewer professionals is challenging, to say the least. Medical device firms always have held the needs of their devices’ end users in mind when creating new products; however, now more than ever, it’s essential to design products that will offer additional efficiencies and save time in America’s bustling hospitals and nursing homes.
Putting the End-User First
Ken Fine, president of Proven Process Medical Devices in East Walpole, MA, noted that OEMs’ outsourcing partners have bolstered and expanded their capabilities over the past few years to be able to give their clients an abbreviated supply chain that can better meet all of their needs in getting products to market quickly. For instance, Proven Process offers services that span the entire product life cycle, including specification development, concept development, feasibility analysis, prototype assembly, product design, verification and validation, regulatory support (including 510[k], IDE, PMA and CE submissions), pre-clinical and clinical support, new product introduction manufacturing and full manufacturing. Fine noted that, in recent years, more customers have sought help in collecting end-user feedback on proposed products.
In July 2000, the FDA released its human factors guidance, Medical Device Use—Safety: Incorporating Human Factors Engineering into Risk Management. “Since then, we’ve seen the large OEMs incorporate the principles of the guidance into their own design control systems, which results in a higher level of interface between the design organization and the end user,” Fine said.
Design services firms throughout the country noted that more of their customers are asking them to talk with end users before creating a product.
Front-end user research is a new area for most of our customers, and everyone does it differently,” reported Reade Harpham, principal industrial designer and head of industrial design strategy for Battelle Medical Device Solutions in Columbus, OH. “The biggest mistake OEMs can make is going for the broad and shallow information. Talking with nurses for one day in a corporate boardroom setting is not a real representation of where they’ll be using the product or instrument.”
To be able to design a product that will best meet users’ needs—and be easy for them to understand and use—you must watch users in their own environment, Harpham explained. You observe how they hold their tools, what side of the operating table they stand on and where they are looking (since most surgeons often are looking somewhere other than at the instrument in their hand; perhaps at a computer monitor, for instance).
And rather than asking people how they perform a procedure, you must watch it in action since there are always subtle differences between the professional’s perception of how he/she does his job and the reality. This level of contextual research is best conducted both before a new product or instrument has been designed and then again with prototypes.
“Basic research is still the underlying contributor to a successful product,” noted Paul Mulhauser, president of FactorsNY, LLC in New York City. “When we design surgical instruments, we always go into the OR to see how the procedure is done—even if we’ve observed it before. When I’m observing, I’m not looking at a product or instrument. I’m observing the process, the procedures, any errors that are made and differences between what a user says he or she does and what is actually done. ”
Seeing the procedure once often isn’t enough, experts believe. “We like to videotape live observations because you tend to focus on one or two things while you’re watching a procedure. On re-watching it, you may find [the users] are making adjustments with their other hand because of a product’s poor design,” said Dick Meyst, president and CEO of Fallbrook Engineering, Inc. in Valley Center, CA.
Of course, you also are likely to encounter some surprises. FactorsNY developed a skin stapler for one client and, during observation, saw the surgeon was using it in an upside-down position. “I learned early on, no matter how well you design a product, and how obvious you think it is to use, someone will use it differently,” Mulhauser said. “That’s why products must function just as well if they’re not used in the manner envisioned.”
Harpham agreed. “I’ve never been in a focus group where we haven’t been surprised,” he said. “I’ve never been in a group where people have used the product exactly as intended. Often it is very difficult for the project team to witness the products not being used as expected. The cool thing is, once we started to expect the unexpected, we were able to fully utilize what we learned to make the product design even better and exceed customers’ expectations,” he continued. “That’s why we stress that it’s essential to put your proposed product in the hands of users as early as possible so you can more easily manage changes.”
Meyst also believes that OEMs should put their proposed product into the hands of end users in all markets in which they intend to sell. “It’s definitely a world economy,” he said. “You need to know what is going on in other parts of the globe. Identify all of your markets and talk with users in each of these markets, even overseas. Look at both US and international competitors’ products and designs.”
By reviewing such a broad range of offerings, OEMs and their design services partner will be able to create more robust designs. In addition, they may find that they should develop different versions of the final product to account for differences in use and expectations in other large markets.
Furthermore, OEMs should ensure that their end-user groups are a large enough representation of market requirements and expectations.
Doug Hiemstra, president of Hiemstra Product Development, LLC in San Francisco, CA, shared his concern that too many companies tend to collect anecdotal rather than scientific data. “Too often, we’re asked to make a site visit to talk with one doctor to watch how he or she uses a product,” Hiemstra said. “But different doctors do things differently, so it would be more instructive to observe more users.”
Increasing a design services firm’s role in end-user research can provide a strategic advantage for OEMs. “By allowing us to work with end-users, we can uncover unmet user needs that then lead to the development of breakthrough product designs,” reported Tor Alden, principal of HS Design, Inc. in Gladstone, NJ. “The final product then will have a competitive advantage and stimulate user demand, which saves on sales and marketing dollars in the back end. Design creates demand. It’s all about innovation and differentiation.”
Getting From Great Idea to Great Profits
As important as designing the product is, it’s also essential to design a proper path to launching well-crafted products as expediently as possible. “OEMs today are analyzing the device and success of a product up front to decide if it makes financial sense for them to enter the market before progressing with a concept,” reported Bruce Richardson, vice president of product development for BC Tech in Santa Cruz, CA.
He noted that OEMs are more likely to ask themselves, “What is the annual sales potential for this product?” The number must justify the time and resources that will be devoted to the project, of course.
Time is another concern. “Every additional week in production costs the company more in associated overhead, which is a big concern, especially for startups,” Richardson said. “You need a good plan from the start or you will flounder.” It’s just like planning to drive from California to New York to attend a friend’s graduation. You can plan for the trip to take five days, but if you detour south to visit Florida because you have a sudden urge to visit Walt Disney World, you will miss the moment your friend receives her diploma.
Therefore, the OEM’s project manager plays a critical role. Rapid prototyping and other technologies have become so inexpensive to use, with such fast turnarounds (overnight in most cases), that nearly every project employs them. Since iterations can be accomplished so easily, it’s possible to continue designing—and redesigning—a product ad infinitum. Savvy project managers will work to define the product and its features and functions as specifically as possible from the project’s outset, which should help limit the number of necessary iterations.
“Our president likes to say, ‘Better is the enemy of good,’” Maylish noted. “You can iterate a design forever, constantly making it better, but you need to stop at some point. That’s where the project manager becomes invaluable. As an outsourcing partner, we will make as many iterations as we’re asked. The project manager must make the tough decisions and keep the project on track. The project manager must know the culture of his or her firm, the expectations and what designs will fly.”
Maylish added that the more people on the project, the more complicated it will be and the more difficult the decision process. “It’s best to have four to nine team members involved on most of our projects,” he said.
Another difficulty can be overcoming a myopic mindset. “A common mistake we see is that R&D engineers are focused on an implant or core technology, and they spend too little time thinking about the delivery system. They design this wonderful delivery system to deploy their technology, but they forget it has to leave the body, going back in the opposite direction. That’s where we come in,” Hiemstra said. “Product design can be more complicated than expected, and there may be more areas that require time and effort than initially realized.”
Scope creep for the new invention can be a challenge as well. An OEM initially may intend to include five particular product features in its new offering but, after talking with prospective end-users, find that four other qualities are important.
The OEMs often will choose a smaller set of requirements so they can get to market more rapidly, with plans to improve the device in the next generation,” explained Ben Clawson, president and CEO of BC Tech.
Meyst agrees. “We advocate getting the product into the marketplace and generating sales,” he said, adding that OEMs shouldn’t wait until they have a perfect product, because that is a moving target.
Alden pointed out that design firms will work with OEMs to find ways to combine technology groupings to minimize complexity, thereby possibly allowing a few more features to be incorporated without significantly disrupting the schedule.
More Than Design
Today’s OEMs outsource design services for all sorts of reasons: to get a product to market more quickly than would be possible using an in-house team, to allow internal resources to be devoted to other core competencies and, in some cases, to get a fresh perspective.
Clawson told the story of one company that came to BC Tech for help several years ago. For years, a stent maker had trouble with its delivery system. After just a few weeks of brainstorming and testing, BC Tech offered several solutions, one of which was selected. “Sometimes all that’s needed is a new way of looking at a challenge. Our experts work with a variety of projects so they can develop solutions using a broader range of experience,” Clawson said.
Outside design services can benefit OEMs in additional ways. For instance, often outside designers are well acquainted with an extensive array of materials and manufacturing methods, allowing them to choose just the right elements for a new concept.
“We’ve seen historically that every amount of dollars put into design at the beginning of a project comes back twofold in manufacturing cost savings, time to market and/or performance in the marketplace,” Alden said. He noted that his company, like some others, has developed strategic partnerships to be able to offer customers a greater portfolio of development paths. HS Design has joined forces with companies (including offshore firms) that specialize in different development and manufacturing services—with varying quality, price and turnaround points—so that it can offer a broad range of services and capabilities to OEMs.
Creating That X Factor
To develop new products that meet both users’ needs and expectations and OEMs’ sales projections, an innovative, user-friendly and reliable design is a must. One of the biggest mistakes companies can make is moving too quickly to rapid prototyping—before they’ve conducted in-depth end user research and assessed alternative approaches. Taking enough time to ensure users’ needs will be met in the best way possible, while perhaps adding one or two features users didn’t realize they need but which observation shows would be valuable, will boost OEMs’ bottom lines.
“Ultimately, it’s the extent to which a product exceeds the end users’ expectations that creates the excitement that will generate the greatest sales and profitability,” Mulhauser concluded.
Stacey L. Bell is a freelance writer who specializes in business and marketing issues. She is based in Tampa, FL.