Shifting the Approach to Design
As Medical Devices Increasingly End up in the Home, Designers Focus on Ease of Use and the Product “Experience”
In an age of patient awareness, the design of medical devices has taken a significant turn. With consumers better educated about diseases and preferring to become at-home caretakers for themselves and their family, they are driving the development of products that are easily understood and easy to use. With defibrillators now readily available to consumers as if they were household appliances, this product class is just one example of how OEMs are simplifying design for mass consumption.
Designing products to be more intuitive, easier to use and less prone to accidents have long been a goal for the design engineer, but these mandates have taken on new meanings as more patients assume the responsibility of medicating themselves. Whether it’s an in-home infusion pump, portable monitor or some other interventional device, many medical products are reaching homes in record numbers. As a result, designers must be mindful of a new group of users and their skill level when deciding function and form. Even when the product is marketed to trained clinicians, designers must remain mindful of the need for making products easy to learn and use, contract design service providers say. More importantly, functionality must not suffer even as user interfaces are simplified. These two countering trends are indeed making the engineer’s job more difficult at a time when project timelines are shrinking.
The User Experience
“The thing that’s driving the market is the experience with the machine or what it does and how it enables them to do things better,” said Reade Harpham, head of industrial design strategies at Columbus, OH-based Battelle, which provides design and development services to the medical device industry. He said that one of the key trends these days in the medical device market is to take lessons from the consumer products market. By using innovative industrial design, OEMs and their outsourced design partners can add functionality to products. In fact, industrial design has grown to encompass functionality in addition to how a product appears or feels, he added.
Design service providers say developing more consumer friendly products is just one of the trends driving outsourcing today. As medical device OEMs become more at ease with the practice, they are letting vendors take over critical functions such as product design and engineering.
A growing number of OEMs realize that many firms these days offer more than just industrial design or engineering services; rather, they have adopted holistic approaches that can take product development from concept to manufacturing. Some firms are even assuming research duties. Moreover, these firms typically boast capabilities much broader in scope than the OEM’s internal resources. By leveraging the partner’s depth, the medical device company can cut development time, reduce costs and realize savings in the technology transfer. This has led many OEMs to solicit the input of their design partners much earlier in product development efforts.
Ken Fine, president of East Walpole, MA-based Proven Process Medical Devices, a product development firm, said OEMs have shifted their approach when engaging design partners during the past 10 years.
“I find that they are outsourcing more things closer to their core technologies than in the past,” he said. “Ten years ago, we would get work for some of the accessories such as programming or design for leads. Now they are outsourcing the whole thing (medical device).”
He said many medical device clients are asking for turnkey solutions, involving not only the design but also engineering, validation, technology transfer and even manufacturing in some instances. This has been especially true among small, virtual companies that have little internal resources. While these types of firms have always engaged in outsourcing, he said they are more at ease these days with handing design and development functions to an outside partner.
As they become more acclimated to outsourcing design services, their tendency is to involve service providers earlier in the process, which some firms say results in real benefits.
“In the past five years, there’s been a real evolution of looking for outsource partners that have the ability to get involved early in the design process,” said Kevin Bramer, president of Louisville, KY-based Medventure, a design firm that specializes in minimally invasive products, handheld devices and catheter-based technologies.
Bramer said medical device OEMs often want design partners to consider more than just the design; they want a vendor who will keep an eye on their customer’s bottom line. Value-added services such as figuring out whether a proposed project makes sense under a specific reimbursement model, examining the average sale price of a product and weighing the return on investment capital (ROIC) often help OEMs make better decisions when they have to decide whether they should pursue a project. While not all clients will need these services, many smaller, start-up firms can benefit from a design partner’s experience on these issues from other projects.
“From our client’s perspective, it’s an ROIC” consideration, he added.
Some firms are going further. For instance, Foster-Miller in Waltham, MA recently launched its Innovation Express program, which not only helps OEMs develop new products but also provides technology forecasting. In a sense, the company is trying to provide services even before the concept stage.
Bob Andrews, the medical division manager for the commercial group at the firm, said the program is aimed at capitalizing on the trend toward full-service outsourcing. While many development firms are starting to offer manufacturing in conjunction with design services, few are able to help clients sort out the various technologies in the marketplace—which he contends is an important service to companies.
“You need to be able to understand technologies and assess them and know when they are ready for product development,” he said.
But can design and development firms provide too much, rendering the OEM less capable of fostering its own internal resources? And what are the risks with depending on partners for design ideas?
Steve Maylish, director of business development at Irvine, CA-based Aubrey Group, a medical device product development group, said there are always inherent risks in outsourcing, especially if OEMs choose the wrong partner without the appropriate competencies. When that happens, instead of the outsourced design firm accelerating product development, they can slow the process.
“The risk on the design side is that you are paying a design team to come up to a learning curve,” Maylish pointed out.
On the other hand, he pointed out, medical device OEMs face a dilemma when it comes to the question of whether to outsource design and engineering functions. Many companies view design as their core competency. While some companies prefer to retain internal control over the design process with internal staff, it’s difficult to justify the engineering headcount once a project is completed. Often, designers are resigned to serving as support engineers, a role that fails to fully leverage their skills and experience. As a result, these OEMs might experience talent flight as design engineers move onto more challenging and creative positions at other companies.
This problem can be especially daunting if the OEM portfolio is small or its IP is limited. Larger companies typically have many projects in the pipeline, so justifying headcount is less problematic. However, Maylish noted, “one-trick ponies” are likely to gravitate toward outsourced models.
Aside from the dilemma of maintaining a design and engineering staff, medical device companies often look outside for design skills they don’t possess. Design firms offer a wide breadth of knowledge and experience for a number of reasons. For one, service providers typically have worked with a variety of medical products and can draw upon their experience. Moreover, some companies aren’t limited to just the medical device space, which tends to be slower at adopting cutting-edge technology. For instance, wireless standards such as 802.11 and bluetooth have been around the computer industry for many years, but the medical device market only recently began examining ways to incorporate them into devices that talk to each other.
Additionally, with medical device designs becoming more consumer friendly, firms with experience in appliances, electronics and other household products have a broader understanding of the human factor.
“Ten years ago products were all beige. Now doctors, nurses and clinicians expect more of a consumer product feel,” Tor Alden, a principal at HS Design in Gladstone, NJ, said of the convergence of industries. “There’s a trend to merge the competencies down the road.”
A design firm with 35 years in the medical packaging field, HS Design also has a thriving consumer product development business. Alden said that experience has helped his company better understand the value of form and appearance. This is especially important as a burgeoning class of at-home medical devices such as diagnostic kits and continuous passive motion (CPM) machines reach consumers. Making interfaces easier to understand without losing functionality has become critical in the design process.
To make devices more convenient for consumers, designers are blending traditional mandates with new user requirements. For instance, portability, ease of use and reliability have always been required of device designs, but as products reach the home, they also must be less obtrusive and blend with the surrounding environment, according to Allan Cameron, a principal and industrial designer at the Design Continuum in West Newton, MA.
He pointed out that discretion is very important to patients and that they don’t want bulky devices to reveal their ailments. At the same time, he added, designers must make products appear dependable so that patients feel comfortable using them. For example, Cameron’s company recently worked on a sleep apnea mask, and how the product fits in its surroundings was a consideration in the design.
“In the bedroom, you want this thing to disappear as much as you can but you still want to instill confidence in the user,” he said.
That’s why industrial designers are playing a more important role in the development of medical devices. While many medical products don’t need the elegance of, say, an iPod, some can benefit from an ID designer’s touch, especially if the form can improve the user experience.
Another consideration that design engineers must keep in mind these days is the risk factor when consumers use medical devices themselves. Because they typically receive little training, have a tendency not to read instructions and make more assumptions when operating devices, they may be at greater risk of misusing products. To prevent this from occurring, designers must make devices as foolproof as possible, according to Paul Dowd, president of Bronxville, NY-based Creative Engineering, a contract service firm.
“You often have health and life at stake,” he said.
Even when the target user is a trained physician or clinician, design engineers must make the product simple to use. That’s because doctors also want to spend as little time training as possible. With a wide array of therapies available in the market, a product’s convenience factor is inextricably tied to its acceptance in the market and success, according to Ben Clawson, CEO of BC Tech, a Santa Cruz, CA-based medical device development firm. He said that while having the top physicians in a medical specialty embrace a device is great, that device’s success hinges on the other physicians adopting it as well. OEMs want a product’s design to be acceptable to 100% of the market.
An example is the drug-coated coronary stent. Even though Johnson & Johnson reached the market first, Boston Scientific captured the lion’s share because its delivery system was viewed as easier to use.
“If you are going to develop a product, you have to make the product so that the [level] B and C surgeons can use it. You can’t make the procedure so difficult so that only 5-10% of the surgeons can use it,” said Clawson.
Clearly design trends these days are shifting toward ease of use. While this has always been a goal of design firms, the growing use of medical devices in the home has provided greater impetus than ever to reach that goal. Even in hospitals and doctors’ offices, medical devices that save practitioners time are more likely to score points with buyers. And that’s a message designers are clearly paying attention to.