Originally Published May/June 2000

Special Report

Product Design: The Shape of Things to Come

As sophisticated devices move from the physician's office, the focus of medical design is shifting to the end-user.

Benjamin Lichtman

Recent technological advances in the medical industry are uncovering an interesting paradox: devices are becoming more complex, while manufacturers are being asked to make them accessible to less-skilled users. This is particularly true for device OEMs creating products for the point-of-care, home-healthcare, or consumer markets. All three types of products depend on effective design in order to meet market needs.

A diagnostic device created for Alara Inc. by Bridge Design Inc. estimates bone density by radiographic absorptiometry. The Metriscan features an open, user-friendly design and is meant to replace a cumbersome test requiring x-rays to be sent to a laboratory.

A concern for cost reduction on the part of both governments and insurance companies has placed medical products for consumers and less-skilled clinicians in the spotlight. "Hospitalizing patients any longer than strictly necessary is not affordable anymore, especially in the context of a rapidly ageing society," notes Carel van Houte, senior industrial design manager at WeLL Design Associates (Zeist, Netherlands). The design firm is currently updating its 1996 research project into the future of the healthcare market. Van Houte cites four key technological areas influencing the home-healthcare market: diagnostics, such as pregnancy and glucose tests; drug delivery devices, such as hypodermics and inhalers; electric devices, such as atomizers and infusion pumps; and communications technology, such as alarms and monitoring equipment. "Currently there is a growing demand for home-healthcare products in all four of these fields," he says. WeLL has designed drug-dispensing equipment for home use, as well as an intranet interface used for hospital staff communications.

"The economics of treating patients is evolving, hospitalization is expensive, and interventions are becoming less and less invasive," says Marc Piel, director of InterDesign (Paris). "Patients recover more quickly and can go home sooner, but in some cases still need treatment," he says, adding that this trend has had a direct effect on his company's medical activities. Piel notes that InterDesign's medical product design work focusses on "devices that can be used by the patient at home without having to go through a learning process." The company's portfolio includes a noninvasive microwave system for prostrate treatment.

The new demands placed on device manufacturers have fundamentally changed the work of medical design engineers. The pivotal role normally played by medical product design is given even greater weight when a device is aimed at a nonclinical user. Bill Evans, president of Bridge Design Inc. (San Francisco, CA, USA), explains that medical device designers have traditionally assumed professional intervention. "We have taken it for granted that a doctor is involved in the application of a product, so we didn't necessarily need to make it 100% foolproof," he says. "But nowadays, doctors are busier than ever—there is a sense of information overload. As a result, whatever you can do to make your medical device function more like a consumer product will inevitably make it more marketable," Evans adds.

Bridge took this into account in its design of a bone-density diagnostic device for Alara Inc. (Hayward, CA, USA). The Metriscan device is used to identify people, particularly older women, who are at risk for fractures. "What makes the device unique from a design point of view is that we designed it to be user-focussed and very approachable," says Evans. "We opened up the area where users put their hands, to make the procedure as unintimidating as possible. What we're saying with this design is: 'This thing's got a very low dose; don't worry about it, it's just going to take a second,'" he adds. Evans notes that the open, user-friendly design has been instrumental in distinguishing Metriscan from competing products. "One of Metriscan's competitors is a product where you put your hand basically into a hole, and that seems to be much more intimidating," he says.

Some designers suggest that there is great potential value to be gained from adapting consumer design techniques to the medical sector. Andrew Hobbs, healthcare business development consultant at Cambridge Consultants Ltd. (Cambridge, UK), cites the example of classification of features on a product, including the technique of adding pronounced features with a high "excitement factor." Cambridge Consultants has experience in the design of medical products that are marketed to consumers, including a palm-sized, computerized fertility monitor.

The aesthetics and graphic design of this syringe pump were developed by DCA Design Consultants. The device incorporates an intuitive user interface, as well as a simplified casework assembly that reduces manufacturing costs and facilitates repair and maintenance.

Hobbs notes that advances in other areas—such as wireless communications in consumer electronics—have had an impact on medical design and will continue to do so. "The first adoption [of new technology] will be in the high-volume consumer markets, but one of the secondary markets will be medical." He observes that the medical device industry has a long history of what he refers to as "technological coat-tailing." From an aesthetic point of view, advances in consumer product design have raised the bar for excellence in medical product design. Even when a device is aimed at a highly skilled user, such as a surgeon, its design can be integral to the product's success. Designers note that clinicians, like patients, tend to favour devices that are intuitive and pleasing to use. Jeremy Offer, creative director at Geo Ltd. (Cheadle, Cheshire, UK), comments, "Surgeons are using beautifully designed consumer products outside of work. Why shouldn't they be using beautifully designed medical devices?"

Clearly, safety is the primary concern in the design of any medical device. But the steps taken to ensure product safety deserve special consideration when the user is no longer a physician. Hobbs offers the following advice for manufacturers of consumer or home-healthcare products: "A lot of emphasis should be placed on the user interface." Hobbs stresses the importance of preventive design in product safety: "OEMs must consider not only how the patient will use the device, but also ways of preventing the patient from misusing it," he says.

Robert Woolston, medical and scientific director at DCA Design Consultants (Warwick, UK), agrees. "We try to make it simple for the user," he says. "The idea that designers hold in mind is that if a product can be misused, it will be. Ideally, the product should be intuitive to use." He adds that electronics can be an important tool for designers attempting to prevent misuse of a device.

A device might actually be quite complex, but as far as ergonomics are concerned, it should be easy to use, with an easily understood interface. "There is a semiotic consideration here: a device's form should help to suggest its function," says Woolston, highlighting a syringe pump project undertaken by his firm, where particular attention was paid to the design of the control panel to allow use by less-skilled staff without compromising accuracy or reliability. "The device also has a simple, appealing aesthetic, with smooth surfaces and large radii. The latter are highly practical as they make the device very easy to clean," he says.

Existing market studies can be an invaluable tool in product design. "Knowing what worked and what didn't can be vital information when designing a new product," says Eliot Lazar, president of elCON medical consulting (Buffalo, NY, USA), a company that has developed surgical instrumentation for ophthalmology, as well as medical-grade plastics for DuPont (Grand-Saconnex, Switzerland). "You can make the best product in the world, but if there's no market for it, then you can't sell it," he says.

Lazar also notes that a device must be compatible with a patient's illnesses and disabilities. "It should integrate a broad understanding of a patient's symptoms into its design," he says, adding that this is an area where clinicians can make especially significant contributions to product design.

Indeed, gaining formal or informal feedback from users has become an essential part of the medical design process, and any manufacturer would be well advised to consult with the patients or clinicians who will eventually use their products. "Our best tools are basically our ears and eyes," says Bridge Design's Evans. "We listen to the concerns of the user. For a designer, it is sometimes shocking to learn the richness of this information," he adds.

A third important element in medical product design is prototyping. Mike Pearson, principal at Pearson Matthews Design Partnership (Kingston upon Thames, Surrey, UK), remarks that if a design firm can't produce prototype models very accurately and quickly, then products may enter a feedback loop that lasts for months. Pearson adds that his company has in-house facilities for electronics development and rapid prototyping, as well as its own regulatory affairs consultant.

Design firms stress that product design is an investment. "If you know that your product will be used by clinicians with less-specialized skills, or will be used in a self-administered procedure, you should consider spending E52,000–E104,000 on industrial design," says Evans. "This will lower service calls, and therefore costs. It will also lower your liability as a manufacturer, because it will probably make your product safer. Finally, for all of these reasons, designed products are going to be more attractive to managed-care companies and purchasing groups. There is increased competition in the device market today, and if you can make your product better than a competitor's, it will succeed."

A personal air filter designed by Geo Ltd. offers relief to asthmatics and hay fever sufferers. The device creates a protective curtain of air and is worn like a headset.

Pearson emphasizes the potential cost savings to be enjoyed by manufacturers that choose to invest in the design phase. "By the time you've spent 15% of your budget [on a product's development], 85% of your downstream costs for things like tooling and production are already fixed. So you have to get it right at the beginning."

One obstacle in the development of innovative medical products is that the machinery used to manufacture them tends to be specialized and therefore quite expensive. "The feedback I get from some manufacturers is that they are cautious of investing in point-of-care product development," says Woolston, "A flexible, step-by-step approach seems to be favoured, where the product can be used for a number of different tests and the design, planning, and installation of manufacturing equipment allows production investment to be made and extended [such that] the risks can be seen as reasonable."

Pearson observes that the focus on design issues is a relatively new concern in the medical sector. "Medical products were pretty crude until a few years ago," he says. "Devices were being built by a cottage industry, and the big companies were not taking into account the differences between the laboratory sector they were supplying and the point-of-care market."

Given the rapid pace of technological change, what can we expect from tomorrow's medical devices? Many in industry predict that the Internet will have the same revolutionary effect on the healthcare industry that it has had on consumer markets. Douglas Anderson, chairman of Crombie Anderson Associates Ltd. (Dunfermline, Fife, UK), predicts that the Internet will make it possible for primary care providers to offer improved patient support with the use of remote information sources. "The Web, and hence the possibilities for telemedicine, are now developing rapidly," he says, "and I see great potential for manufacturers who are open to new ways of supplying the customer that are increasingly closer to the patient than in the past."

Photo by Beverley Harper

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