|Medical Device Design: Learning from the Consumer Industry|
A traditional medical product (left) designed for function. The redesign (right) incorporates form and aesthetics as well as function.
Conventional wisdom holds that the design and development of medical devices differs significantly from consumer products because of compliance and regulatory requirements. However, by using development strategies borrowed from retail industries, device developers and manufacturers of larger, more technical medical devices used by medical professionals and staff can create products with distinct competitive advantages. Medical device companies can surpass their competition—and possibly gain market share. To do so, they must offer products whose forms are complementary to their functions. Moreover, products must be more intuitive, easier to use, and visually more appealing than their competitors.
The medical device industry is increasingly driven by the same trends that influence the consumer industry. It is important to look at these trends in context to understand challenges confronted by medical device manufacturers, primarily those developing products specifically for use by clinicians and in hospitals. An examination of some new product introductions and product redesigns demonstrates how savvy medical device companies can create successful products and increase profit margins by embracing consumer-product development strategies.
Consumer Industry Trends
Industrial designers, engineers, and manufacturers consider a complex combination of factors when developing products for the consumer market. These include production costs, competitive pressures, consumer perception of value, time to market, end-user research, ergonomic concerns, and user-intuitive designs.
Production Costs. Most consumer product developers are disciplined about setting and meeting goals to minimize per-unit production costs. Such costs are driven down through innovations in product design, development, and manufacturing processes. For instance, in the personal computer industry, exponential increases of computer chip processing power occur roughly every 18 months—counterintuitively accompanied by price drops. Because this industry continually improves its production and manufacturing processes, it can lower production costs while introducing more-powerful products.
Competitive Pressures. Consumer product developers prepare for competition aggressively in the early product-planning stages. In general, consumer product developers excel at integrating new technologies into their products. New technologies can provide a competitive advantage or can enable a company to enter new markets quickly. For example, dolls are now highly sophisticated toys that integrate photo sensors, voice chips, pressure switches, and electromechanical activators.
To stay at the forefront, companies in the retail industry regularly reinvent their products. Innovative technical solutions will do even better in the market if they leverage the industrial designer's skill at taking user needs into account. In the medical industry, it is often easy to overlook the importance and attraction of the form to the user if the designer is focused too closely on the engineering and purpose of the product.
Consumer Perception of Value. Retail products are designed to appeal to end-users' emotional and cultural expectations. Function and form are equally important, especially in the case of electronic or technology-based products like the iPod. This product has successfully married a user-friendly, sleek, slim design with highly technical capabilities.
The handle on this Olympus resectoscope has a smooth and
precise feel, making them respected by users.
In the medical device marketplace, a number of products differentiate themselves from their competitors through the subjective perception of value. One example is the Olympus resectoscope handpiece. Although all of the major competitors in this field offer a device that functions well, the Olympus device might be perceived to be of higher quality because of its smooth and precise motion as well as its surface finishes and overall form and feel. As a result, these resectoscopes are highly respected by users.
Manufacturing costs are generally going to be similar for products that are purely functional and for those that are perceived by consumers as having a higher value. In fact, margins for products with a higher perceived value are often larger, because end-users will pay more for them.
Time to Market. The success of a retail product manufacturer is often driven by its ability to deliver products when the end-user needs or wants them—and by its ability to beat its competitors to market. For example, because it must bring anticipated product upgrades or new products to market before the Christmas buying season, the toy industry has perfected the art of launching new products quickly and cost-effectively.
Although the medical market is faced with restrictions, testing, and checkpoints that the consumer industry is not subject to, device manufacturers still have the opportunity to minimize the development time of a new product by looking at how the consumer market players manage the product introduction timeline. For example, consumer product companies initiate design transfer activities with preliminary information rather than waiting for specification packages released via official engineering change orders. These activities include selecting vendors using unofficial specifications, beginning tooling and fixture design while final part details are being refined, and ordering low-risk materials. Other activities can include using single-source development and supply contractors and putting a process in place to allow decisions to be made before each specific detail is finalized—a technique sometimes referred to as fuzzy-logic decision making.
Although medical device companies do need to be careful not to violate the design control process, they can be creative and risk-tolerant from a business-decision-making point of view. Device companies, especially large ones, can become stuck in a rut of compliance gridlock. However, much of this gridlock could be avoided if companies could see the difference between risk-based business decisions and compliance-mandated control requirements.
Because of the effort and time it takes to get a medical product designed, developed, approved, manufactured, and sold, it is clearly advantageous for manufacturers to be willing to spend time and money early in the design and development cycle. Doing so ensures the strongest and most competitive product in its category.
User Research. The consumer industry develops product concepts and fine-tunes current product offerings through systematic and thorough customer or user research. Quantitative surveys and qualitative methods such as focus groups help determine user needs and enable companies to develop product concepts accordingly. Product developers observe users interacting with multiple prototypes of a single product. And once a product is developed, it may be tested in a limited launch or in a single test market to determine whether refinements are needed before a broader market introduction.
Although this method and process have been used with consumer prescription medical products, as seen with the design and development of EpiPens, insulin pumps, and blood glucose meters, this is less likely to be applied to larger, more technical medical products such as radiological equipment for hospital use.
Ergonomics. The safety and comfort of the end-user are important design concerns in the consumer industry. Many products are now designed to minimize the physical exertion required by the consumer. For example, ergonomic toothbrushes and razors sport easy grips and angled heads for improved ergonomic performance.
Although medical device companies are now mandated to consider human factors and ergonomics during the design process, there is considerable opportunity for improvement within the industry. Meeting the ergonomics compliance criteria by getting feedback from medical professionals does not necessarily mean that a perfectly tailored ergonomic solution will result. Even in 2007, many of the user interfaces of medical devices, such as handles, buttons, graphical user interfaces (GUIs), etc., are designed by engineers who are not formally trained in human factors, ergonomics, or industrial design. By contrast, the user interfaces of consumer products are almost exclusively controlled by professionals skilled in these areas. In general, the medical device industry has a long way to go with regard to ergonomics and human factors.
User-Intuitive Engineering. In the retail industry, products that are difficult to understand and use languish on store shelves. To maximize efficiency and appeal, successful retail products incorporate user-friendly designs and features. For instance, intuitive GUIs make computers and mobile devices easier to use by taking into account the way that humans interact with computers.
Medical Device Industry Challenges
A user-friendly, ergonomic design is essential for devices such as breast pumps that face strong competition.
The product development process in the consumer industry evolved to address these challenges out of necessity. The factors controlling the product design and engineering process in the consumer industry—production costs, increasing competitive pressures, consumer perception of value, time to market, ergonomic concerns, and user-intuitive designs—need to become a higher priority in the early phases of medical device development.
As the demand to reduce healthcare costs increases, hospitals and medical facilities are pressuring medical device manufacturers to be more competitive, innovative, cost-effective, and efficient. In addition to their effect at the institutional level, it is interesting to note that such cost pressures have also led to the development of diagnostic devices that can be used by the patient. With this trend, the medical devices prescribed by a doctor but used by the consumer have necessarily had to become more intuitive, easier to use, and easier to handle. Moreover, medical manufacturers are often aware that with home-use products, the users often have a choice. Manufacturers understand that if their product works better, patients will ask their doctors to prescribe that brand. Like the consumer industry, the medical device industry must continue to evolve to address these challenges. Fortunately, the same technology and process improvements that have driven the evolution of the consumer industry are now more readily available to medical device manufacturers.
More-efficient and more-economical product design technology enables medical device manufacturers to develop products that are more appealing to the end-user, whether it be the doctor, hospital staff, or patient.
For example, quick-turn prototype injection molding is rapidly becoming a de facto process for designing and developing medical devices. Being able to have an injection mold built in two to three weeks is allowing companies to test real prototypes for durability, safety, and effectiveness. These parts can support the production representative requirement for verification testing in a way that traditional prototype methods such as machining, stereolithography, or fused-deposition modeling cannot. In some cases, quick-turn early molds can even support the initial introduction of a device to the market, or at least allow for beta builds and initial field testing.
Other short-run rapid prototyping processes are also available for printed circuit board fabrication, sheet-metal stamping and bending, wiring harnesses, machined parts, and many other parts of a medical device. Although these quick-turnaround processes can be expensive compared with the eventual production costs, they allow developers to evaluate a product design with confidence that the real product will behave similarly once produced with normal production methods. This enables a company to drastically reduce its risk of finding surprises once the production tools are made, and it can significantly improve the project schedule.
Improving Medical Device Development
In the medical device industry, product development principles borrowed from the consumer industry can be applied to both new products and next-generation versions or total product redesigns.
New Products. Such principles can be used to extend a product's leadership by entering a new category or setting a new standard. For example, the market for a device such as a breast pump that is sold over the counter may be crowded with a number of well-established competing products. The company may only succeed by introducing a product that would set a new category benchmark.
In such cases, focus group research can uncover critical existing-product sensitivities that can guide the new product's design and development. It may find, for example, that most existing products are too bulky to use discreetly or comfortably in confined areas. This finding may lead designers to develop a lighter device with a smaller footprint, making it a more compact and sleeker design.
Breakthrough innovation is sometimes needed to stand out in a category. Engineers may need to create—and patent—a unique technology that differentiates the product from its competitors. Creating a new technology may involve testing various material textures, product shapes, and motor-speed variations to create a precise design that will improve product performance, end-user comfort, and ease of use.
Product Redesign. Customer research can also be a valuable tool, especially when a manufacturer finds that a device is difficult for end-users to set up and operate correctly, or very time-consuming to troubleshoot and repair when problems do occur.
An analysis of such a product's design may include human factors research, which can show whether a product is too unwieldy to manage. This research can result in engineering improvements such as expanded hand ports and a new control panel configuration to ensure optimal operability.
Next, engineers may review the assembly and maintenance requirements of the product and recommend subtle changes and additions such as improved cable routing, revised subcomponent layout, or removable panels that make maintenance areas easier to access. In this manner, an intelligent new design can dramatically reduce product downtime and improve the productivity of the end-user.
In terms of look and feel, an unadorned white box fabricated from sheet metal could be replaced with a high-impact, injection-molded polymer outer shell with contemporary color and styling.
Investment in redesign and engineering costs may be recovered through substantially lower per-unit manufacturing costs, by cutting assembly time, or by reducing the cost of materials. And if customers perceive that the new product has a higher value than the old one, the company could sell a less-expensive unit for a higher price, thereby increasing its return on investment on the redesign process.
Although many medical device designers, engineers, and manufacturers do borrow strategies and techniques from the consumer market when developing and redesigning products, it is important to integrate these strategies at the forefront of the process when the product is being engineered. By taking into account production costs, increasing competitive pressures, consumer perception of value, time to market, end-user research, ergonomic concerns, and user-intuitive designs, medical product developers can create unique products with distinct competitive advantages.
In addition to developing winning products with greater appeal and higher perceived value, medical device companies that take advantage of new design tools and that can accept some tolerance for risk can significantly reduce time to market while minimizing manufacturing costs. As a result, companies may be able to accelerate revenue recognition through earlier market entry and increase their gross margin because lower per-unit costs improve their return on investment.
David Robson is director of new business development at Ximedica, an Item Group company.