Attend a medical device conference and listen to what you hear—or better yet, what you won’t hear: people discussing how to leverage industrial design (ID) throughout the development cycle for optimal results. More likely, comments will be made about how design is something you do “at the end to make it look pretty.”

This is because sometimes manufacturers are uncertain about how to integrate ID into the development process, so they prescribe single ID activities, usually relating to ergonomics or form factor (aesthetics). Frequently, ID is brought in too late to have an impact or too early when it is likely to get criticized as being unmanufacturable. As a gross generalization, the uncertainty resides in the fundamental difference between the education and training of an industrial designer versus that of an engineer. The former is comfortable processing disparate pieces of information, creating multiple opportunities, knowing that many are wrong, and then evaluating them. The latter is more disposed to creating comprehensive lists of requirements and then executing to them. Both are valid, but FDA guidelines and engineering processes have tended to be bias toward the more structured development method.

However, particularly in the medical device industry, ID can play a critical role early on and throughout the development process. Proper use of ID ensures that devices are targeted to market need, appropriate for brand aspiration, and fit (and safe) for human use. Often the right approach to ID will increase the speed to market by ensuring that critical factors are considered early in the process. Also at an early stage of development, ID can facilitate a conversation between marketing, engineering, and usability functions, providing options and visions to aspire to and discuss—and similarly turning the findings from use risk assessments into design implications. Providing the focus that projects deserve, ID can create opportunities, develop the best form and function, help teams gain consensus, and differentiate brands to competitive advantage.

It is important to consider a few high-value functions:

• Creating opportunities. Someone once said that everything ever produced is done twice, first in the mind and then in reality. Industrial designers are masters of creating options that can be evaluated by the team. Frequently they hear their clients say, “I’m not sure what I want, but I’ll know it when I see it.” Driving facilitated brainstorming activities with ID alongside engineering and marketing creates better options and better outcomes.

• Designing for best form and function. This may involve not just considering that the product will be used by surgeons, for instance, but that a product will be used by surgeons who are young, older, male, or female, and handled by nurses, technicians, and other hospital staff. What is their role and purpose in handling the device? As each different user picks it up, what does optimal form and function mean to him or her, and to overall efficiency? Identifying and designing products based on all nuances of their use can make a huge difference in the overall success of the product.

• Gaining consensus. While anyone in the industry knows that it is rarely a straight path to a final product, they all recognize that there is a target, albeit hazy at first. Generally, teams start out with some marketing requirement and develop user needs and product specifications. But these either can be prescribed too early, be in conflict with each other, or fail to really capture what is needed. This is where industrial designers get involved, creating sketches and models of products and systems as conceptions or embodiments of product and asking the question, “Is this what you meant?” This may even involve gaining feedback from physicians, technicians, marketing, and so forth. ID is comfortable with the front end of innovation. This activity allows teams to be aligned for a far more efficient execution long before the design history file is initiated.

• Differentiating brands. Branding involves expressing a whole set of aspirations, and conveying them through the physical product is one of the ways to do it. As competition in the field increases and older devices commoditize, soft marketing becomes more important. Sometimes this is called the “brand in the hand.” Apple is perhaps the best general example of this—every product and interface is part of the experience. But there are many others: Closing the door on a Mercedes-Benz is part of that German engineering story. DeWalt product lines express the durability and reliability across every tool. Every material, form, and color is carefully considered as part of the family. Brand language in the medical field can evoke safety, technology, comfort, and value across many devices, and it can create a brand loyalty to follow. Philips Healthcare is an example of a company with a very sophisticated view and management of its brand across many product lines and verticals.

• Safe use. As FDA has identified, use error is a focus area with about 98,000 deaths per year attributed to avoidable medical errors.1 Physical and cognitive ergonomics must be considered alongside form and function development. Informal heuristic reviews must be conducted all the way through the early development cycles with formative and summative tests conducted at specific times. Then the findings along with final usability validation must be rolled up into a safety submission. There should always be an interface between a physical object product form, a user interface, a package, or instructions for use and a human.

But how is it done?

While the benefits of incorporating ID into the full development process may be clear, it is not necessarily easy to do. In part, the generalist nature of ID education is not well suited to the nuances and rigors of the medical field. A few colleges have a medical device focus. Cincinnati (The University of Cincinnati College of Design, Architecture, Art, and Planning) has a very strong program that creates collaboration between engineering and ID disciplines. In the United States, ID has aligned itself closer to an aesthetic discipline than a competitive business activity—although the emergence of “design thinking” has perhaps helped a little.

Nonetheless, the entry point that is most understandable relates to usability, and its many facets are now required to be considered in most devices. As home-use products enter the market, whether diagnostic or therapeutic, the value of ID will become more evident as a competitive tool. Marketing directors and their engineering counterparts will increasingly see the use of ID professionals as part of their suite of must-have skill sets. Simply addressing the clinical need alone is no longer enough—or worse, using ID to “make it pretty” has missed core competitive opportunities. Leading device manufacturers around the country are beginning to strategically partner with ID capabilities, whether in house or outsourced, and the value is quickly being realized across their organizations.

ID companies and colleges are also beginning to learn the language and entry requirements to the field, and to understand the drivers, and then tailor themselves appropriately. Ultimately, this will lead to better devices that are safer and more user-centric and able to express the identity of their brands cohesively and with full impact.

Footnote

1To Err Is Human: Building a Safer Health System, (Washington,DC: Institute of Medicine, 1999.

The power of integrated design

A first-generation technology for endometrial ablation to treat menorrhagia required two hands to operate, many disparate components, constant visual monitoring, and low-volume construction. It was tiring to use, prone to errors, and complicated to set up and train clinicians on. After extensive research at the hospital, followed by observing and charting its use, Ximedica responded with multiple improvements for the second generation, including fewer steps, fewer components, and a simple guided user interface to lead clinicians through the program. A magnetic coupling impeller incorporated into a disposable cartridge enabled the technology to reside in the capital goods while simplifying the disposable. By including the heating system and manometer into the same disposable cartridge, the complexity of the system was minimized. Adding a filter to the cartridge addressed failures associated with clogging. Overall, the redesign of this technology combined 30 steps into just three, improving workflow and making clinicians’ jobs much easier. The form factor of the product was conceived to clearly differentiate itself from both other technologies on the market, as well as its prior embodiment. Users were able to implement the new technology in multiple environments from outpatient clinics to emergency rooms. Throughout the process, the ID team worked with researchers, engineers, and the marketing team to ensure the new generation met its full potential.