04.08.14
Key Technologies Inc.
When a product fails, for whatever reason, there are always consequences; but when a medical product fails, the consequences can be expensive, painful and/or life threatening. While it often is reported that more than two-thirds of injuries in hospitals are attributed to “human error,” they often are caused by poor user interface design. The understanding that the root cause of most human error lies in the device design has led to “usability engineering”—traditionally a field concerned generally with human-computer interaction—becoming more rigorously ingrained in the medical device development cycle. This further has been enforced by the U.S. Food and Drug Administration’s focus on usability engineering in its mission to ensure safety and efficacy. Medical device developers have been left to figure out how to install a detailed usability engineering process into their system. How that process is integrated can affect the overall efficiency of the development process and success of the resulting devices.
When we talk about usability engineering as it applies to the medical device industry, we have a specific definition in mind. We see it as the systematic approach of discovering and applying relevant information about patients, operators and their use environments to the design of products used to safely and effectively achieve a healthcare deliverable. The design team takes the outputs of the user and environmental research and generates a device design, which then is evaluated for how well it enables safe and effective use with the end users. The challenge for those of us developing these devices is to integrate the philosophy of usability throughout the design team. When this is done well, we create an environment of empathy and understanding between users and the design team, which ultimately leads to a better and more usable product. Ultimately, we want a device that becomes an extension of its user. To do that, we need a team of people who are invested in the success of each product on a practical and emotional level.
Figure 1.
When it comes to actually creating a device, design teams often are compartmentalized by specialty: industrial designers, mechanical engineers, electrical engineers and computer engineers. Usability often is incorporated into a design team in a similarly auxiliary way, especially since a usability team is not directly involved in the design process, but rather feeds the process through discoveries during research and formative testing. However, sometimes the usual way isn’t the most effective, and we believe it should be reconsidered. A compartmentalized approach to integrating usability often can result in a design team that lacks adequate appreciation of users’ needs and, unfortunately, this can lead to usability being one of the first goals sacrificed when striving to meet technical goals. This mistake is due to compartmentalized design team members often being focused on their specific technical hurdles rather than feeling tied to the end product and the effect of that product on the lives of its users.
Figure 2.
Compartmentalized Design Team Approach
We prefer an alternative team structure, where key members of the engineering and design teams combine with the usability team in a more integrated model. We believe that removing the division of labor between design execution and usability engineering processes ultimately leads to a blending of skill sets, which results in an efficient transfer between usability engineering tasks and design tasks through shared appreciation for the users’ needs. Designers and engineers who are involved in contextual research and formative testing will have a more real understanding and appreciation of the usability challenges that face a particular product. They no longer are dependent on secondhand information from others’ interpretations of the research results. With empathy for end users, it is more likely that those executing the design will be able to create a product that satisfies both the user and technical needs.
Additionally, designers and engineers that are involved in the formative testing process have a better idea of the metrics their design will be evaluated against, and developing user requirements and design specifications that satisfy those user requirements also is more efficient when the research process is shared amongst the team.
Integrated Design Team Approach
We experienced the benefit of this integrated team approach here at Key Tech firsthand during the development of an auto-injector for patients with rheumatoid arthritis. Members of our engineering and design teams were brought into the earliest meetings with arthritis patients and learned about the challenges and difficulties of living with rheumatoid arthritis on a daily basis. Listening to the stories about difficulties experienced by these patients was an equally emotional and inspiring experience. It brought new meaning to a variety of usability-oriented design goals, such as trying to optimize the hand grip circumference of the injector to be comfortable for patients to hold. Since the team now had an emotional reference associated with the target grip circumference, it suddenly became much more than a numeric constraint. It became a means to make someone’s life easier. An experience such as this can mean the difference between a successful product and one in which under-appreciated user needs were sacrificed in order to overcome a technical challenge, such as cramming electro-mechanical components into a small hand grip.
A project team that embraces usability as a philosophy to be followed throughout a project, not just as an arbitrary requirement that they must meet, is a crucial step toward producing a successful product. And like most successful team structures, leadership must come from the top. A project lead must have a keen understanding of the usability engineering process, as well as its importance to creating a design that works best for users. The project lead has to integrate usability engineering processes in the project plan and make sure that designers and engineers are following through with usability engineering techniques in each design phase. In actuality, only a portion of each team’s members will be executing the usability engineering process, but when results are shared and discussed with an entire team who understands and embraces usability and its methods, communication is more efficient, and your product is more successful.
Building empathy and a personal connection to the end product of a design are powerful motivators, but there are other reasons to involve team members with technical expertise in contextual research and formative testing as well. Quite often during the interview process (during research and formative testing), users are curious about possible features or device performance. These moments can offer a wealth of information that might otherwise be lost without the presence of those team members with the technical expertise to shape the discussion. Recently, we had a situation involving a user interface on a device. One of our computer engineers was part of this formative study, which included using a semi-functional prototype. As the team evaluated the installation of a single-use disposable that interfaced with a lab device, user feedback indicated that the timing of certain workflow tasks needed to be tweaked. The computer engineer present was able to revise the software real time to optimize several device sequences and collect immediate data from end users. Without the presence of this computer engineer, the session certainly would not have been as productive since additional prototype iterations would have been required to tease out the optimal setting.
With technically complex prototypes, it is very helpful to have a technical team member present for formative testing to help troubleshoot any issues that may come up and stall or derail the process, such as a display cable disconnecting in the interior of the device or a minor software update that may be required. Time is money, and having a technical person on site to make sure that coordinated site visits and user visits to design houses go smoothly may be the difference between a successful session and a waste of time.
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Usability requires highly trained personnel and detailed processes, and we’ve found that an integrated team of usability engineers and other design team members ultimately creates safe, effective, intuitive and, most importantly, life-changing and life-saving medical devices. This new, collaborative team design requires members who are willing to look at a bigger picture than they have before, such as device usability and product experience, while balancing decisions of isolated technical details. As with all things new and different, there’s a learning curve, but the results are worth it—more efficient design processes that create better products and a design team that feels a personal stake, and finally, a sense of accomplishment, on both a team and individual level.
Alex Flamm is a mechanical engineer at Key Technologies Inc., a medical and industrial product development company located in Baltimore, Md., and is experienced with multiple facets of product development. From detailed electro-mechanical design to usability engineering and industrial design, he enjoys rolling up his sleeves, shaping a product and watching it grow from concept to production. Flamm has been involved with or managed several products that were developed using Key Tech’s integrated approach to human factors and usability engineering. He has a Bachelor of Science in mechanical engineering from Syracuse University.