Your Device Is Safe And Effective, But Is It Desirable?
By Craig Scherer, Insight Product Development
Over the last few years, the term human factors engineering has become permanently and inextricably linked with any discussions on effective and appropriate medical device development. Human factors are used to optimize designs to users’ capabilities while minimizing the negative consequences of their limitations.
With the adoption of the AAMI HE75 guidance, the FDA’s expectations around how to utilize effective human factors for device development has become better understood and more widely embraced. Clinicians and lay users alike have specific and significant use-related challenges that need to be addressed by device developers. The FDA’s oversight helps to ensure that devices cannot be misused in ways that can cause accidental harm. Implementing a sound human factors plan offers device companies additional benefits, like lower training and in-service costs, minimized probability of recall, and diminished frequency of liability litigation.
However, the truth is that the FDA is not concerned with your devices’ sales numbers, adoption rates, or any other indicators of market success. It exists to ensure that your device is safe and clinically effective. Looking at the bright side, though, the FDA human factors guidelines require multiple rounds of formative research, and this research, if appropriately designed, can be leveraged to create more user-centric and appropriate solutions.
The Importance Of Desirability
As the development team incorporates findings from the iterative formative evaluations, it is possible to transition from design inputs that help create useful and usable devices to inputs that make a product desirable. Desirability transforms a product from merely acceptable to a solution that encourages adoption and long-term brand loyalty, achieves differentiation in a crowded marketplace, and helps support better medical outcomes.
Desirability may seem like a strange word when talking about a medical device, but consider these synonyms: appeal, cache, attraction, interest — attributes that product developers try to achieve in virtually every industry. The design of medical devices is no different. Target users will not accept user experiences that introduce annoyances and frustration into their workflows. Medical products and systems should support the way we live and work, be consistent with our core belief systems and expectations, and provide us with experiences that mesh well with our goals.
Desirability in consumer industries has been the focus of countless market and user research studies. With the rapid convergence of consumer healthcare and the medical device industry, exceptional user experiences have gone from perk to expectation. Doctors won’t accept a cumbersome interface when they go home at night and control their home through a smart device using a Nest system app, so why would they accept a clumsy medical device interface?
Likewise, when the subject of disruptive medical technology comes up, we naturally assume that developers will force us to adapt our attitudes and behaviors around these groundbreaking devices when, in fact, the more our expectations and desires can be accommodated, the more apt we are to adopt and continue using these new solutions.
All things being equal, desirable features, function, and usability details can be instrumental in convincing potential users to choose your FDA-approved device over a competitor’s product. Both may be deemed safe and effective, but the more desirable version clearly will have the upper hand in the market.
Variability Of Desire
Desire, like any emotion, can mean different things to different people. It is important to research and understand this variability throughout the development cycle. Human factors engineering focuses on understanding the user experience and the intersection of users, their environments, and their product. In a traditional human factors plan, each of these variables has to be understood individually and collectively to develop that safe, effective device. Through research, these same variables can inform the development team about frustrations and irritants that should be minimized, and how to create experiences that fully satisfy both a user’s needs and their desires.
Medtech’s user variability in can be enormous. One would be hard-pressed to think of another industry where the most skilled, educated, and experienced users — surgeons, for example — use identical medical devices to treat a patient that non-skilled, untrained caregivers — such as patient family members — use to treat a loved one in the home. Think about the range of emotions that one user may experience, while another does not: emotions like nervousness and fear, experienced by a lesser skilled user, might be replaced by feelings of irritation and even disgust by a more skilled user, who does not feel supported by a device’s “simple” interface.
The variability within these user groups can add to even more uncertainty. A doctor that has been trained in a fellowship might have completely different views from one trained in a rural hospital. If the target user is a patient responsible for their own self-care, think about how different co-morbidities or basic age-based physical capabilities can affect a user’s emotional state and user experience.
Another key part of the user experience equation is environmental variability. Consider our earlier example of a device used both by clinicians in a hospital — even in the ICU — and lay persons in the home. Think about how basic conditions can vary in these two environments, accounting for differences in lighting, noise, humidity, clutter, other people, etc. Contextual inquiry is very important when the target users’ environments vary to such extremes. These influences can have an enormous impact on the overall user experience and, as such, it is highly advisable to observe people, their devices, and their workflows in the actual environments where the interactions take place. Observing, frustration, anger, and confusion, versus delight, happiness, and pleasure, in real time, can greatly influence how user needs are articulated and accommodated.
Effectively Evaluating User Needs
As device designers, we must establish a hierarchy of user needs so that we can understand how to prioritize design inputs when there are competing needs. We must also figure user experience elements into the creation and evaluation of these needs. Every device has critical-to-function requirements that are non-negotiable. But as we move down the list, there are many “nice-to-haves” that can greatly affect a product’s desirability, and there usually are multiple ways to physical embody a target feature, each of which may render a product more or less desirable.
Iterative formative evaluations help to move past usability and functionality and to test users’ overall affinities to our solutions. Keeping desirability in mind as we evaluate our early proposals can go a long way to creating optimal user experiences. Considering desirable attributes or features as we do our formative usability testing will help to ensure that we are continually optimizing the user experience throughout development.
Designing for desirability can give medical device manufacturers an edge when competing against other, similar FDA-cleared solutions. Creating optimal user experiences and going beyond safety and efficacy is the best approach to creating devices that encourage adoption, are a pleasure to use, and ultimately play a part in driving better medical outcomes.
About The Author
Craig Scherer is senior partner and co-founder of Insight Product Development. Craig plays an active role in key account management, working with companies ranging from early stage tech organizations to the largest healthcare OEMs. He is also a director of Insight Accelerator Labs, Insight's in-house med device accelerator, helping medtech start-ups deliver transformative technologies to healthcare. Craig holds a BFA in industrial design from the University of Illinois at Urbana-Champaign and an MBA from the University of Illinois at Chicago.