Medical devices help doctors and laboratories make diagnoses, administer medications, or provide assistance with daily living to patients with disabilities. While the patient is always at the top of the mind when developing a new or improved device, many additional considerations explain how user experience influences medical device design.

Benefits of User Experience Data

Researching the user experience (“UX”) provides a wealth of data that can save time and money. By addressing actual (rather than perceived) needs, device developers can design products that enhance usability and reduce the number of iterations necessary to produce a device that appeals to customers and users. In the past, a device might have been considered a success if it could be proven safe and if it did what it was supposed to do, no matter how clunky or confusing it happened to be. Now, except perhaps for the most complex and critical devices that sustain life itself, users may expect to be able to use and understand a device right out of the box. Researching user expectations is an essential part of the design process.

Defining the User

All users are stakeholders, but not all stakeholders are patients. From conception to prototyping, medical device design must consider all the people who will interact with the device. Each person who encounters the device has a “user experience.” Therefore, the many different roles and skills of the people who interact with the device factor into device design. This means expanding the design viewpoint for medical devices from only doctors, nurses, and patients to lab technicians, nurses’ assistants, cleaning and waste disposal staff, and everyone else who may encounter a device in the course of their role within the user universe. It also means involving users from the beginning of the design process for a completely new device. The key is understanding the users’ needs, without expecting the user to articulate them precisely or to propose solutions.

The “Henry Ford” Problem

Henry Ford is often quoted (with or without substantiation) as saying, “If I had asked people what they wanted, they would have said a faster horse.” In a similar vein, Steve Jobs said, “People don’t know what they want until you show it to them. That’s why I never rely on market research.” Jobs’s quote is often misunderstood to mean that he ignored the user experience. Others believe that is a misinterpretation, as Jobs also said, “Our job is to read things that are not yet on the page.” While users may have difficulty articulating what they want and need, they will know it when they see it. No one is suggesting, for example, that nonengineers engage in mechanical engineering for diagnostic devices. Rather, Jobs’s quote might be understood as referring to the value of observation.

Getting out into the environment where UX occurs and simply observing how users interact with the device provides a wealth of data and is an essential aspect of the first stage of what is called the “design thinking” process.

How Design Thinking Plays Into Medical Device Design

Design thinking is a system for understanding complicated problems from a human-needs perspective. A widely recognized model for design thinking comes from the Hasso-Plattner Institute of Design at Stanford University. This model maps out five important stages of a human-centered design process that can help medical device manufacturers and their design partners incorporate UX into their designs.

Stage One: Empathize

Medical device designers may think they know what problem they are trying to solve, but they’ll do a better job solving it if they take an empathetic approach. Empathizing requires setting aside assumptions and taking the time to observe and engage with users to understand their emotional reactions, motivations, and needs as they express them. It requires immersion in the user’s environment to gain a better understanding of the issues and concerns a user may voice. An empathetic approach withholds judgment about whether addressing a user’s needs and concerns is economically feasible or mechanically and biologically possible. The “empathize” stage of design simply seeks to understand a problem or a need from the user’s perspective.

Stage Two: Define

The “define” stage involves synthesizing and analyzing the information gathered through the “empathize” stage of the process. Putting together all the comments, reactions, issues, and concerns users expressed, designers who use the five steps of design thinking develop a statement of the problem they are trying to solve from the perspective of the user’s needs, not their own. Rather than defining the problem as an organizational need, such as “we need to sell more infusion ports for cancer patients,” the problem is stated as “cancer patients need a smaller, less invasive way to receive infusions.”

Stage Three: Ideate

Every organization has its own way of brainstorming. The “ideate” stage is simply that—put your team to work coming up with ideas that address the problem, as you have stated it, from the user’s perspective. Some organizations even use a method called “worst possible ideas,” which encourages participants to come up with the most ridiculous, untenable, silly notions possible. This takes the pressure off the team, encourages a free and open exchange, and even results in laughter. As teams work through their horrible ideas, they get to the point where the digging results in some potentially very good ideas.

Stage Four: Prototype

Having developed their ideas, the design team now prepares a model or version of the product, or a part of it, that they can evaluate, either through visualization or actual production of a prototype device. The prototyping process implements ideas intended to address the problems or needs identified in the earlier stages of the design thinking model. Prototyping helps designers compare their ideas to aspects of the user experience. The team will pick and choose which specific design elements should move forward for further study or modification, and which should be rejected as out of sync with the needs identified by observing UX.

Stage Five: Test

Testing a prototype assumes that additional iterations may be necessary. The testing phase may flesh out additional user needs and reactions that could result in further design changes intended to more closely address how users react, feel about the product, and behave in response to it.

The user experience influences medical device design throughout the process, but not necessarily in a straight-line march through the five stages of the design thinking model created at Stanford. The process can be “nonlinear,” involving one or more stages, circling back to previous ones or even leaping ahead, until the design team is satisfied that their device design addresses the needs and reactions of all end users. The goal is to develop a design that meets all regulatory requirements, is safe and effective, and causes users to recognize a device as exactly what they wanted but may not have been able to specifically define.