UX design processes are constantly evolving as the industry continues to embrace IoT (Internet of Things) technologies. With this evolution comes a need to focus on improving UX (User Experience) protocols in the design of medical devices. UX, driven by human factors engineering (HFE) requirements, has become a foundational component in user-centered design to ensure better treatments and patient outcomes. Strong UX protocols give designers and manufacturers a competitive edge in an increasingly crowded market and help to ensure regulatory approval from global bodies that are now requiring robust use-error mitigation processes.

Why We Need New Focus on UX

Both medical device design and the variety of end users are evolving. Doctors, nurses, and medical technicians are a homogenous user group, but patients and lay caregivers have wildly varying abilities due to demographics, education, and comorbidities. When developing devices for a global market, there must also be an understanding of cultural and regional differences among end users.

What’s more, the types of medical devices seeking commercialization have expanded. Self-care devices, robot-assisted devices, and a growing focus on interventional medicine, minimally invasive procedures, and connected diagnostic and preventative care technologies, are changing both healthcare and the needs of users. At the same time, insurers and healthcare facilities are focused on reducing overall operating costs through the use of distance care and telehealth options that transfer some workflows to relieve pressures on the clinical environment. These types of medical devices, therefore, require much more simplistic interfaces to support the nonclinical end-user.

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As electronics become more ubiquitous, their costs continue to fall. Even the most simple devices may contain touchscreen displays controlled by complex software routines, enabling the operator to access hierarchical data. This can complicate the ability to quickly find and interface with important displays and controls. Thus, creating a user-friendly workflow that directs the operator from one screen to another is critically important to manage these extensive interface demands. Often referred to as Digital Health, these new technological trends have all but replaced mechanical and binary (on-off) analog circuits, which reduces unit costs for sophisticated interfaces.

Guidance from the Digital Health Center of Excellence

Recognizing the importance and the speed with which the digital healthcare transformation is underway, the FDA CDRH created the Digital Health Center of Excellence (DHCoE). This group aligns and coordinates digital health work across the FDA. The group was not created to determine marketing authorization decisions, but to provide regulatory advice and support to the FDA’s regulatory review of digital health technologies. Now in phase 3 of its planning, the charge is to be a partner in advancing technological opportunities with developers and issue guidance to modernize FDA policies in this new digital environment.

The mission of DHCoE to ensure “timely access to high-quality, safe, and effective digital health products,” coincides with the importance of the user experience in medical device design and development.

How UX Brings Value to the Device Design Process

A common misconception is that UX is only about making the device interface easy to use. UX  embodies numerous issues that impact design considerations. It is a complete ecosystem that embraces the device and includes hardware, software, unified communications, and location-based services.

Medical devices should be aesthetically pleasing to the user—whether in-home or in a clinical environment. They should also seamlessly incorporate into the care environment wherever it may be. Devices should be intuitive and easy to navigate—much like the technology that controls smart TVs, digital appliances, and personal mobile products.

Keeping that guidance in mind, good UX design requires a holistic approach that leverages human factors engineering, industrial design, and graphic user interface (GUI) to unite purposely intentioned aesthetics with optimized usability. This holistic approach maximizes the user experience with the device in its relationship to the use environment.

When to Start the UX Process

The beginning of the design process is the optimum time to bring in the UX team. The UX component of the design process will provide a strong foundation for ongoing design activities, as UX has a significant impact on the marketability of the device. Failure to consider these factors early on may result in information becoming siloed among different design teams, which can result in expensive and time-consuming workarounds.

As a development partner at the onset of a project, UX experts and methodologies can be incorporated into the activities of the entire design and development teams from concept to commercialization. Beginning with generative HFE user studies—or contextual inquiry (CI)—specific interface needs, expectations, and aspirations are established, all of which drive subsequent design objectives and logic workflows. It is important for designers to remember they are not designing interfaces for themselves. The device should be validated against CI studies that establish user requirements.

Case in Point: Contextual Inquiry

Using CI as a foundational exercise helps establish the spoken and unspoken needs of all stakeholders. It identifies and characterizes potential use case challenges and work-around patterns and implications. Potential use errors or related hazards are identified, which results in more detailed and robust device requirements.

Participants in a CI study provide a kind of “show me, don’t tell me” exercise through hands-on demonstrations of how the device would be used in a specific environment. For example, in a home environment, the participant can verbalize how they use the device, but CI visualization uncovers how the participant might be using unintentional workarounds to achieve the prescribed outcomes. Therefore, the CI process can identify issues that could be alleviated with a redesign of the device or a completely new approach. The CI process includes four important strategies: planning and logistics, fieldwork, analyzing the data captured, and finally translating and synthesizing that data into actionable recommendations to the design and development teams.

Understanding the Environment for Use

Designers engaged in healthcare projects must understand the specifics of the environment in which the device will be used. If designing for patient interaction with the device, UX designers need to consider such characteristics as the age(s) of the users, physiological challenges, mental states, comfort levels, and skills related to the technology. If the device is intended for medical staff, designers need to study how these end users would interact with the device in their natural environment. This includes understanding the expected workflow (e.g. users might need to operate adjacent devices in order to complete the task at hand). UX designers should seek to optimize the interaction with the device and eliminate unnecessary steps that may distract the clinician from their main task, without taking shortcuts that may increase user-error.

UX designers ideally work alongside HFEs to conduct GUI design studies. This resource partnership provides a design-agnostic observer (HFE) to objectively observe user interaction and apply unbiased analysis to the next iteration of the design. For example, if redesigning an existing product, the new GUI should consider maintaining some legacy elements while addressing any current challenges and new elements.

Designers also need to thoroughly understand business and market strategies for future product updates, established by corporate stakeholders, in order to determine an implementation plan for the design “platform.” The design of the interface then takes into account how to structure the GUI architecture to allow for these future updates to be easily integrated.

Additional Tools in the UX Process

UX tools include visual and branding sketching, workflow/logic charting, journey mapping, GUI wireframing, and user testing. Adobe XD and Axure are common software design tools for creating early simulations and prototypes, specifications, and diagrams and can assist designers in determining the best characteristics and interactions with a potential design. These digital outputs also streamline the transfer of UX design to software engineering for accurate coding into the production design.

Using Virtual Reality (VR) and Augmented Reality (AR) tools during the research phase provides designers with simulated 3-dimensional perspectives to evaluate spatial quality, physical reach, and visualization of the UI. VR technology, which is used in early device development, has rapidly evolved to become an affordable, valuable and easy-to-use development tool. VR and AR tools also can reduce or eliminate far more costly approaches such as physical mockup development.

UX Focus and Regulatory Compliance

Innovations in mission-critical products such as medical devices have always been transformative and are expected to increase at a rapid pace, as will the technology ecosystems that drive their designs. Operational success will always be at the center of this transformation to ensure operational value for the end-user, whether it be patient, caregiver, clinician, or maintenance teams within the healthcare continuum. Success requires a clear focus driven by the HFE charter and realized through a thorough UX design approach that ensures future devices will be deployed safely and efficiently with minimal training and gain regulatory approvals and market acceptance.