Philip Remedios and Irina Samkova, BlackHägen Design02.03.23
User experience (UX) methodologies driven by human factors engineering (HFE) requirements have become a key component in the adoption of user-centered development approaches for medical devices. With global regulatory bodies now insisting on robust use-error mitigation processes, UX designers have a formidable task of instituting superior user interfaces that are intuitive, friendly, and reliable despite rising operational complexity and parametric adjustability.
User expectations in this mission-critical environment have encouraged further advancements in technology and procedural improvements that are impacting the way medical device manufacturers approach the design process. In addition to creating more user-focused devices, manufacturers are looking to minimize time to market, which means compressing development cycles to reduce non-recurring expenses (NRE), streamline design validation, and accelerate revenue generation.
User types are also rapidly evolving. Untrained and unpredictable personas substantially add to the requirements burden experienced by today’s UX designers. Doctors, nurses, and medical technologists are a homogenous user group compared to patients and lay caregivers with wildly varying abilities due to demographics, education, and comorbidities. If adding to this need is the development of global devices, then one also must understand cultural and regional variabilities.
Rapidly expanding new markets include not only self-care devices, but also robot-assisted, interventional, minimally invasive procedures, and connected diagnostic and preventative care technologies. While end-users and clinicians are always open to new and expanding opportunities, insurers and healthcare facilities are looking to reduce overall operating costs—which promotes demand for distance care with telehealth options to transfer some workflows beyond the clinical environment. These types of devices, therefore, require much more simplistic interfaces to support the non-clinical end-user.
As the cost of electronics continues to fall, even simple devices may contain touchscreen displays controlled by complex software routines, enabling the operator to access a myriad of hierarchical data and complicating the ability to quickly find and interface with important displays and controls. Creating a user-friendly (logic) workflow that navigates the operator from one screen to another is critical to manage these growing interface demands. Often referred to as Digital Health, these new technological trends have all but replaced mechanical and binary (on-off) analog circuits, reducing unit cost for sophisticated interfaces.
Gaining this kind of attention from regulatory authorities focuses on ways to ensure there is “timely access to high-quality, safe, and effective digital health products.” This is where DHCoE’s mission coincides with the importance of the user experience in medical device design and development.
With that guidance in mind, good UX design requires a holistic approach. Using a complex interplay of human factors engineering, industrial design, and graphic user interface (GUI), appropriate product methodologies are leveraged to unite purposely intentioned aesthetics with optimized usability. This approach is intended to maximize a positive user experience and its relationship to the environment.
Regardless of all the tools included in the HFE process and, most particularly, as they relate to UX approaches, it is important to involve the UX team while requirements are being established to address all relevant aspects of the UX. By not doing so early in the process, information may become siloed among different design teams, which can result in expensive and time-consuming workarounds. The UX component of the design process will provide a strong foundation for ongoing design activities with the knowledge that these activities are based on a thorough and investigative journey with an end result to benefit the device’s marketability.
Designers engaged in healthcare projects must also 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 users’ age, physiological challenges, mental states, comfort levels, and skills related to the technology. Alternatively, if the device is intended for medical staff, they need to study how these end users would interact with the device in their natural environment as well as understand the expected workflow, considering they might need to operate adjacent devices in order to complete the task. UX designers should seek to optimize the interaction with the device, eliminating unnecessary steps that may distract the clinician from their main task but without taking shortcuts that may increase use-error.
UX designers ideally work alongside HFEs to conduct GUI design studies. This resource partnership provides a design-agnostic observer (the 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 for continuity 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 these future updates to be easily integrated.
Deploying virtual reality (VR) and augmented reality (AR) tools during research phases provide designers with simulated three-dimensional perspectives to evaluate spatial quality, physical reach, and visualization of the UI. VR technology has rapidly evolved to become an affordable, valuable and easy-to-use development tool used during early device development. While some methodology investment is required, VR and AR tools can reduce or eliminate far more costly approaches such as physical mockup development, logistical costs, and schedule impact. Study participants can evaluate these virtual concepts swiftly and concurrently anywhere on the planet, which may feature touchscreens, hard keys, pumps, connections, and other interface features.
Philip Remedios is principal and design director at BlackHägen Design, an R&D consultancy focused on medical device innovation. With a combined design and engineering background, Remedios has spent most of his 34-year career in executive consulting roles, developing project plans, and managing integrated technical teams, schedules, and budgets.
Irina Samkova is lead UX designer at BlackHägen Design. Irina received a bachelor’s degree in Graphic Design from New York City College of Technology. Though she started her career with a focus on designing non-interactive visual content, she soon found herself drawn to the world of UI/UX. It was a natural transition as the rapid pace of creating graphics for digital products had to be combined with a relentless focus on the end user and their needs. Tying the end-product to user needs is the core design approach Irina always takes.
User expectations in this mission-critical environment have encouraged further advancements in technology and procedural improvements that are impacting the way medical device manufacturers approach the design process. In addition to creating more user-focused devices, manufacturers are looking to minimize time to market, which means compressing development cycles to reduce non-recurring expenses (NRE), streamline design validation, and accelerate revenue generation.
User types are also rapidly evolving. Untrained and unpredictable personas substantially add to the requirements burden experienced by today’s UX designers. Doctors, nurses, and medical technologists are a homogenous user group compared to patients and lay caregivers with wildly varying abilities due to demographics, education, and comorbidities. If adding to this need is the development of global devices, then one also must understand cultural and regional variabilities.
Rapidly expanding new markets include not only self-care devices, but also robot-assisted, interventional, minimally invasive procedures, and connected diagnostic and preventative care technologies. While end-users and clinicians are always open to new and expanding opportunities, insurers and healthcare facilities are looking to reduce overall operating costs—which promotes demand for distance care with telehealth options to transfer some workflows beyond the clinical environment. These types of devices, therefore, require much more simplistic interfaces to support the non-clinical end-user.
As the cost of electronics continues to fall, even simple devices may contain touchscreen displays controlled by complex software routines, enabling the operator to access a myriad of hierarchical data and complicating the ability to quickly find and interface with important displays and controls. Creating a user-friendly (logic) workflow that navigates the operator from one screen to another is critical to manage these growing interface demands. Often referred to as Digital Health, these new technological trends have all but replaced mechanical and binary (on-off) analog circuits, reducing unit cost for sophisticated interfaces.
Support from the Digital Health Center of Excellence
Recognizing the importance and the speed at which the digital healthcare transformation is underway, U.S. federal regulators have recently formed the Digital Health Center of Excellence (DHCoE). This group, which is part of the evolution of the Digital Health Program in the Center for Devices and Radiological Health (CDRH), will align and coordinate digital health work across the FDA. Although not charged with marketing authorization decisions, it will provide regulatory advice and support to the FDA’s regulatory review of digital health technologies. Now in phase 3 of its planning, which began in 2020, its aim is to not only be a partner in advancing technological opportunities with developers but also being committed to issuing guidance to modernize FDA policies in the digital arena.Gaining this kind of attention from regulatory authorities focuses on ways to ensure there is “timely access to high-quality, safe, and effective digital health products.” This is where DHCoE’s mission coincides with the importance of the user experience in medical device design and development.
A Holistic UX Approach Brings Value to the Design Process
UX isn’t just about making the device interface easy to use—a common misnomer. Rather, it embodies a myriad of aspects involved with design considerations—a complete ecosystem surrounding the device that includes hardware, software, unified communications, and location-based services. Devices should not only be aesthetically pleasing to the user, whether in-home or in a clinical environment, but should also seamlessly incorporate into the care environment. They should also be intuitive, much like the technology that controls ubiquitous devices like smart TVs, digital appliances, and personal mobile products.With that guidance in mind, good UX design requires a holistic approach. Using a complex interplay of human factors engineering, industrial design, and graphic user interface (GUI), appropriate product methodologies are leveraged to unite purposely intentioned aesthetics with optimized usability. This approach is intended to maximize a positive user experience and its relationship to the environment.
Where to Start in the UX Process
Incorporating UX methodologies should not be an afterthought and need to be applied from the beginning of the design process. 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, so CI studies establish the user requirements the device should ultimately be validated against.Regardless of all the tools included in the HFE process and, most particularly, as they relate to UX approaches, it is important to involve the UX team while requirements are being established to address all relevant aspects of the UX. By not doing so early in the process, information may become siloed among different design teams, which can result in expensive and time-consuming workarounds. The UX component of the design process will provide a strong foundation for ongoing design activities with the knowledge that these activities are based on a thorough and investigative journey with an end result to benefit the device’s marketability.
Designers engaged in healthcare projects must also 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 users’ age, physiological challenges, mental states, comfort levels, and skills related to the technology. Alternatively, if the device is intended for medical staff, they need to study how these end users would interact with the device in their natural environment as well as understand the expected workflow, considering they might need to operate adjacent devices in order to complete the task. UX designers should seek to optimize the interaction with the device, eliminating unnecessary steps that may distract the clinician from their main task but without taking shortcuts that may increase use-error.
UX designers ideally work alongside HFEs to conduct GUI design studies. This resource partnership provides a design-agnostic observer (the 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 for continuity 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 these future updates to be easily integrated.
The UX Toolbox
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.Deploying virtual reality (VR) and augmented reality (AR) tools during research phases provide designers with simulated three-dimensional perspectives to evaluate spatial quality, physical reach, and visualization of the UI. VR technology has rapidly evolved to become an affordable, valuable and easy-to-use development tool used during early device development. While some methodology investment is required, VR and AR tools can reduce or eliminate far more costly approaches such as physical mockup development, logistical costs, and schedule impact. Study participants can evaluate these virtual concepts swiftly and concurrently anywhere on the planet, which may feature touchscreens, hard keys, pumps, connections, and other interface features.
Superior Design Innovations Require a UX Focus
Innovations in mission-critical products such as medical devices have always been transformative but are expected to increase at a rapid pace, as will the technology ecosystems driving their designs. At the center of this transformation will always be the need for the design to enable operational success from the intended end-user—patient, caregiver, clinician, and maintenance teams in the healthcare continuum. This means a clear focus provided by the HFE charter and realized via thorough UX design approaches to ensure that future devices will be deployed safely and efficiently with minimal training.Philip Remedios is principal and design director at BlackHägen Design, an R&D consultancy focused on medical device innovation. With a combined design and engineering background, Remedios has spent most of his 34-year career in executive consulting roles, developing project plans, and managing integrated technical teams, schedules, and budgets.
Irina Samkova is lead UX designer at BlackHägen Design. Irina received a bachelor’s degree in Graphic Design from New York City College of Technology. Though she started her career with a focus on designing non-interactive visual content, she soon found herself drawn to the world of UI/UX. It was a natural transition as the rapid pace of creating graphics for digital products had to be combined with a relentless focus on the end user and their needs. Tying the end-product to user needs is the core design approach Irina always takes.
