9 Tips to Maximize Impact During Early Phases

User Experience (UX), Human Factors (HF), and Industrial Design (ID) each have a major impact on the success of new medical devices. Their influence is especially important during product definition and early phases of device development. In this blog, our team of engineers, scientists, and designers share unexpected UX, HF, and ID benefits that help them explore possibilities, hone concepts, and transform ideas and products into a viable solution.

How Soon Should UX, HF, and ID Jump In?

UX, HF, and ID is critical in phase zero of product design. Think of them as primary design input.  What are we doing? What form factor is it going to be? For example, consider a diagnostic test. Is it going to take place in a lab, or are we going to do it as a testing kit at home? That’s critical to design. It can’t be overlooked.

When things are less defined, UX, HF, and ID are an important part of de-risking technology. The development team needs to understand the target user and these experts are trained to interpret and understand patient and user needs and desires.

Human Factors analyze the device workflow and identify areas that device users find annoying, including issues that users can’t explain. This results in a lot of eureka moments at the beginning of project development which allows for innovation to happen. HF looks at a process and goes, “oh, wait a minute, you guys thought it was X? It’s this other thing that’s causing the issue”. In general, if technology is frustrating to use or doesn’t fit into a workflow it won’t be used.

ID in the initial phase of product development sets the stage for the overall function of the device. ID defines needs and design constraints through preliminary HF and UX research. Engaging with end users and looking at existing devices in the market is critical to creating ID sketch concepts with holistic considerations.

TIP: Avoid tunnel vision when coming up with concepts. Explore wild ideas and identify unique approaches to address the design brief and set boundaries on what should go forward. Establish ID involvement early on in product development. ID ties the user and device together.

Industrial Design (ID)

Industrial Designers can be very powerful in furthering early product development, giving a vision for the team and investor collateral, Industrial design is often a bridge between what the project sponsor intends to bring to market and what engineers think is feasible within the constraints of the program.

TIP: Make sure ID works closely with the engineers to avoid giving a vision that’s unattainable.

ID speaks to the desired end user experience. Do you want a spa experience or a quick in and out walk in clinic trying to process as many people as possible for a Covid test? Do you want a device that’s ”in, out, and done” or “let’s spend some time and make the patient experience feel relaxed”.

HF/ID input helps inform factors that aren’t purely technical. They identify what needs to be considered about the device form and how it interacts with patients and users. For example, a good camera is not the same thing as a good camera that interfaces with the user or patient’s face.

TIP: It’s useful for engineers to inform HF and ID what the technical needs are. Be careful not to bias the HF and ID team’s thoughts. Tell them “the device needs to do XYZ” but avoid going into how it should look or the shape. That’s input ID should provide the technical team. Don’t bias them before they give their input.

What Does What?

TIP: Co-locate ID in the same group as UX and HF. There are many crossovers, and the disciplines feed each other.

ID helps reimagine what the device could look like while technical team members focus on de-risking technical aspects. A device must be an attractive product that people want to use. Engineers do not solve those problems. The UX, HF, and ID team address those areas of the product vision.

TIP: Project sponsors and investors that are not engineers or highly technical can be harder to engage in the technology of a device you’re going to develop or models you’ll train. A rendering created by ID showing the form of a device (whether it’s a handheld or a device that is rolling on a cart or hanging on the wall) that looks fantastic can capture sponsor and investor imaginations and make them think “this is how cool my device will look like”. That’s a valuable tool, especially early in the project.

Human Factors

While non-HF team members may also consider the workflow, their focus is solving technical, regulatory, or quality problems. HF experts know how to catch workflow issues and then help implement solutions throughout the team.

Realistic Expectations (Delivering the Promise)

Connecting UX, HF, and ID with the technical aspects of a project is just a first step in determining whether a concept is going off board or not. You don’t want to set false expectations but want to get clients salacious about where the project could go and what their device could be.

TIP: A well-defined industrial design and branding strategy for investor and/or clinical grade prototypes reduces churn between the groups to retain the aesthetic considerations while allowing for realistic constraints.

TIP: Reality in devices and renderings from the beginning is a must. When we show good industrial design images to clients, they get excited, their investors get excited. Without UX, HF, and ID engagement, there can be quite a disruption later. “You gave me the pictures. Why doesn’t it look like that?” There also must be thought about how the device is going to be made, how it is going to go forward, how it is going to be used, those kinds of things in initial sketches.

TIP: ID should always check in with Quality Assurance/Regulatory Affairs (QA/RA) team before going too far down the design. Labelling is a huge area that often comes up. The device needs a unique device identifier (UDI) label. Space for the UDI must be designed into the product. There can’t be a giant, beautiful logo without this required information.

When HF and ID are ignored in Product Definition and First Phase Development, added cost and delays are often incurred later. Devices designed without HF considerations have flaws that can be tough to correct and sometimes require a full redesign. For example, even the most technically advanced probe, if weight requirements are not considered, may be too heavy for users. And a scary looking advanced imaging machine can drive away patients based on its appearance.

HF and UX are similar in many ways, but different in detail levels. HF looks at how the device fits into the workspace and UX centers more on how the user can efficiently interact with the device function in that workspace. A device with a lot of emotional impact affects the workflow and the quality of the user experience. A device skin with membrane buttons is part of the User Experience. UX addresses interactions of software and firmware function beyond just holding, using and engaging. Is it a membrane pad or is it a bunch of keys? Or is it a big screen or a touch screen? These are some UX areas that define the device without necessarily touching on workflow.

Don’t Forget Software, Simulation and Nuclear Medicine

Software by itself doesn’t necessarily compel medical device stakeholders and investors. Showing what the User Interface (UI) will look like generally creates a lot more excitement than “here’s how we’re going to optimize this specific loop in your UI update function”.

UX and HF have close synergy with Computational Modeling and Simulation (CM&S).

CM&S typically analyze and advise whether to strengthen a certain part of the device structure or changes so the device performs as expected by conducting structural analysis or flow analysis on a device design. HF input on one set of initial designs and simulated drop testing and fatigue analysis resulted in massive changes.

Nuclear medicine is a relatively unique example of how usability and user safety intersect. UX, HF, and ID have a huge impact on product definition. For example, where is the optimal place for buttons or loading / unloading points to ensure minimal radiation exposure over many years? Not putting your hand in the path of a radiation beam might seem obvious, but in some cases gloved hands are not nearly as susceptible to radiation as other parts of the body like eyes. As a result, they aren’t a priority. Only through understanding the user needs, human behavior, and device technology can we create a wholistic design that addresses both acute and long-term design.

TL;DR

• UX, HF, and ID are critical in early medical device design, especially during phase zero.
• Early engagement helps de-risk concepts and capture unspoken user needs.
• Industrial design aligns form with function to support both users and stakeholders.
• HF ensures safe, usable workflows — even before technology is finalized.
• Collaboration across engineering, design, and regulatory reduces costly rework.