Human Factors Engineering’s Role in Medical Device Design and Adoption

Even if a medical device satisfies every technical and regulatory requirement during development, its most demanding test still lies ahead: real-world use.

Clinical environments introduce unexpected pressures, interruptions, constraints, and human behaviors that no bench test can fully replicate. These ad-hoc scenarios greatly impact how a device is used, how frequently it’s used, or whether it’s used at all.

Failing to consider elements like patient discomfort and clinician workarounds from the outset of the design process creates variability, and that variability creates risk. Human factors engineering (HFE) provides a structured way for teams to mitigate it.

Converting early HFE insights into design decisions that inform safer, more consistent solutions helps prevent headaches now, while equipping devices for more successful adoption later.

Human Factors Risk: Thinking Beyond ‘User Error’

Training and individual behaviors are a small part of the human factors risk equation. In many cases, issues emerge from interactions between a device, its users, and the environment.

Device hazards often only appear once they enter real clinical environments where patient experience, workflow demands, timelines, physical effort, and cognitive load determine outcomes. HFE anticipates these obstacles by encouraging designers to formulate a better understanding of the following variables:

• How people behave under pressure
• How variability across users affects performance
• Where design decisions amplify or reduce risk

If a designer ignores these elements, they instead assume the ideal technique during discovery—which means your go-to-market design may have built-in adoption fiction.

The Critical First Step: Problem Definition Before Solution Obsession

In discovery, teams tend to immediately seek a solution based on assumptions, existing products, or familiar workflows without stepping back to explore root problems or alternative vantage points.

Yet the time and cost saved through this approach will often reappear downstream in the form of late-stage redesigns, delayed transfers, regulatory challenges, and ultimately, adoption failure. There are two smart ways to avoid this:

1. Start with expansive, aspirational thinking. Create the ideal experience first, then handle feasibility limitations later. Teasing down a concept is typically easier and less costly than expanding a concept that started too small.
2. Seek perspectives beyond your immediate network. The end users who actually interact with the device (clinicians and patients)can clearly identify problems that then inform your solution; not the other way around.

Early discovery period should aim to define the broader problem first, asking questions like:

• Who are all potential users across settings and experience levels?
• What does success look like from their perspective?
• Where does friction already exist in their current workflows?
• Which constraints are real versus assumed?

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The Two Key Voices Frequently Missing from Early Discovery

Two of the most influential user groups in early discovery, patients and clinicians, usually double as the most underrepresented.

Neglecting their insights isn’t due to lack of appreciation or intent. Teams are busy, and the gap between lived frustration and scalable product design may feel too wide. These groups, however, carry the right perspective to help close it.

Considering the Clinician

When devices add extra steps, create mess, require unnecessary physical effort, or demand retraining, clinicians must default to workarounds: user-invented processes that keep workflow moving but can introduce unintended hazards.

When a workaround becomes standard practice, many of the upfront design risks have already worked themselves out. Now it’s up to the design team to refine the concept to ensure marketability.

Take early irrigation procedures as an example. When using syringes, clinicians nationwide spent decades improvising solutions (i.e., poking holes, attaching makeshift components) to prevent splashback. The workaround solved a real-world frustration but created massive inconsistencies.

All it took was one clinician to recognize the pattern and formalize his concept as a standardized product, seeing that frontline challenges could translate directly into manufactured solutions.

Considering the Patient

Patients always seem to come last in user flow conversations, despite being a primary deciding factor in sustained adoption. Discomfort determines behavior, so if the public doesn’t like a device, they won’t consent to its use.

Flashback to the COVID-19 pandemic, for instance. Patients dreaded nasal swab sampling because it was painful and invasive, which shaped a poor reputation that stuck. Today, the Journal of the American Medical Association Network reports a third of Americans would refuse testing if respiratory symptoms appeared. They’d rather wait it out than willingly face discomfort.

Across all medical device applications, tolerability affects compliance, compliance affects consistency, and consistency affects outcomes. Designing for HFE and end users prevents this pathway from becoming a costly trap throughout development.

Clinician Perspective in Design: High-Value Input That Doesn’t Derail Engineering

Clinicians provide essential context into human factors work, revealing certain issues that only surface in bedside practice. They are not expected to design devices or dictate technical solutions. Their value lies in articulating problems, constraints, and lived experiences.

Frontline professionals recognize less obvious elements of resistance among patients and teams, so their insights should be incorporated early on. Effective clinician involvement may entail:

• Uncovering clinical problems (not validating design solutions)
• Ensuring accurate representation across roles and settings
• Setting clear boundaries to preserve engineering ownership
• Aligning recurring touchpoints with development milestones

These findings help reduce the risk of overfitting designs to a single perspective while keeping designs grounded in HFE practices and real clinical use.

Practical HFE Actions to Reduce Risk and Improve Compliance

Missing the big picture of user flow comes with business and compliance consequences. It also undermines the reason many entered this profession in the first place: improving patient care.

Teams can strengthen risk mitigation and support safer adoption through several practical actions:

1. Map user flow end-to-end before locking form factor assumptions, including upstream and downstream interactions.
2. Define broad user personas early, reflecting variability in dexterity, literacy, experience level, and demographics.
3. Run formative usability loops early and repeatedly, using multiple representative users to identify patterns instead of isolated preferences.
4. Document trade-offs explicitly, capturing why certain features advanced while others were deprioritized.

Adoption: The Greatest Measurement of Success

While regulatory clearance and technical performance mark important milestones in device development, sustained adoption remains the ultimate measure of success.

To achieve it, teams must look beyond their own assumptions, gather varied perspectives, and leverage core HFE principles to translate frontline insights into durable design decisions—all as standard steps in the early design process.

Not only does this strengthen consistency, reduce rework, and support smoother regulatory pathways, but it aligns devices with how clinicians practice and how patients experience care. Naturally, adoption follows that alignment.

Thanh T. Nguyen, PhD, MSN, FNP-C, is chief technology officer of University Medical Devices, and lead designer and developer behind its nasal lavage sampling device, MicroWash. He is a highly accomplished healthcare professional with an extensive background in emergency medicine, medical research, and academia. Dr. Nguyen is deeply committed to integrating technology into medicine to address care disparities and improve patient outcomes.