Why Human Factors Matter in Healthcare Software and Device Design

When we think about healthcare technology, whether it’s a patient monitoring device, an electronic health record (EHR) system, or a telemedicine app the focus often falls on features, performance and compliance. Yet one crucial factor is frequently overlooked: human factors.

Human factors refer to how people interact with technology, systems and environments. In healthcare, this means understanding the capabilities, limitations and needs of clinicians, patients and support staff and designing solutions that fit seamlessly into their workflows.

Overlooking human factors in healthcare software and device design can lead to usability problems, increased error rates, slower adoption and even patient harm. Conversely, when human factors are prioritized, the results include safer devices, more intuitive software, reduced training time and better patient outcomes.

In this article, we’ll define what human factors in healthcare are, share real-world examples, explain why they matter in software and device design and outline actionable ways to apply them effectively backed by principles from human factors engineering and healthcare industry standards.

What Are Human Factors in Healthcare?

Human factors in healthcare refer to the study and application of knowledge about human abilities, limitations and behaviors to the design of systems, devices and processes. The goal is to ensure that technology and environments support optimal human performance, reduce the risk of errors and enhance safety for both patients and providers.

In a clinical setting, human factors encompass:

• Cognitive aspects – how clinicians process information, make decisions and manage mental workload.

• Physical aspects – how people physically interact with devices, controls and interfaces.

• Organizational aspects – how workflows, team communication and policies impact performance.

The World Health Organization and groups like the Clinical Human Factors Group (CHFG) emphasize that human factors are about designing systems that make it easier to do the right thing and harder to do the wrong thing.

Whether applied to a surgical tool, a medication dispensing system, or a hospital software interface, integrating human factors into design ensures that products are intuitive, fit the user’s context and work reliably under real-world pressures.

Examples of Human Factors in Healthcare

Human factors in healthcare can be seen in everyday interactions between clinicians, patients and technology. These factors influence usability, safety and efficiency and when overlooked, they can contribute to errors or poor adoption rates.

Common examples include:

• User Interface Complexity – An EHR system with cluttered screens and buried functions can slow documentation and increase the risk of entering incorrect data.
  
  

• Alarm Fatigue – Excessive or non-prioritized alerts from monitoring equipment can desensitize staff, leading to missed critical warnings.
  
  

• Workflow Mismatches – A software tool that doesn’t align with how clinicians naturally record patient data forces unnecessary workarounds.
  
  

• Environmental Distractions – Poorly placed controls or displays in a noisy ICU may cause delays or errors in administering care.
  
  

• Cognitive Overload – Requiring clinicians to remember multiple steps without prompts or visual aids increases the chance of mistakes.

These examples show that human factors extend to how a system supports decision-making, integrates into workflows and responds to the pressures of a clinical environment.

By studying these factors during the design phase, developers and healthcare organizations can proactively remove friction points, improving both user satisfaction and patient safety.

The Role of Human Factors Engineering in Healthcare

Human factors engineering (HFE) is the discipline of applying knowledge about human performance, limitations and behavior to the design of systems, devices and environments. In healthcare, it plays a critical role in ensuring that technology is safe, effective and intuitive for its intended users.

HFE draws from psychology, ergonomics, design and systems engineering to create products and processes that fit the user, rather than forcing the user to adapt. This is especially important in healthcare, where clinicians often operate in high-stakes, high-pressure environments and must make quick, accurate decisions.

Applications in healthcare include:

• Designing medical device interfaces that reduce the risk of user error.

• Creating EHR workflows that align with clinical routines.

• Optimizing alert systems to prioritize critical information and minimize alarm fatigue.

• Ensuring patient-facing tools are accessible to users with varying literacy and mobility levels.

Regulatory bodies such as the FDA require human factors considerations for certain medical devices to demonstrate safety and effectiveness. Similarly, healthcare organizations adopting new software increasingly recognize HFE as a core component of successful implementation.

By embedding human factors engineering into the development process, healthcare technology can become not only more compliant but also more usable, more efficient and safer for all stakeholders.

Why Human Factors Matter in Software and Device Design

In healthcare, the stakes for software and device design are exceptionally high. A poorly designed interface, unclear workflow, or confusing control layout can directly impact patient safety, clinician performance and operational efficiency. This is where human factors play a decisive role.

Safety: Integrating human factors principles into design reduces the risk of errors. For example, intuitive device controls and clear on-screen prompts help prevent incorrect medication dosages or procedural mistakes.

Usability: When software or devices are designed with the user in mind, they require less training, reduce frustration and allow clinicians to focus more on patient care rather than navigating complex systems.

Efficiency: Human-centered design streamlines workflows, cuts redundant steps and eliminates unnecessary cognitive load, enabling faster decision-making and better time management.

Compliance: Regulatory bodies like the FDA and standards such as IEC 62366 emphasize usability engineering as part of product approval. Demonstrating that human factors have been addressed can speed up compliance processes.

Adoption: Even the most advanced technology will fail if it’s not embraced by its users. Solutions that align with human needs and behaviors see higher adoption rates and sustained engagement.

By embedding human factors into every stage of software and device development, healthcare organizations can deliver solutions that are safer, more effective and better aligned with real-world clinical environments.

Key Principles of Human Factors Engineering in Healthcare

Applying human factors engineering (HFE) in healthcare requires more than a general focus on usability. It involves adhering to core principles that ensure technology aligns with human needs, capabilities and limitations.

1. User-Centered Design
Begin with a deep understanding of the end users — clinicians, patients, or support staff and their workflows. Every design decision should support how they naturally work.

2. Usability Testing
Evaluate prototypes and final products with real users under realistic conditions. This helps identify design flaws that may not surface in a lab setting.

3. Error Prevention
Design systems that make it easy to perform the right action and difficult to make mistakes. Examples include confirmation prompts before critical actions and color coding for medication types.

4. Workload Management
Limit unnecessary cognitive load by presenting information clearly and prioritizing critical data. Reduce redundant tasks and automate where possible.

5. Accessibility & Inclusivity
Design for diverse user abilities, literacy levels and languages. This is especially important for patient-facing apps and devices.

6. Iterative Improvement
HFE is an ongoing process. User needs evolve and designs should adapt through continuous feedback and updates.

By following these principles, healthcare software and devices can become more intuitive, safer and better integrated into complex medical environments, improving both clinical outcomes and user satisfaction.

How to Implement Human Factors in Healthcare Technology Development

Integrating human factors into healthcare technology development requires a structured approach that combines user research, iterative design and continuous evaluation.

1. Engage Stakeholders Early
Involve clinicians, patients and administrators from the start. Their insights reveal workflow realities and user needs that can shape the design direction.

2. Conduct Task and Workflow Analysis
Break down how tasks are performed in real-world environments. Identify potential friction points, error-prone steps and areas where technology can streamline processes.

3. Create Prototypes and Wireframes
Develop early models of the software or device interface to visualize design concepts. Low-fidelity prototypes help test ideas quickly without large investments.

4. Perform Iterative Usability Testing
Test designs with real users in simulated or actual environments. Use their feedback to refine the interface, content layout and interaction flow.

5. Integrate Training and Support Materials
Design intuitive help features, quick-reference guides and onboarding modules to support users post-deployment.

6. Establish Feedback Loops Post-Launch
Gather ongoing user feedback to monitor adoption, identify issues and prioritize improvements. This ensures the product evolves with user needs and changing healthcare practices.

7. Document for Compliance
Maintain detailed records of human factors activities to meet FDA, ISO and IEC requirements for usability engineering.

By embedding human factors into each stage of development, healthcare organizations can create solutions that fit naturally into clinical environments, reduce risks and enhance both patient safety and staff efficiency.

Human Factors and Regulatory Compliance

In healthcare technology, human factors are often a regulatory requirement. Authorities recognize that usability directly impacts safety, making it an essential element of compliance.

In the US, the FDA requires human factors engineering for many medical devices, especially those with significant patient or clinician interaction. Manufacturers must demonstrate through usability testing and validation that the product can be used safely and effectively by the intended users, under expected conditions. This is documented in human factors validation reports.

Internationally, IEC 62366 outlines usability engineering requirements for medical devices, while ISO 9241 provides guidance on human-centered design principles. Both stress the importance of iterative design, real-world testing and risk management.

For healthcare software, standards like ISO/IEC 62366-1 and ISO 9241-210 are increasingly referenced in regulatory submissions to show commitment to safe, user-friendly design.

By integrating compliance considerations early from stakeholder engagement to final validation, organizations can streamline approval processes, avoid costly redesigns and deliver products that meet both regulatory and user expectations.

Challenges in Applying Human Factors in Healthcare

While the benefits of human factors integration are clear, applying them in healthcare software and device design comes with practical challenges.

Budget and Resource Constraints – Human factors research, usability testing and iterative redesigns require time and funding. Organizations under pressure to launch quickly may skip or minimize these steps.

Resistance to Change – Clinicians and administrators accustomed to existing workflows may be hesitant to adopt new systems, even if they offer usability improvements.

Limited Expertise – Many healthcare organizations lack in-house human factors engineers or designers trained to apply these principles effectively.

Complex Clinical Environments – Testing in real-world healthcare settings can be logistically difficult due to patient privacy concerns, shift schedules and unpredictable workflows.

Competing Priorities – In multi-stakeholder projects, balancing human factors with feature demands, compliance requirements and cost constraints can be challenging.

Addressing these barriers requires strategic planning: securing leadership buy-in, allocating dedicated human factors resources, involving users early and ensuring testing is as close to real conditions as possible. By doing so, healthcare organizations can overcome obstacles and deliver solutions that truly enhance safety, efficiency and user satisfaction.

Partnering with Experts in Human Factors for Better Design

Successfully integrating human factors into healthcare technology often requires specialized expertise that many organizations don’t have in-house. Partnering with experienced human factors professionals can bridge this gap, ensuring your software or device is designed for safety, usability and compliance from the outset.

A qualified partner brings:

• Domain Expertise – Understanding of clinical environments, workflows and user challenges.

• Technical Skills – Ability to translate human factors research into practical design solutions.

• Regulatory Knowledge – Familiarity with FDA, IEC 62366 and ISO usability engineering standards.

• Testing Capabilities – Access to usability labs, simulation environments and user recruitment networks.

When choosing a partner, evaluate their track record in healthcare projects, their ability to involve stakeholders effectively and their approach to iterative design.

At Latent, we integrate human factors into every stage of healthcare technology development from early discovery and prototyping to validation and post-launch refinement. Our approach ensures solutions not only meet regulatory requirements but also deliver real-world benefits in workflow efficiency, error reduction and user satisfaction.

By collaborating with experts, healthcare organizations can build products that truly fit the people who use them and the environments in which they work.

Conclusion

Human factors are a patient safety imperative in healthcare software and device development. By understanding how people interact with technology and designing around their capabilities, limitations and needs, healthcare organizations can create solutions that are safer, more intuitive and more effective.

From reducing cognitive load to aligning with real-world workflows, integrating human factors early ensures technology supports clinicians and patients. It also aligns with regulatory requirements, accelerating approvals and improving adoption rates.

Ready to create technology that truly works for the people who use it?

Contact Latent to discuss how we can help you deliver safer, smarter and more user-friendly healthcare solutions.