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Human Factors Engineering

Optimize safety and user experience in medical devices through CLEIO’s proven Human Factors Engineering expertise.

We Elevate User Safety and Enhance Product Quality through Our Human-Centered Approach

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Human factors engineering (HFE) is a proactive approach integrated into the design process to minimize the risk of use errors, especially in medical device development. Also known as usability engineering, this discipline aims to improve the overall quality of both physical and digital products, from safety to user satisfaction, throughout all stages from requirement definition to validation.

By adopting a human-centered approach, our experts design products that align precisely with the needs, capabilities, and behaviors of intended users, ensuring that the devices are intuitive, effective, and safe for all.

What We Do

Field Study

Contextual Inquiries

User Needs
Tasks Analysis
Use-Related Risk Analysis
Heuristic Evaluation
PCA Analysis
Usability Gap Analysis
Formative Evaluation

Our Human Factors Team is Fully Integrated into the Development Process

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At CLEIO, our human factors engineering team is an integral part of the design team, which is an important detail. By working closely with user experience (UX) and user interface (UI) designers, as well as industrial designers, we place a strong emphasis on user experience to enhance satisfaction. As a result, the products we develop, particularly medical devices, are not only safe and effective but also pleasant to use.

Thanks to cross-disciplinary collaboration, our human factors engineering experts maintain constant contact with other teams, from mechanical and electronic engineers to software developers, thereby dissolving boundaries between disciplines. They are involved from the start of a new project, overseeing the development process.
This approach ensures that the design requirements gathered during expert evaluations are shared across all teams. Our aim is to create a product that meets the diverse needs of users and beneficiaries.

We Design to Mitigate Use-Related Risks

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Human factors engineering evaluates how well a product can be used by specific users to achieve designated goals effectively, efficiently, and satisfactorily within real-life usage scenarios. This includes identifying risks and hazards associated with improper use, which could lead to adverse events or compromised safety.
Here are the main activities performed by our team of experts:

Understanding User Needs, Challenges and Constraints

Engaging with users at the beginning of a project is key to successful product development. Through user research, in collaboration with the UX team, we identify user profiles, contexts, and environments of use. This insight helps us recognize pain points in device usage and identify risks to mitigate.

Analyzing, Identifying and Mitigating Usability Risks

By applying methods such as usability benchmarking and heuristic evaluation, we analyze how a product or a medical device is used (through task analysis) to pinpoint potential risks and identify critical tasks based on collected data. Our quality assurance team plays a key role in the risk management process through close collaboration and dedicated support.
Additionally, other members of the design team contribute significantly to risk analysis and the identification of risk control measures, including user interface specifications.
Our goal is to find concrete solutions that ensure the product maintains an acceptable level of risk.

Promoting an Iterative Design Process Through Formative Evaluations

We employ an iterative, user-centered process that generates multiple versions of a solution, all aimed at creating a product that truly meets user needs.

We regularly conduct formative evaluations to test these concepts, and more specifically, to enhance the development of medical devices, making them safer, more intuitive, and user-friendly.

This testing process is crucial for refining instructional materials and training programs, such as instructions for use (IFU), which are integral components of the user interface.

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We Help You Meet Regulatory Standards for FDA Approval

Our human factors engineering experts help you understand and meet the regulatory expectations for medical devices. They guide you through the specific requirements needed for market approval.
Working alongside our quality assurance team, they provide a comprehensive usability report that complies with regulations from the Food and Drug Administration (FDA) Health Canada, and the European Commission regulations.

The standards we routinely work with include:

ISO 13485:2016
ISO 14971
IEC 62366-1
AAMI HE75
FDA Guidance Docmuents

The Many Benefits of Integrating Human Factors in Medical Device Design

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A medical device designed with a focus on human factors is more likely to succeed in the market, be preferred by users, and comply with industry regulatory standards.

Enhanced Cost and Time Management

Integrating human factors reduces costly redesigns and shortens development timelines by addressing usability issues early on.

Easier, Faster, and Safer User Training

Human-centered design ensures intuitive interfaces, simplifying training and minimizing the risk of user error.

Reduced Need for Technical Support

A well-designed medical device empowers users, decreasing reliance on technical support and lowering operational costs.

Increased Sales

Understanding the end-users’ needs is essential for creating impactful medical software. Our designs focus on intuitive interfaces and functionality that support healthcare providers and patients alike.

Higher Utilization Rates

Understanding the end-users’ needs is essential for creating impactful medical software. Our designs focus on intuitive interfaces and functionality that support healthcare providers and patients alike.

Stronger regulatory compliance record for US, Canadian, and European markets

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Frequently Asked Questions About Human Factors Engineering

HFE identifies and mitigates use-related risks by focusing on user behaviors, environments, and potential errors during device interactions. This reduces the likelihood of misuse, enhancing overall patient safety.
HFE focuses on designing for human capabilities, while usability engineering emphasizes the ease of use and satisfaction with a product. Both work together to ensure medical devices are effective, safe, and user-friendly.
Formative evaluations are iterative tests conducted throughout the development process to refine design concepts based on real user feedback. They help improve the product’s usability, safety, and user satisfaction before final validation.
HFE helps meet FDA, Health Canada, and European Commission requirements by providing thorough usability reports, risk assessments, and design justifications. This process ensures compliance with standards like IEC 62366 and AAMI HE75.
We conduct contextual inquiries and user research to understand the needs, skills, and limitations of all potential users, from nurses to technicians. This data helps inform design decisions that cater to diverse user groups.
In the post-market phase, HFE can be used to monitor device usage and gather feedback to inform future updates or iterations. Continuous user feedback ensures ongoing product improvements and helps manage post-market risks.
We test instructions for use (IFU) during formative evaluations to ensure they are clear, intuitive, and easy to follow. This helps reduce training time and minimizes user errors during device operation.
By designing devices that are intuitive and easy to use, HFE minimizes complexity and the potential for user error. This reduces reliance on technical support and improves user independence.
HFE identifies usability issues early in the design process, preventing costly redesigns and ensuring efficient product development. It also accelerates the regulatory approval process, saving both time and resources.
Use-related risk analysis identifies potential user errors and device misuses that could lead to safety risks. Mitigating these risks early ensures a safer product and higher regulatory approval chances.

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