Human Factors Engineering

An Integrated, Human-Centered Approach

Considering human factors in the medical device design process means choosing to minimize the risk of medical errors to enhance patient safety and care quality.

This transversal process aims to fundamentally improve physical and digital product quality, from safety to emotions, from the definition requirements to the validation.

At CLEIO, we have specialists in this field. They take an integrated, human-centered approach to designing products that are perfectly aligned with user needs, capabilities and behaviors.

What we do

Field Study

Contextual Inquiries

User Needs

Tasks Analysis

User/SMEs Interviews

Use-Related Risk Analysis

Heuristic Evaluation

PCA Analysis

Usability Gap Analysis

Formative Evaluation

A Cross-Disciplinary Collaboration

CLEIO’s human factors engineering team is part of the design team, a crucial detail. Working closely with user experience (UX) and user interface (UI) designers, as well as with industrial designers, allows us to focus on user experience and increase user satisfaction. As a result, our medical devices are safe, effective, and pleasant to use

Our human factors engineering experts maintain constant contact with all other teams, from mechanical and electronic engineers to software developers, eliminating boundaries between disciplines.

This integration means that our experts’ assessments translate into design requirements shared across teams, aiming to create a product that meets the diverse needs of users (nurse, technician) and the beneficiaries (patients).

Our Methodology: Designing to Mitigate Risks

CLEIO’s human factors engineering team is involved from the start of a new project to oversee the medical device development process.
Our approach involves:

Understanding user needs, challenges and constraints

Engaging with users at the project’s beginning is key to successful product development.

Through user research, in collaboration with the UX team, we identify user profiles, context and environment of use. This insight helps us recognize device usage pain points and identify risks to mitigate.

Analyzing, identifying and mitigating usability risks

Engaging with users at the project’s beginning is key to successful product development.

Through user research, in collaboration with the UX team, we identify user profiles, context and environment of use. This insight helps us recognize device usage pain points and identify risks to mitigate.

Promoting an iterative design process through formative evaluations

We employ an iterative, user-centered process to produce several solution versions, aiming for a product that meets user needs.

We regularly conduct formative evaluations to test concepts, advancing medical device development to make it safer, more intuitive, and more user-friendly.

These evaluations are also valuable for refining instructional materials and training (instructions for use), as these are integral to the user interface.

We Help You Meet Regulatory Requirements

Our human factors engineering experts assist you in understanding and meeting regulatory expectations. They guide you through discipline-specific requirements for medical device market approval.
Working alongside our quality assurance team, they provide a comprehensive usability report complying with Food and Drug Administration (FDA) Health Canada, and European Commission regulations.

The Many Benefits of Considering Human Factors in Medical Device Design

A medical device designed with human factors in mind is more likely to succeed in the market, with users, with regulatory authorities.
The benefits include:

On the blog

Human Factors: Why Should They Be Considered When Designing Medical Devices?

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