Human Factors Consulting

Your Users Are Human.

Our Consulting Is Too.

As the foundation of user-centered design, human factors engineering (HFE) is a vital part of nearly every development project. At Kablooe, we leverage our decades of HFE experience and proven track record of creating products people love to provide our clients with the human factors consulting services they need—with an extra dose of human.

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See Our Usability Engineering In Action

Our Human Factors Consulting Capabilities

From supplying usability engineering files and creating design requirements to supporting risk management efforts and ensuring HE75 and IEC62366 compliance, Kablooe’s start-to-finish HFE expertise will help you meet all regulatory requirements and create a device your users can’t put down.

Contextual Inquiry
Contextual Inquiry delves into users' natural environments, revealing insights beyond traditional VOC methods. Insights gained inform the design process, which ensures the final product is user-centric.
Use-Related Risk Analysis
Use-related risk analysis assesses potential risks linked to device use, focusing on user interactions and behaviors. It identifies and mitigates risks throughout the product's lifecycle while prioritizing user safety.
HFE Plan
A Human Factors Engineering plan guides the incorporation of human factors principles into system design, aiming to enhance performance, safety, and user satisfaction by considering human limitations. It is crucial for usability engineering and regulatory submissions.
Formative/Summative Studies
Formative studies refine the user interface as they develop, enhancing device design. Summative studies further validate this usability with a precise protocol, conducted by skilled moderators like Kablooe, ensuring thorough validation.
Usability Studies
Usability studies enhance product design by gathering user feedback on prototypes or simulations, ensuring products meet user needs and expectations through effective observation and assessment.
Usability Engineering Report
The Usability Engineering Report is a vital document summarizing findings, analyses, and recommendations from usability activities. This is crucial for regulatory submissions and user-centered design, offering stakeholders valuable insights for product improvement.

Are You Ready To Make Products People Love?

Devices should delight users in ways they’d never expect. We do that.

We Handle the ‘Not So Fun’ Stuff Too

Most devices these days are highly regulated, particularly those in the medical field. So let our human factors consulting team take many of these tedious and time-consuming compliance tasks off your plate. This ensures your involvement in the approval process is as simple, streamlined, and straightforward as possible.

Our HFE core competencies include:

  • Submitting HFE files to the FDA
  • Supporting risk management
  • Conducting formative and summative studies
  • Ensuring HE75 and IEC62366 compliance
  • Following HFE design protocols
  • Any other regulatory requirements you need to meet

Let's Work Together

David, AtriCure
I’ve worked with Kablooe on a number of med device R&D projects over the years. They’ve always been responsive, thoughtful, and innovative in their efforts…

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Kablooe Design

8560 Cottonwood St NW #100

Minneapolis, MN 55433