Human Factors Engineering

PEOPLE ARE AT THE HEART
OF EVERYTHING WE DESIGN

Kaleidoscope Innovation Human Factors Engineering works with clients to produce devices and experiences informed by physical and psychological research and insights. From wearable tech and surgical devices, digital health and warehouse layout and operations, our team has specialized expertise in medical devices, combination products, and consumer products.

Our human factors engineers have worked with manufacturers including Amgen, Baxter, Ethicon, and Medtronic.

Let’s Talk

We Deliver Compelling,
Actionable Results

Comprehensive Support
From research to recruiting to reporting, we provide comprehensive human factors and usability engineering support to our partners to meet the expectations of the FDA’s constantly evolving guidance and international standards.

For clients with complex regulatory needs involving human factors, we have our own in-house regulatory experts that our team collaborates with on a regular basis.

  • Translating research-based user needs
    into actionable requirements
  • Scoping and planning your human
    factors effort
  • Formative usability studies
  • Summative usability validation studies
  • Ethnographic research

  • Heuristic evaluation
  • Use-related Risk Analysis (URRA) and Use
    Failure Mode and Effects Analysis (uFMEA)
  • Task analysis
  • Defining anthropometric requirements
  • Strategic guidance for FDA interactions

Case Study: Tandem Mobi

The R&D teams at Tandem Diabetes Care were developing the world’s smallest, durable insulin delivery system – Tandem Mobi. Tandem Mobi would be the first insulin pump that had the only control and display interface provided from an app through an off-the-shelf iPhone. Tandem needed a skilled and trusted partner to extend its internal human factors team and supply experienced researchers to assist in conducting the formative studies and a summative study required for submission to the FDA.

This was one of the largest and most complex projects undertaken by Kaleidoscope’s Human Factors team. Working with some of the top human factors consulting and recruiting companies, Kaleidoscope successfully provided additional team members who assisted in all phases of the program.

The Tandem Mobi system received FDA clearance in July, 2023 and was commercially released to the market in early 2024.

Companies that invest in human factors engineering early in the development process gain efficiencies and save budget while also producing better-designed, more intuitive products that their customers will value.

Our Expertise Goes Beyond
Human Factors Engineering.

Product Development Resources and Support
As part of Kaleidoscope Innovation, a world-leading design, product development and consulting firm, we can offer clients more than just human factors expertise, including end-to-end product development research and expertise and access to resources in emerging tech through our parent company, Infosys.

What’s more, our Human Factors team’s frequent close collaboration with Kaleidoscope’s multi-disciplinary departments gives us an immersive understanding of every phase of the product development process. It’s an invaluable level of insight and experience we bring to every project.

Get to Know Kaleidoscope Innovation

Collaborative Teams

We frequently collaborate closely
with these Kaleidoscope teams.

  • Regulatory Affairs
  • Design Research
  • Graphic Design
  • Engineering

Schedule a consultation.

We welcome the chance to support your engineering needs.
Get in touch.

Andrew Bryan
Director, Human Factors |

As leader of our Human Factors engineering team, Andrew has deep expertise in human factors with nearly 20 years of experience in medical device and combination product design and development.

LP Contact - Andrew
*Required Field