Brighter research.
Bolder discovery.
Better design.


Human Factors is more than just a checkbox.
It’s the difference between a product that simply
functions and a product that users can trust.

Supporting Human Factors and Design Research needs from early-stage strategy to market submission.

SERVICES

Early-Stage Generative Research

Human Factors begins at the very beginning stages of product design. We utilize strategic Early-Stage Human Factors Research activities that empower you to uncover real user needs early, so you can build your product concept on insights, not assumptions.

  • Human Factors Strategy & Planning

  • User Needs Discovery

  • Contextual Inquiry & Ethnography

  • Qualitative & Quantitative Surveying

  • Cognitive Walkthrough

Human Factors Analysis

Understanding and mitigating usability risks proactively is the key to safer and more effective human-centered design. Applying our structured Human Factors Analysis process throughout your development lifecycle allows you to identify key usability risks, begin to map the user’s journey, and start translating human complexity into actionable design decisions before requirements are locked.

  • Known Use Problems Analysis

  • Task Analysis

  • PCA Analysis

  • Heuristic Analysis

  • Use-Related Risk Analysis

  • Expert Review

Human Factors Studies

Nothing provides clearer insight than getting your product in the hands of users themselves. Whether it’s to identify areas of actionable design opportunity in a Formative Evaluation or prove your device’s safety and effectiveness in a Validation Study, we are prepared to ensure that your study is planned, conducted, and reported on with success.

  • Formative Evaluations

  • Summative / HF Validation Studies

  • Vendor Management (Recruiter, Facility, etc.)

  • Project Management

Human Factors Documentation

In a regulated environment, robust and clear Human Factors Documentation is a must for a successful marketing submission. From planning to reporting, we work to provide strong compliant documentation that will not only set you up for regulatory success, but demonstrate a thoughtful and comprehensive human factors program.

  • Use Specification

  • HF Plan

  • Protocol Development

  • Report Development

  • HFE/UE Report Support

  • Documentation Review

An independent practice with small-firm flexibility

BDHF Consulting works closely with teams to integrate quickly and seamlessly into their product development process, efficiently turning insights into actionable design direction without the unnecessary overhead. With experience in surgical devices, combination products, diagnostics, capital equipment, and digital health, BDHF brings a flexible and collaborative approach to complex user challenges spanning across the healthcare industry. 

Human Factors is more than just a checkbox. It’s a driver of better outcomes, more usable design, and safer healthcare solutions. At BDHF, that belief is reflected in every step of our process, and makes the difference between products that function and innovation that pushes the boundaries of healthcare.

Braden DeVine
HF Consultant

Let’s begin the
conversation.