Human Factors Engineering

Scientific, Risk-Based Methodologies Identify and Prioritize HFE Directives for Design Teams
Contextual Inquiry
Simulated Workflow
Projective Mapping
Virtual/Augmented Reality Testing
Insight Translation

The primary objective of BlackHagen’s Human Factors Engineering (HFE) team is to ensure product designs meet user needs and minimize use-related risks, ultimately producing products that achieve the highest levels of user satisfaction, safety, and market success. BlackHägen Design’s Human Factors Engineers possess vast expertise in applying their understanding of human behavior, abilities, and limitations in the context of users’ interactions with a product or device and its user interface. Our HFE team thoughtfully works to understand our clients’ needs and constraints to tailor an effective approach to HFE that will achieve the goals of the current design and development phase.

Our services encompass comprehensive support, starting from early user and design research (Contextual Inquiry) to generating essential documentation for Design Controls, conducting expert reviews or heuristic analysis, user preference studies, iterative formative evaluations to assess use-related risks and summative/validation testing. Unique to BH’s process is our cross-functional collaboration with our internal or client’s Design teams to develop equitable design solutions and risk-control measures to optimize product designs. Our team’s documentation and reporting are quality-compliant and meet requirements for regulatory submission.

  • Generative User Research
  • In-house Usability Test Suite
  • Usability Engineering File Development (IEC 62366 compliance)
  • Task Analysis
  • Expert/Heuristic Analysis
  • Formative User Evaluation Studies
  • Use-related Risk Analysis 
  • IFU / Labeling Validation
  • Summative Usability / Validation Testing
  • HFE Reports for FDA Submissions
  • Responding to FDA Deficiencies
Other Services
Clear Filters
Collaborative and Concurrent Engineering Evolution Results in Outstanding Product Solutions

BH’s design engineering team work closely with human factors and user-experience members to fully understand the product vision as interpreted through powerful user-studies, respecting evolving innovation and product differentiation strategies. The combined team balance all desired project goals to determine the best system solutions that will ultimately drive the success of the product in its defined market.

Delight End-Users by Developing Control Interfaces that Understand their Needs at every Level

Superior user-experience relies on the successful integration of industrial and UI design, whereby all aspects of the user interface are thoughtfully and elegantly executed, resulting in efficient and accurate device operation. BH’s UI designers work closely with their ID and systems/software teams to embrace advanced technologies and control features that are logical, attractive, reliable, and highly efficient.

Interpreting User-Research into Powerful Product Concepts

The industrial design process considers and integrates system-level architecture into a variety of mechanical concepts to explore the best-balanced solution that addresses user-needs, while optimizing the workflow experience through intuitive functionality, passionate aesthetics, and pragmatic efficiency. At BH, our designers are experienced in defining the best approach to mechanical layout, materials, finish, and methods of assembly that ensure ease of use, service, manufacture, and sustainability at the lowest unit cost.

Consistent User-Needs Discovery Informs the Design Process

Conducting relevant research with all intended end-users at project inception is vital to fully understand market requirements, operational safety, and functional specifications. BH identifies and interviews all user groups to better understand the entire workflow spectrum, ensuring a holistic approach to defining design inputs, evaluating performance criteria that ultimately drive successful product validation.