Human Factors Engineering

Human factors expertise embedded in the product development process, from start to FDA approval
Human factor engineering research
Medical device design is complicated
Developing a medical device is one of the most risk-filled endeavors a company can undertake.

To mitigate those risks and clear the regulatory hurdles, human factors engineers must complete rigorous formative and validation (summative) studies. We provide expertise early and at key points in the development process based on deep medical device design experience in:

  • Contextual inquiry
  • Definition and HF documentation
  • Formative and validation studies
  • Design validation studies
  • HFE/UE reporting
  • And more
Human factor designed pieces on a board
We bring an approach beyond traditional human factors product development
At Delve, we integrate human factors throughout the design process.

With experience in industrial, mechanical, biomedical, psychology, neuroscience and instrumentation engineering, HCI and interaction design, we are comfortable working with designers and engineers throughout the development process.

The process creates devices that are lower risk, cost less to develop, and are ultimately more human-centered to engender brand love and loyalty.

Delve human factors engineering services lab
Are you ready for the FDA?
The FDA expects a certain level of Human Factors work. Not having it will cause costly delays.

We can create documentation for your FDA submission, and you can even use our quality management system. We adapt our multidisciplinary process to the standards your project needs to demonstrate to the FDA that your device is safe for clinicians and patients, including:

  • ISO 13485
  • ISO 14971
  • ISO 11226
  • AAMI TIR 59
  • IEC 62366
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Drop us a line and find out how we can help move your business forward.

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Our Human Factors Engineering Team

Our Human Factors Engineering Services

  • Contextual inquiry (ethnographic research)
  • Task analysis
  • Workflow and experience mapping
  • Literature searches
  • Anthropometric studies
  • Form studies
  • Concept development
  • Heuristic evaluation
  • Digital interface information hierarchy and information architecture
  • Digital interface wireframing
  • Concept preference testing
  • Use error risk analysis
  • Formative usability studies
  • Validation usability testing
  • HFE/UE Reports for FDA submissions
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A primer on what, how and when the discipline of human factors is used in the design and development of products.
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