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
Like what you see?
Drop us a line and find out how we can help move your business forward.

Related case studies

Dexcom in use cropped touch up
Dexcom G6
While users of the Dexcom system greatly valued its enhanced ability to monitor their glucose levels, applying the subcutaneous Dexcom sensor to their bodies was an obvious pain point that was a barrier to wider adoption.
06 Work Case Study Pro Nova H1 @2X
ProNova SC360
Imagine being strapped into a large machine, completely immobilized, for an hour while it delivers high doses of radiation to treat your cancer. Imagine doing this daily for up to six months.
06-Work-Case Study-Bioventus Exogen-H1-1186x667 @2x
EXOGEN® Ultrasound Bone Healing System
EXOGEN® is the only FDA-approved bone healing device that uses ultrasound to stimulate the body’s natural healing process. Therapy is performed at home by the patient in a simple process that takes 20 minutes a day.

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
06-Work-Case Study-Diversey ProSpeed-S1-667x667
The role of human factors in product design
A primer on what, how and when the discipline of human factors is used in the design and development of products.
06 Article Amrish No Threat H1
Designing systems instead of assigning blame
In the immediate aftermath of any newsworthy accident, we often hear the words "human error" or "user error".
01 hero 1
Countdown to MDR: Are You Ready for the New EU Medical Device Regulation?
How does the new EU Medical Device Regulation relate to human factors and usability? It depends if your medical product is existing or new.
Like what you see?
Drop us a line and find out how we can help move your business forward.