Ximedica

Human Factors Engineering

Human Factors Engineering

Our Human Factors Engineering team applies their robust knowledge of the areas of ergonomics, human cognition, and human perception to determine use errors and identify risk scenarios.

Usability & the FDA

Governing bodies like the FDA require that usability be incorporated into the development of medical devices. By rigorously following industry standards like HE75 and ISO 62366, we incorporate human factors throughout our development process ensuring all devices are developed for safe and optimal use, meeting regulatory submission requirements.

Our Team Members aren’t just familiar with HFE Guidances and standards, they author them.

Our Human Factor’s team is comprised of human factors experts who hold advanced degrees in Kinesiology, Cognitive Science, Psychology, and Biomedical Engineering with backgrounds in academia and Fortune 500 companies. In addition we are active voting members of AAMI and other industry associations.

Human-Centric Design

We understand Human Factors is more than usability testing and regulatory requirements-it’s about designing for the user and for market acceptance. Our Human Factors activities minimize use error, mitigate risk while also ensuring the device is satisfying to use and trust in the device is built.

Ximedica’s tested and proven human factors processes utilize the following activities and tools:

  • Determine user profiles & use environment profiles
  • Task Analysis
  • User Needs Assessment
  • User Error Identification
  • User Error Analysis/UFMEA
  • Formative Studies
  • Validation Studies

 

Related Resources

Wherever you are in your process, Ximedica can help.

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At Ximedica, our people define who we are.

More About Our People

Lenny Nemiro

Lenny Nemiro

Senior Manufacturing Engineer

Cahalan Sullivan

Cahalan Sullivan

Manager, Business Development & Operations Support

Faith David-Hegerich

Faith David-Hegerich

Senior Mechanical Engineer

Ken Baker

Ken Baker

Principal Systems Engineer

Jeffrey Wallace

Jeffrey Wallace

Program Manager

Dave Copeland

Dave Copeland

Director, Human Factors Industrial Design