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

Wherever you are in your process, Ximedica can help.

contact us

At Ximedica, our people define who we are.


More About Our People

Rebecca Huebner

Rebecca Huebner

Human Factors Engineer

David Copeland

David Copeland

Director of Human Factors Industrial Design

Tim Clarke

Timothy Clarke

Mechanical Engineer

Bill Kane

William Kane

Principal Mechanical Engineer
Maria Swenson

Maria Swenson

Design Assurance Engineer
Hope Hopkins

Hope Hopkins

Director of Communications


Rhode Island

55 Dupont Drive
Providence, RI 02907

T: 401.330.3163
F: 401.626.3356


1000 Westgate Drive,
Suite 119A
St. Paul, MN 55114

T: 651.641.3600
F: 651.641.3601

Hong Kong

Unit 02A, G/F.,
Enterprise Place,
5 Science Park West Avenue,
Hong Kong Science Park,
Shatin, N.T., Hong Kong

T: +852 2117 0991
F: +852 2117 0993

Or contact any of our locations by email.

Certification Information

Certification Information

Ximedica is ISO 13485:2012 Certified and FDA Registered. As a full-service development firm, Ximedica has an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.

ISO 13485 CertifiedNSAIFDA Registered
AdvaMed Code of Ethics SupporterWe self-certify compliance with
US-EU Safe Harbor Certification