Human Factors Engineering (HFE) and Usability Testing for IVDs

Good ideas become best-selling devices when usability is put front and center. TE Connectivity helps IVD manufacturers optimize their underlying technology and reduce overall risk by making sure the user experience is seamless and safe while meeting FDA HFE requirements and international guidelines such as IEC 62366-1 and IEC 60601-1-6.

Usability Engineering for Point of Care and Other Life Sciences Devices

As a developer of microfluidic cartridges and associated instruments, TE works with manufacturers to plan and design for ease of use, reliability and safety right from the beginning. We regularly conduct design audits, evaluate prototypes and perform heuristic analyses on a wide range of devices. Because we have extensive in-house engineering and prototyping capabilities, we can iterate and test preliminary designs quickly, allowing us to get to final form faster. 

Our Usability Testing Addresses a Range of Seen and Unseen Risks

Risk reduction is an important benefit of human factors engineering. The TE engineering and usability teams work together to ensure your device is safe and intuitive to use. Doing so lowers your risk, streamlines the regulatory approval process and keeps you in compliance with design control requirements.

As part of our standard process, our team follows FDA Human Factors guidance and IEC 60601-1-6, if applicable.  We look at all aspects of the user experience, including physical risks and psychological-based barriers to use that may not be anticipated.

User Risks

  • Device exceeds physical or cognitive
  • Abilities of user
  • Non-intuitive use of the device
  • Use environment prevents proper use
  • Anticipated
  • Inappropriate use



Device Risks

  • Physical hazards
  • Mechanical hazards
  • Thermal and electrical hazards
  • Chemical hazards
  • Biological hazards
  • Cross
  • Contamination hazards


Human Factors Validation Testing

Testing your device with actual users of the device in real-world conditions is a critical aspect of validating the design. Our on-site facility includes an observation room with multiple high-definition cameras. You can witness tests performed on your device in person or remotely via a secure web link. We recommend clients do so as there is so much to be learned from seeing your device used firsthand. If you are modifying a device, we can help you determine which tests to perform based on your risk analysis.

Proven IVD Expertise, From Concept to Market