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.
Proven Expertise, From Concept to Market
Our Usability Testing Addresses a Range of Seen and Unseen Risks
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
