COVID Testing Kit uFMEA Case Study

COVID Testing Kit uFMEA Case Study

COVID Testing Kit: uFMEA Case Study Overview Regulatory submissions for medical devices must demonstrate that use-related risks are identified, analyzed, and mitigated. Failure to sufficiently identify these risks can lead to use errors with real patient safety...
Safety and Satisfaction: Balancing Human Factors & UX

Safety and Satisfaction: Balancing Human Factors & UX

Safety and Satisfaction: Balancing Human Factors & UX By Gianna Maaddi In the world of product development, Human Factors (HF) and User Experience (UX) are treated as distinct disciplines. While UX is associated with digital delight, Human Factors is seen through the...
What Users Can Tell You Before Formal Validation

What Users Can Tell You Before Formal Validation

What Users Can Tell You Before Formal Validation For many medical devices, the first time companies hear from real users is after the product has already been designed. By then, the design is already too expensive to change. Early discovery research can be a...