Discover how the FDA's new guidance emphasizes human factors engineering in AI-enabled medical device softwares. Explore the role of usability in ensuring safety and innovation for AI-based submissions.

Discover the critical role of human factors in aligning FDA's EDDO guidance with real-world usability. Explore strategies for ensuring drug delivery devices meet both technical precision and user-centered design requirements.

Discover how balancing small and large sample sizes in human factors studies can enhance usability and safety in medical device and drug delivery device development. Learn the strategies to optimize evaluations for diverse user populations.

This article discusses the FDA's draft guidance on Use-Related Risk Analysis (URRA), highlighting its alignment with long-standing industry practices and the notable inclusion of drug products with complex regimens. Discover how this new guidance impacts human factors engineering in drug delivery medical devices and combination products.

User needs in prefilled syringes. How to define them. Case study

Critical role of user needs for developing patient-centered drug delivery devices.

Understand a practical example on how to create a task analysis for an auto injector.

Explore the critical role of Task Analysis in designing user-friendly and safe medical devices and drug delivery devices. This method helps identify potential use errors, optimize usability, and create intuitive interfaces, ensuring devices meet user needs while enhancing safety and performance.

Explore the evolution of human factors and usability in pharmaceutical drug delivery devices. This post highlights the role of user-centered design in ensuring devices are safe, effective, and tailored to patient needs. From FDA guidelines to global regulatory standards like IEC62366, it traces how usability testing and human factors have become essential in designing patient-friendly devices.

Explore the importance of using unbiased scripts in pharmaceutical human factors evaluations. Unbiased scripts help prevent leading participants toward unnatural behaviors, ensuring accurate and impartial results. This post covers best practices for creating neutral scripts, controlling bias, and ensuring scientific rigor in human factors studies, which are crucial for developing safe and effective drug delivery devices