Conquering the Human Designing Medical Devices for How People Actually Think

Medical device safety depends not just on how devices are designed, but on how people behave under real-world conditions. This session examines universal human cognitive traits including attention limits, expectation bias, memory constraints, and time pressure, and their role in use-related risk. Drawing on cognitive science and clinical examples, it makes the case for design strategies that go beyond training and labeling.

Key Topics Covered:

• The distinction between user-centered design and human-centered design

• Common cognitive biases and performance limitations relevant to medical device use

• Why training and labeling are insufficient controls for many use-related risks

• Design strategies to prevent, reduce, or mitigate the consequences of human error

• Implications for human factors validation, risk management, and regulatory submissions