HUMAN FACTORS AND MEDICAL DEVICES
According to the FDA’s “Applying Human Factors and Usability Engineering to Medical Devices,[1]” human factors engineering is the application of knowledge regarding the behavior, abilities, limitations, and other characteristics of medical device users and how that affects the design of medical devices. In the development of medical devices, considerations in three major components of the device and user system determine if there is a use error or if it will serve its correct use: the users, the device use environments, and the user interfaces. In order to ensure a medical device is operating as intended, companies must monitor the following: device components, product setup, user interfaces, documentation and user workflow. If a device functions as intended but is prone to user error in operation, or has inherent design flaws that are not optimal for specific use cases, this could put patients at risk.

Importance of Human Factors in Product Development
Why Implement Human Factors Testing
• Easier device maintenance and repair
• Reduced need for user training and retraining
• Minimal risk of use error
• Reduced risk of adverse events
• Reduced risk of product recalls
How to Implement Human Factors Testing
How Can Human Factors Affect My Custom Connector or Cable Assembly
• Safety mechanisms (i.e. proper shielding to eliminate risk of shock, or electrical interference)
• Optimal cable size and length
• Material characteristics (i.e. flexibility and stretch to prevent use fatigue)
• Operator error due to device positioning in treatment locations that may have space or layout constraints.
[1] Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff. FDA Publication February 3, 2016.
