HUMAN FACTORS AND MEDICAL DEVICES
According to the FDA’s “Applying Human Factors and Usability Engineering to Medical Devices,” 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.
Global Interconnect, Inc. (GII) has engineering expertise in the design, development and quality testing of wiring, cables and connectors. Our full regulatory capacity and Chief Medical Officer allow us to assist in optimal design and regulatory strategy surrounding these critical device components. In addition, GII vertically integrates with product manufacturing to ensure quality workmanship to design specifications. With this expertise and feedback throughout the full product life cycle, GII can anticipate issues and design around them for optimal component design and manufacture. Global Interconnect can assist in product design to optimize product features and specifications. A product optimally designed for use with inherent safety should result in increased product safety, market adoption, and sales.
Steven S. Brooks, MD MBA FACC
Chief Medical Officer
 Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff. FDA Publication February 3, 2016.