In February 2016, the FDA released a guidance entitled, “Applying Human Factors and Usability Engineering to Medical Devices.” The intention of this document, in combination with IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices, is to maximize the safety and effectiveness of devices for intended users, use and use environments. Its purpose is to direct manufacturers to ensure their device user interface has been designed in a manner that will either eliminate or reduce use errors to the greatest extent possible by taking the user, user interface and use environment into consideration during design and development.
Human Factors Engineering applies the knowledge of human behaviors, abilities and limitations to the design of the medical device interface. To get a handle on Human Factors Engineering, which you might also hear referred to as Usability Engineering, there are a few terms you should be aware of:
- User Interface: includes all parts of the device a user will see, hear and touch, including packaging, labeling, training, physical controls and display elements
- Use Error: a user action – or lack of action – that was different from what the manufacturer expected and could result in harm
- Critical Task: a task that, if performed incorrectly or not at all, could cause harm to the patient or user
The FDA is now requiring several types of device manufacturers (as described in the FDA draft guidance, “List of Highest Priority Devices for Human Factors Review”) to conduct Human Factors Validation Testing. As an industry, we will see an increasing number of manufacturers required to conduct these studies, especially as more devices are available for home use and integrating software for more complex user interfaces.
That being said, many device manufacturers are not required by the FDA to conduct formal Human Factors Validation Testing, but they may still wish to consider it for their product. Human Factors, particularly usability relating to task efficiency and user satisfaction, can enhance a medical device’s commercial success. In simpler terms, people prefer to use products that are easier and more enjoyable to use. Business benefits of Human Factors Engineering include:
- Reduced time to market because user interface design shortcomings are identified and addressed early on
- Improved regulatory review times because submission packages are convincing from a usability perspective
- Increased sales because devices can be marketed as “user friendly”
- More effective training because devices are more intuitive
- Reduced demand for customer support because devices are easier to operate and trouble shoot
- Improved patient treatment compliant rates
- Increased use of features
- Reduction of adverse events and potential reduced risk of product recalls
Many of these benefits occur because of user feedback that has led to improvements to the device user interface. Following an iterative user interface development process that includes receiving feedback from user groups, design evaluation, prototyping and usability can lead to an effective and pleasant user experience. For manufacturers who are not required to conduct formal Human Factors Validation Testing, processes can be combined. For example, risk related to use errors can be combined with the Risk Management File created for IEC 60601-1 compliance. Depending on the device, Human Factors Validation Testing could be combined with the execution of software validation. And, if a clinical study is being conducted, human factors could be performed simultaneously.
The most difficult aspect of Human Factors Validation Testing is knowing the extent to which it needs to be conducted at the various design, development and commercialization phases, especially when you are challenged with limited resources. At MethodSense, our regulatory, human factors and marketing experts can walk you through the necessary steps for deploying successful human factors testing, so your device can reap the commercialization benefits.