Evaluating Medical Devices Remotely: Current Methods and Potential Innovations

Area of Science:

• Medical device engineering
• Human factors research
• Usability testing

Background:

• The U.S. Food and Drug Administration (FDA) requires human factors evaluation for medical devices.
• Remote testing yields comparable results to laboratory studies but is less common for usability assessments.
• Advancements in technology facilitate synchronous and asynchronous remote data collection.

Purpose of the Study:

• To review and describe existing remote testing options for medical device design and evaluation.
• To provide practical methods and tools for conducting remote research.
• To guide the selection and combination of tools for valid remote medical device testing.

Main Methods:

• Systematic review of remote evaluation methods for medical devices, including label testing, instruction verification, and usability assessments.
• Coding of reviewed methods based on essential attributes for usability studies, such as supported media.
• Development of a framework to aid in selecting appropriate tools for specific research goals.

Main Results:

• Examples of adapting existing medical device usability studies for remote data collection were presented.
• Novel systems, including 3D printed and virtual prototypes, were introduced for remote testing.
• Guidance on targeted participant recruitment for remote studies was provided.

Conclusions:

• Remote testing presents both opportunities and challenges for medical device evaluation.
• Current remote methods are generally adequate for most medical device testing needs.
• Validation of high-risk Class III medical devices using remote methods requires further investigation.