Trend Alert: Evaluating and Improving Complex Medical Device Systems
Members of the Human Factors Cast Digital Media Lab attended the virtual run of the International Symposium on Human Factors and Ergonomics in Health Care 2022. One of the main themes that stood out to us at the symposium was a focus on how we can better evaluate and improve complex medical device systems. These systems range from those used in hospitals to homes to wearables and multiple-use environments; systems millions of people use daily and are becoming more common as technology advances.
Complex Systems Presentations
Several presentations focused on how to evaluate and improve complex medical device systems:
Human factors (HF) engineers from Medtronic and Cambridge Consultants presented “Conducting and Reporting a Summative Validation on a Complex System, with Participant Teams, in Record Time - DURING A PANDEMIC,” in which they discussed how complexity influenced their study, how they collected study data while working with surgical teams, how they integrated input from non-HF practitioners, and how they developed a method to test and report at the same time.
UserWise, Inc., HF engineers presented on “Use-Related Risk Analysis of Complex Interconnected Medical Devices.” Topics covered included the inputs of use-related risk analyses (URRAs) for complex interconnected medical devices, relevant regulations, current standards and guidance, best practices, and helpful hints.
Orthogonal presented “Accelerating the Continuous Improvement of Existing Connected Medical Devices Using Product Analytics.” They examined how product analytics can be applied to the use of Software as a Medical Device (SaMD), digital therapuetics (DTx), and connected medical devices, determining that product analytics can contribute to continuous enhancement, device operations, end-user support, and improved health outcomes.
A breakout panel discussed “The Human Factors of Connected Devices.” The panel focused on HF issues with connected drug delivery devices, including device design, user interfaces, best practices, testing, validation, and regulatory strategy.
While each presentation had unique insights and perspectives, we pulled out some of the common themes and suggestions from them to make a list of things we should keep in mind when looking to evaluate and improve complex medical device systems:
- End-users will be varied: Think about every person who will be interacting with this system, then consider if there are ways we can group some of these users together without compromising our user groups
- There may be multiple use environments: Think about the lifecycle of the device (e.g. will it be reprocessed after use?) and the various settings in which it can/will be used (e.g. clinics, homes, wearable, mobile)
- Remember to include the fringe tasks: Fringe tasks are important to the proper functioning of the device (e.g. calibration, resetting the device, transferring information, charging), but may be forgotten when focusing on what we want the device to do
- Organize the URRA to best fit the situation: URRAs can be formatted differently depending on what we are evaluating. We can put all product components into one table, separate risk tables by the product components, or we can separate them by user group or use environment
- Itemize potential causes of hazard-related use scenarios: The hazard-related use scenario itself can initially be written broadly, then broken down into multiple possible root causes. By spelling out these potential issues, it can be easier to identify effective mitigation strategies
- Carefully consider how data will be displayed: Think about screen size, what users will want to identify from the data quickly, and the best way to display the data to be easily interpreted
- Keep the purpose in mind: Why are people using this system? Is the information we are providing them with helpful? We also need to determine early in the process if we want our system to provide therapeutic advice (e.g. “you have this condition”) and consider the impact of our system’s feedback on the user (e.g. will the data we share with a user scare or confuse them?)
- Ensure user privacy throughout the system: Data privacy and cybersecurity are major issues in today’s connected world. Remember to be mindful of protecting users’ data throughout the system to help boost user confidence
This is not a comprehensive list of everything we need to consider when evaluating and improving complex medical device systems, but it can be a good place to start.
Photo by Anna Shvets from Pexels (left)