Optimizing Human Factors Testing: Engaging End-Users in Medical Device Development

The integration of human factors testing as part of regulatory compliance in healthcare is essential for ensuring the safety and effectiveness of medical devices. This presentation discusses the significance of human factors in the development of medical devices by illustrating how important it is to incorporate the end users in the device development process.

First, the challenges participants face in real-world settings are discussed and how we can handle them during evaluations. Participants might face feelings of anxiousness or judgement, especially if they are struggling to complete a task. This can lead to incomplete or inaccurate test completion which can negatively impact the accuracy of feedback. An effective way to combat this is by making them feel comfortable during all steps of testing.

It is also important that the simulated environment closely resembles the real world. We want to make sure we set the testing space up to be as realistic as possible so that HCPs and patients are in a similar mindset to what they will be when using the device in the real world. But, if the participant is overwhelmed by the evaluation and environment because there are cameras, microphones, and multiple observers in the room, it will be harder to gain any usable feedback. Therefore, this presentation will offer strategies to optimize the testing process to overcome these barriers, including fostering a supportive environment that encourages open and honest feedback.

Next, we consider optimizing the overall process from recruitment through testing from a human factors lens. HCPs are often busy, while patients with certain conditions can be hard to find. Because of this, it is crucial to make the most of the time available with them during the study and plan for both the best and worst-case scenarios that could occur at any part of the process. Detailed scheduling, contingency plans, and clear instructions can help manage the process.

Lastly, to ensure HCPs and patients wish to be part of future user testing, it is essential to convey the significance of their input for improving device design and, ultimately, patient safety. This can be achieved by providing feedback on how their insights have directly influenced design changes and improvements. By keeping them informed, interested, and engaged, HCPs are more likely to view their involvement as an essential part of their professional role, rather than as another task to add to their list of responsibilities. Similarly, patients can feel empowered that they are helping to pave the path for their treatment plan and helping other patients along the way.