When it comes to medical devices, the primary goal of a usability study is to observe user interaction with the investigational product to help ensure developers are building a safe and effective device for the end user. Taking into account the human experience, related capabilities (e.g., physical, sensory, emotional, intellectual) and environmental factors during use as well as device interface design, MMI usability studies help determine how easy the device is to use for the patient. With a growing number of patients now managing their heart health at home with cardiovascular (CVD) medical devices, it creates a significant need for developers to better understand if the device can ultimately be used as intended by patients with safety, effectiveness, ease-of-use, and user satisfaction always in mind.

In this white paper, we will outline:

• How MMI usability studies help account for the human experience
• Key differences between usability studies and clinical studies
• Considerations for usability study design and execution
• Benefits of conducting usability studies for CVD medical device developers