I led human factors and UX activities for the CareLink SmartSync MRI Access Application. This Class III medical device is an app and hardware system allowing clinicians to check and control settings for cardiac medical devices, such as implantable pacemakers and defibrillators. These activities included:
My goals were to create an intuitive user experience with minimal safety risks to patients and clinicians, improve the MRI patient care pathway, and achieve compliance to US and international regulatory standards.
The Premarket Approval (PMA) supplement for this system was approved by the FDA on August 16, 2021.
Prior to this role, I led human factors testing and supported design for multiple releases of a similar system, the CareLink SmartSync Device Manager. While I cannot share details about the system’s functionality, screenshots of the iPad app can be found on the Apple App Store.