Case Study: Advanced Complaint Handling Automation at Medtronic

In September 2023, Medtronic and the MDIC Advanced Manufacturing Clearing House launched a pilot in collaboration with the U.S. Food & Drug Administration (FDA) to evaluate and define conditions where advanced technology can be effectively and compliantly incorporated into the processing of medical device complaint records. Specifically, Medtronic targeted the implementation of Generative Artificial Intelligence (AI) technology coupled with rule-based automation for the pilot. Historically, the complaint handling process at Medtronic has been almost completely manual, from the initial intake of the complaint through complaint closure. Through this pilot, Medtronic identified areas where advanced technology could assist in data entry, summarization, and process recommendations, enabling complaint handling specialists to focus their efforts on critical analysis and the more complex tasks. This report summarizes the collaborative work between MDIC, FDA, and Medtronic to successfully design and implement compliant use cases of Artificial Intelligence in complaint processing and the lessons learned as a result.