While the Predetermined Change Control Plan (PCCP) framework for making changes to medical devices was highly anticipated, many regulatory and medical device manufacturers have opted ‘no thanks’ given the immense upfront overhead of predicting the future of changes and how to validate the future changes after launching AI/ML devices. Instead, companies are sticking with locked algorithms and updating them through submission or choosing a Special 510(k) submission for updates to the AI models or AI/ML product changes. There are situations when a PCCP is appropriate, but this article will suggest some approaches to following the intentions of the PCCP while focusing on some ‘gems’ of engineering activities that should be a priority to overall product success.