In 2015, the Clinical Trials Transformation Initiative’s Quality by Design Project published their CTTI Quality by Design Project intended to “support proactive, cross-functional discussions and decision making at the time of trial development.” In addition to CTTI’s comprehensive set of recommendations, the MDIC Clinical Trial Design working group has created with some additional considerations for quality and efficient medical device clinical trials. This joint webinar provided an overview of both groups’ effort to promote clinical trial quality by design.