STUDY OBJECTIVE: The Centers for Medicare & Medicaid Services currently endorses a door-to-balloon time of 90 minutes or less for patients presenting to the emergency department (ED) with ST-segment elevation myocardial infarction. Recent evidence shows that a door-to-balloon time of 60 minutes significantly decreases inhospital mortality. We seek to use a proactive risk assessment method of failure mode, effects, and criticality analysis (FMECA) to evaluate door-to-balloon time process, to investigate how each component failure may affect the performance of a system, and to evaluate the frequency and the potential severity of harm of each failure. METHODS: We conducted a 2-part study: FMECA of the door-to-balloon time system and process of care, and evaluation of a single institution's door-to-balloon time operational data using a retrospective observational cohort design. A multidisciplinary group of FMECA participants described the door-to-balloon time process to then create a comprehensive map and table listing all process steps and identified process failures, including their frequency, consequence, and causes. Door-to-balloon time operational data were assessed by "on" versus "off" hours. RESULTS: Fifty-one failure points were identified across 4 door-to-balloon time phases. Of the 12 high-risk failures, 58% occurred between ECG and catheterization laboratory activation. Total door-to-balloon time during on hours had a median time of 55 minutes (95% confidence interval 46 to 60 minutes) compared with 77 minutes (95% confidence interval 68 to 83 minutes) during off hours. CONCLUSION: The FMECA revealed clear areas of potential delay and vulnerability that can be addressed to decrease door-to-balloon time from 90 to 60 minutes. FMECAs can provide a robust assessment of potential risks and can serve as the platform for significant process improvement and system redesign for door-to-balloon time.