From Concept to Clinic in Four Months: Accelerating a Wearable Combination Product Through Integrated Device Support

Getting a novel wearable combination product from development into clinical trials is rarely a straight line, and compressed timelines only raise the stakes. This session presents a case study of how one pharma company moved a wearable drug delivery device into clinic within four months, supported by integrated device engineering, regulatory submission readiness, updated quality management processes, and a clear device roadmap built to align technical, regulatory, and business priorities.