This insight brief outlines key considerations for designing medical device clinical studies across the pilot, pivotal, and post-market stages. It explains how each stage serves a distinct purpose, from early feasibility and safety evaluation in pilot studies, to demonstrating safety and performance in pivotal trials, and finally to real-world evidence generation and surveillance post-market. The brief highlights common design challenges, including defining appropriate endpoints, selecting suitable comparators, managing evolving regulatory expectations, and balancing scientific rigor with operational feasibility. It also emphasizes the importance of aligning study objectives with regulatory and market needs early in development. By connecting thoughtful study design to effective protocol d

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