Within the complex and dynamic ecosystem of medical device development, innovation cannot advance without a solid and timely clinical strategy. This Focus explores the crucial role of Early Feasibility Studies (EFS), preliminary clinical investigations that allow the assessment of a technology’s initial feasibility and safety in a limited number of patients.
Through a detailed analysis, the document explores how EFS are not merely a procedural step, but a true strategic lever for manufacturers. They enable the collection of early, essential data to optimise device design, accelerate development timelines (go‑to‑market), and mitigate clinical and regulatory risks.
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