Innovation in the medical device industry is both essential and challenging. True innovation must begin early, be structured and strategically managed, and consider regulatory feasibility from the outset. Time-to-market must be treated as a critical design constraint—not an afterthought. By integrating compliance expertise into innovation workflows, leveraging digital tools, and fostering cross-functional collaboration, MedTech companies can reduce development time and accelerate safe, effective, and user-centered products to market. Innovation and speed are not mutually exclusive—they are two sides of the same competitive edge. This chapter illustrates why time-to-market is critical to the economic success of medical device manufacturers and outlines the key factors necessary to achieve this objective. Practical examples are provided, focusing on the dimensions of “innovation” and “speed to market.”