Did you know that 60% of startups cannot survive beyond five years, and 75% will ultimately fail?

These failures frequently stem from late regulatory involvement, underestimation of remaining development work, and the compounding effect of early oversights.

To mitigate these risks, a structured approach is essential, emphasizing early and continuous regulatory engagement, meticulous documentation through a trace matrix to ensure cross-functional alignment, and a well-defined regulatory strategy that aligns with the chosen FDA pathway. Prototyping and manufacturing must be carefully managed, considering the impact of material and process changes, and prioritizing design for manufacturability.

Finally, a strategic commercialization plan, including appropriate sales strategies, a clear understanding of the target market, robust intellectual property protection, and adequate funding, are crucial for navigating the complex medtech landscape and achieving sustainable success.