The most compelling reason for robust remediation processes is straightforward: patient lives depend on it. Medical devices that malfunction, contain design flaws, or develop unexpected issues can cause severe harm or death if not promptly addressed.

An effective remediation system catches problems early, minimizing the window of potential harm.

When promising medical device ideas are abandoned due to market barriers, the true cost extends far beyond the immediate financial investment and regulatory burdens. Patient lives that could have been improved or saved are affected.