The Complexity Threat: Why Medical Device Teams Need a New Approach to Product Requirements

New technology development in the medical device arena has led to increasingly complex new products. This trend will likely increase due to the increasing market of IoT, SAaMD (SW as a medical device), AI, Health Apps, etc. With increasing complexity comes the advent of errors and device failures. This industry trend is evidenced by an increase in product recalls and security issues. Projections indicate that both the frequency and severity of these problems will continue to rise.