Every year, the FDA authorizes more than a thousand new medical devices. These innovations represent significant progress in healthcare technology, offering new solutions for diagnosis, treatment, and patient care. Small companies drive the majority of this innovation.

However, few of these reach technologies reach low and middle-income countries. This gap is not due to a lack of intention from companies or capability in these regions, but rather stems from complex factors including regulatory challenges, market access limitations, and resource constraints. Bridging this divide is crucial to ensure that the benefits of medical innovation reach all corners of the globe, ultimately improving healthcare outcomes and saving lives worldwide.