One Seat Decides When Your Medtech Startup Crosses the Valley of Death
The global regulatory landscape for Software as a Medical Device (SaMD) has reached a definitive inflection point as of March
Kalpesh Hegde
August 19, 2026
The global regulatory landscape for Software as a Medical Device (SaMD) has reached a definitive inflection point as of March
The global regulatory landscape for Software as a Medical Device (SaMD) has reached a definitive inflection point as of March
Every few weeks someone in my field publishes a post arguing that Quality and Regulatory is not a cost center,
Preventive health is having its moment.
Full-body MRI. Genetic risk profiling. AI-assisted vascular analysis. Multi-cancer early detection. All of it
The gold standard of molecular diagnostics is undergoing a fundamental phase shift that renders the traditional laboratory model obsolete. As
We are moving away from devices that demand our attention and toward those that support our intention. The most productive