As a previous Senior Policy Advisor at the FDA, as well as a seasoned leader within the CRO industry, Sugato has cultivated expertise in a plethora of regulatory pathways, including dossiers for combination products, expedited pathways, protocol development for medical devices, and more. During his 11-year tenure with the Center for Devices and Radiological Health (CDRH) at the US FDA, Sugato developed specialized expertise in drug-device combination products, digital health technologies, and critical care medicine.