I understand that in clinical development it is important to determine the potential value of a device or drug. How should the proposed value proposition guide or relate to design of clinical development path?
Recently, the FDA released a guidance document regarding Artificial Intelligence algorithms for comment. What is your thought on AI processes under FDA regulation? https://www.fda.gov/medical-devices/software-medical-device-samd/global-approach-software-medical-device-software-medical-device