The landscape for clinical testing of biomedical devices has evolved rapidly over the last 5-10 years. In particular, the use of advanced control algorithms, such as model predictive control, are now being reviewed by the FDA as components of closed-loop devices. In our work with the Artificial Pancreas (AP), we have developed master files and other supporting materials to support IDE (Investigational Device Exemption) studies. In this talk, I will share some of the challenges in developing algorithms for regulatory review, including the role of simulation studies, communication architectures, algorithmic design, and IDE studies. I will extrapolate from these experiences to project the opportunities for advanced control in pharmaceutical operations.
