It actually does, but in a measured way. You have to have a hybrid approach. Agile for stuff like little software features and bug fixes, waterfall for big im

It actually does, but in a measured way. You have to have a hybrid approach. Agile for stuff like little software features and bug fixes, waterfall for big important (often safety and effectively tied) milestones they often precede an animal or human study. Iterate the smaller less safety critical features (which are often software based) and then align the exit of one of those phases with a hardware freeze that captures key safety and effectivity in the hardware and then do a cadaver, animal or human study to prove it. You don't want to apply agile to the hardware usually.