FDA clearance is a real pain. I spent some time at a medical device manufacturer and saw very long cycles from R&D to FDA clearance. I see their point about th

FDA clearance is a real pain. I spent some time at a medical device manufacturer and saw very long cycles from R&D to FDA clearance. I see their point about the high average cost of most medical devices, but I'm interested in why they started out with an infusion pump... that market is pretty competitive, even in the low-cost segment.