And on R&D; the QC bar for software and manufacturing is much higher. Every process has validation testing. So it is expensive both in R&D and manufacturing. A

And on R&D; the QC bar for software and manufacturing is much higher. Every process has validation testing. So it is expensive both in R&D and manufacturing. Another thing is that these off the shelf CGMs don't really differ in quality to their prescription only counterparts, which have a pretty extreme risk profile (patient death or hospitalization if it spits out the wrong number). They use the same parts so those costs are inherited.