Comment by mlsu
17 hours ago
Until recently, if you offered a pump that _could_ be controlled by another device (such as a phone) you would have to offer your own "controller" device, even if 99.9% of your customers have a phone already.
So, this companion device is kind of a thing that Insulet had to release. You'll see this with CGM's too -- there's a small companion device sold with the Dexcom G7 (the "controller"), even though everyone just uses their phone.
This is kind of a regulatory quirk; basically from the FDA's point of view you had to have a complete standalone system, that did not include the phone, in order to be able to prescribe it. I think they do not require companion devices any more, it's OK to release something that requires the user to have a phone.
So essentially, it's like this?
"we plan on users having a phone to connect to it and use primarily. FDA requires a primary/backup. well it's already phone-controlled, go find a phone that works with it. needs to be cheap, cuz no one will really use it anyway"
That makes a little more sense. I was imagining the development process involving both devices, rather than one device first, then determining what the second would be later.
Thanks for the insight!
Its also for security.. outside the US, you still cant use a regular phone with the omnipod.