So can someone tell me - a non-insulin-dependent individual - why would an insulin pump need to be (controlled by?) a phone (in this case, the Nuu phone referenced)?

Surely there is a way to cheaply obtain bluetooth and a controller without saying "we'll just use this already existing hardware - that happens to be a whole-ass phone - because it's $5 from China"?

Kinda feels like that just screams data-stealing, regardless of where it was made.

Security… The PDM is walled off completely, it cant install apps, its not on wifi, you cant change any settings. The issue is that a PDM technically could easily kill you, by giving you a lethal dose of insulin.

Funny thing is that the newer Omnipod 5 from the same company works with regular phones now, but only in th US.

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.