The regulatory approval pathway for a combination drug/device platform, with a automatic clinical decision component, is a nightmare. Assume one did create the

The regulatory approval pathway for a combination drug/device platform, with a automatic clinical decision component, is a nightmare. Assume one did create the device, and got it to work across a wide patient population with varying diets, disease severity, treatment responsivity, etc., and then (somehow) got approval for it. Existing insulin pumps are already challenging to get reimbursed under insurance, and they have a more straightforward regulatory approval path with lower R&D costs. The super pump would need to be reimbursed for quite a bit more money to justify the increased R&D costs. That is going to be a very hard sell under quality of life improvement alone—clinical data showing an improved patient outcome or decreased long-term healthcare costs is what is needed. You're benchmarking against existing pumps with separate monitors, which sets a high bar.