The companies that tried to enter the business were drug companies, not device companies. No expertise in volume manufacturing of medical-grade injection-molded plastic devices. There are companies which can do that.[1] There are automatic inspection technologies which can detect even minor flaws.[2] But the typical injection molding vendor isn't that good.
Consider the typical failure rate of ball-point pens. That's consumer-grade injection molding.
It sounds like it's harder than we might think to make this work.
Given that, and the low volumes, it might not be that profitable even at $600 per sale.