[rcxdude]

It's a relatively low volume, customised product, likely with high development costs (even if it doesn't fall under medical device regulations, making something battery- powered that you stick in your mouth is gonna need a good safety case). It's also very valuable to those who use it, so the market can support the high price needed to cover development (the per unit costs are likely much smaller: note you can buy two for nearly the same price as one).

[ktallett]

They definitely need to follow regulations as otherwise this misses the entire market that it's aiming at. You are far better of incorporating this into medical settings than just people with disabilities and disposable income.

[rcxdude]

For devices like this it's not super obvious how well the tradeoff works: the cost of development can multiply, even if the sale price to the insurance companies can go up correspondingly. There's a growing trend of companies developing assistive tech that is affordable without insurance, specifically because the overhead that is added by the insurance and medical device development process is so large (and often questionably valuable to a lot of patients).

[ktallett]

I'm not exclusively suggesting the US market. I'm suggesting the rest of the world where you can get a contract and sell in bulk to national healthcare. Whilst I do agree that there are a few companies like this, the negative is discovery and these being unavailable to people who are tech illiterate or unable to set it up which in this case is a significant number. Considering how useful it could be for people with significant paralysis, having a device that your health are provider can't recommend, aid you with, etc would be infuriating.