I hope the incubator works but I'm not hopeful. Not only can you not sell it in the developed half of the world because getting XXX approval would cost million

I hope the incubator works but I'm not hopeful. Not only can you not sell it in the developed half of the world because getting XXX approval would cost millions. You probably can't sell it if your company is registered in the developed half of the world! Even if you have no intention of selling it in the US, just tell your US corporate lawyers that you plan on selling medical equipment anywhere and they will have kittens. You can sell it in the the 3rd world (sorry - human resource rich) countries but that means selling it either to a local government who will want a large payment of approval fees, - generally in cash. Or to a UN style inter-government aid agency which will want all the same sort of XXX approval as the FDA but also requires the same sort sort of cash 'consultancy fees' on the ground to actually get the stuff used. I was involved in a similar project to make wheelchairs for mine victims - it's legally a lot simpler to build and import/export the mines than the wheelchairs. The only way to get it used is to put the plans on the net and hope people build it for themselves.