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(In the US) If you make a medical device paid for by Medicaid, you have to have FDA approval. Which honestly, now may be the time to try and get it?
So specifically I was thinking of adaptive furniture. There's special programs in some states for folks with long term disabilities to help with purchasing adaptive furniture. Think restraints/locks/alarms for things that a cognitively impaired person might need, such as if they get up in the middle of the night, or door alarms and the like.
For a real world example, my youngest was diagnosed with level 3 autism. Because of his diagnosis he qualifies for our states Medicaid expansion which is intended to cover all of the random costs of having a special needs child that normal kids wouldn't cost, like door alarms, a fridge lock or we almost had them pay for putting a fence in our yard because he tries to run when outside. We were looking at what could be described as a crib for kids too big for a crib, and all of the options cost a minimum of $10k and a median of about $20k. That would be an extremely easy market to disrupt with a lower cost solution since I highly doubt it actually costs anywhere near $10k to make such a bed
What I'm saying is that adaptive furniture is likely a registered class II medical device which goes through FDA approval. So the bed isn't 10K, but (a portion) the FDA registration is. The consequences of failing to register something that qualifies as medical devices are 1) fines 2) payments to anyone harmed and/or 3) time in federal prison.
Sure you could easily "disrupt" the market, but the market could easily disrupt the rest of your life.
Restraints are 100% a medical device and I would highly doubt you would either be allowed to purchase or be reimbursed for one that's not approved.
Edited to add: https://www.registrarcorp.com/blog/medical-devices/medical-device-registration/fda-class-ii-medical-devices/ A quick explainer (marketing from a business that helps companies register devices) since the FDA website is ... not super clear nor helpful.
Huh TIL thank you