First, you will need a products liability policy. Insurance is costly for any medical device if you are operating in the USA. Depending upon the nature of the device, premiums can run anywhere from $5,000 to $10,000 per year just for General Liability. If excess coverage is needed it may cost even more. Products Coverage will be required if you plan to distribute through any medical office or distribution channel. This would also be a requirement for a health insurance company to approve and pay for it’s use. Get a quote at Built Around your Needs and Requirements
Second, getting it covered as an approved medical device through health insurance so customers may use it a little or no cost. In the USA it would require FDA approval, there are many companies that offer this service to assist you. Also partnering with a Doctor who is in the field of practice where your device will be used.