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Karl Sanford4-Sep-12 10:21
professionalKarl Sanford4-Sep-12 10:21 
Not to kick you while you're demotivated, but, there are some big challenges ahead of you. I tried to do some similar product ideas in the health arena, and there are two things that will quickly become the bane of your existence. Just wanted to share these with you so that you don't get surprised later on:

1) FDA Medical Device Clearance: If it's a device, and used in health care, chances are that it needs some type of approval/clearance. If it touches a human in any way (like blood pressure, EKG's, etc) you are guaranteed that you will need approval before you can sell or make claims. Here is a resource to help: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm[^]

2) Health Insurance Payment Authorization: If Doctors/Nurses can't charge it back to an insurance provider in some way, good luck getting them to use it. First, you will need the FDA approval on the device. Then, you will need to hunt down people who can make these decisions (if they actually exist). Many of them will say that they just follow medicare payment guidelines for DME (durable medical equipment) payments. So then you try to get a determination from CMS (center for medicare/medicaid services)... HA! Then, you will need to make your case as to why your device is better than all the rest, and how it will improve patient outcomes. To do that, you need clinical studies... to do that, you need doctors interested in actually being a part of the research (it is quite a commitment), then you will need funding for the research, so you begin writing a grant proposal. Then, you will need to buy a wig because you have pulled out all of your hair.

Also, on the payment front, if you try to make the argument of physician oversight billing for time spent reviewing results from the device, you may be out of luck. Physician oversight payments for tele-health are pretty restricted.
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QuestionCollaborate on a business rule application Otherwise advise on the idea Pin
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GeneralSide project for fun Pin
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QuestionCare to give this a spin? Pin
Ravi Bhavnani21-May-12 16:34
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QuestionLooking For Development Partner Pin
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