[giantg2]

It's mostly because my young kid has SVT and it would be useful to stick on a monitor occasionally to see if there are brief breakthrough episodes evading our periodic pulse checks. Of course they have monitors to do this already, but they are very expensive even for short uses and this use case wouldn't need as much detail or sensitivity.

[rnavara]

Sorry to hear about your kid, SVTs can be tough. May be worth asking your pediatrician about other options for monitoring that are suited for pediatric use!

[giantg2]

I actually have another idea for a medical device (different specialty). Do you have any advice or suggestions for someone like me (non-medical) to get started?

[Rssnkgp02]

Cool. I would recommend emailing a doctor in that specialty and asking them if seems like a good idea. Or alternatively, you could ask a bunch of patients to determine need for it based on their experiences. If it is something in pain management, I may be able to help.

[giantg2]

Thanks, I meant from a paperwork perspective, trials, etc. I know about the FDA website for medical devices. Not sure if there's anything specific to what is essentially lab equiptment interfaced with a cell phone (not patient worn or anything). So I'm just guessing, but I would think approval and testing would be easier for say a home pregnancy test vs a ECG.

I've already validated that the idea would be useful. There's a potential annual patient population of around 7 million people in the US. Even at 10% adoption, that could be revenue of $100-200M with a conservative guesstimate profit margin of 10-20% at that level (variable costs are low, so that should be higher as it scales). Current price of testing is high enough that I think this device could fit into that range or under cut it, with a multifaceted improvement to patient experience. A brief search turned up no competitors.

Now I'm trying to decide if I should spend the money to build a prototype and file a provisional patent or not. It depends on exactly how expensive and lengthy the approval process is, how HIPPA might or might not apply, etc. The type of software it will require will also be a challenge for me since I've never made anything like this.