The FDA might shut down the independent App developers but I don’t think the would shut down the Apple Watch for being able to run those Apps.
These studies cost tens or hundreds of millions of dollars, take months or years to run, and then the process of getting the FDA to approve your product takes more millions of dollars and more years.
I don’t think a breast cancer screening study would cost hundreds of millions.
You could go to a hospital that does breast cancer screening and let every patient scan themselves with a device while they are in the dressing room.
Then you can gather the statistics of whether the software can reliably produce the same diagnosis as the existing technology.
This is entirely incompatible with quickly evolving technology in a market with many small / new players trying out various ideas.
Yes. Especially at the beginning you would have most of the software being developed by the company who sells the device. Business wise that means it might be very worthwhile for a company who develops this technology because they might have a monopoly on the marketplace.
I don’t think a breast cancer screening study would cost hundreds of millions.
That’s the wrong analogy; we’re talking separately selling a device that tells you some metric, not a diagnosis like breast cancer. So presumably you have to compare it against some existing way to measure that metric.
I don’t know how much testing & FDA approval normally costs for nontrivial “metric only” devices (e.g. glucometers), but on the outside view, I doubt it’s cheap as you say, because everyone in the system has incentives to raise the price, just like for drug trials.
Especially at the beginning you would have most of the software being developed by the company who sells the device. Business wise that means it might be very worthwhile for a company who develops this technology because they might have a monopoly on the marketplace.
And product wise that would result in the same kinds of products we have now, i.e. extremely conservative and slow moving. And approved and marketed for just a few uses, instead of being open-ended like you suggested.
The FDA might shut down the independent App developers but I don’t think the would shut down the Apple Watch for being able to run those Apps.
I don’t think a breast cancer screening study would cost hundreds of millions. You could go to a hospital that does breast cancer screening and let every patient scan themselves with a device while they are in the dressing room.
Then you can gather the statistics of whether the software can reliably produce the same diagnosis as the existing technology.
Yes. Especially at the beginning you would have most of the software being developed by the company who sells the device. Business wise that means it might be very worthwhile for a company who develops this technology because they might have a monopoly on the marketplace.
That’s the wrong analogy; we’re talking separately selling a device that tells you some metric, not a diagnosis like breast cancer. So presumably you have to compare it against some existing way to measure that metric.
I don’t know how much testing & FDA approval normally costs for nontrivial “metric only” devices (e.g. glucometers), but on the outside view, I doubt it’s cheap as you say, because everyone in the system has incentives to raise the price, just like for drug trials.
And product wise that would result in the same kinds of products we have now, i.e. extremely conservative and slow moving. And approved and marketed for just a few uses, instead of being open-ended like you suggested.