[mionhe]

I work in this field, and I've never seen a device that isn't dead simple be able to clear the FDA for $200k. I've definitely never seen a medical device with software anywhere near this.

The reason people don't switch to medical devices is because even a fairly simple device without software or electronics can still take between $750k and $1.2M to develop and clear the FDA. Adding software is a cost & time multiplier.