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by mionhe
112 days ago
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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. |
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