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by coolwulf
861 days ago
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NeuralRad is being used during the clinic practice workflow at the moment. The platform currently is not FDA 510k cleared so we had to establish an IRB with the clinics which are building the platform into their clinical workflow. |
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I understand why the audience’s instinct is to judge you by the standards they’d judge a clinician or a formal medical device manufacturer, in that history of medical tech is littered with examples of well-meaning engineering efforts unintentionally causing harm.
As a counterbalance, though, I’d like to speak to the charitable interpretation: after all, how many times have I as a tech guy relied on practitioners in other fields to tell me what they could use, and whether what I built was helping them? It seems like you’re being judged on your skills as a practicing oncologist or full-scale US-market medical device manufacturer, when maybe a more fair frame might be that of a person who tries to help professionals whose work they admire by building tools they ask for.
I feel like just as it’s somebody else’s job to know how to doctor cancer, it will be somebody else’s job to prove that the tech is safe and appropriate to commercialize or popularize (what else is regulation for?).
From one person who likes making stuff to another person who makes stuff, though, I appreciate your good intentions, your creativity, and your follow through-and I admire your grace handling criticism here!