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Informational CDRH’s Regulatory Science Priorities


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I've noted that there is trend to slap "science" on everything that moves these days.

A colleague and I have an ongoing email exchange with the subject line, "Everything's a science these days." Apart from the one above (which I will neither say nor type), some "sciences" we have duly noted are medical science, clinical science, patient science, decision science, clinical decision science, and data science.

Seems to be one of those things where people are hoping that, if you just say it enough times, maybe it will come true.
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Ronen E

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I mostly agree, but isn't Medical Science real science?... In Australia, this is the undergraduate program you enrol on to become an MD.


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I think you must be talking about what has historically been referred to as "pre-med" in the US. Don't know what they are calling it these days. I think a whole lot depends on what definition of "science" you use. I think pre-med is a study of what scientists have learned about specific subjects (e.g., biology, chemistry) that are likely to be useful to an MD. It doesn't produce scientists, but it prepares them to study medicine, which is not science.

But what is and is not science is not really my point here. The trend to calling everything a science is what has my attention, in its own right. The more people repeat something, the more likely it is that the opposite is true. I know what drives the constant repetition of "innovative" and "innovation" in the medical device industry, which is actually pretty darn weak on innovation. What is driving "science, science, science" is what I"m puzzling over these days.

My best guess is that, within the medical device industry, they are calling everything a science in lieu of having any actual science. If there is an area in which the medical device industry is even weaker than it is in clinical everything, it is science.

I suspect the same may be true of CDRH, since regulators tend to reflect the industries they regulate. I think more broadly, the US wants to pretend it has science, when mostly what it has is technology. But my perspective on this may well be skewed by the fact that I'm constantly surrounded by technologists instead of scientists. Maybe there are still some scientists out there somewhere. Possibly hiding in a basement waiting for the "all clear" signal to sound.
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