Robert M. Califf, MD

Our lungs inhale almost 1M liters of air every day.
Device Regulation

I have been in numerous meetings recently about the impediments to device development in the US.  There is no question about the migration of device R&D out of the US with resultant loss of jobs on a fairly large scale.  My colleague Richard Stack, who is an emeritus professor and now runs a device incubator fund in the Triangle, has emphasized the fact that he would prefer to work in the US, but cannot afford to do it in the current environment.  On the other hand, the January 21st issue of the Lancet had a scathing editorial by Richard Horton on the lack of rigor in the UK and European system, and its effects on human well being of research subjects.

The middle ground here is elusive.  How do we encourage development of new technologies that require evaluation in human research participants?  It would be interesting to hear some new ideas.



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