[Mahler9th]

"Mike is trying to drive the discussion towards introducing a device into our existing system, a product that would go through testing, approvals, etc."

That is not quite right.

I think I have been pretty consistent... I encourage folks to consider the bigger picture. That is the point. It might be helpful to understand that there IS a system.

I have 40+ years of experience watching the "system" evolve. I have been to FDA hearings. I have had a product get a PMA (a form of FDA approval) and wind up on every major evening news station and in every major newspaper. (The Secretary of Health and Human Services issued a press release heralding the approval as a major step forward in the diabetes space... the stock shot up but I could not participate).

I have seen large businesses shut down and yellow taped due to FDA intervention to protect the public health.

I have seen many, many companies in tech like Apple think that the med device world is easy, only to re-budget and refocus efforts after meeting extensively with FDA and coming to a higher level understanding. Companies like Apple and Google are some of the largest employers of technical talent in the emerging new world of med tech.

For this situation, I think some of what is needed will come through the "system," and some will come through processes carefully modified to take on risks versus rewards. I am pretty sure that this is already happening with testing-- evaluation of samples collected from patients. I think that labs have been allowed to start helping in a "strategically relaxed" modified system.

(When I think about that, I think about Theranos. What a mess that was.)


I think Roche recently got an approval in a day.

I think the situation calls for these kinds if steps, and I think that informed and experienced folks are working really, really hard to find ways of assessing risk versus reward.

I believe that some, perhaps many or most efforts will have a better chance of positive impact if the system is at least partially understood. Of course not only the regulatory system, but also the healthcare delivery system associated with the ICU and ICU-like environment that is apparently required in this situation.

And of course, there are laws in place, and I reckon in some instances new laws might be required, and those might take more time to get through than product development in our system of government. Even in these circumstances. But I have not studied that aspect.