¿ªÔÆÌåÓý

  1. BITX20
  2. Messages
Single Messages Topics Expanded Polls

Re: Best wishes to our friends in India

 

¿ªÔÆÌåÓý

Well let me see if I can straighten a few things out.

I¡¯m not completely sure about the website not being updated but I think we had to freeze the design and there was some concern about some thing about you can¡¯t release stuff outside of your release to the FDA? ??

We had a outside group advising us on how to present material to the FDA. In retrospect, I think we made some wrong turns there. ?

I wasn¡¯t really in charge of that aspect but I would have urged for much earlier telephone calls to and from the FDA representative to straighten out exactly what they wanted. ?There was a lot of concern expressed by others that any conversations with the FDA would just lead to mountains of additional documentation required. ?

I don¡¯t think the actual events support the conclusion at all. ? I may be wrong, but I think dad and I and others developed features that the FDA simply didn¡¯t want and eventually had to be stripped out to get it down to the simple thing that the FDA did want, and that cost us precious time.


Acting on a guess as to the FDA¡¯s desires there was a choice to try to find a manufacturer which I think hurt us badly. ? Again here I think if we could do it over again we would have spent more time just talking to the FDA and less time guessing their requests.


The major problem with the submission was that we had to jump a lot of hurdles merely to find all of the standards that they wanted us to certify compliance with. I screamed loud and hard that we couldn¡¯t do anything without those standards document¡ª A lot of the standards organizations charge a ton of money in order to make money for themselves but one of our group was able to discover ways to get us just about every standard we needed.

Oh my heavens above, I spent hours and hours reading these standards and answering really simple and stupid questions about our certification to those.

My background included both medicine and engineering, so I was able to answer things lickety-split. ?others in the team were much more cautious, overly so I believe, and moved much more slowly to answer the reams of questions that we had to answer in the certification questions.


Again, my observation of the FDA was that they actually were bending over backwards, but the delays that our team sometimes caused themselves due to overcautiousness, pushed us past the initial Histeria and the final submission did not occur until people were much less interested. ??


It¡¯s just my opinion but had we known that we could talk much more freely with the FDA people, I think we would not have done much of the exotic development that I personally did and we would have submitted a much simpler design six weeks earlier and gotten it approved. ? We were just operating in the dark. None of us had ever dealt with the FDA before and people were terrified.?


There was a huge problem that I tried to tackle that we had zero legal protection for our volunteer developers and since most of us no longer worked for the University of Florida, we were going to be left hanging in the wind. ? I put a several day stop to the work until the lawyers gave us some legal protection! ? Never again will I begin a project for a university without demanding legal protection from the get-go. ?The lawyers at UF actually did Hercules an effort to get us protection, but they actually had to run background checks on the list of people that I submit it, because they were concerned for legal liability if they offer protection to a known felons!

They did all of that in the background and got that back to us within I think two or three days. I was very impressed and I think in the end those lawyers deserve a lot of appreciation. ? It was our stupidity to begin without having these legal items taken care of.


We had a wide range of skills working on this project. Some people had vast experience covering lots of different areas, and others were much more narrow in their expertise. The incredible hysteria over the virus caused huge problems for us, with University of Florida refusing access and refusing some persons even to be on campus to work on this project. ? Some fairly surreptitiously activities took place to try to get this project moved forward. The number of people who stood up to help us is just extraordinary. ?I was on the campus, and even much more so over the Internet.

In the end, I think the FDA created a rather difficult system, but had we more experience dealing with them I think we could¡¯ve gotten through it six weeks earlier and had a big success.




On Apr 27, 2021, at 15:59, Jack, W8TEE via groups.io <jjpurdum@...> wrote:

?
Arv:

Off topic, but one of my grad school buddies took a job in DC at a small agency. A few months into the job, the director of the agency came around and told everyone to let the "In Box" stack up for the next few days. A few days later they had a "surprise audit" by the GOA. The director took the opportunity to plead for more workers because, as they could see by the In Boxes, they were swamped. He got more workers.

When I asked why (remember we were econ students), he said: First, there is zero reward to being efficient. Second, your position on the DC Social Ladder was a function of how many people you managed. The unimportance of efficiency is not unique to Capitalism. My Comparative Systems prof spent two years in Russia and became close friends with a Soviet bureaucrat who ran a major rail line. When he was coming close to the end of the current Five Year Plan, he was extremely short of his metric ton/miles quota. No problem. He loaded up 400 gondola cars with rocks and ran them back and forth between Moscow and Vladivostok until he surpassed his quota. He was rewarded for exceeding his quota.

I think there is a lot of similar crap going on in DC.

Jack, W8TEE

On Tuesday, April 27, 2021, 3:46:39 PM EDT, Arv Evans <arvid.evans@...> wrote:


Jack

Maybe Pogo was right? "We have found the enemy, and he are us!".
After all the FDA as a government entity is just the government
employees that we hired to do things in our name!? 8-)? 8-)

Arv
_._


On Tue, Apr 27, 2021 at 1:35 PM Jack, W8TEE via <jjpurdum=[email protected]> wrote:
Arv:

I really don't know. All I know is that things were progressing rapidly and I know Gordon had one working on his coffee table! Then everything was turned over to the U of F team so they could take care of all of the paperwork. After that, the web site literally died. The last post that I have saved was back in September. It probably didn't help that the UF team's leader got frustrated with the rest of us and quit "to write game code". His absence may have hurt the effort in FL. Perhaps Gordon knows more...

Jack, W8TEE

On Tuesday, April 27, 2021, 3:20:43 PM EDT, Arv Evans <arvid.evans@...> wrote:


Jack

Seemed that things died just after being submitted to the University
of Florida.? Was this killed by the FDA, or by the University of Florida?
While it doesn't matter much now, it could be that politics and funding
in academia contributed to the project's demise.?

Might there be interest in India in taking over the project (and willingness
at the University of Florida to release the information) so that they (India)
could build their own ventilators??

To comment on an earlier comment...It only seems like the US is the first
to be ask for help, but that is because our view from the US makes it
seem that way.? When anyone needs help the US politicians automatically
give press conferences that make it seem like they are going to do
something.? But it rarely happens, is too little, too late, or nothing happens.
If you observe this from a different country the view is quite different.
Been there, done that.

Arv
_._


On Tue, Apr 27, 2021 at 11:36 AM Jack, W8TEE via <jjpurdum=[email protected]> wrote:
Bob:

I've read back through the posts and did not find anyone who said the FDA prevented other countries from using the ventilator developed here. I am the owner of the Ventilator group site you mentioned and worked with Farhan and Gordon on the ventilator. Things moved along quickly until the design was sent to the U of F medical team who were preparing the documents for FDA. Somewhere in that process, everything just died. I still think glaciers move faster than the FDA on almost everything except budget requests. If other countries want to use the ventilator, seeing a "waiting for FDA approval" whether they need it or not, is still an impediment. With tens of thousands of people dying worldwide at the time, I do not understand why FDA couldn't kick itself in the ass and get things done.
--
Jack, W8TEE


--
Jack, W8TEE


--
Jack, W8TEE

Join [email protected] to automatically receive all group messages.