Everythng Im working on now is to get us through the FDA.
1.? We had a defined number of failures on our tests by both software sets; a small team of us have been working on the SIMPLE CODE and Zeeshan has been gracious enough to work on the other code set.? Without a code set that passes my tests (which have been published his more times than I can count).....we don't have? a "product" in the first place.
2.? Ashhar Farhan graciously spent the last 3 days rewriting the entire user interface to dramatically expand the possible controlled items, reduce the size of the RAM used, and add huge flexibility.? ?The reason was that we were unable to pass one of my 42 tests.? ?That part is now FIXED and over the past 4 days I've fixed most of the rest and Jack Purdum fixed the blocking delay calls (it was simple).? ?In the process we rewrote the vent controller to add ACTIVE PEEP and ASSIST Ventilation (extremely helpfut to making people **survive**)? --- Ashhar has now delivered his code and after a few SNAFUS on my part...it is running on a real ventilator.? ?There are a few loose ends to re-connect and re-update, but we are very cclose to a package that may pass my 42 tests.
3.? I reached out to Zeeshan today encouragng him to bring the other code set up to readiness for a test also.? I wanT EVERYTHING POSSIBLE that works to be available for our team, so ANYOnE who is willing to work....we have begged to work.? A UF volunteer also documented the other code set -- all of that important to us.
4.? The Team at UF has finally grasped two things I have been "suggesting" for several days:
a)? If you DONT answer the 34 questions I found in the FDA applicaton (five days ago) to which we DO NOT have anyone who has read the applicable regulation and CAN ANSWER..... you don''t have a submission.
b) if you DONT do all of the above quickly--- the FDA is likely to decide this is not worth pursuing.
Apparently they ahve received a BUNCH of submissions---and not a single one has been approved so far.? ??
IF ANY OF YOU UNDERSTAND THE VENTILATOR WE HAVE BUILT REASONABLY WELL, AND ARE WILLING TO READ THE DOCUMENTS [WE HAVE THEM] IN ORDER TO ANSWER YOUR BEST ANSWER FOR 2 OR 3 OF THEIR 34 QUEUESTIONS WE NEED ANSWERED --- i CAN HAVE TRAVIS GIVE YOU A COUPLE OR 3 QUESTIONS TO ANSWER.? ?DON'T MAKE A CAREER OF IT.? ?GET BACK ANSWERS WITHIN 12 HOURS.? ?JUST DO THE BEST YOU CAN.? IF YOU DON'T KNOW, YOU DON'T KNOW -- AND SAY SO!!
Thats where we are, folks.? Oh and if anyone out there wants to take on the job of managing the entire software effort --- WE ARE LOOKING FOr SOMEONE CRAZy ENough to taKE That ON!!!? ?The two people we approached so far, declined.? ? ?You need to understand everything we have done, and have to do, and be able to test and understand all of the code.? ? It's a pretty high bar, but some of you surely could.? ?And you have to have it done, by the way, in about 72 hours.??
Gordon
