Jack Rayfield. Thanks for your input to this thread in the last couple of days. It has prompted me to: 1) thank you for your relatively balanced input, and your patience; and 2) join the group so that I can post as well as lurk.
Actually I haven't figured out how to initiate a posting yet, which is why I'm emerging in reply to yours.
I've decided to join in, to take a bit of the heat off Mike Jacobs, who pays my salary (more than his!) and who needs a hand responding to you guys from time to time.
For those of you who don't know me, I'm VP Research and Development at Pyng Medical Corp. What I propose to do is respond from time to time with non-proprietary information (surely you don't expect more than that!) on the F.A.S.T.1, its past successes, present status and likely future. I'll also do my best to keep some of you folks realistic.
For example ...
1) No the need and the market are not going to go away no matter how long it takes us to make our way into volume production.
2) No we're not the slightest bit concerned about the B.I.G. folks getting FDA approval (though we were a tad surprised). We know we have a more attractive and far better product, we're far ahead of them or anyone else in development, and in the meantime they'll do some good marketing, helping to familiarize paramedics and EM physicians with adult intraosseous infusion.
3) No nothing is going wrong with our field trials, we're continuing to work with our best sites, we'll have our 100 patients party shortly, and we reckon that we've got pretty much all the information we need from the trials, to proceed to redesign for volume production.
4) Yes of course the suggestion is riduculous that the F.A.S.T.1 is the slowest of the competitors for adult intraosseous infusion. We had a design target of 90 seconds or less to achieve vascular access. Our field trial results are showing 60 seconds or less. People have used the B.I.G. in 3 seconds or so. What's going on. Well, if I only have to do what the B.I.G. does, I can do it with the F.A.S.T.1 in less than 2 seconds and I invite anyone in the neighbourhood to come and watch. The remaining 58 seconds are associated with the things which are built into the F.A.S.T.1 system and are NOT PRESENT IN ANY OTHER SYSTEM, namely ... cleaning and disinfecting the site with alcohol and betadine, land marking the site and identifying the exact target site using the F.A.S.T.1's targeting patch, providing for strain-relief so that the first accidental contact with the infusion line doesnt pull out the intraosseous connection or cause massive leakage, and hardening the site so it is not susceptible to interference from all the activity and movement in the vicinity of the patient and the patient can be safely rolled, lifted, transported and treated without the need for the caregiver to pay any more attention to the IO site. How about it ... is that worth the extract 58 seconds? Ask your local paramedic.
What else can I help you with? |
