The size of both the initial and eventual market are major uncertainties. I'd be surprised if private sector dollar sales volume were not at least in the 6 figures or low 7 figures in the first year. The Scottsdale Rural Metro site indicated 350 uses per year; San Diego, I'd imagine, would add a like amount. Even if other orders initially come mainly in dribs and drabs for pilot use, they should add up at least to some hundreds, as interest by now should be fairly widespread among researchers at university hospitals as well as among the most technologically progressive users.
A military order could of course at once give Pyng 7 figure sales volume and by helping to legitimize the product ignite wider and deeper interest, leading to more numerous and larger private sector orders. Successful publication of a series of medical journal articles would have a like and even larger effect, but here the time lag is longer.
Long term the big uncertainties are (1) just how often does the IV fail to work promptly for time-critical patients? and (2) how often will the FAST1 be used for first-line access? For (1) we have a range estimate by Dr. Johnson of 30% to over 50%, implying a US market of some $20 to $40 million for this use alone. There appears good reason to expect that the FAST1 will ultimately capture this market virtually in its entirety. However, I would like to see references to literature and data backing up the 30-50% estimate, as I'm not certain all emergency MD's would give the same figure. Perhaps Dr. Johnson could comment on this point. Is the 30-50% range calculated by the Fernence and Weiker study? Does it come from their own survey data, or from a literature review, or both? Or is it your own personal ballpark estimate? Is it a consensus estimate among emergency MD specialists?
There is even more uncertainty surrounding the extent of use for first-line access. Here what the FAST1 has going for it is its greater speed and reliability as compared with the IV. Against it is cost. But as I've said, if greater speed significantly affects just one time-critical patient in a few hundred, it can more than justify the cost of using the FAST1 routinely. Initially, there will be no scientific data on patient outcomes or speed. But clinicians can observe the FAST1 in use and make their own judgment. At first, most will see the IV as the conservative choice, as it is the traditional procedure. But as experience with the FAST1 grows, some will see its speed and reliability as sufficient to make it the more conservative choice with regard to patient outcomes. Within a few years, there should be scientific data on speed and reliability. Data on patient outcomes will take much longer as it will require sample sizes in the thousands. Who knows what the outcome will be? What's going for the FAST1 is the traditional bias to use what's better medically, and for time-critical patients, what's faster and more reliable for vascular access is likely to be better. Against it is the new cost-consciousness, though this can cut either way depending on how large the estimated benefits are of faster vascular access. |
