To: Jack Rayfield who wrote (4060 ) 6/28/1999 5:45:00 PM From: Bernard Elbaum Read Replies (1) | Respond to of 8117
What is the market for the FAST1? In one of your recent posts jack says that the FAST1 is now a proven product but size of the market is a "huge" question. I can post the following in light of an email correspondence I had with Dr. Johnson. Pyng is very confident in the estimate of 4.8 million IV's established in the pre-hospital environment in the US and Canada each year. This number was established by a study commissioned by Pyng that used survey data and met scientific standards of publication. However, Pyng regards the market information as valuable competitive intelligence and has no plans to publish it for a few years. The figure Pyng cites of a 10-20% failure rate applies to this total of 4.8 million IV attempts. However, this group includes everyone who gets an IV, including those merely with broken legs and such; it is unlikely the FAST1, given its cost, would be used on any but patients presenting an urgent need for administration of fluids. This key group--which chiefly includes cardiac arrest and trauma patients, amounts to about 15% of the total, or an estimated 720,000. For cardiac arrest and trauma patients, the estimated failure rate for IVs runs higher. Dr. Johnson mentioned 30% conservatively and perhaps more than 50%. This is the prime Pyng market. Dr. Johnson also expects some practitioners will turn to the FAST1 for first-line-access; the name of the device is "first access for shock and trauma" and reflects that expectation. How many is not clear. The estimated market size of 500,000 patients in the US and Canada which Pyng cites is based on a rough estimate of use as backup to IV and as first-line access, along with other uses in hospitals, etc. The implication I draw is that it seems a safe bet that Pyng will at least command a modest market niche, and there is considerable upside potential. The figure of 500,000 is not the lowest number you might estimate, but not the highest either. I personally am impressed with the following calculation for time-critical patients. If just one patient in 100 is likely to suffer serious adverse consequences from slight delay in successful administration of fluids, then even from an insurance company's point of view, it should be cost effective to buy and use FAST1 device for all time-critical patients. However, I was unable to elicit any comment from Dr. Johnson on this point. As more use develops, there should eventually be controlled studies that establish that the expected time of successful fluid administration is less for the FAST1 than for the IV. However, new regulatory rules on prior patient consent have for now made impractical a planned Harvard study of this sort for first-line access for cardiac arrest patients. Once studies of this kind go forward, they should go some distance in convincing some practitioners to use it for first-line access. Some will not wait for the studies but will draw their own conclusions from use. I'd expect some to be impressed with the same logic as I and also to favor the faster device on philosophical grounds for time-critical patients. Establishing the impact on patient outcomes directly in terms of mortality, organ damage, etc, is, I believe, much, much harder to establish as large sample sizes are required to get significant results; there is a chicken-egg problem here, in order to prove with statistical rigor that the FAST1 is good for patient outcomes, you'd have to already be using it on large numbers. Practitioners therefore will be making their own decisions based on uncertain data as to which device is cost effective, though for time-critical patients, there should ultimately, once the FAST1 is widely used, be an argument that the Pyng device is the more conservative choice in that is less risky for the patient. In the face of uncertainty of this sort, one might expect epidemiologists to conduct a meta-analysis of data from existing studies to try to unravel what is known about the impact on patient outcomes of a difference in a few minutes in establishing vascular access. A meta-analysis of this sort might try to shed light on the decision practitioners face by offering some sort of extrapolation from what is known. But I am just speculating here. I don't know if Pyng contemplates such a meta-analysis is in the offing, or views it as feasible. Perhaps Dr. Johnson could comment.