So one of the things we use is a technique called scoping. Scoping is a method by which we actually test first an early prototype of a needs statement. We do that by laying out the combination of problem, population, and outcome in a single sentence and one of the challenges with scoping is we try and push the limits of both being very specific and the less specific by what we call scoping up and scoping down.
This was the original needs statement that was given to us and the one we went with is for a way to reduce intraperitoneal adhesions that decreases hospitalizations for small bowel obstruction. We changed it to intraperitoneal just to be a little more specific about the abdominal area but also we changed the outcome to small bowel obstruction because we thought it would be easier to measure in a clinical trial setting because we could monitor the patients coming in for that one purpose. To narrow the scope a little bit we thought we would focus on intraperitoneal adhesions from only abdominal surgery. For this one it’s not just the surgical population; it’s just anybody who gets an adhesion but here is the surgical population and another step below would be women who have infertility due to adhesions.
Expanding the market a little bit we thought we would go into the broader wound healing Market looking at just wound healing and fibrin deposition and even bigger than that maybe we could figure out a way so that patients don’t need gastrointestinal surgery in the first place. the original needs statement that was given was, “A way to prevent adhesions resulting from abdominal operations that reduce the rate of adhesion-related hospitalization.” So the team actually ended up starting with what they thought was the centerpiece, which is a way to reduce intraperitoneal, so very different from these are the adhesion abdominal operations, and they defined it as intraperitoneal adhesions that decrease hospitalization From small bowel obstruction. So really the decreased hospitalization is the outcome as a consequence to small bowel obstruction. But then what you do is force them to actually scope so what are the other opportunities because it’s not just hospitalization for instance; it’s not just intraperitoneal adhesions.
We really can modify the population and we can modify the outcome and kind of challenge the limits on what we’re capable of. So by scoping up much more focus we say it’s a way to reduce intraperitoneal adhesions resulting from abdominal surgery, very specific, that decrease mortality, much more from small bowel obstruction. And if we even go tighter a way to treat pelvic adhesions in women of childbearing age that reduces infertility related to adhesions. Now although it looks like we sidestepped to the side a little bit and said where did fertility come from?, it’s a consequence, it’s another very specific cause of adhesions that’s a much smaller, a more focused network and we’re talking about a completely different outcome. On the other way if we spoke down and we’re going much more broad we can say it’s a way To address wound healing and fibrin deposition that reduces adhesion-related hospitalizations so it’s much bigger. We’re trying to reduce adhesions as a whole and they bring in a mechanism here, which is fibrin deposition and ultimately what would be the ideal situation is a way to treat gastrointestinal disorders that reduces the need for abdominal surgery. So in other words if I never had to have surgery in the first place I’d never have an adhesion, if I never had an adhesion, I’d never have a small bowel obstruction so that’s why this is scoped down. And you can imagine these markets are much, much larger here than they are here and more focused.
ultimately the team at least at this point, and again these needs statements are constantly changing and evolving with more diligence and more knowledge, has kind of settled here, which is they think it’s a way to reduce intraperitoneal adhesions that decreases hospitalization because we know that a good portion of the hospitalization for small bowel obstruction is due to adhesions and it’s not just related to surgery. It’s all intraperitoneal adhesions, which is what they’ve chosen now. Now whether this specific needs statement is actually exact, I would say no; they haven’t gotten there quite yet. But they’ve gotten closer and so with each step of the process, with each week they iterate in a sense, they do more information, we’re going to be modifying and so this part is the modifier as far as what part of hospitalization? Is it the length of hospitalization, the consequence of hospitalization, the cost of hospitalization, or all these combined? So this outcome of hospitalization still is soft. We don’t know how to measure it exactly. Is it binary either in the hospital or out of the hospital or is there something more impactful? And then this relationship between adhesions, surgery, and small bowel obstruction has to be better defined. And so at the end we want a really clean, nice sentence that’s black and white to everyone when they read it and know exactly what we’re going after.
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