McCaney: I would add a note about what Kwame said with just respect to the overall study. Every product is unique. That's something about medtech. It is a little bit more challenging and perhaps a little bit different from that regard from biopharma regarding study design and many of the other aspects.

One of the things to answer your question specifically about what surprised me, and this goes to a little bit of the reimbursement component of our findings with respect to reimbursement emerging as a barrier – more so of a barrier according to the study results – than regulatory would previously seem to be. And that kind of gets to that market access component, with the tradeoffs associated with breakthrough.

Now, one of the things that surprised me specifically was that I heard from several founders and executives in interviews that there are a lot of products out there that they want to develop that could be developed, but there is such uncertainty about who would pay for it that they're not getting explored. That they're not getting developed.

And when we're thinking about the importance of safety and efficacy, and the role of the regulatory process, and of course reimbursement is looking at ensuring that it's reasonable and medically necessary, the question begs, what reforms are needed with respect to the reimbursement process if there are innovators out there who feel they can do more and develop more products, but couldn't find a way to pay for them, so they're not exploring those opportunities? That, to me, was surprising.

And so, from a health system perspective, from a practitioner perspective, I would love to see more of those devices and those ideas come out into sort of the mainstream so we can explore them all as an industry and brainstorm how to pay for them, and how to get them to market.

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