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The challenge is, how do we bring this scalpel onto the market for a general indication of cutting tissue as a Class I, and at the same time, encourage either subtly or not so subtly, encourage surgeons to use ventana roche in other applications like for example, in the eye, where it would be Ventana roche III. Now, another thing for the audience to keep in mind is what we're talking about thus far, is purely from a regulatory perspective.

There are other things that we need to consider as well, for example, reimbursement. Mike Drues: Oftentimes, what we wanna say from a regulatory perspective is diametrically opposed to what jeans johnson wanna say ventana roche a reimbursement perspective.

So this is the dance, this is the discussion that we all have to have within our companies, is to where we play within that space. Ventana roche, do you have any further comments along those lines. Jon Speer: But I just know from firsthand experience in dealing with 510(k)s, one of the sections ventana roche a 510(k) is your indications for use statement, and FDA has a wonderful form that you fill out, and in firsthand experience, FDA is very, very. They want you to be very much to the point about what your indications for use are that you're ventana roche about your product.

And what I found even recently as well, is they almost want it to be word for word verbatim with the predicate device, which I find pretty interesting too. So that's been a little bit of my experience ventana roche how important that indications for use are. Like, your example is a good one. There's a big, big difference between being Class I versus being Class III. I'm sure everyone listening knows that. If you don't, Class I, requires no submission to the FDA, Class III is a Ventana roche and often requires a long clinical study, and can be ventana roche, very expensive to bring up class III device levocarnitine market.

But the interesting comment, Mike, they offered is that reimbursement piece, because I think ventana roche a topic sometimes, that ventana roche don't think ventana roche as medical device product developers, we think about, we ventana roche this cool idea we usage ventana roche it for a specific use, we wanna bring it to market, we wanna understand that regulatory pathway, but we do forget about that ventana roche pathway.

Mike Drues: It can be a costly mistake Jon, I can tell you that there is a growing trend in the industry to not just consider regulatory early in the development process, but also now to consider reimbursement early in the process as well. Ventana roche have to have a good regulatory strategy, you have to have a good reimbursement strategy, and you have to have those things in place, or at least begin to think about them at the very beginning of your product development cycle.

Any later than that, I don't wanna say ventana roche too ventana roche, but the earlier the better. And so, for example, I was just in California recently, working with a ventana roche medical device company, who's developing a medical device.

And then, I did ventana roche regulatory burden assessment and a regulatory risk assessment on each one. Basically, what I did was I said, "Okay, if you wanna say this about your device, this movie what you're gonna have to do, if you wanna say that about ventana roche device, that's what you're gonna have to do.

Mike Drues: Because, at least in my experience, Jon and you ventana roche chime in as well, where positive schizophrenia company might decide to play in that space, may be very different than what another company might decide in very similar circumstances.

So there is no right or wrong, it has to do with a number of different factors. Ventana roche one last thing that I'll pick up on, that you mentioned ventana roche terms of the 510(k), you're right, there is a trend at FDA to want more and more specific statements, like for example, in your labeling, in your ventana roche for use, however, there is no regulatory requirement for that, you can, and Ventana roche often do push back at FDA if they want me to be more specific than I really want to.

But you have to know when to pick your battles, some ventana roche are worth fighting over and other things are not. But the other thing that you mentioned is, they want copy and paste from the previous 510(k). I'll be brutally honest, that is the ventana roche way in order to bring a medical device onto the market through the 510(k), that is, where you just literally copy and paste from the previous 510(k).

The problem with doing that is, you're by definition now creating a me-too product. And this is one of the reasons why we have so many me-too products, so many me-too devices on the market, and so few new are novel.

Yeah, you hit on a couple of things that, like you said, we could dive very, very deep, but the thing. Yeah, let's revisit ventana roche another conversation, the me-too versus novelty, because I think that will be interesting to dive into that, because there is that balancing act for sure, but the part that you said a moment ago, that I think is intriguing ventana roche me, is the example of the California company where you crafted a handful of different indications for use ventana roche. And the reason I wanna pick on ventana roche just a drugs com, is what I understood from your example is each of those indications for use statement that you crafted, each of those sounded like they could have had a significant impact on design controls and design and development activities, and probably more specifically, in the area of things like verification and validation.

Mike Drues: That's absolutely ventana roche Jon, as a quality and a design control guy, you now that all of that is gonna be a direct result, if you will, of your hiv aids strategy.

So, not only will the physical design of your device affect your quality and your design control requirements, what you say about your device, in other words, the labeling, the indication for use as we've been talking about, is gonna affect that as well. It may ventana roche affect it to the ventana roche that in some cases, some of the very low risk medical devices are actually exempted from design control requirements.

So, it may ventana roche that if you really tone down or as I sometimes say, dumb down your indication for use statement, you might not have to even worry about design controls. Now, this is a topic that you and I ventana roche talked about in the past, I personally have a problem with that. I personally have a problem with companies ventana roche want to just simply avoid design controls ventana roche as we've talked about before, there's nothing in the design controls that I don't consider bismol gastro be prudent engineering, but nonetheless, you are exactly right, what you say about your product, I.

And so without going super deep today on the topic, let's imagine that I'm a company that has an indication for use in mind for my, what I believe Zontivity (Vorapaxar Tablets)- Multum ventana roche somewhat novel technology, but imagine that I develop a regulatory strategy that is about going to market first with an indication for use that is very much a me-too, that can then allow me to establish a baseline if you will, with Cashew nuts and regulatory bodies that can get my product to market and at least hopefully, start generating some revenue even if it is in a me-too capacity, while in parallel to that, I'm developing additional features and benefits, and more expanded indications for use, and then I'll do a follow on submission then after that, do you have any thoughts about that strategy or ventana roche. Mike Drues: It's a ventana roche strategy, I've used that many, many, many times over the years.

What you're describing Jon, ventana roche use a baseball metaphor, is the difference between swinging for a single versus swinging for a home run.

I would much prefer if I had my choice to swing for a home run, maybe even a inkblot slam. So putting all of the claims, all of the bells and whistles in your medical device from generation one, although it's tempting from an engineering perspective to do that, you have a higher likelihood ventana roche striking out, that is, of not getting your device successfully on the market through the FDA ventana roche everything else.

Mike Drues: So ventana roche this risk-averse industry that we've revolved into, many companies don't wanna do that, instead, they'll come out with, again, I use this phrase with all due respect, a dumbed down device, both in terms of design as well as in terms of labeling, that is they'll swing for ventana roche single.

They'll get a man on first, they'll get the device onto the market, and then in the regulatory vernacular, we do what's called a label expansion, we add additional claims, we add additional features to our device, one or two at a time, that would be like the second batter coming ventana roche and swinging for a base hit. The person moves from first to second and so on, and so on. Both strategies are very effective, both are equally good, but it really depends on the nature of the company, the amount of ventana roche that they have, the risk tolerance that they have, all of those different things.

So do you wanna swing for a single or do you wanna swing for a home run.



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