[Transcript] The New Wave of Interventional Radiology Sourcing 5/10/2018

Steve Suhrheinrich:  Well good afternoon, or good morning everyone depending on where you are. This is Steve Suhrheinrich with Curvo and it’s a pleasure to have you on this call. Today we’re going to be talking about interventional radiology. I know people are still getting logged in and they’re still getting the Zoom up on their computers, but we’re going to go ahead and get going because we do want to try to make this within 30 minutes. We’ve got a lot to cover today.

A couple of housekeeping things just to let you know, this is being recorded, so if you’d like to see this again you will get a recording of it. I want to encourage you to ask questions. We will monitor the questions as they’re asked and there’s a Q&A button on the Zoom panel, you should be able to see that on the bottom. You just hit that Q&A panel and you can ask a question. You can also chat. If you want to do that that’s fine too, there’s a chat window where everybody can see it. That’s been pretty effective in the past if somebody chats there and you can get feedback from the attendees as well. So feel free to use either one, the Q&A or the chat. If questions come up during we’ll try to address them during the presentation, but we’ll definitely take time at the end.

All right, I’m going to introduce Andy Perry right now. He’s the CEO and founder of Curvo. He will take it from here. Andy, go ahead.


Andy Perry:  Great. Thanks, Steve. If you are using the Q&A or the chat just ask no heckling of the hosts or the panel members that my confidence is easily shaken so it can’t be steered off in any way.

Just like Steve said, thank you everyone for joining us. I’m excited to dig into this topic. I don’t know if any of you have ever followed around a physicist in the cath lab or observed cases IR lab or cath lab, but it’s a lot of fun honestly watching these ladies and gentleman that are also like mechanics of the vasculature, watching them do their work and even more importantly, do things to relieve suffering for patients, and save limbs, pretty cool area for us to explore today.

First of all, I’d just like to give a little bit of overview on the Curvo Quick 30 premise. What we like to do with these is take a clinician perspective. We’d like to give a sourcing perspective. Then today we’re doing something really special, we’re treated with a material scientist Ph.D. who is very skilled and knowledgeable in the peripheral vascular space. So I’ll make his introduction in just a moment, so we’re adding a little product perspective today as well.

So I’m your host. I’m Andy Perry, co-founder and CEO of Curvo. As has been our typical format sometimes we’ve had physicians live for these, other times we just a questionnaire and we go over those results. We’ve got a questionnaire completed today by Doctor Phillip Orons, Chief of Radiology at UPMC, so really excited to get that perspective.

As I mentioned before we’re joined by Doctor Randy Scherer. He’s Chief Scientific Officer of Kirkwood Scherer Capital Ventures with also a long track record in the medical device industry as well. With that lovely pic of Randy and his family, I’ll leave it to the audience to determine which one is Randy.

I also go Drew Mays for our sourcing perspective. You’re friendly and well-known to most of you as Director of Customer Success here at Curvo. So he’s going to color our perspective with a little bit of market data and insights at what we’re seeing going on with customer space.

In absence, Doctor Orons thank you, Randy thank you, Drew thank you.

All right, let’s get right to it. Doctor Orons, Professor of Radiology at UPMC, Chief of Interventional Radiology, co-author of many scientific papers, book chapters, monographs, and presentations; grad school at Drexel, medical school at Philadelphia and fellowship trained. So a guy with a unique perspective.

As many of you know UPMC has got a great reputation around sourcing and value analysis, really done some of the leading and innovative things in the industry over the years, so great to have this.

Doctor Randy Scherer, again, he’s Scientific Officer at Kirkwood Scherer Capital, former Senior Project Manager at Dekra, so he got a front row seat to the regulatory space when it comes to peripheral vascular devices; Former Regulatory Scientist at Cook Medical prior to that and he’s a Vanderbilt alum. So those of you in the FCC either hold it against him or don’t hold it against depending on your school allegiances. But just an extremely smart and talented, knowledgeable individual in this space. We’re very fortunate to have Randy join us.

What I’m going to do in this format is we’re going to go over Doctor Orons’ perspective. One of our goals with this is to really help, in the supply chain, help us understand how our doctors are learning about new devices, learning what devices cost, and who’s really that source of truth or information for the clinician, how interested are they in it, where are they seeing changes. We’re going to take some of Doctor Orons’ answers and just bounce them up against Randy and against Drew as well to get any insights we can out of it.

The first thing we always ask is how often do you look at new products. We want to get a sense of reality when they’re checking the market and what those mechanisms are. So Doctor Orons is saying that it’s fairly often that he’s taken at least monthly meetings from vendors where he’s looking at products. For some of you it’s one on one and for some of you it’s new information, but the conferences and the professional associations are such a source of new product learning. It’s where the device companies launch their products, it’s where they can really capture the captive audience of the physicians, and surgeons, practitioners. So really, if you’ve got a category manager in your supply chain organization dedicated to cath lab and IR, really important to understand when those conference dates are. If not attending on your own be very brief of what’s going on in those conferences and what some of the trends are, what are some of the launches that are happening in concert with those conferences. That will keep you in lock step with your physicians.

Randy, Drew any surprises there?


Drew Mays:  No not from a sourcing perspective, that seems to be a trend on most of these categories that we review that doctors are really learning from the conferences in these specialized groups.


Andy Perry:  Randy any surprises?


Dr. Scherer:  One of the surprises that I see actually is in question number three that the physician actually refers to the IFU whenever it cups with the devices.


Andy Perry:  There you go. A little something you’d know a bit about I guess there Randy.


Dr. Scherer:  Yeah usually they understand how the thing works and they go right into it.


Andy Perry:  The IFUs, and you mention it and it’s great, those are a rich source of information educationally for a supply chain professional. If you get into those IFUs they have to be public information, they’re required as part of the FDA regulations. Randy, correct me if I’m wrong, but you can find those on the device company’s websites and it can really help you get up to speed on the use cases for the products, and indications, and also just on the category in general.


Dr. Scherer:  Yeah that information was what was utilized to gain the regulatory approvals in the different regions around the world otherwise they can’t be in the IFU.


Andy Perry:  I think this is the first one that we’ve done where the physician mentions the IFU as major criteria, and guiding evaluation. That’s cool. That’s a good insight.

It’s interesting, perhaps UPMC is doing something to tee up that information to Doctor Orons, he in later questions talks about his role in the Value Analysis Committee, but it is interesting that in researching alternative products or looking at new products we’re consistently, the hospital supply chain is not in the conversation.


Dr. Scherer:  Correct.


Andy Perry:  They’re not learning about new products from the hospital supply chain. Seldom are they learning what the device costs from the hospital supply chain, a little bit different here with Doctor Orons on the cost side of it, but still, we’re not out in the front as the supply chain in helping to educate our medical staff on new products and what’s going out. It’s more reactive on our side, unfortunately.

Any thoughts or reactions there Randy or Drew?


Dr. Scherer:  I would just say that we see in common that we get requests or item lookups from customers of new products of that’s reactive, now they need to figure out how much it costs before they can implement it into their organization. So yeah, I would agree that it’s very that the supply chain is leading or investigating newer maybe cheaper products or more efficient products. Yeah, I would agree with that.


Andy Perry:  It’s really two things. You have within many supply chains, of course, there’s going to be a reticence or hesitance to proactively suggest new devices. It’s almost like a nightmare scenario for most of us. But there’s the other side of the supply chain really not being viewed as a credible source of authority or information for this. It’s almost a positioning branding relationship thing that’s a real opportunity we have with their medical staff, of course on the costs, we know that. We know that our clinical staff members, in general, most of our hospitals are not finding out about a device in the supply chain. That’s a big black for us and a real opportunity for us. But even to be able to be viewed as a trusted partner for information about new devices and educating our surgeons on how they compare to what they’re using, what the clinical value proposition is … I don’t know, Randy any experience there or thoughts? Is it almost comical to think of the supply chain as that source of information or are there several opportunities there?


Dr. Scherer: No I think there are some real opportunities for you guys to think of it from that particular perspective. Primarily whenever you think of the medical device companies their customer isn’t the supply chain, it’s the physician, especially when you’re talking about more advanced devices with competition in the space. They aren’t going to try and convince the supply chain because they’re probably not at the SIR and guest meetings, they’re there to convince the physician on an efficacy standpoint or some advantage of their product that will drive them to then bring that back to the hospital.


Andy Perry:  Yep, yep. No, very good. We’ll do a little bit of summary of a few of these questions. Scientific data’s most important to Doctor Orons’. He does look at the IFUs, which we said was interesting. They do rely on the reps, taking some of it with a grain of salt, or a lot of it with a grain of salt looking for anything peer reviewed that’s coming from the reps of course to help give it that level of steam, but still looking it, still take it, even if it’s with a grain of salt, relying on scientific data that the reps are providing or studies that the reps are providing. It’s an influential source, whether we put that mental discount on it or not it’s still a source of information that’s being used to make device decisions, even from somebody who is fairly intellectually rigorous I would say, or determined to be objective like this gentlemen. That flow is still happening.

Now on the cost side, Doctor Orons’ is saying he doesn’t have anything to do with establishing the cost up front. I think that’s really what he’s trying to get at here, that he is differing completely to UPMC supply chain for their contracts and for their discipline practices and what they’ll pay for a particular device. That’s the way I view this is because later on he establishes a cost that’s extremely important to him, but what he’s saying is I’m not going to get in the middle on this stuff up front, I leave that to them. I care about what the device costs, I’m going to take that into consideration on whether I use something. If somebody’s trying to get a product then they need to go talk to the supply chain to figure out the price.


Drew Mays:  Yeah, I would agree. I think he’s trusting his supply chain staff to go get the best price for that product, but he’s willing to listen if the product seems to be a little egregious on the price. I think it’s a little bit of both too. I think it’s common.


Andy Perry:  He and his supply chain are basically saying, “You do you, I’ll do me and we’re going to work together and come up with the best thing.” As an academic medical center I’m sure there are some research obligations and needs, and training young clinicians on multiple products and methods. So it is really interesting to hear though cost effectiveness is paramount. The system is willing to pay a premium for unique devices. They better be really unique or serve a purpose that can’t be substituted. They’ve moved to a limited number of vendors for devices like balloons and stints. There are certainly covered stints that are only made by a single manufacturer, have no good alternatives, so a little bit of being judicious there.

Now I think we’re going to be able to get into a little bit of Randy’s area of expertise. So I’m going to skip on down to right now … and these slides will all be available for you if you want to further parse them and drill in. We ask in number eight what products are you not willing to switch. He’s saying it’s a hard one because there are certain procedures that require very specific products. He mentions the TIPS procedure and certain types of embolization, very specific tools. But he really can’t think of a product he wouldn’t be willing to consider changing if there was a satisfactory alternative. I would say this is a pretty common perspective. If something is off limits, or at least what a surgeon is verbalizing to us in these surveys, if a product is off limits it’s because they don’t know of a satisfactory alternative.


Dr. Scherer:  Agreed.


Andy Perry:  Here’s another gap, an opportunity for us in supply chain is to be on top of the market and to be proactive in having all the detailed knowledge and information about alternatives that could be satisfactory and what’s coming out, and not doing it with an agenda with our surgeons, but being that trusted source of information.

Randy, what are you seeing as some of the more differentiated things that are out there in the marketplace now?


Dr. Scherer:  I think whenever you’re talking about the more advanced type procedures, such as TIPS that he even mentions here it’s really going to be driven a lot by what that physician was trained on. A lot of these medical device companies hold big symposiums and training workshops for these physicians earlier in their residency stages. Then they kind of continue pushing that product on them throughout their initiation into more of a clinical practice. Once they’ve used it, it becomes that matter of personal preference, which you actually see in his response of question number nine. They use it because it is their preference, it’s what they’ve used their entire career, what they trained on. That’s kind of the trend that we’ve seen from medical device companies in trying to catch a physician early in his career to train them on the advanced procedures. There’s always novel produces that come out in the interventional radiology space because it is such an exciting and multi-faceted treatment area. Even embolization you’ve got drug loadable spheres that came out a couple years ago. Then you’ve now got degradable drug loadable spheres that are in development. So those types of things are the next edge that companies are looking at from a product perspective where they’re trying to create the differentiation he’s talking about for it to be adopted by the community.


Andy Perry:  Some things to be aware of particularly it sounds like are in the embolization space. That’s where a lot of the maybe new product innovation or differentiation is coming. For all our supply chain team members out there just kind of have your radar up and think about what your strategy’s going to be around these embolization products and how you might want to take a sourcing strategy according to that particular category.

Then TIPS as well, I’m not as familiar with the TIPS process, but I think that is for cirrhosis of the liver, I believe? It’s essentially relieving hypertension-


Dr. Scherer: Correct.


Andy Perry:  … in the liver. It’s making backflow. Randy, you want to elaborate on that for us a little more?

Dr. Scherer: You nailed it there. They’re essentially trying to bridge different regions of the liver with covered shunt and covered stints to reduce that pressure. It is a complicated procedure, which requires a lot of expertise on. Again, I think that goes back to why he used that as his example because once you’ve been trained on something in a complex procedure like that it’s going to take a lot for you to shift to something new without a significant advantage.


Andy Perry:  Right, right. Makes a lot of sense. It might be a lower volume area for many of our listeners or if you’re a large destination referral center it might be something to really be thinking about. But your hands might be tied from a sourcing perspective there and there might be good reasons.


Dr. Scherer:  Yeah, yeah.


Andy Perry:  There might be some very good reasons. Now as we go on to question nine we ask what products are you willing to consider alternatives because the technology is all the same. He’s saying almost all of them and he’s verbalized that above. There isn’t anything that he’s not willing to consider, it’s just there may be areas where he doesn’t know of a good alternative or there may not be one.

If we’re looking at splitting out from a sourcing perspective products that he sees are most similar and interchangeable, guide wire is obviously introduction sheaths and access sets. So a lot of those access commodities, and the sheaths, and guide wires, some subtle but important differences between catheters, so he’s not really willing to put them in that same category, but conceding that much of it is personal preference.

Randy, how much do you see the device companies trying to differentiate in sheaths, guide wires, and access sets? Does it jive with what Doctor Oron’s is saying or are there some attempts in the marketplace by device companies to really stand alone in those more commodity areas?


Dr. Scherer:  I think there are a few differentiators that you see, but one of the points we’re going to talk about here in a minute I think is the evolution of new procedures for IR and that’s really could be a pedal access. So we can talk about that a little bit later here, which kind of drives a little bit of the development of those interchangeable parts at the smaller sizes. But with catheters, you do see a big driver there. You’ve got steerable catheters, you’ve got different types of reinforcements on those catheters, coded catheters, antimicrobial coated catheters, so there are very distinct differences for the different types of usage that those physicians are targeting and what advantages those products bring to reduction of bloodstream infection within the hospital, ability to access different regions of the body for delivery of embolization spheres or coils. It very much does come down to the advantage of that product and what that physician’s preference is.


Andy Perry:  Yeah, no, that’s good. I appreciate those insights. I think that’s a great segue Randy into some of the market perspective or product perspective elements that you’re seeing. Feel free to go ahead and keep that baton and maybe elaborate a little bit more.


Dr. Scherer:  With the access devices that I was speaking of one of the procedures for critical limb ischemia and trying to pass through a lesion to either do a balloon angioplasty or place a stent, atherectomy, they do a femoral approach trying to come down from the top, antegrade, to cross that lesion. Over the years, at least the last few years, they’ve developed smaller sized micropuncture introducer sets for retro/tibial pedal access, so they’re coming from the retrograde approach bottom-up from the foot. Those lesions are actually softer and able to be crossed by devices and saves actually limbs pretty substantially in the publications that you’ve seen in that particular space from amputation type procedures that would be required. It’s kind of an advancement and really shifted those interchangeable devices that were mentioned a minute ago, the guide wires and the microcatheters, and the access products to smaller sizes so they could save patients’ limbs and have really provided a significant advantage I think in the treatment realm for IR and peripheral intervention approaches.


Andy Perry:  Just to recap there one major theme would be in those more commoditized product areas the access devices for the introducers, and the sheaths, and the guide wires it’s not so much a new treatment technology but for those deep PADs below the knee really taking that different method to go through the food instead of through the femoral artery, catch that lesion from the backside where softer, more penetrable, and more easily treated. Very interesting, yeah.

It’s so cool because this is what’s great about this space is you’re saving limbs. That’s amazing. Think about, mission-related. This is such a clinical win too.

I think Drew’s got some data, you might just want to share. Drew, do you see any cost differences in the marketplace between that pedal approach through the foot or the femoral approach? The differences in the French size, is there much cost difference in the marketplace?


Drew Mays:  Yeah the pedal is the access kits or the introducer kits are about average, $10-$15 cheaper for the introducer sets. The catheters there’s not a big variation based on the French size, 2.3 to about a 5 or anything, but definitely some savings there especially if you have a high volume they’re using of the more commoditized items. There are some decent savings to be had there.


Andy Perry:  So interesting, even cheaper to do the pedal approach from a supply perspective, if minimally or larger cheaper. But then so much better potential clinical result based on what [crosstalk 00:24:58]. These are the kind of wins we’re searching for, supply chain, if it’s cost neutral, if it’s cost reductive and increasing quality than man, that’s the thing we got to be all over all day long. So pretty cool. There’s a chance for us to go out and a get a win in supply chain and work with our medical staff and do that.

What I think is most interesting about this space is there are so many ways that the practice patterns can vary, can treat the patient. Randy, I think this is going to lead into your next bullet really. So go ahead and take it away.


Dr. Scherer:  One of the trends that we were seeing after 2017 there was some products that were removed from the market, Abbotts degradable stint for coronary treatment. Boston Scientific also decided to really halt their product because the long-term studies really showed there wasn’t any superiority or benefit to those products being utilized. That really stunted and really slowed down any potential development of biodegradables for peripheral use, which would be more along the lines of the interventional radiologist doing those types of procedures in the limbs. So we’ve seen increased development of drug-coated balloons and drug-coated stints for those procedures. They’ve done a fantastic job of evaluating all those new products clinically in the clinical studies to show the advantages of drug-coated stints versus drug-coated balloons. As those technologies continue to develop it’s just going to be even better for the physicians long-term, for the patients as well in how they respond.


Andy Perry:  Drew, what are you seeing in the market in data as far as the use of coated balloons?


Drew Mays:  We’re definitely seeing a tick up in the coated balloons over the past 12 months or so. We’ve seen utilization from our hospitals that are indicating that’s the shift, they’re using more of those coated balloons.


Andy Perry:  Then as far as pricing, so utilization going up loosely across the market what’s the pricing doing in coated balloons right now?


Drew Mays:  There’s a little tick up but it’s pretty level. There’s no major increase in price, could change as the utilization stables itself or continues to grow and they realize they got their hooks. The practice is there to be had too… but yeah, it’s pretty much level as far as the pricing goes.


Andy Perry: Then what kind of price ranges are we seeing for drug-coated balloons in the marketplace?


Drew Mays:  Anywhere from $1500 to $2000 for a peripheral drug-eluting stent.


Andy Perry:  For a coated balloon?


Drew Mays:  Well coated balloon, the high end $1600, low end $1300. The cutting balloons high end $700, low end $650. So not a big variation, but definitely one of more cost efficient to use the cutting if applicable.


Andy Perry:  I believe it is, yeah. So we’re definitely seeing in the data validation of increased usage and even a little bit of increased price pressure when it comes to drug-coated balloons. This is something to be aware of for sure. Okay, very cool.

Randy, your last bullet on some of the market trends that you’re seeing, movement toward detachable embolization coils.


Dr. Scherer:  Over the last three to five years there’s been a shift in physician preference for detachable embolization products as opposed to pushable coils. Part of that I think goes to what they’ve been trained on some of the newer products that were out on the market, the interlocks from Boston Scientific, the retracted products from Cook, they allow for placement of those coils. Then if you don’t like where that coil’s placed you can obviously pull it right back. That provides a significant advantage for complex procedures again from a physician perspective. Those started taking over the market share from the pushable coils which had been around since the early 70s, probably even earlier than that. That is one of the trends that we’ve seen.

Also, controlled delivery of PVA particles or embolization spheres with catheters that have flares on them to prevent reflux and off-target embolization, so embolization occurring where you don’t want it to occur whenever you’re delivering those products.


Andy Perry:  Right, gotcha. Any idea on the incidents of aneurysm or I guess embolization needs in the marketplace? I really have no clue.


Dr. Scherer:  In terms of volume?


Andy Perry:  Yeah, would we be expecting procedure volume to be stable or increase? Are these new devices even opening up previously untreatable conditions? Do you have any read there?


Dr. Scherer:  Yeah I think that the embolization space with coils is probably going to be pretty stable in terms of growth. You’ll see continued increased growth due to obviously increase in the number of treatable patients in the world. However, whenever you start thinking of embolization particles or spheres there’s been a procedural advancement that’s occurred over the last three to five years with particles being used for benign prostate hyperplasia, which is classically treated by a urologist with TURP, which is transurethral resection of the prostate. They’ve tried to pioneer utilization of embolization spheres to shrink the prostate from the blockage of blood flow and necrosis perspective.

Then the other space that I think you see a lot of growth with embolization particles is within the treatment of hepatocellular carcinoma for trying to target some of those liver metastases. Yeah, so you’ve seen a shift and probably will continue to see an increased shift in the growth of embolization spheres in that area with different drugs loaded on them to help maybe bridge that patient to transplant.


Andy Perry:  Gotcha. That’s extremely insightful and corroborated. We’ve got Doctor Orons saying, “Hey, this is a space where there are some really unique devices,” and we’ve got Randy saying, “These unique devices are also usurping some previous treatments and therapies for them.” In our supply chains let’s really be mindful of this and keep an eye out for what we’re doing in our category and sourcing strategy around embolization products, so extremely helpful. Good stuff.

The problem with this being a quick 30 is that our 30 is up. This is such an interesting category. It’s really fascinating. If you haven’t studied this space, if you haven’t observed any cases out there in the audience I really encourage you to do that.

We’re at the end of our 30 so we do want to leave time for questions. Steve, I’m going to turn it back over to you and let you field any questions that we’ve got. We’re happy to stay on for a few more minutes and field those.


Steve Suhrheinric:  Okay, just getting off mute. Anybody who’s still on feel free to put those questions in the Q&A or in the chat. One I believe more for Randy is just the product categories that you would lump into interventional radiology, what are those?


Dr. Scherer:  Oh man, everything. It’s such a big space. You’ve got interventionists that are also placing feeding tubes, you’ve got all the way from the vascular access type treatment products to the stints, the covered stints, embolization products. It is such a large space. I know we kind of talked about that briefly yesterday. I was trying to get a reading on where we wanted to go with this because it is such a large space in terms of product families, they can be grouped into IR.


Steve Suhrheinrich:  Okay, that’s good. Thanks for answering that. And that’s the … Oh, we have another question.

“So in the atherectomy market, many products appear to be customized to different types of plaques.” That may be more of a statement than a question.


Andy Perry:  I think Randy can expand on that for sure. Randy, what’s your level of familiarity of the atherectomy device being specific to the type of plaque?


Dr. Scherer:  I agree. There are different types of atherectomy devices that would be used in different situations. Again, I think it’s going to go back to also some of that physician’s training on those particular types of products, what they prefer. There haven’t been too many studies that have differentiated the atherectomy products from rotational type products to laser products, or ultrasound breakage. I can agree. I think that they are probably associated with better performance and different types of plaques. But from what I’ve seen I think it goes a lot back to the physician.


Andy Perry:  That’s just it, the practice patterns can be so varied. For the same lesion you could, and correct me if I’m wrong Randy, but you could use an atherectomy device or you could go in with one of those little true paths and bore a hole in the lesion, and then go in with a cutting balloon, and then go in with a stint.


Dr. Scherer:  Exactly.


Andy Perry:  There could be so much variation. Or you could not do that at all and just bypass the lesion, right, and do a graft?


Dr. Scherer:  It is. There are so many different ways to treat these patients, which sometimes is a great thing. It also can be challenging, I’m sure, from an operation’s standpoint and making sure you’ve got the products that are necessary and actually perform the best because of the multiple types of approaches to treat a lesion. It is difficult to differentiate from the clinical data that’s out there what is the best approach because it’s just not standardized across the interventional community.


Steve Suhrheinrich:  Well this is a good lead-in to our next chat question, which is, “What’s the best way to approach IR physicians on standardization of products?”

My answer to that would be good detailed cost and utilization case level analytics, peer comparative, surgeon one, surgeon two. I like putting their names on it, but show if we stratify it and we just look at PADs, so you look at those peripheral arterial disease blockages, and that’s what you’re talking about, and you look at the different case level cost and utilization comparisons across your surgeons and you just put that data in front of them you’re not coming with any preset position of an idea or foisting a new product on them. Begin to share those case level cost and utilization analyses, I think that’s the best way.

Randy, coming from a device company background if you’re trying to move practitioners in a common direction any suggestions there?


Dr. Scherer:  Well I think it goes back to the point that I make on the clinical data. You’ll see a lost of postmarketing studies on these products because most of them don’t require a clinical trial to get to market when you’re talking about the standard products, the guide wires, the catheters, the access devices. To convince a physician that it was a good approach I needed to do a post-market study on that particular product to show the advantages because they’ve been classically trained on the antegrade approach. They believed in that and didn’t think that this was something that could be done. The device companies had to provide the clinical data to support a transition to that procedure whenever it did provide advantages.

In this space, if it’s a product that doesn’t require a clinical study before it comes to market you’re going to see those post-market studies that are going to help drive the data and information for a position to want to adopt a product. If it’s a product that does require a preclinical study before approval then you’re going to see a comparison probably to the top competitor on the market or at least something that is a comparable competitor to what you’re seeing in the space to either show not inferiority or superiority. Then if it shows superiority well then they’ve got a marketing goal that they can go out and really transition a space over to utilization of their product.


Andy Perry:  I think that’s a great insight to answer that question around standardization is you have some really rich data sources through the regulatory approval path that can help you tee your clinicians up with how to make those decisions. If it’s something that’s coming through on a 510(k) and there’s a substantially equivalent device showing that information and stratifying your product mix that way to help illicit some standardization from your doctors. But then, mining those post-market studies and putting those in front of those ladies and gentlemen to help them decide really on these devices that are claimed to be differentiated what’s the post-market study really showing. I think that’s extremely insightful as good methods. Again, it’s about in the supply chain being the strategic leader who’s embedding the right tools, and analytics, and people resources, and an interdisciplinary team that’s helping your clinicians make the best value decision for your patients. It’s not about foisting a product. It’s not about being the gatekeeper.

Drew, is that consistent with what you see in good leadership in our customer base?


Drew Mays:  Yeah I would agree. Anytime you foist something on a physician it normally ends badly. It’s finagling those conversations to get their input, so it’s an open-ended statement or an open-ended request like what do you think? Here’s a new product, we’re using three of these and two of these, tell me the differences to really engage them on the clinical side that anytime you’re demanding a change you’re going to get a lot of fight-


Andy Perry:  It may not go well.


Drew Mays:  Yeah.


Andy Perry:  It’s best to give them the tools to take the baton and become your advocate in making good decisions.


Drew Mays:  And sharing that cost data too, that’s the biggest thing we’ve noticed.


Andy Perry:  They’re hungry for it.


Drew Mays:  Yeah, they want it and they’ll tell you why you should pay more for that or why we shouldn’t be paying more for that. So yeah, I would agree.


Andy Perry:  That’s good.


Steve Suhrheinrich:  That’s great. We do have another question guys.

This one is, “Thoughts on the off-label use of biliary stints.” The question is, “Are you seeing them used in peripheral vessels?”


Dr. Scherer:  I’ll address it here, just kind of in a roundabout way. Yes, I have seen it and have seen transitions from actually both ways, some of these drug-coated peripheral stints have been considered for usage in the biliary space as well. I say yes that it occurs, but it’s physician preference. It’s always been the medical device community and regulatory community’s perspective that a product is approved for a procedure, it’s demonstrated that it’s been safe and effective in that procedure. We don’t control how a physician chooses to utilize that product in a different space because that can prohibit innovation for patients. I also see the flip side where if a product is used off-label it does bring some risk to the physician and the hospital that would be allowing that to occur I guess. Those are a roundabout way of answering it. My thoughts are predominately on the you don’t want to stifle innovation because it could save a patient’s life. But I also see the regulatory risks associated.


Andy Perry:  I’m curious, is there any path of least resistance? Is it more common for the device company to get a peripheral stint approved and then go back and get a biliary indication later, or is it easier to go the other way? Any insights there at all?


Dr. Scherer:  Yes and no. It’s going to come down to yes, what is the easiest regulatory pathway to gain approval for that product. Then obviously you want to see adoption of that product in the space that you’ve gained approval. But there is some strategy around if that product has potential to be utilized in other areas you can monitor where that product is being utilized from a volume perspective a medical device company. Know that you may have some advantages if you were to transition to a different indication that would allow you to market specifically to that type of treatment.

In terms of the medical device community’s view, they’re wanting to get the product to market as quickly as they can so they’re going to take the path of least resistance and then potentially adopt it for other areas.


Andy Perry:  Yeah, no for sure. How that translates into your sourcing strategy then your spin visibility you might want to be aware that if you’re pulling based on [inaudible 00:45:01] end codes you don’t want to overlook those biliary stints that might truthfully be used differently or peripheral stints that might be used in a biliary application. So very good question by the audience member there.

This has been outstanding. Randy, I can’t thank you enough. Steve’s going to do our closing, but I just want to personally tell you how much we appreciate you joining us.


Dr. Scherer:  Glad to join you guys, great organization, good people. Love what you’re doing.


Andy Perry:  Yeah, well thanks. Thanks man. Steve?


Steve Suhrheinrich:  Thanks Andy and thanks Drew and Randy. So just to wrap things up, again, this was recorded so we will be sending you the recording.

There are future Quick 30s coming up. Hopefully we’ll keep them within 30 minutes, but you never know. Total joints is next, Stan Mendenhall is going to join us along with Bruce Cavanaugh from New Hanover Hospital to talk about those categories.


Andy Perry:  Great.


Steve Suhrheinrich:  Then we’ll be filling in some of the others over the next several months and you’ll see some invite updates around that as well. So hopefully you’ll join us.

If any of you have any experience in some of these categories that you’d like to share and be that sourcing perspective we’d love to have you on and talk with you about this. So please let me know. You can find me at steve@curvolabs.com and that would be great to have you participate.

That’s it. I hope everyone has a wonderful rest of your day and thanks for joining.


Andy Perry: Thanks Steve.


Dr. Scherer:  Thank you guys.


Steve Suhrheinrich:  Thanks Randy.


Andy Perry: Thanks Randy.