BoneChat #29 - Validating your concepts from idea to clinic - Lisa Voronkova

So we are live with Lisa Voronkova. She's the CEO of a stealth startup called Ova Solutions, and she's basically just a tech entrepreneur in, uh, the medical wellness space. And Lisa's going to lead a discussion around validating your idea or concept before you get too far along in it. Handing the mic over to Lisa. Welcome.

Sure, thank you. I prepared some slides, but please feel free to interrupt me. So it's not like a report or something. As I mentioned, I just noticed that this question is usually omitted in the startups, and I think it's an interesting way of addressing the understanding of the value, right? So understand where are you in this pyramid. So I think that everyone should start by identifying what makes your product or service valuable. And it seems so obvious, but I think it's critical to understand which one thing can be improved, like one aspect. So it can be like better patient outcomes. It can be like some Cost savings can be improved efficiency. And to start identifying what makes your product or service valuable, you may want to begin by analyzing the needs and understanding the care pathway in general. So like, talking about medical devices, you can consider specific problems faced by healthcare providers and problems faced by patients. That your device is aiming to solve. And once you gather this information, you can map out how your product can address these issues. So look at patient outcomes. How will your device improve their health or quality of life? So cost savings, for example, will your device reduce the cost of treatments? Will it reduce the hospital stay? How it would affect further medical procedures for the patients. And second step is comprehending the value. So by this stage, you already have a plan how to monetize, and then you may want to calculate the potential cost savings by comparing the current cost of dealing with the problem that is addressed by your device with some projected costs after implementing your device. And here a bit further today, we would discuss the care pathway and how it would be affected by the device. So it's actually might be a bit challenging to calculate this cost and prove that there will be some savings involved. And then you may want to quantify the value. So you convert your understanding into some measurable terms. So you focus on this matrix and here's the one that I put together. So the one that you may use for understanding what can be changed. So here's like direct reduction in healthcare expenses, as I mentioned, including hospital stays, including treatment in general, some procedures, maybe aftercare. Then of course, patient outcomes, right? So metrics that demonstrate better health results, like reduced complication rate, for example, after orthopedic surgery, we see that there are reduced complication rate because of use of your device. Talking about quality of life, some insurance companies care about it, some don't. But it measures the loyalty of the client to the insurance company. Thus, it might be interesting. Also includes quality of sleep here, so it can be measured by questionnaire during the clinical trial. Next one, opioid consumption. So maybe your new device, new technology can lead to reduction in the use of opioids for pain management that also like decrease risk of addiction and decrease associated healthcare costs. And the rest of here, like time to ambulation, recovery, readmission rates. So pretty clear. Length of hospital stay can be interesting. And there's something that I've just mentioned. So it's like, We have to figure out to whom we're communicating our value because I just started working with another startup that makes implants and they use the same presentation. Doesn't matter if they talk to a payer or to a hospital. And I think that can be optimized because when you're talking to a clinician, they care about different things. And when you're talking to a payer, they care mostly about money. They're not quite aware of the entire care pathway, right? So Anthony, talking about your device, how do you think— how would you talk to a clinician? How do you talk to payer?

Oh yeah, they're two different conversations. I think for a physician it's more ease of use, Less complications and faster, faster approach.

Okay.

And then, you know, for, you know, payers and things, yeah, you gotta look at the, where are the cost savings? Is it an operating time per minute? In the operating room cost per minute? Recovery? Revision rates with other procedures. All those come into play.

So have you talked to them or are you still considering pushing it as a—

We are early stage pre-revenue development and those are on our radar of things that, you know, I've gotten surgeon buy-in. Administrator buy-in from an ASC perspective. So I know we're kind of on the right track, but, you know, we're up against SI Bone, who has infiltrated the, you know, the payers pretty well. So we have to figure out how to navigate it that way because it's a different approach. But those are all things all on the radar, you know, as we hit our development milestones and go through regulatory and reimbursement landscaping.

When we were part of Techstars, we noticed one company which was in a similar stage as yours formed a customer advisory board. So what they did, they approached insurance companies, like two players. I believe in their case, the most open one was Blue Cross Blue Shield. And they say, well, guys, they were specifically talking to an innovation manager. They said, okay, so we're not trying to sell you anything. Just help us to understand what we're missing here and what we don't know. About your business, but you still see some opportunity in case we succeed for yourself. And so that's how they after all managed to get a paid pilot with them. But well, it didn't happen right away, but it took just half a year for them to step into this. I think it was pretty smart to like just put an advisory guy. And yeah, like as a final part is just to communicate the value, but this thing I think everyone is doing right. What I noticed also is that if we're talking about the care pathway, let's say your solution affects this part, that means that if you're calculating the cost would it be, would some cost be affected here, like on the next steps after you implement your solution and there would be like next steps involved or not really. So that's what I've seen how it usually calculated for presentation for the insurance company, like not just the use of the device, but also next step needed.

So, so, Lisa, that— when the metrics are— go back to the metric slide. That was really— it's amazing how much validation information you can potentially acquire. But my question is, how do you— some of those metrics are easy to obtain, and some of them are very hard. How do you— here we go. Yeah, so how do you, how do you capture all this stuff? And I mean, let's talk about Anthony's stuff, and specifically he's got a new spine device.

So, so yeah, hypothetically I would just make a list of this and would talk to insurers before starting the clinical trials, asking what do they care the most, because different companies use different payment models. So is it like what they care is payment per patient per month, for example, and saving cost per patient per month, or you're trying to target adoption rate. Or you're trying to target some specific plan and then you would probably choose not all of them, but 1 or 3 the most to prove that with your device, there would be some improvement in this metric. I'm talking about not specific metrics like quality of life, as I mentioned, are like hundreds of different questionnaires, but you may use specific one. So you just need to ask your patient population these questions at some point, so during the research to show the difference.

Yeah, there's lots of post-market surveys you could use. Some are formal, some are informal. Um, And it takes a lot of, takes a lot of patience to, to see a trend compared to a baseline. Interesting. I never think of the payers, you know, the payers are the last ones you think about, but it's probably the most important for a lot of companies.

Yeah. That's something I noticed that, um, you're starting thinking about it sometimes even after you already drafted and started clinical trials. But maybe that's your main client after all, because they gonna pay. Yeah.

Well, let's open it up. Somebody have a specific question about how to validate a product procedure? Well, unique solution.

Well, I guess with, with the, you're talking about clinical trials, you know, what if, uh, the product's just 5-10K where you don't need a clinical trial. You just need biomechanical equivalence to a predicate.

Yeah.

Well, I would say the 510 is just a hunting license. It's not— I think you're always going to need nowadays in the US and definitely Europe, you're always going to need post-market data.

My question would be, how you prove that you're better than some solutions on the market? You still need to show some results despite, um, like clinical trials.

Yeah, in the SI space or in the SI joint space, uh, you know, SI-BONES focus predominantly more on patient satisfaction. For the most part, where a lot of the complications are hidden and not— or they're underreported. But if you really peel back the layers of the papers, and even one specific, the Maud paper, it points to a lot of complications. Yet they're the gold standard.

Well, that's interesting.

Talking about, um, cooperation with the insurance in general, I found one interesting resource that I want to share with you, and I noticed that some of Bonchan members are friends with Dr. Sollet. Who is, um, leading this blog. So I shared in the chat the article where he's talking about, um, how to negotiate with payers, and I think it, I think it's a good one. Also, here is another one. Yes, Mark.

I was going to ask Anthony because I think this is a great slide, but like somebody said, I might have been Tiger Buford, great, how do you prove it, right? And Anthony's point about the 510 was one I was going to say, like, that it's, it's like biomechanical. But I, my question sort of is, um, can you, well, can you pick one or two and do your sort of post-marketing, um, papers, your research, you know, you're, you're testing it at, you know, like Anthony, in your case, like you're your 5, uh, Alpha Team surgeons and you're testing like, or measuring just blood loss or, um, time to ambulation, whatever it is it would be on the SII side that's maybe different than patient satisfaction or additionally to, so that you can say we have equivalent that they do, but we also have more data based on where something where you think you're going to to win it. But Lisa, like, how do you— the question sort of is, how do you know what matters before you set your study up, right? That's sort of what you're talking about. It's like, hey, I know what I think matters, but what do the end payers think matters? And in some cases, it might be the hospital and so— or surgery center. And I guess sometimes it's the insurance, right, Anthony?

I mean, yeah, yeah, I think it's a great— that's a great point. Yeah. Which one, which, which one, I guess, even like ranked, which one would you rank as the 5 to focus on in a post-market study?

Right. Also ones that, you know, you're going to do well in, right? Like, let's be honest, we're going to measure what we know we do well in. But like, I'm thinking like length of the bottom one, the second one up from the bottom length of stay is an enormous one for hospitals more so than ever. It may not have application, Anthony, to yours, knowing your procedure a little bit. But, how do you— how would you test that, Lisa? Sort of like, I don't know when you do it in the process, but when would you test it so that you set your studies up to prove out these points? Would you put a list like this in front of whoever you think the non-clinical decision makers are, the payers or the health system or whatever and say, hey, do these matter? And which ones? And force rank them. Like, how would you do that?

So as I mentioned, I've seen very efficient way of having a customer advisory board, right? But before putting this list in front of your advisor from a payer side, I would of course try to hide or eliminate the one that I'm not sure if we're gonna perform well on. Something that you mentioned, right? Because in any startup, you already have some preliminary data. And I've been working in this previous startup, like tools for measuring the gait after the surgery. And we noticed like in which metric we can perform good enough and which we probably would not. And another way to rank This matrix is to see how big is the issue for this specific diagnosis. So we would just gather statistics and say, uh, what would be the average cost for, let's say, complications, what would be the average cost for hospital stay and so on. And see, um, usually once you did this calculation, you can see that 1 of 3 metrics here matters, and the rest is just not really significant. So you don't even want to include them into study because they would have no economical effect to, like, payers or to clinicians after all. Good.

Yeah, Mark's happy. Let's go to Mauricio.

Oh yeah, this, this is very, very interesting because I know I've made the mistake of falling in love with an idea and taking it too far and then realizing it's a very hard thing to sell. So, so I've learned the hard way to, to, to be very disciplined. And my, my, my thoughts were, okay, maybe in a 510 you don't do do a clinical trial, but you do need to build an evidence base to support your claims. And if you're in a 510, you're probably in a space where maybe you're disruptive, but you are innovative on a scope that you know you're going to be innovative on. And that's where understanding who is going to be the final decision makers for your for your device are. So one, if you're targeting a, for instance, I'll talk about a nail for orthopedics or something, you have to know where those procedures are being done and what are the criteria. So if it's a procedure that's being done in like high complexity university settings or larger health systems, you know you're going to have to be in contract and you're going to have to find claims under probably these metrics that are going to help you support to a contract committee with your certain champion that they should offer you a carve-out. So you should always be a couple of steps ahead and understand not always that the fact that there's a big market doesn't mean that there's a big market for you, especially in this industry. So you have to be very very smart about it. And I do feel like even if you get a 510 and you can use it in a clinical setting, that is just step one. And then you're— that's where your surgeon advisors and your KOLs become really useful because that's where you design maybe smaller studies like patient-reported outcomes, even some specific small cohorts to measure many things. But this is I think this is something that had I seen this 10 years ago, my life would be very different.

Excellent. It's like all roads lead back to the VAC committee. It seems like it. What kind of— Mark, do VAC committees, are they asking these questions?

They're not really asking them. They just, this is what they're looking for though. You know, if they were asking questions, Tiger, we'd all be a lot, have a better understanding of what they wanted. They're not, but this is what they're looking for. That's why I was like, I was looking for things that I know from a health system standpoint. That's a little bit, it's a little bit different than an ambulatory surgery center that isn't owned by the health system, obviously. But, um, These are, these are, and I would add to this, there's some strategic factors that all end users want. Surgeons, ambulatory surgery centers, health systems in the US, where you can say, hey, we not only took care of your patient fused, little blood loss, their postoperative pain scores were low, but it also let us do A, B, and C, which coincides with what you're trying to accomplish from a health system, you know, and so Um, they, it all, I hate to sound like a broken record, Tiger Buford, you, you were the broken record there. It does, it does seem to all come across their desk. The problem is they're not telling people what they're looking for unless you ask them. And then you ask them and I'm finding most companies actually have a lot of this stuff. They just didn't know it was as important as, um, it is. So, and in Lisa's point, she's talking about thinking about it beforehand. But yeah, like, they're really looking, obviously, look, number one, cost savings, they think is important, but it's not that important. It's not as important as everybody thinks, but improvements in patient outcomes. Time to ambulation, time to recovery, those are very important things. Readmission rates, depending on the procedure, are Patient satisfaction is, and length of stay absolutely is, and hospital-acquired conditions are also very important, but those are so hard to— those are, especially when it's infection, they're so hard to prove. So, but yeah, like, I think Mauricio said it very well. You got to think about who are all the people that are going to have a decision on this, and can I get them wins, right? Can I, can I not just the surgeon and not just the patient.

Well said.

Go ahead, Elizabeth.

Hi, Lisa, question for you, but also I started thinking that perhaps Mark might have some input here too. I'm looking at the preventive care impact and thinking about the statistic that roughly 42% of Americans are obese at this point, and I I can't see that getting much better anytime soon. Can you talk a little bit more about measuring preventive care impact? I mean, certainly orthopedic surgeons I've spoken with really don't have an interest in making people go on diets before surgeries. But they have to get into the psychosocial stuff. So if you could talk a little bit more about that, that'd be great.

So sorry, I think I missed the question. Can you tell me a bit more? So you're talking about the—

some ways of measuring preventive care impact.

I mean, that's got to be exceptionally difficult. That is true, because that is something that affects, like, way bigger population. It's very hard to measure in general. I honestly haven't faced this type of study. Maybe someone from the chat did, someone from the group, because usually studies I've seen that are focused on something that is after the injury already. And it's very hard to understand the impact. You need to have like probably really huge patient population to measure it.

Yeah. I don't know that we're there yet. As far as the society taking that into, into account, I don't know, Mark, what do you think?

I don't know if as a, as a species we'll ever really truly get there, but, uh, from my experience. But I was going to say, you know, Elizabeth, would you like— since most of the people here are ortho spine, um, I was sitting here thinking like the cervical artificial discs, um, the preventative care impact would be decrease of second surgeries in the next 7 to 12 years, like I'm just trying to think about that sort of thing, right?

Like, looking at it from that angle.

Sure.

And I'd be curious what anybody on here thinks. But, um, I remember hearing this years ago, hospitals saying, yeah, it's an artificial disc and it's, it's great. But, um, if the patient comes back for another surgery in 8 years, that's actually good for us. Right. And you start to hear the, And they'd say, well, maybe insurance companies like it. And then insurance companies would say, well, people change their insurance every 3 years. So we don't really care either.

Okay.

Not my favorite day in healthcare when you would hear those things. Yeah. So I don't know if anybody else has ever heard those things, but that would seem to me, Lisa, like a preventative care impact lease that would, I think would make most sense to most of the people in here because of our musculoskeletal backgrounds, I would think. Your thoughts on that are welcome, Lisa.

Yes, I understand. Um, so, um, again, different countries have different approach to, um, healthcare. And so, um, I worked with one startup who was targeting both United States and Singapore, and then, um, I noticed the difference in the approach there, is to say that Okay. If people are changing insurance after 3 years of being with one to another one, that's really not something that would interest an insurance company. And talking about negotiating with the insurance company as the topic you raised before, right? So there are some common types of pushback I heard from them. So like they, are saying, okay, we are not interested in the form, like we don't believe you, or we're not agreeing with you, or like, we believe that it's gonna work what you designed, but we're not sure if it's worth our efforts, or we don't think it's practical or gonna be used. So, um, here, what I noticed in some companies that succeeded is that, uh, they tried to build a good relationship with a certain insurance company who shares their values in the first place, because there are some players in the market like Humana, for example, and maybe you can name some others who, among other metrics, also have this retention rate for their customers and they're trying to keep as much as they can because then they can offer like better plans for them. So again, it goes to— all goes to the money point where you can say, okay, we can keep your retention at a good level because you can get this, this, this benefits to your clients.

Yeah, go— yeah, going back to Elizabeth's comment, I think the United States will never be able to really invest in preventative care because it's— we, what we really do here is sick care. We don't do healthcare. And like, like somebody said, uh, insu— people change cities, they change insurance companies, they change employers all the time. The countries that are in like Europe and Scandinavia, they actually track the cost of treating a patient from cradle to grave. Uh, remember When we, we got the NIH approval to sell Magic Rods in the UK, and the way we did that was we showed that a child was going to have, uh, 10, uh, grow— growing rod surgeries in their lifetime with the current technology. But with ours, they only had, they only had one surgery for a lifetime. And so after, I think it was after the first 2 and a half surgeries, we were net positive or cheaper to treat that patient. So, and I, yeah, the UK's got, I don't know, it's like $200,000 per person per lifetime in their budget. And they track, but we'll never be able to do that in the United States. It's, it's the Wild West here. Interesting.

That's really interesting though, Tiger. I, I'd never heard that story. And that makes total sense. One payer. Yeah, one bucket of money. One payer.

Yeah, yeah, they track, they track the patient. Yeah, it's like if the United States would do that, if we had national healthcare, we would do that. Everybody would be tracked based on their Social Security number for life. And but it's never going to happen.

Interesting.

Another— any other questions around this topic? This is great. Well, let me throw out— oh, there you go. Well, I was talking with a startup CEO this morning, and I'm not going to mention names, but, um, I'm a big fan of doing your first surgeries outside the country just to get— before you get FDA clearance in the US, um, because your first design is never your best design. You're going to start off with design 1.0, and you're going to have 2.0, 3.0, 4.0, and you're going to— it's going to constantly get better, the implants, the instruments. So it's really important to get once your device is designed and it's safe, but not necessarily FDA-cleared, it's really important to get that surgical experience early and figure out what's cumbersome about it and watch the patients heal for a few weeks or months and see if it works or not. And that, I think that's an important metric to get early rather than late.

I don't know.

I, I have worked for two startups that had a mantra where we do all of our first surgeries in faraway lands, and we don't, we don't hurt anybody, but we want to get early feedback before we go to full launch.

Yeah, I'm a, I'm a big fan of that, but that's, uh, and I, I also think that, uh, one thing that's very important about overseas is that first you have, if you have a key advisor here who's, I don't know, a guy on the top of their field, you find a specialist in South America, in Asia, they will be jumping through hoops to work in a project that's directed by this high-profile surgeon in the US. So you can leverage that to also get early sales. And also data is a lot cheaper to gather. So if your IRB fees are cheaper, my personal experience in Colombia, as long as the devices are cleared by INVIMA, which is a 3-month process, insurance will cover, like public government will pay for the devices even if you're in a study. So you can run studies and actually be profitable while running your studies. And this is very important. I found that there's good options. And also you can prove all of these claims before you even pitch anyone in the US.

We're on the same page. How do you test surgeon adoption? So, you know, you design something, it's— you've got a couple of KOLs, everybody says they want it. But then you've gotta one day when you grow your company, you've gotta take it to Omaha and find a surgeon you don't know to use it and, and get through their VAT committee. So how do you test surgeon? How do you test surgeon adoption early?

I would say you may want to start with some champions called leaders in the industry. So how we did it was the previous startup, we found some channels on YouTube and these people are always looking for devices or something to talk about, something new. So it was actually a pretty good conversion rate for us. So let's say every 2 out of 10 surgeons got back to us and 1 out of them actually invested in that previous company because they are leaders in the space and they're interested in something new and they're probably easy to convince about something. And then when you growing it, probably having this type of leader using your technology would be a good sign for new people using your product.

Interesting. So you, so you found them on YouTube, basically they were asking for a device or they were—

No, they, they just bloggers.

Showing expertise.

Yes.

Just bloggers. One blogger from the UK, which was not like pretty relevant to us, but still he had a lot of followers from United States and other blogger from California. So they were talking about their experience in the surgery room. And some new technologies sometimes trying to build their own personal brand, but you know, they're as any creator, they at some point are running out of the ideas and they're always looking for something new to talk about it. So at first it was interesting because it was at least mutually beneficial to let's say, make friends in the industry while talking to each other. And then we built stronger relationship with them.

Interesting. So you're looking for the early adopter profile. That's really interesting. That is fascinating. Okay, let's see. Mark's got a comment, and then Dennis, and then Alessa.

Well, I, I was going to say, um, having been around several startups, um, one of the thing— including all sorts of new ideas and products and services and things like that, uh, one of the things I've learned to do is basically a salesperson, right? He's, um, I'm always wary of the, uh, thought leader or the, the early adopters because I think they end up telling people like Alyssa or Mauricio or Anthony how awesome it is. And that doesn't help with the shiny object syndrome we talked about— Lisa was talking about early on— where they've just fallen in love with their baby. And because I live in an area where there's a bunch of old Pennsylvania Dutchies that, like, again, they think the Chipotle in town is going to cause a, you know, an earthquake because it's— I take it to the ones who tell me no about everything. And then, and then I learned why that 80%— there's the early adopters, the 10%, the never adopters, 10%. And then the 80% or so, you know, in the middle of it. And I listen to that. I tell the company, come on, Alyssa, we'll take your new spine product out and we'll take it to the people who are going to tell us no. And then I'm going to ask them why. And then we're going to listen because that'll tell us what the 80% of the market's thinking about, why they shouldn't try something early on. Because I'll tell you, when I was at Globus, I got smoked plenty of times because I was, oh yeah, they listen up there and they got 3 surgeons up there, all of whom we know, and it's the greatest thing. You know, and you got out and I got a bunch of surgeons, they're like, this is the dumbest thing I've ever seen. Awesome. Right? So I would listen to the smart, the early adopters as to why the yes, it's great. And then I'd listen to the never adopters as the no, it's dumb and ask them both the same question. Why? Because it'll tell you what the big part of the market does. And I'm usually the crash test dummy, it seems like, or the canary in the coal mine. So I knew Alyssa would laugh at that because we were talking about her thing this weekend.

So yeah. Excellent. Yeah, just to add to Mark, we always ask the surgeon not what they thought of the device, but what does your partner down the hall think of the device? What are you— would your colleagues use this? And they give you the real answer because it takes the ego out of the question. They'll give you the real answer. Dennis is up.

Uh, just a comment and a question. Can you hear me okay?

Yes.

Uh, first of all, thank you for a great presentation, Lisa. Uh, on your slide where you have all the listed outcomes, uh, in adopting— in identifying early adopters, I try to tend to go to people who work in a registry or are well published in these types of metrics, whether it's been enhanced recovery internationally and especially like in particularly spine. Have you any experience in using registries with these outcomes? And is that data that's been accepted? Because I've been pretty successful with that. I'm just curious as to what the consensus is here.

Can you tell me about your case? You said you were pretty successful. How it was like?

I've been doing a lot of pain management products and devices in the space for the last 10 years. That all required outcomes data. But by the time we start— we actually created the study, looked at the PROMs, it was— and then you did the study, it was too late. So we moved to registries. Uh, for example, as an example, I would tend to go to Carolina Neurosurgery and Atrium because they're heavily involved in their own registries and their data is pretty good and they have all the metrics that you're talking about. So I'm just using that as an example. I mean, have you had any experience in that, or is team? Because to me, getting the outcomes data is, is critical to being able to prove your case quickly in a validated method.

So, um, well, when I pulled this metrics, I was keeping in mind that, uh, every startup wants to exit at some point, and, uh, then depending on who is your strategic buyer, you may want to adjust this metric. So for example, if I, as a startup, want to not to grow as a business working with the insurance companies, but let's say I want to, I have in mind a hypothesis that I want to exit to an interested buyer who is bigger medical device production company, like, I don't know, Stryker, let's say, then I would adjust this metrics that I would focus on based on what they are looking for. For and what matters to them. And if you're saying that they already have some metrics in mind, then I would just try to prove that with my device, the result would be improved after all. And, um, in our recent product, we were doing FDA clearance before we actually received any metrics at all.

Okay, I was trying to, I was just trying to find out from the group and yourself what you thought about registries versus doing the data from registries to studies and picking KOLs that actually are involved in registries so they can get the post-marketing data pretty quickly. Just to carry out, I just, we've been successful with that. I just, I wanted to get some consensus from the group and from you.

Thank you. It also depends on how innovative the device is. So for example, One of the recent cases I've been working at was, um, scales. And like, there are plenty of different products similar to that. So it's easy to prove that this specific one is like better than the others, just, um, in a way that you're putting together a patent, right? When you're doing this, you're saying, okay, there are like these other patents and we are better than these guys because of this. So on. And, um, if there's like something truly new, truly innovative products, not saying like technology-wise, but something that would change the process completely and would affect a lot of steps in the care pathway, then, um, probably that may not work because you need to prove like too many things and you might want to have at least small trials before that. Okay, thank you.

Yeah, Dennis, don't— I mean, post-market studies collect a lot of data, you know, a lot of patient satisfaction and mobility and, you know, a zillion things where registries are a little top— they, they are more, um, uh, broad where they usually test, uh, reoperation rates or survivorship. How long has the device been in. Is, is that true?

My experience has been now with the enhanced recovery and the metrics that, that Lisa showed, you can pull, you almost most of the registries and top places have all that in there and you can pull that specifically for your product or for the surgeries that you're, you're doing. That's been my experience. That's why I've tended to go after KOLs that do a lot of enhanced recovery or rapid recovery programs because you want to show that your device or whatever your methodology is, is actually providing a benefit. And those are the guys that are constantly pushing the envelope versus are they early adopters or not. These are the guys that are saying, I'll try, I'm going to try something that's going to prevent, potentially provide a minimally invasive incision, you know, whatever it is that might enhance the recovery to the, to the surgery that they're doing. I don't know if that answered the question, but that—

Yeah, it does.

It's going to go on to that.

Interesting. Okay.

Uh, Lisa.

Yeah. So I, um, on that slide, I would also add, uh, with all of the, the key points of metrics, I would op— I would add operational throughput and, uh, the ability for information to be repetitively disseminated. I think those are, those are two key factors that can prevent a product from being allowed in. If it increases OR time or if the entire hospital has to be trained on it, it can really slow down the entire hospital process. And I've been in the big major trainings with grand rounds lectures for every unit in the hospital. It's a big undertaking and it costs a lot— the hospital a lot of money. And then if the technology cannot— it can only be sold through the CEO's mouth and/or a PhD's mouth, the product gets lost every time because it just doesn't translate well to the market.

Great point.

Mauricio? Yeah, one thing that I was thinking with all this conversation is that you should target two different groups. So one is the early adopters. They're the guys who are going to use you early. They're the guys who are going to try your procedure and try your device. And from a growth standpoint and from gathering real data evidence points, this is very important.. But you should also, in the curve, you should find all of the laggards and all the people who, you know, when you tell them, hey, I have this new 3D printed plate for whatever surgery, and they'll tell you like, I'm fine with what I have. Sitting down with those guys is very important to, one, polish your sales pitch, and two, like burst your bubble a little bit. So I've had 1.5-hour talks with surgeons who told me, you know what, your product is crap, I don't believe in that. And then you dig into that and I'm like, why? And you learn a lot and you actually come back with either, you know, many potential development avenues that might be useful in the future to convince this doctor, or actually you end up convincing them. But it's a really enriching exercise.

Interesting.

So here we've got a chat question from Laura. Says the— let me read it to Lisa. The VAC may also be interested in efficiency, time to discharge, OR time, safety, staff satisfaction. Does this replace— and does this replace another technology?

Interesting. I'm not quite sure what is efficiency and how you measure it. So probably it should go to some specific case, right? Time to discharge and like also safety. So it probably should be some another metric. Staff satisfaction, never seen someone honestly cared about it. Maybe in Kaiser Permanente, they also trying to focus on the surgeons because they want to attract the like top players. But maybe you can name some other hospitals that I'm not aware of that actually care about the staff satisfaction metric. Other than that, I can't think of someone. And I'm not sure what does it mean about, does it replace another technology? So like meaning that you have to spend a lot of time implementing your new decision into the hospital care.

I think it means, does this product, uh, get rid of another product and make it faster, better, cheaper? Does it supplant another product?

Yeah, so that's like a entry barrier. That's something that Alissa said right now, from what I understood. So probably it would make it harder to implement in hospital care. Interesting.

How do you measure, how do you measure the simplicity of the product? So either the, uh, the, the having less steps to put it in or having less training to put it in? It's the— how do you measure the installation being easier than your competitors?

Oh, so, um, this is something I would say that also, uh, described in one of the articles I sent in the chat. It's how much it affects, like, all the further steps after your product is implemented, not only at the moment of implementation, but also Maybe you need some specific aftercare and so on. And it also all should be considered when you're thinking about implementing it in a certain hospital. Probably the best way is just to take a look at their protocol and then, uh, also see by yourself all the steps taken. For the patient and maybe interview some patients to know what was their experience, how they came in first, how they got discharged, did they came back, and what were like the next procedures for them to understand which of these procedures you may affect by implementing your decision.

Interesting.

And back in product development, we used to measure this. We just video the cadaver mock surgery, and we would literally count the number of steps. And if there was 143 steps to put our thing in and 120 steps for the competition, we would be in trouble. So we'd have to simplify. And Mauricio's back.

Yeah, one source for patient insights that I found a lot of very valuable information is Reddit and also Facebook. So if you— there's usually groups around the procedure that you are trying to tackle, and patients post and share a lot, and it's— and they also talk about surgeons very candidly. So it's a very interesting place to be like a reader.

But don't, don't you get a lot of angry patients? You don't get happy, happy patients?

You get a little bit of both, but also like the, the angry patients are the ones that are causing problems to, to everyone in the chain. So those are the ones you want to help, help look better. But in, in, in, in our case, in jaw surgery, there's, there's, yeah, there's 150,000 people on the Reddit group for jaw surgery.. And it's, it's super enriching.

Fascinating. And can you collaborate with them and ask, you know, medical device company?

Yeah. I mean, yeah, you can to a point. I mean, you can't engage them and do sales activities, but I, I've done like AMA sessions with them and answered questions about the titanium and how it's made and That, that has been appreciated by the patients.

Interesting. Anthony, I wonder if there's SI fusion groups on Reddit or Facebook.

Yeah, that's, you know, there's, it's kind of a, I wouldn't say controversial, it's just kind of, I view it as no man's land because Spine, neuros, and orthos don't necessarily look at the SI joint in their residencies and fellowships. And then the joint orthos, they're not really concerned about it either. So who's looking at it? So you've got another customer potentially, which would be controversial with the pain interventionalists. But Europe, again, leading the way in this, they have you know, a sacroiliac joint, I think it's called SI-MEG, a European KOL group that looks at it specifically. I believe it's out of Germany or Switzerland. But I'll definitely give a look at the Reddit. And you know, I've even had patient, you know, patients look me up on LinkedIn and stuff about it. It's like, wow. And, and there's a lot of groups, as everybody was saying, on Facebook about it.

Wow. Yeah, it's unfiltered. It's unfiltered conversation. But there's pro— there's probably good, really good— like Mauricio said, there's probably some really good pearls of wisdom in there and, and some learnings. Because we, you know, as medical device companies, we don't really see the patient anymore after they leave the operating room and they, and they physical therapy and they go home and, you know, we completely lose track.

Mhm.

Well, Lisa, this has been great. Anything else to wrap up?

Oh, I just want to say that Reddit is really great resource. I made a mistake with like my previous startup, so I made an account and then I was trying to promote it somehow, and then I got banned very fast. But if you try to play that you're just a patient and you're asking other patients about their experience, you can actually learn a lot. Um, I would agree though, that most of the reviews are negative because when you're happy, unlikely that you would go to Reddit and talk about your great experience with something. Just forget about it. It's not something that would trigger you to write.

What's the stats? If you, if you go to a restaurant and you have a bad meal, you you tell 10 people, and if you have a good meal, you tell 1 person. I think it's 10 to 1.

Oh, I think with restaurants it's different because now we have so much loyalty programs and so on, and Google encourage you to put a review and so on.

Yeah.

Yelp, Yelp helps.

Yeah. Yeah.

Yeah.

Well, this is great. Thanks, Lisa. This has been very, very interesting. We all need to think about the payers and what they need upfront for sure. Insurance companies, um, it's usually an afterthought. So thanks, thanks a lot for presenting. Anthony's going to present, uh, June 13th. He's kind of coming out of the closet with his new SI Fusion device. That'll be it.

It wasn't ready 6 months ago. It wasn't ready.

All right. And we got to get Mauricio up on the docket one day too.

Yeah, I, yeah, I'm ready. I was close to volunteering to this for this one, but then I saw Lisa and I was like, okay.

Yeah, Lisa jumped really fast, which was great. It was excellent. Just go to, go to the Slack channel and you can see the schedule of presenters and just grab an open slot.

Yeah, yeah, that works.

All right, thanks, Bone Chatters.

Another good week.

Thank you. Thanks, Lisa.

Excellent.

I'll take care.

Bye.