Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

MedTech Founder 101: Shifting from Corporate to Startup with John Schindler

Written by Etienne Nichols | April 13, 2026

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with John Schindler, CEO of Liquet Medical, for a "MedTech Founder 101" masterclass. With over 25 years of experience at industry giants like Atrium and Merit Medical, Schindler shares the "painful reality checks" that come when transitioning from the structured umbrella of a large corporation to the high-stakes, resource-dependent world of a startup.

The conversation dives deep into the philosophy of "novel but simple" technology. Schindler explains why simplicity is often harder to fund but essential for physician adoption and long-term market success. He challenges the current industry obsession with over-engineered solutions, arguing that the pendulum is swinging back toward intuitive, easy-to-use devices that don't "break the system" of healthcare delivery.

Finally, the discussion covers the tactical realities of commercialization, including the nuances of the "Valley of Death." Schindler outlines why a limited market release is often superior to broad distribution and emphasizes the importance of building strategic enterprise value through intentional clinical data that speaks to both regulatory bodies and hospital value analysis committees.

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Key Timestamps

  • 00:45 – Introduction to John Schindler and Liquet Medical’s mission.
  • 02:15 – The Corporate vs. Startup Reality: Losing the safety net of big-company resources.
  • 04:30 – Simplicity vs. Complexity: Why investors favor "shiny" tech but physicians crave simplicity.
  • 07:50 – The MedTech Innovator Experience: Leveraging human capital and "pressure testing" your company.
  • 10:15 – Unlearning Corporate Silos: The necessity of radical collaboration in early-stage teams.
  • 12:40 – Clinical Data Strategies: Moving beyond "clinical wins" to hospital value analysis.
  • 15:30 – Establishing "Soft Endpoints" for payers and rural healthcare settings.
  • 18:20 – Negotiating as a Cash-Strapped Startup: Approaching vendors and regulatory services with humility.
  • 21:10 – The Regulatory Chess Game: Why early engagement with the FDA prevents timeline resets.
  • 24:35 – Commercialization and the 510(k) vs. IDE strategy.
  • 27:15 – The Risks of Distribution Agreements: Why products "fall to the bottom of the bag."

Top takeaways from this episode

  • Master the Holistic Approach: Founders should seek exposure to every facet of the business—sales, management, and business development—to understand how their innovation responds "in the trenches."
  • Everything is Negotiable: Especially for cash-strapped startups, approaching regulatory and quality service providers with humility can lead to flexible contract structures that help build a strong foundation early.
  • Clinical Data is for Post-Submission too: Don't just collect data to satisfy the FDA; identify "soft endpoints" that prove economic value to hospital value analysis committees and payers.
  • Control Your Launch: A Limited Market Release (LMR) allows a startup to "get their nose bloodied" on a small scale, refining the sales methodology before attempting to scale nationally.
  • Avoid the "Bottom of the Bag" Syndrome: Be cautious with large distribution agreements early on. If the sales force isn't properly incentivized or trained, your product may be ignored in favor of higher-margin legacy items.

References:

  • MedTech Innovator: The world’s largest accelerator for medical device companies.
  • Hal Stowe (Eurofins): Referenced for his recent article on the strategic value of a purposeful regulatory strategy.
  • Etienne Nichols: Connect with the host on LinkedIn.

MedTech 101: The 510(k) vs. IDE  

In this episode, John mentions having a 510(k) clearance but needing an IDE trial.

  • 510(k): Think of this as the "Me Too" pathway. You are telling the FDA your device is "substantially equivalent" to one already on the market. It gets you through the door, but often with limited claims (a "tool claim").
  • IDE (Investigational Device Exemption): This allows your device to be used in a clinical study to collect safety and effectiveness data. It’s like a "permit" to do the deep research needed to prove your device can treat a specific, high-stakes condition like a pulmonary embolism. 

Memorable quotes from this episode

 "The complexity can actually break the system in some ways. Physicians always gravitate back towards simplicity—things that are easy for them to wrap their heads around." - John Schindler 

Feedback Call-to-Action

 We want to hear from you. Did John’s take on simplicity change how you view your product roadmap? Do you have a "Founder 101" topic you want us to cover? Send your thoughts, reviews, and suggestions to podcast@greenlight.guru. We read every email and pride ourselves on providing personalized responses to our MedTech community.

Sponsors

This episode is brought to you by Greenlight Guru. For MedTech founders looking to avoid the regulatory headaches discussed today, Greenlight Guru offers the only dedicated Medical Device Success Platform. From their industry-leading QMS (Quality Management System) to their robust EDC (Electronic Data Capture) solutions, they help you move from concept to commercialization faster while staying compliant. Connect your quality data to your clinical trials to build the "ring fence" of value John Schindler discussed.

 

Transcript

Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode and today I want to talk about kind of like an episode that I'm calling MedTech Founder 101.

Maybe a blueprint for your first time device launch.

The idea is that most startups fail by, they fall in love with the technology and they ignore the brutal reality of healthcare economics. So today we're going to talk to a founder who spent 25 years Industry giants before building his own.

So, we'll try to talk about the actual tactical, the practical tacticals as I describe them. But with us today to talk about this is John Schindler. He is the CEO of Liquet Medical.

Am I saying Liquet, right?

John Schindler: It's Liquet. Liquet, Latin for the word to clear.

Etienne Nichols: Yes.

John Schindler: So yeah, it's okay to clear.

Etienne Nichols: Oh, okay. All right, man, that's, that's very poignant in the regulatory world as well. But after senior roles at Atrium, Merit and he's now commercializing novel vascular drug delivery tech, he's a veteran of the Medtech Innovator Accelerator.

And John understands both the corporate machinery and the high stakes survival required to lead any early-stage company. So, John, 25 years in corporate medtech, what's. What do you feel like is one of the most painful reality checks you've faced?

John Schindler: Yeah, and so, yeah, that's. That, that's a great question. I think it's so much easier to innovate technology when you're under the umbrella of a much larger corporation.

Etienne Nichols: Right.

John Schindler: You know, you, no worries about where the check is coming from, how you're going about, you know, it's a very structured environment. There's lots of players and resources available to you and everybody has their own, you know, mission. That's part of, you know, trying to bring something new and innovative to the, to the table. Right.

And so, when you hang your own shingle and you open up your own company, it's suddenly all of those resources. It's your responsibility to build those resources and go get the resources because these are cash hungry organizations.

Right. And so. And it takes a lot of capital to kind of do what we're doing. Right.

To bring significant impact. And so, I would say that that is probably the biggest learning for me is. Yeah. I'm not a natural fundraiser and so going through that process has been real eye opening to me.

Etienne Nichols: Well, we may have to come back to that because I actually, if, if it comes naturally to someone, I don't feel like they might be as good of a teacher than someone who's had to really force their way and figure it out.

So, I want to ask you about that, but I also want to ask you about Liquet's technology because when we spoke last, I remember a phrase you used novel but simple tech.

And maybe I made that up. But I'm curious if you feel like simplicity is harder to fund than maybe a complex or over engineered solution.

John Schindler: Yes, I absolutely think that that is true. Right.

But I also think that if you do a good job of illustrating the simplicity of the device in the end of things.

Etienne, it's always been my experience over the past 30 years in that device that you know, when things get too complex, they move out of the realm of, you know, physicians wanting to adopt that technology and it really gaining great traction. Right.

The complexity can actually break the system in some ways. And so, I think the simpler, the easier to use. And the inventor of our technology, Dr. Patrick Kelly, he says this so often, you know, that physicians always gravitate back towards simplicity.

Things that are easy for them to use, easy for them to wrap their heads around. And so that's absolutely true with us and this technology.

And I think it's also true that in anything med device related, where you've seen the, where you've seen the devices move into this really complex area, the pendulum always swings back at some point.

And we're kind of going through this NIDUS right now. I think the pendulum is actually kind of swinging back relative to pulmonary embolism in terms of reducing the complexity. The desire is there.

And so, I think, you know, we're in a good position.

Etienne Nichols: If we kind of look at both of those two topics. So, the simplicity and the maybe difficult, the difficulty in funding something simplistic versus something more complex or you know, wow, it's a robot with AI or whatever. Of course, let's throw millions of dollars at that versus something that's simple and straightforward.

Let's go back to the question I wanted to ask too, about being a self-taught fundraiser maybe, or I don't know what you want to call yourself. What are the things you've learned there?

Yeah. How have you succeeded?

John Schindler: Yeah, I mean I think again relative to the simplicity and the idea of the device staying simple or being simple, I also think that it's very much true. The story that you build around the device and the innovation that you're bringing to the table. Right.

And for us, you know, personal experience in this space and the passion has to be there if you want to ensure that something's going to be successful. But it's absolutely true.

Something that's shiny and new and very complex and has all these bells and whistles.

It is easy for an investor to buy into that technology versus having something a little bit more simple.

But I also think it's also true that we connect with a lot of investors when the message is simpler and the technology is simpler. And so, I think that is a sword that has two sides to it.

Etienne Nichols: Can you talk a little bit about Your experience with MedTech Innovator and what you learned going through that?

John Schindler: Yeah, yeah. I mean, I think these ecosystems, first of all, MedTech Innovator is probably one of the most respected, if not the world's most respected incubator accelerator ecosystem. Let's just ball all that up together into one basket because that's kind of in my mind how I think about them, but it is absolutely true. A really special environment, pressure testing these companies to make sure that they are, you know, relevant in the space. They have the ability to do something impactful.

And I think when you look across the spectrum at all the companies that have been involved in MedTech Innovator, that is certainly true.

And so, like anything relative to these kinds of accelerators, the more you lean into them, the more you get out of them. And so, I think that was absolutely true with our experience.

You know, you can take a backseat and not be proactive and really engaged, or you can be very engaged. And there are so many resources in that ecosystem available if you are willing to embrace them and make it a part of your strategy.

And so that was absolutely true for us and something that we really benefited.

Benefited greatly from.

Etienne Nichols: Yeah, that was something I was curious to hear you say, just because I think a lot of companies or, you know, so I was at Medtech Innovator as a judge a couple weeks ago and I could tell some CEOs and founders, they're just there to wear the pin later on to in front of a founder or.

Or in founder in front of a investor and just to say that they were a MedTech Innovator alumni or whatever, but others are really interested in like, no, give me feedback, give me feedback, gimme feedback.

And. And those you could tell, wow, they're growing just today. They've grown from this morning. To this evening.

And yeah, I think it's, it matters what you put into it.

John Schindler: Yeah, I couldn't agree more. I also think, you know, listen, we, you know, we're, we're, we're a very experienced team. We have a lot of experience on the commercial side of the business. Right. And we've developed a ton of technology.

Many household name type technologies like the ICAST coverage stand is a great example of that. Right. Yeah, that is one of the, you know, product that hits some really high levels of success with Atrium Medical at one point in time and blessed to be a part of that process.

Not just from a sales perspective, but also device iteration as we, as, as I was a part of the business development group moving forward and that product through the, through the company.

But you, you like to think that you know a lot about this space, but the truth of the matter is, is that there's always more things to learn.

Always.

And I think the value of Medtech Innovator is bringing all of these great, the human capital all into one ecosystem where you have access to all these people who can force you to look at things in a different way. Right. Which is how you learn and grow and the organization gets more sophisticated, your innovation hopefully improves, et cetera.

And so.

Yeah, yeah.

Etienne Nichols: Well, so if we go back to the idea of just founder 101, I'm curious about, you know, what direction you might want to take as far as what you feel like you can teach others founders out there. Other early stage.

I don't know if you. One of the things I'd be curious is if there are any corporate habits you felt like you had to unlearn.

John Schindler: Yes, well, I think certainly in the corporate environment there, there tend to be silos and job responsibilities, Segregation. Right. And so, it's not every company that works that has a very collaborative ecosystem and environment where people are just willing to do whatever it takes to make sure that the product is successful.

And so, I would say that as a startup you need, you need everyone kind of pulling in the same direction. Right.

And so, you can't afford to have those silos or that laser beam thinking that this is the only way to do something. And so yeah, so flexibility and the ability to collaborate with those people around you.

I was very fortunate to be surrounded by people in my early part of my career, especially with Atrium Medical relative to Atrium Medical, small family owned business that grew over the course of 30 years,

but was very fortunate to be surrounded by a lot of people who cared about me and my own Professional development.

And I benefited greatly from that. But that was a great example of a very collaborative environment where people just, they stepped outside of their traditional role to make sure that oftentimes to make sure that we were all doing what needed to be done to make sure the profit is going to be successful.

And so, I like to think about us here at Liquet as trying to create that same kind of flavor for the culture. Right.

And so, when I think about Atrium and our experience there, that's what I think of when I think about Liquet and what we want to be.

Etienne Nichols: That's one thing our CEO used to say, or maybe it was a previous CEO that would talk about at Greenlight Guru with culture, how culture. Everybody wants to just dance in the rain, and the culture is raining down on us, but you have to be, every single person has to be one of the people reigning that culture and raining it onto each other. So, I thought that was a great illustration.

John Schindler: But yeah, yeah, I agree.

Etienne Nichols: What do you think? A. What, what about when it comes to clinical data?

I feel like I see a lot of things about clinical wins aren't enough.

You have the commercial background. How do you actually translate that into, you know, something that a hospital value analysis committee would care about?

What are your thoughts there?

John Schindler: Yeah, and so, I mean, I, so this, first of all, this is super important, right? I mean, I think there is clinical data and then there is well thought, intentional clinical data.

And how do you come about? Well, you know, understanding.

Because at the end of the day, as a startup, we're trying to create strategic enterprise value in this organization. Right. And one of the best ways to do that is to make sure that the clinical data aligns with, you know, what would be impactful. Just not just sometimes from a cost economic perspective, but, but also, you know, relative to the payers or the reimbursement strategy or even frankly the quality of life, not just for the patient, but also for the clinicians, as an example. And so, you know, maybe there are some things, there are some ways you can think about costs related to that. Right.

But the clinical data, you know, relative to us, is, is how we really build that ultimate ring fence around the true value of this organization, if that makes sense. Right.

And so, we want to be very intense, you know, purposeful about, you know, the, the endpoints that we're looking, that the FDA is looking for. But also, what could we also think about in terms of like secondary soft endpoints that would help us connect those economic cost, economic beneficial dots as we're Approaching the commercial strategy.

Right.

And so, one of the things that I think about often with our device is it's easy, it's simple, it's more cost effective than anything that's on the market. Right.

But we have to make that reality make sense, not just in the large tertiary care facilities, but also in the rural and community hospital settings. And how can we impact that cost scenario in each one of those settings?

Right.

And so, whether we're keeping the patient in their own center of home and we give the physician some confidence in their ability to treat in an outline facility, you know, where they wouldn't have access to necessarily advanced technologies to help them, you know, keep that patient there and not lose that revenue generating income stream. Right.

And so, there's, there's a lot of value to that. So.

Etienne Nichols: Yeah.

John Schindler: And I love that you could go on for days about this. I'll stop on that one.

Etienne Nichols: No, that's great. I love how you talk about the, the softer endpoints. And I think there's been some talk about how it makes sense that you need the clinical data for post submission, not just to get submission to the FDA or whatever.

You need something that will prove that the device is effective in the hands of the actual user in a way that they want to see that data as well.

But I think maybe the disconnect, because on a logical standpoint, I think a lot of people get that idea.

But the difficult part might be how do we know what it is exactly that they need and how do we establish those endpoints.

John Schindler: Yeah, yeah, yeah. And this is, listen, I think this is as a startup especially, it's, this is why you want to build, you know, really thoughtful, intentional scientific advisors around you as a company. Right. Yeah. Who really understand the market and the landscape and what you're trying to accomplish relative to the innovation.

And it's working closely with these individuals to understand, well, what would be meaningful and how does that translate into value to the health system or the payer or the provider, whatever, whoever sit, you know, in front of you.

So yeah.

Etienne Nichols: I've asked a lot of kind of like maybe leading questions, but I know you have things you want to talk to founders about, so maybe I should be a little bit more open ended. I'd love to hear any actual advice like this is man, if I could go back to myself when I first started this medtech company.

This is what I wish I knew.

John Schindler: Yeah. You know, when I think about my, my journey to kind of get to where I am today. Right.

You know, I started this whole thing off as a sales guy way back in the day. And I think sales is super important.

Right. I think you have to understand in the trenches how your innovation is going to respond and more importantly, how you would go about educating those people so that they understand the significance of the innovation.

And so, then I moved into management, then I moved into business development. And that was a very formative portion of my career, really, where I had the chance at atrium to wear a lot of different hats, so got exposure to a really broad swath of, hey, this is how we run a clinical trial and this is how we support a clinical trial. Or you know, you know, this is how we talk to doctors about iteration or if they want organic innovation from us, you know, what are the steps that is necessary to kind of get that in place and stuff.

And so, and I think about, you know, what I wish I'd had known early in my career.

I think, I think I have been really super fortunate to just have this nice holistic exposure to a lot of different things.

And so, for first time founders, I would encourage them to go get that holistic approach to the entire process because I think that's super, super valuable.

So, I don't know if I'm directly answering your question, but the other thing I think that maybe I learned along the way is that as you're building your own company, everything's negotiable and not to be afraid to negotiate.

And that's true for just building the company and understanding all the ecosystem components that go to it and the foundation of the company, et cetera. But to realize that there are many ways to deliver the end result and you have to be open to that process of negotiating to make sure you get what you need.

Etienne Nichols: Can you give me an example of negotiation maybe that, that you're like, oh, this kind of surprised me that we were able to do this or that was, it was a thing.

John Schindler: Yeah, I mean, I would, I would point to, you know, some of the, some of the folks that we've leaned on in terms of industry ecosystem support.

Right.

Regulatory services is an example. Right.

As a cash strapped, early startup company, sometimes it behooves you to approach these people with humility and hey, we don't have a lot of cash here, but what can we do to get this process started? Because we want to move in that direction, make sure the company has a strong foundation.

Right.

And so, I would say that, you know, these opportunities to negotiate, you know, the, the different various contracts that you put into place in order to get to where we are today. And so, yeah, that would.

Etienne Nichols: That is an interesting chess game.

Yeah, well, it almost seems like a little bit of a chess game to a certain degree, because I've. I've spoken with some people, some investors say, well, their regulatory strategy is just really not baked.

They don't seem to know what they're doing. Well, they can't afford to pay a regulatory person just yet to go through their whole thing, but that they need that in order to get the funding.

So that is kind of a chicken the egg situation. So, to your point. Yeah.

John Schindler: Yeah. And I'm reminded by a piece that was just written by Hal Stow, who's a. He's a regulatory guy who works for a company called Eurofins, and he recently put out an article that I thought was really instructive.

It was, you know, around your regulatory strategy and really understanding the strategic value that having a purposeful regulatory strategy can actually bring to the organization. And so, if anybody's interested in that copy,

you know, you can find it on LinkedIn. All credit to how Stow S T O W e is how you can find him. And it's a great read. And so.

And I think something every founder should actually read, digest, and really embrace.

Etienne Nichols: Awesome. I'll have to look him up. Is it how?

John Schindler: Oh, how. Yeah, okay, cool.

Etienne Nichols: I'll find him. Yeah, maybe that's something. Conversation I need to have with him about something. But so, okay, so the regulatory strategy makes sense. What are some other strategies that you think?

You know, I didn't expect to need this this early.

Anything come to mind?

John Schindler: Ah, yes. Well, capital.

Etienne Nichols: Talk to me about learning to fundraise. Yeah, talk. We kind of skirted that a little bit. I want to learn more about this.

John Schindler: Yeah, Yeah, I mean, I think so. I'll go back to, you know, understanding when. When it's appropriate to involve a true regulatory professional or a quality professional. Right. And because they.

That's instructive in terms of the journey and. And how you build a great foundation for the company.

And so, I would say that for us, we had such a foundation of experience in this area. We were smart enough to know early in the process that we need strong people in these areas. Right.

So, I don't know if that directly answers your question, per se. I don't know that there's one person or one thing that really strikes me as, hey, I wish we would have done that earlier in the process.

You know, I'm a big believer in communicating with the FDA often and early and I think you can avoid a lot of headaches and problems, and you know, resetting timelines and spending a lot of capital unnecessarily if you involve them in the process early and often.

And so, I think, you know, sometimes I think people avoid doing pre sub meetings and that can, that can be problematic for, for some organizations.

You know, I don't have any specific examples of that. In the past it have all been in my corporate environments. Right. Where we chose to ignore the advice or not engage the FDA quick enough in the process.

Etienne Nichols: So, have you been involved in those actual pre sub meetings?

John Schindler: Yes, and it's always interesting to me. They're very script and formulated and you know, how does the agency feel about this? And you know, it's, that part has actually surprised me.

Etienne Nichols: Yeah.

John Schindler: Because I tangentially involved with the processes of taking things through the FDA. But we always had a clinical affairs team at these bigger companies. Right. And so yeah, that was their domain and they were in discussions with the FDA.

And so, I never really had the opportunity to interact like I have with this, this company.

Etienne Nichols: So yeah, I, I, I just want to see. I, I mean obviously we can't go back and look at a videotape necessarily of you walking into your free first pre sub but just what you were expecting versus what you got or experienced.

I don't know if you want to go in a little bit more detail. I think people sometimes see it as a black box like oh, the pre sub meeting that we have to go to.

John Schindler: Yeah, well we came into that meeting, and I'll just say this because I'm a talker. Right. And so, and I'm, I'm a very open individual.

Etienne Nichols: Yeah.

John Schindler: As you can probably tell.

And I wear my emotions on my sleeve too. And so, I think it's, you know what was interesting to me is our regulatory strategist saying now John, I'm going to do all the talking in this meeting and then, and then besides me, it's going to be my co, your co-founder, Derek hall, the scientific guy here. Yeah. We're going to be the ones talking. And so, you probably shouldn't say anything.

Etienne Nichols: Did that happen or.

John Schindler: Yes, that absolutely happened.

Etienne Nichols: Took the orders.

John Schindler: No.

Etienne Nichols: That's good. Yeah, that's awesome.

Well, yeah, I don't think people should be intimidated necessarily by doing that. And I agree. You gotta, I mean talk to the, it's not gonna hurt you to, for the most part there may be some edge cases where it could hurt you to talk to the FDA, but for the most Part take those pre sub meetings.

John Schindler: Yeah. And even in those situations where the FDA is going to give you very scripted advice about what you should be doing. Right.

And then, and then, you know, you know that you have to allocate funding to make sure that you do that. Right. And so, I think that's one of the biggest learnings here really for, for us, you know, in our process, had we not communicated with the FDA early, they may not have really understood what it is we were trying to accomplish.

Right. Yeah. Yeah.

Etienne Nichols: So, I want, I want to hit on your commercial experience a little bit, just see if we can draw some, some lessons from that because.

John Schindler: Mmmm

 

Etienne Nichols: Again, we've talked a lot about the valley of death in medtech at least recently.

Some of the publications I've seen. The Valley of death is not necessarily pre submission, although getting that funding is important.

A lot of times it's after you've submitted, after you've been cleared or whatever, you know, approved, granted, whatever your pathway was after that, actually getting into the hospital, getting into the hands of the physician. So, from a commercial standpoint, what kind of advice can you give into? It's actually making that first sale.

John Schindler: Yeah, yeah. And so, I, and listen, this is the, this is the area we're in right now. Right. We have two FDA cleared devices and sometimes that creates some confusion for people, especially on the investment side. You know, John, why aren't you just mass producing these things and selling them, you know, writ large?

Yeah. And we could, if we wanted to develop a lifestyle company and not really set this company up for long term strategic acquisition or an M and a transaction, we can do that.

But I think what a lot of people don't understand about the regulatory environment relative to us is we have a 510(k) clearance, which is essentially a tool claim at this point.

And so, we're very special in the sense that we, this is the first time the FDA has, has provided a clearance, if you will, relative to delivering medication into the pulmonary system. Right. And also, for the direct cardiac measurement of that environment. Right. And so those are two very big firsts for us. Right.

But it's also true that we, we need, like all the other companies, we need to do an IDE trial for the treatment of pulmonary embolism. Right. Before we can actually, you know, go gangbusters and start selling this at large.

And so, in that process between where we are now with this FDA clearance, well, the natural progression here is to, you know, get some cases done.

Right. We need to raise a little bit of money to get through our contract transfer phase on the manufacturing side so we can actually scale up and actually start producing.

But relative to the commercial strategy, we want to dovetail the commercial strategy and the limited market release, if that's what you want to call it, with the completion of that IDE trial. Right.

Is you get onto the market too early and it's hard to sustain that traction and that adoption. Right. In some cases, it can be. And so, because you don't have the capacity, you don't have the capital to really drive a footprint of sales across the United States.

Right.

And so, we want to be very purposeful about how we do that.

But at the same time, you also want to be at once you get your FDA clearance for the treatment of.

Right. That's when the gloves can come off and you can really flush out the company, hire a lot more salespeople.

And now everything they write in an email won't put somebody in jail if they say the wrong things. Right? Yeah, that's the reality.

And so, I think some Companies struggle after FDA clearance on a 510(k) as an example, before they get that IDE.

Right.

And it's about making sure you have the capital necessary to make that next step.

Etienne Nichols: I see. Okay. So really there's a lot of strategy that goes into your commercial, you know, launch and, and, and cascading launches, I guess, if you, if you will.

John Schindler: Yeah. And I'm a, I'm a big believer.

And we've done this multiple times in the past. Right. I'm a big believer of a limited market release. Put it in the hands of a small group of people, you can wrap your arms around them, you know, understand where your nose is getting bloodied. Right. How do the. How are the doctors finding the product? How are they experiencing it? The touch and feel of it.

Is. Is it doing what we say it's going to do?

Paramount. Right.

But then also, you know, what can we learn about that early sales interaction so that we can then put that into a more repeatable methodology when it's to really grow the sales organization at large.

Right.

Etienne Nichols: So how did you. So, have I. I would assume that you've mult. Experienced multiple different types of market releases. So, the limited market release, it makes a lot of sense to me.

Are there any situations where that might not make sense, any.

For someone out there listening that you think, okay, there's, there's some exceptions here.

Can you help us understand that?

John Schindler: Yeah, there are definitely some exceptions. Right. And I would say, you know, we've watched maybe the Valley of death for a lot of companies is they'll sign a distribution agreement with a large strategic.

Right.

And on the surface of that, that, that seems like a really great way to approach the market.

And it can be, it can be based on the kind of technology that you've got.

But oftentimes what you see is that the, the startup or the early company, the organization kind of loses control of the environment. Right. They can't, they can't drive the sales force, they can't set the objectives for the sales team.

Right. They've made some commitments on inventory and things like that that then can become problematic for them down the road.

But it's more about, you know, the distribution guys and gals, you know, are they interested in talking about it?

Are you compensating them enough to actually talk about it? Yeah. Pull it out of the bag or does it fall to the bottom of the bag? Right. And they never talk about it, in which case you, you're not going to have a great experience going to the market.

Etienne Nichols: Yeah.

John Schindler: And so that makes. Yeah, I think there's products that lend themselves well for distribution and then others that don't necessarily.

 

Etienne Nichols: That makes total sense. When I'm thinking about the distribution model. I mean, I can totally see where if that distributor had maybe competitive product that gets a higher margin, then they would be incentivized. I mean, maybe not directly, but incentivized to not sell your product, maybe sign with you and then sell these other products because now they don't have this competition.

Hopefully that never happens. I'm being a little bit, you know, just imagining here, but yeah, interesting.

John Schindler: It is an interesting dynamic, and I think you have to really take each one of these into consideration. I've seen distribution deals where the product is wonderful, but for one reason or another,

it wasn't adopted early and it fell to the bottom of the bag. And it's usually compensation related, frankly. Right. If they're not properly incentivized to pull it out and talk about it.

Yeah.

It's going to be tough. Right.

Salespeople are motivated by money, largely. That's not true. And there's other ways to motivate sales folks. But, but money is a big driver for the reason why they're in sales to begin with.

Etienne Nichols: It's a, it's a brutal way, you know, way to live your life if you're not, you know, succeeding.

John Schindler: So no, so it's fair, you know, either way, move on from that individual. Right.

 

Etienne Nichols: Yeah. So. Okay, so I can see that being a good. The Limited, marketed. That makes sense from a strategic perspective.

How do, how do funding, how does that conversation go when you're talking to those, you're trying to raise funds from?

Because I can see them, you know, maybe pushing for one thing or another. What kind of pushback do you get?

John Schindler: Yeah, I mean, I think for, I think this is the biggest message that we try to deliver to those interested in working with us or funding us.

And that is, you know, the prize at the end of the day really is let's, let's, let's build some core strategic value in this organization. And the best way to do that is to make sure that the clinical data aligns with the cost, economic data aligns with the market adoption and the early approach to the market.

And if we can all get onto the same page and, and we've bought into that philosophy, then,

you know, then all, then all of our incentives should align, and the capital will probably be there to support us.

And so, but that's what we're working on right now, honestly, is helping people understand the process that's in front of us over there. It's a pivotal time for us as a company.

Etienne Nichols: Right.

John Schindler: We're moving from that, that translation on the clinical side into the commercial side. Right. And so, I want to be sure that we're purposeful about it and the way we go about it.

 

Etienne Nichols: Yeah, I love that I mentioned something earlier about how some companies fall in love with their tech before they, before they really fall in love with the patient.

Curious how you've navigated that.

John Schindler: It's, it's funny you bring that up. I mean, I, I'm going to say, I'm going to give some kudos here. I'm going to forget the guy's name now, but I want to say it's, it's Rob Fitzpatrick or.

I'm drawing a blank on that. But the name of the book is called the Mom Test.

Etienne Nichols: I've heard of that book.

John Schindler: Have you heard of it? Yeah, I love it. It's, it's interesting way to think about the discovery process. But I think, you know, when you're in the midst of trying to figure out, does this innovation have legs?

Can we make a real company out of this?

Does the market support it? Is the market big enough? All of that stuff.

You know, the essence of that book really is, you know, you never ask your mom, you know, whether your idea is a good idea or not, because she's always going to tell you it's a good idea.

Etienne Nichols: Yeah.

John Schindler: Yeah. So, you really have to be Purposeful and intent and intentional about how you ask these opening questions with clinicians when you're trying to arrive at the real problem.

Right.

And for us, it's simple. Right. I mean, in our area, relative to our device, there's a high rate of complications.

And some of that, not all of it, but some of that is relative to the fact that we miss the mark a lot with these patients. We end up leaving blood clots behind.

And that's problematic for the patient, as you can imagine, down the road because blood clots have this morphology in the chronology of how they form over time. Right. And they eventually, if left in place long enough, they'll eventually turn into scar tissue, and that's not good in the pulmonary system.

And so, if we can do the best job upfront to try and eliminate as much of that clot as possible, then I think we're all off to the races in a meaningful way in terms of producing better patient outcome, more durable patient outcomes down the road. Right, yeah. And so that's absolutely true for us. Right. And so, we, we have this situation where, well, how do doctors really know when they should stop delivering this medication that's designed to break up these blood clots? Right.

And so, the answer to that is serial CTs. But nobody, you know, take the patient down for a CT and do it every five minutes until we can figure out what's going on with the patient.

I'm being absurd here, but yeah, yeah, right. Or, or we could give them a device that monitors the patient's pulmonary pressure in real time, and it helps them understand.

Well, are, you know, are the vessels open?

Are they, is, is blood flowing through the way it should or not?

And if it's not, then maybe we should be on the therapy a little longer. Right?

Yeah.

The insidious thing about blood clots are it doesn't take much of this blood clot busting medication to really get these patients kind of feeling better. Right. And you take that pressure off the heart,

they respond pretty quickly and then it becomes very, wow, when, when do I stop?

You know? Yeah. And so that, that's the problem.

Or that's one of the problems, I should say.

Etienne Nichols: When you compare it to that every 5-minute CT, it makes it seem like such an elegant solution. So that's. Yeah.

John Schindler: Again, I will go back to this, I think, you know, easy to use, you know, doesn't take the doctor too far out of their treatment algorithm, but do at the end of the day, you know, do you need a rep there? A hundred percent of the time to support the case.

And in our case, no, once the physician is, is on board and they, you know, they, they push and flip catheters hundreds of times every week. Right. And so even in the rural hospital settings that have radiology or cath lab suites, you know, they're, they're used to placing catheters all the time. Right. So this isn't. There's no learning curve here for them.

So now it's just a matter of, well, how can we make this process a little bit more, you know, intuitive?

So.

Etienne Nichols: Awesome.

John Schindler: Yeah. Simple as good.

 

Etienne Nichols: Yeah. You know, in engineering, we always talked about, because that's my background, we. We focused on the truly engineered product is when you've taken everything away that you can and you're left with the thing that solves the problem. That's, that's what you.

John Schindler: Yeah. And when I think back on my career about those situations where the nursing staff or the physician, they're forced to calibrate machines, you know, to, to just. The education or maintenance of a machine interface. Right. In that environment can be problematic for a lot of people.

It's, it's added cost, but it's also just understanding how to interpret what's going on. Right. And so, we purposely designed this catheter to interface with the monitor that's at the patient's bedside already.

And they, they understand that interface it. You know, and now we're just translating this pulmonary pressure into a number that they can see, and they can monitor in real time.

Yeah. And so, yeah, we're trying, we're trying to keep it simple. We really are.

Etienne Nichols: That's great. No, I admire that, and I hope those out there listening appreciate, you know, the benefit of the conversation of getting to, to sit at the feet of someone like yourself.

And are you open? If people have questions, can they reach out to you? And where can they reach out to you, too?

John Schindler: Yeah, for sure. You mean, you can certainly find us online at liquetmedical.com that's a great way. LinkedIn, my profile. John. John Schindler. Like Schindler's List. You're, you know, welcome to connect with me on LinkedIn.

And, and I, you know, kudos to greenlight guru. You know, we've been a wonderful customer of yours since, since.

And I will say this for, for the, for the benefit of the audience, I think there's, there is real utility to having your eQMS system set up as early in the process as you can, because it just streamlines things. It makes things so much easier when it comes time to the submission, et cetera, et cetera. And so, I'll give that shameless plug to Greenlight.

Etienne Nichols: Well, I appreciate it. Hopefully it makes audits a little bit less stressful and just life a little bit better. That's the goal.

John Schindler: So, for sure, for sure.

 

Etienne Nichols: Well, appreciate you coming on the show. It's always good to see those, you know, customers of Greenlight Guru, but really medtech professionals, those who are really bettering the lives of patients everywhere.

And it sounds like what you're doing is going to have a big impact if it's not already had a big impact. So really appreciate what you're doing. Have a lot of respect for that.

John Schindler: Thank you, Etienne. I appreciate that as well. And, and thanks for having me on the, on the show. I appreciate it.

 

Etienne Nichols: All right, thank you so much. We'll let you, we'll let you all get back to it. But those of you who've been listening, thank you so much for listening to the Global Medical Device Podcast.

We'll see you next time.

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