Medsider: Learn from MedTech and HealthTech Experts

How to Use Checks and Balances in Your Medtech Start-Up: Interview with Michael Tozzi, President and CEO of TAS Medical

May 02, 2020 Scott Nelson
Medsider: Learn from MedTech and HealthTech Experts
How to Use Checks and Balances in Your Medtech Start-Up: Interview with Michael Tozzi, President and CEO of TAS Medical
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Medsider: Learn from MedTech and HealthTech Experts
How to Use Checks and Balances in Your Medtech Start-Up: Interview with Michael Tozzi, President and CEO of TAS Medical
May 02, 2020
Scott Nelson

On this episode of Medsider Radio, I had the chance to sit down with Michael Tozzi, President and CEO of TAS Medical. Mike and his team are aiming to eliminate surgical mesh by converting hernia procedures to minimally invasive repairs.

Mike has over 20 years of commercial medical device experience and specializes in investor relations, sales & marketing readiness, and improving the execution of early-stage medical device companies.. 

Previous to TAS Medical, Mike served as Chief Commercial Officer at Carevoyance, where he and his team created groundbreaking analytics tools designed to help medical device companies better understand their markets and execute their commercial goals.

Prior to this, Mike helped to build Cardiovascular Systems, Inc. (or CSI) from the ground floor, taking the company from early stage to over $1.3 billion in market capitalization in just seven years. At CSI, Mike held various executive roles in sales and marketing. 

Joining me on this episode is special guest host, Norbert Juist, who runs Sales Performance Resources, which specializes in recruiting for medtech marketing and sales positions. Prior to this, he was a sales rep at Cordis Endovascular, a spine consultant at Synthes, and a sales rep at Ethicon. 

Interview Highlights with Mike Tozzi

  • The origin story of TAS Medical and how Mike got involved.
  • The strategies that TAS Medical followed to go from initial product concept to eventual commercialization.
  • The regulatory and clinical paths that Mike and his team considered.
  • How much the insurance coverage and reimbursement landscape factored into Mike’s early decision-making process.
  • Mike’s approach to raising capital for CSI and TAS Medical. 
  • Common mistakes that early-stage medtech companies make and how to avoid them.
  • Mike’s favorite book, the business leader he most admires, and the advice he’d give to his 30-year old self.

See more...

Show Notes Transcript

On this episode of Medsider Radio, I had the chance to sit down with Michael Tozzi, President and CEO of TAS Medical. Mike and his team are aiming to eliminate surgical mesh by converting hernia procedures to minimally invasive repairs.

Mike has over 20 years of commercial medical device experience and specializes in investor relations, sales & marketing readiness, and improving the execution of early-stage medical device companies.. 

Previous to TAS Medical, Mike served as Chief Commercial Officer at Carevoyance, where he and his team created groundbreaking analytics tools designed to help medical device companies better understand their markets and execute their commercial goals.

Prior to this, Mike helped to build Cardiovascular Systems, Inc. (or CSI) from the ground floor, taking the company from early stage to over $1.3 billion in market capitalization in just seven years. At CSI, Mike held various executive roles in sales and marketing. 

Joining me on this episode is special guest host, Norbert Juist, who runs Sales Performance Resources, which specializes in recruiting for medtech marketing and sales positions. Prior to this, he was a sales rep at Cordis Endovascular, a spine consultant at Synthes, and a sales rep at Ethicon. 

Interview Highlights with Mike Tozzi

  • The origin story of TAS Medical and how Mike got involved.
  • The strategies that TAS Medical followed to go from initial product concept to eventual commercialization.
  • The regulatory and clinical paths that Mike and his team considered.
  • How much the insurance coverage and reimbursement landscape factored into Mike’s early decision-making process.
  • Mike’s approach to raising capital for CSI and TAS Medical. 
  • Common mistakes that early-stage medtech companies make and how to avoid them.
  • Mike’s favorite book, the business leader he most admires, and the advice he’d give to his 30-year old self.

See more...

spk_0:   0:00
Theo. Only thing more scary about losing your own money is to lose your friends or your business associates money so I can tell you it has medical. I am humbled toe have some of my closest friends and closest business associates. People that I respect so much have invested in past medical, and I'm motivated. See it through for a lot of reasons. But I promise you, a lot of it has to do with the fact that there's no way I'm gonna fail. You know, my friends and the people who invested in Tabs Medical on the people who invested in me. Welcome to med Cider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now here is your host, Scott Nelson. On today's program, we've got Michael Tozzi, the president and CEO of TS and Medical. Mike specializes in investor relations, commercial readiness and improving the commercial execution of early stage medical device companies. Previous two ts Medical Mike served as chief commercial officer at Care Boy Answer, where he and his team created groundbreaking analytical tools designed to help medical device companies better understand their markets and execute their commercial goals. Proud of this, Mike helped to build cardiovascular systems, or CSE, from the ground floor, taking the company from early stage. Teoh over $1.3 billion in market cap in just seven years at CS I Mike held in various executive roles in sales and marketing. In this conversation here, some of the things we recover the origin story of t A s medical, including the early product concept and how might get involved with a company mike strategic approach towards taking the product from initial idea to eventual commercialisation, including the regulatory in clinical pads that were considered. How much did coverage and reimbursement or lack thereof factor into Mike's early decision making process, his approach to raising capital for T s medical as well as other Mets Tech startups he's worked with in Mike's favorite business book, the leader he admires most and the advice he'd give to his 30 year old self. There's a lot more recovering this wide ranging discussion, but I wanted to call out a few things before we get started first. Joining me on this episode as a special guest host is Norbert Juice to nobody and I go way back. In fact, we used to sell vascular devices into the same Cath labs. Now he runs sales performance. Resource is and specializes in recruiting for medical device sales and marketing positions. And he's quite good at it. No, but not only brings a ton of industry experience to the table, but he's one of the most honest, genuine and personable people I know. So if you're looking for a new gig or need help recruiting for some open positions, Norbert is definitely your guy. In the show notes for this episode, you'll find a link to learn more about Norbert and his background. And no, he did not pay me to run this message. Alright. Second, if you're new to these Met set or interviews, and I want to be updated when the next interview goes live, head on over to med cider dot com and enter your email address. That's E. D s I. D E. R. Met cider dot com. Rest assured, we will not spam you. In fact, the only time will paying you via email is when a new conversation goes live again. It's super simple. Just visit med cider dot com And right there on the home page, you'll see the opportunity to enter your email address, right. And lastly, as a reminder, if you continue to enjoy these conversations, please give us a rating on your podcast app. Just open the reviews tab and click on the old five stars. Thanks again. It really helps us a ton already. Without further ado, let's get to the interview. All right, Mike. Welcome, Teoh Med cider. Appreciate you coming on.

spk_1:   3:03
Pleasure to be here. Scott

spk_0:   3:05
and Norbert. You ready to rock that air in your, uh, your captain's chair

spk_1:   3:09
ready to rock n roll

spk_0:   3:11
via phone conversations. I know you guys go go back a bit. So anxious toe have kind of Ah, hopefully ah, entertaining but yet informative conversation about Mike what you're doing with task medical as well as just your extensive background in the MedTech space. So, without further due to set the right context, I mentioned in the intro that you're you're the president, CEO of Task Medical. So to give everyone the listeners a better idea of kind of what you're doing now, can you maybe walk us through your technology and maybe even just use a hypothetical patient as an example. Just everyone gets an understanding kind of what you're doing today

spk_1:   3:46
has medical, but by the way, stands for trans abdominal strap. We've got a great concept that the medical grade Zip ties. It zips strapped technology, and we seek to eliminate the need for surgical mesh in abdominal surgery. That's probably good to also mention the unfortunate reality that there's currently 54,000 pending lawsuits and hernia surgery with with regard to mesh. For those listeners of this tuned into medical device for a little while, you'll remember that there was quite a few lawsuits in the pelvic floor reconstructions base and stress urinary incontinence space. This is just turning us. It really hurt me is the next frontier, unfortunately for litigation, So we'll also be talking a little bit about eventual hernia. And most people know what a hernia is. But a eventual hernia starts with the reality that there's five million lap Arata Mies every year in the US and so a lap Arata Me is just when a general surgeon has to open you up for either exploratory or trauma hernia surgery and then of those five million laparotomy that The number one complication is eventual Herning. It's about 11% of them turn into a turn into Herning it. So it's a big patient population. There's over a 1,000,000 eventual hernias around the globe every year. That's a big number yet is about 350,000 just here in the United States.

spk_0:   5:07
I'm sure a lot of the listeners are are semi familiar with some of that hernia related litigation. I mean, I'm no. I wouldn't consider myself an expert in the space by no means, but it's hard to keep up with the MedTech space and not have some sort of like idea of kind of what's been going on there. So can you maybe speak to that mike and a little bit more detail and maybe, how and maybe contrast that to like how your technology is resonating with people who are very familiar with kind of the associate ID kind of litigation risks within the specific to the hernia space.

spk_1:   5:36
Yeah, I will. And by the way, now that I've mentioned it to you guys, I guarantee you'll see it, especially if you turn on the TV after 11 o'clock at night. You'll see these commercials

spk_0:   5:45
thes attorneys

spk_1:   5:47
that are really hurting for these hernia patients. And so when you talk to general, surgeons will tell you that they spend a ton of time with their patients in clinic. The patient will come in, have a hernia, and patients don't want mesh anymore. There's they're scared of it, in large part, probably because of these commercials after 11 o'clock at night, and so there's not an alternative for it. And so general surgeons will spend a significant amount of time in their clinic just trying to educate their patient on the complications of MASH and what to expect. But yet most often it results from pain and infection in the body just fighting this foreign material. And unfortunately, ah, lot of times the mess has to be removed. And so our trans abdominal strap will allow for an alternative to mesh on a number of other things, too. We're also gonna convert a ton of procedures from open procedures to minimally invasive procedures. And so, yeah, we're excited about our value proposition and excited to bring this product market. Did you speak like the development of it, how it came about how you got involved with it so forth. It was fun. I was helping other companies to raise money or early stage medical device companies to raise money. And I came across Doctor Chin. Dr. Chen is a prolific medical device inventor, so he's got over 200 patents to his name and him and our chief operating officer, Tom Kramer, Coat collectively, you know, they've had 20 other concepts or ideas that have made it from, ah, patents for an idea all the way through the commercialization. And so I got talking to Dr Chin and Tom about helping them to raise money, and what one thing led to another just really became more and more interested in their innovation in their journey. So that's how I became part of the company. I decided to take it on as an entrepreneur, help them to raise money. And so here we are two years later, and we're just, you know, less than a year away from FDA clearance and commercialization.

spk_0:   7:47
That's super interesting. And what might get a curiosity, I'm sure we'll get into this a little bit more with respect to your experience helping early stage medical device companies raise raise money, but I'm sure you came and maybe still do come across a lot of different ideas. Or maybe different. Ah, you know, early stage business ideas or concepts. What's particularly attracted you to the technology at task versus, you know, other concepts or ideas that came across your desk.

spk_1:   8:12
Yeah, you know, I think it was the fact the more I learned about it, I realized that this unmet need was not just large, but obvious and present. I'm talking about this this opportunity to provide for a full thickness abdominal wall closure, if you will, a hurting enclosure and do it in a minimally invasive manner. That's not happening today. Almost all of these eventual hernias are being done as an open surgery. And so this presents an opportunity to not just present clinical efficacy for the patient, but huge, huge health care savings literally hundreds of millions of dollars per year to save health care and then also to kind of do away with this issue of mesh right. There's excited me that there's not other companies or innovations that are trying to eliminate measures, a ton of ideas to make mesh safer or to make a better mesh but it's gonna be a great journey. Teoh actually eliminated. And I should also say that it really was Dr Chan and Tom Kramer that interests me. Soto work with them. These guys just have, ah, great track record. There really pros at what they do. There's great great guys to work with. It almost sounds like you to some degree like Dr Chen had the concept, but that you almost pitched them on picking the idea. The market Is that accurate? Yeah, you know, they have. They have the concept down in the I t down on the track record to develop these technologies. Tom Kramer, for example. He owns and operates a medical device manufacturing facility, and he and his engineers they specialize in early design and development. But it was exciting for me because I saw this value proposition kind of come together in this concept of being ableto give surgeons something to offer their patients other than match, and also to convert this large procedure volume mover to minimally invasive surgery. And for those of us who have been a medical device for a long time, know how much fun that is to convert a procedure from open to minimally invasive surgeries. Just a win win win for everybody. So yeah, it all came together and, uh, just a ton of fun working with Dr Jan and Tom Kramer.

spk_0:   10:29
That's super interesting. And I'd love to get And I think we will have enough time to really kind of dig into, you know, some of the lessons learned during your time, kind of at at Connectix and kind of what you saw, whether it was, you know, issues that a lot of med tech start ups based or just other lessons learned in general. I think that will allow us to kind of dig into your background a little bit more, Mike, but specific to tap as while we're on this topic of and you mentioned your your very close toe 5 10 k clearance with FDA, you know, walk us through a kind of your general approach from, you know, when you first sort of begin to collaborate with Dr Chen on this idea, walk us through your generally, like maybe your high level thoughts and then how you begin to put together a strategic approach to commercialization.

spk_1:   11:10
If you were to ask Dr Shannon Tom. They would tell you that you know their concept is to take Class 25 10 K products Rinse of class 25 10 K Meaning that and you find a good solid credit. Get device and you can gain FDA clearance must much faster than having to do some of the longer pathways for FDA approval. And so this is that has, is a class 25 10 k With regard Teoh go to market or thought thoughts around commercialization We plan to, and I should mention we plan to be gain FDA clearance and to three of next year Q 3 20 then start a soft commercial launch a year from running out onto four of 2020. And so that will essentially be a post market registry. And we want to figure out what is the niche for this trans abdominal strapping and ventral hernia. And exactly how many patients did we eliminate the need for mesh? Well. Want to prove that we want to prove how many patients did we convert from an open ventral hernia? Tito. A minimally invasive scent eventual Herning in. Once we know that will also be able to figure out what was the cost savings for free hospital at the hospital level and then beyond that, well, we're just super excited to take this product to market and what will use business drivers, just as we have in the past, I've worked with Norbert Norbert Seem some of this but business drivers is basically when yet when a sales rep for a marketing representative does something that there's, you know, right behind it there sticky adoption and a nice clean revenue to follow. So it's things like medical education and the market development a swell as well as just, ah, disciplined sales, management and execution.

spk_0:   13:00
I think that your point about, you know, devices that you know Dr Chin looks for as an example, is there Can you provide a little bit more context around that? Cause I think that's really interesting, and the reason it it really stands out to me is number. I'm gonna have another chat with with Duke Row. Lean here another couple weeks, and I know with what he's doing with Ajax Health. It's just his new. His new venture firm is gonna tech venture firm, I should say, is really like one of his niches is really specializing in In funding are leading. I should say early early rounds and companies have a clear business model. You know, I think it's amazing how maney how maney, especially it made Maybe it's more common in the MedTech space. How Maney Early stage founders don't really consider the business model. You know, they're really stuck on the on the innovative idea, and it maybe it doesn't have legs at all when it comes toe commercialization. And so is there a lot more like filtering criteria than just, you know, 5 10 k devices when it comes to kind of what you look for, Or maybe maybe what? You know, Dr Chin looks for as an example.

spk_1:   13:58
Yeah, I would say that there is the Doctor. Jin started out by working with a guy by the name of Fogarty inciting, and a lot of people are familiar with Dr Figure T. And early in his career they worked together on a number of different innovations, including the Fogarty chin catheter, And so, over the years since then, he's had I want to say it doesn't products that have made it through to commercialization in large part we do. We look for 5 10 K technologies that provide disruptive solutions, toe large unmet needs and ideally, carry with them cost savings to help care. And if we could, we'd also prefer there to be a reimbursement Playas. Well, that sometimes in today's age, a little bit more difficult and time consuming to generate used to be the opposite, where regulatory and FDA clearance and approval was the big obstacle. But now it's CMS, and so we take all of those things in consideration, and we feel really lucky and fortunate with has, and that we feel like we have all of those pieces in place. So we're excited to tell the story and bring this product to market.

spk_0:   15:08
You know, it's really interesting guy and overlay

spk_1:   15:10
that with the you know, the reimbursement side of it. And I mean with Dr 10. You said, you know, has at any one time, 20 patterns or something with this particular product. Was this one kind of a darling or was this one that was attractive to you for all those reasons? Because I have done other calls where we talked about how, going through the FDA clearance process and, you know, CMF clearance process and all that is just so costly and time since human indeed, now for sure, yeah, and so reimbursement. I think that's what you're asking about. Norbert is a huge component, and so with has or in a good spot in that because most of these procedures are still being done open, there's an opportunity to convert them to minimally invasive surgery. And there's reimbursement there. So there's already substantial increase in reimbursement for hospital centers and surgical centers for doing a lap risk OPIC eventual hernia compared to that of oven open eventual hernia. And so we're lucky in that respect that for those listeners who have launched a lot of disruptive medical device technologies, a ton of fun when you've got something that's disrupted and gonna meet a big unmet need. But that doesn't mean it's already a Grand slam. You you've got other obstacles, especially now getting through different product and maybe is to get your product on the shelf, and they want to see health care savings, right? They want to see that there global population of patients are gonna have a positive outcome, not just acutely, but chronically. After this procedure, and occasionally, if you can launch a technology and on day one, have a reimbursement story that's always a treat, it's rare. But it's in this case. We're excited about that.

spk_0:   17:02
And just to follow up on that, we had. Ah, Norbert and I had a chat with Dan Rose recently on that. By the time this podcast is out, that should that one should be Oppa's well, and he kind of referred to that period of time when it comes to commercialization as the Valley of Death, when you've got, you know, regulatory clearance, whether it's 5 10 k de Novo PM a. And then that time between approval clearance or whatever and when you actually can obtain coverage and reimbursement as that Valley of Death for a lot of companies, because they just don't consider, you know the resource is the time that's needed to actually make that a reality. So I just think it's it's super interesting that you're trying to leverage, or that you're thinking very far ahead in terms of ah, well beyond just the regulatory constraints that you may encounter but also, you know, coverage reimbursement. So, just just to clarify with with your technology, your existing technology With Chazz, Are you leveraging an existing cpt code?

spk_1:   17:55
Yes, yeah, existing for laparoscopic surgical repair of eventual hernia.

spk_0:   18:02
And then when you think about the commercial model, you're making sure that that's priced in a way where it's economically positive for, you know, for the hospital. The physician etcetera.

spk_1:   18:13
Yeah, well, Scott, it's great. It's easy for us right now to do that, because the cost savings of a patient who's gonna have an open ventral hernia compared to that of a laparoscopic. It's a $5000 savings per procedure, right? So not only will we save health care $5000 for for every conversion, but we'll also be able to help hospitals to receive a higher reimbursement to the tune of about $4000 by the way of a higher reimbursement for a laparoscopic repair compared to that of an open ventral hernia human factor in 11% infection rate and how much that costs the hospital as well, no doubt doubt

spk_0:   18:55
So, Mike, it seems like this is a bit of it. A no brainer, right? I mean, if you think about the pitch to the the value analysis team or any sort of influence, or are stakeholder kind of this going to make a decision around bringing in this type of technology? So using that is kind of ah, reference point. How are you thinking about building out, You know, us Salesforce. I mean, we all know that that's incredibly expensive. So do you have maybe some? Are you thinking about ways to do it differently in order to stay lean but also, you know, still experience strong commercial traction as well?

spk_1:   19:28
Yeah. Yeah. Great question, by the way. And I appreciate you sharing your optimism.

spk_0:   19:35
Well, I'm really just interviewing here, Mike. I mean, I mean, for your sales gig, you know that

spk_1:   19:41
you're you're interviewing and I'm closing, so I'll

spk_0:   19:43
send your turn. There you go. No,

spk_1:   19:48
it's a good question with regard toe thinking about commercialization, and with it being as early as a year away, it's definitely something that we talk and think a lot about. So I'm fortunate in that I've worked with some of the most sought after medical device executives and sales reps in the industry today, and so relationships really matter in a lot. A lot of these folks I've worked with with Norbert. He's helped to introduce me to a lot of them. And so what we plan to do is once we gain FDA clearance will spend the 1st 9 months into a what we call a soft commercial launch and will be a post market registry. Where will prove out all of the things that we're trying to accomplish before we do? Ah, large launch. And so this post market registry is gonna be super important to us and will give us the opportunity to show hospitals and to show positions what the metrics look like. And so that will be a big part of our early commercial launch and that that should start as early as a year from now.

spk_0:   20:48
And Mike, that soft launch was that largely driven by the data that you need to collect post market eyes. Part of that 5 10 k clearance? Or is this like, more of a strategic lever that you're pulling?

spk_1:   21:00
You know, man, it's like all of the above. I think we owe it to the space to be responsible and having launched a lot of exciting, innovative, disruptive technologies. That's great fun to do that but with a paradigm changing approach to something, you also have to make sure that your niche ing it to the right patient, right? So I was. I always believed that a niche is a great thing, even if it's a small niche. It's a great thing. You want to use your technology in its sweet spot and let people experiment with it when you know you're gonna have a good patient outcome. And so it's driven largely for that. We want to make sure we get it right to the patient and also, you know, given that we have a class 25 10 K technology, we have the benefit of gaining FDA clearance in the absence of human trial. And so we will limit the use of our technology to just our medical advisory board during the 1st 9 months to complete a good, hopefully responsible post market registry. And then once we take the learning from that, will we'll take it large scale and, uh, look to change the space.

spk_0:   22:04
I love the approach cause immediately my head goes towards like hearing you kind of describe kind of the paths of this soft launch. My head is like, Well, why not go big? Why not start building out? Ah, a sales force and really, really, you know, start to put the foot on the on the gas pedal, so to speak. But I love the approach because there's a lot of synergy and doing kind of all of the above, right. You know, you're sort of how you put it, Mike, like it's good for the space, right? Because it's it's good for the patient. It's good in terms of proving out efficacy and cost savings to the hospital stakeholders. It's good from a regulatory standpoint, it's kind of all of the above. So it's interesting to kind of hear you. Ah, kind of describe that because it definitely resonates

spk_1:   22:41
that well, thanks. Yeah, we're looking forward to execute on it. And, uh, hey, we've got a a complex health care system right now, but it still does have all of its checks and balances to make sure that patients are getting the right treatment. Health care is not being drained, and we want to make sure that we launch this thing the right way and the right patients are treated with our technology,

spk_0:   23:02
right? I guess what I'm trying to say is you know, this sounds like maybe, ah, soft launch formula. You can call it the Tozzi soft launch formula and other vices. Trademark that. But, uh, I

spk_1:   23:13
don't know about that. I I'm following the lead of other

spk_0:   23:17
great medical

spk_1:   23:18
device technology that have paved the way for us.

spk_0:   23:21
Yeah. No, no, no. Yeah, I'm joking aside. I love the approach, and I just think it's it's interesting, Especially when you compare it to other spaces, right, Other spaces outside of health care. And that's just kind of the reality of operating within a a regulated environment with a lot of different ah dynamics to consider as part of, ah, traditional product launch that you wouldn't otherwise have to, you know, in the world of SAS or something like that. So very interesting nonetheless. But Norm, or anything else that you want you want to chat about with test medical before we kind of get into into Mike's background in a little bit more detail?

spk_1:   23:51
Yeah, So with respect, sir, you have a crystal ball and you were to predict, you know, being acquired, which seems to be the growing trend among, you know, start up companies. I mean, obviously it has always happened, but it seems like it happens more frequently in quicker in today's society. How much does that play a role in your thought process? Or do you not really even think about that? And you focus on you know, the path at hand. And if that happens, it happens, you know? How do you strategize for that? I guess I really don't think about it too much. I feel blessed and lucky to have known and worked with a great CDO name was Dave Martin. And I just remember Dave always talking about how to build solid companies not for acquisition, and so clearly our model is to be acquired. And I've got great, really exciting interaction with a lot of the strategic in the space of super interested in what we're involved in. So we're gonna build, has medical, we're gonna build our company, try to build a solid company, and we know that if we do that and we served patient well and we provide an innovation to a general surgeon that they currently don't have, which is an alternative to mesh than, uh, there's a great chance that we will get acquired. But it's not something that that we, you know, I think a lot about here today, for sure. You know, something that just popped in my mind about that is if a current mesh company, let's say, you know, Bt the old bar Dave, all or somebody like that would that almost be admitting that their infection rates and the problems with their mesh if they were to acquire kind of, ah, backup plan technology? You know what I call that? Norbert. I think that's pretty much the definition to the word disruptive. And so yeah, no, you're right, though it is sometimes interesting to see the responses of folks when whenever they hear that our value properties to eliminate the need for mesh. Certainly there's always synergies. And so there will be many patients where we work hand in hand and will well, absolutely need mesh to complete a procedure. But our goal is to eliminate it for as many patients as possible. But there's a great chance that they'll be some some good synergy for a lot of patients between our trans abdominal strap and the use of of mashing the right setting so I'm not know talking about, you know, acquisition versus the tension and so forth. How does international factor into things We started mention that we talked to Dan Rose recently and he was kind of informing us about how, once upon a time, getting approval in Europe. Getting the CE mark was much easier than FDA approval. But that is not the case anymore. It's almost exactly opposite anymore. So there's going into Europe factor into your thought process and decision making. Or I shouldn't just say Europe anywhere internationally, Asia, wherever or again. Are you pretty much focused on the task at hand here in the U. S. I was just out of the European Hernia Society in Hamburg, Germany, and they spend an entire day on regulatory and you're absolutely right, Norbert. It is far more difficult today t gain regulatory approval overseas than it is here in our great United States. So it does play in, though we do have a PCT and we have intellectual property protection cover and 90% of the globe when you look at revenue generating countries and medical device, and so it's definitely part of our strategy, but we're definitely wanting to disrupt this U S market space first, and then the European space will follow that.

spk_0:   27:32
You know what's interesting is is quite literally, before you know, we're recording this conversation. We had an internal call with respect Teoh R O. U s regulatory strategy at Juve, which is the a company that I helped co found and where I spend most of my time these days. But as we ranked kind of the near and mid term O. U S strategy with the big Three countries regions being Canada, you in Australia, you was the last because of the hurdles. Now that her required toe for ce marking. And it's just amazing to think that, like, 5 to 7 years ago, it was the exact opposite, you know, to get a CE mark and to begin, you know, making some inroads in Europe was the easy layup, you know, versus the U. S. As an example. So that's a pretty significant change in a relatively short amount of time.

spk_1:   28:16
No doubt they're sure it's changed. And, um, I hope that it hoped that it gets easier for us to do business to gain regulatory in the future overseas But for right now, our strategy here has medical is gonna be Teoh attack this u S market. It's a big, healthy market. That's really where the litigation concern is is here in the United States. So there's 350,000 procedures for us to play in a nice big sandbox and we'll start here, but definitely bit beyond that. We look forward to engaging around the globe and all ventral hernia.

spk_0:   28:49
Cool. So if you guys are OK with it, I love the transition and learn a little bit more about your background. Mike, Um and I know I know, Norbert. I'm sure you can, you know, because because you and might go back quite a ways you could probably speak Teoh, help, help chime in with some or interesting questions than than I am. But maybe it makes sense to kind of, you know, I want to go back to far right, because I couldn't remember a lot a lot, a lot of stuff from my, you know, first gigs out of ah, out of undergrad. But I know you spent quite a bit of time at CS I Mike, especially in their in their early days. early days of commercialization meant maybe we kind of start there and kind of lead into your work at QinetiQ sales consultant, cause that's certainly an interesting transition to go from a pure play sales capacity to a consultant working with other early stage medical device companies.

spk_1:   29:37
I do think of CS size is an important place that I worked at and met some great people. And, you know, I'm a sales guy. So that's like many of the people probably listening to this call. And I'm a proud carrying bag holder, even still today. And so that's what I did it, C s I and got involved in sales, training and sales leadership on dMarc eating. And I guess it was just fun toe lock arms with people and work towards a common goal. And so CFCs I was that for a lot of people, not not just me. And so I grew a lot professionally and just really met some fantastic people. So it was just a great experience. And then after that, I got into consulting. Not so much, because I love to teach our love to consult. I think it was really just it was my first way of being an entrepreneur, which is really now I look at it and think that's really what my calling is. What I love to do is to just get involved in ideas and try build them from the ground floor. And so at Connectix, there was a lot of fun, though working again with early stage medical device technology, helping them to draft their value. Propositions and their stories and their scripts better understand that their landscape in the space. And it's different with every client, as the both of you know, cause I think you're both kind of involvement, that same endeavor. So it's a ton of fun, and that led to me somehow I don't know how this that led to me helping early stage companies to raise money. And then that was so much fun because raising money has thought of to be one of the more difficult things to do is in an early stage company of any kind, but much less medical device. And so we came up with a way to do that seemed to work really good for seed rounds, and ultimately that's what led me to pass. Medical was the interest for another entrepreneur to try to raise money. So I'm not sure if I answer your questions, but that's kind of that kind of my history dating back where, I guess the last 15 years or so And I think that's perfect. I think the thing that is most interesting is, you know, looking at it for somebody on the treadmill er driving in their car, whatever it is, you know, if they're thinking themselves, you know, what do I do next? You know, And how do I make that next transition? And I mean, I think, you know, part of the moral of the story from you is just go do it. You know, it wasn't like you had this capital raising experience. Yes, went, did it. And the fact that you did it made you incredibly valuable. I don't think that's put words in your mouth, but I don't think when you left CSE, you thought, Hey, there's a huge niche for fundraising, you know, and raising capital. And that's what companies are looking for. And I'm gonna go do that. I think you, however, came into that and it made you incredibly valuable. And, you know, you found out that what? You have a skill for it or you figured out how to do it effectively or or what? But it became a big part of who you are and how you got to where you are when you agree. Yeah, well, Norbert, I'm like, I'm learning every day and I have a lot more to learn. And so I would just say I remember talking to somebody whenever I was consulting with kinetic sales consulting and my interest was to just be involved in early stage companies. I just love being involved in early stage, especially early stage medical device companies. And if you really look at the core team of an early stage companies, I'm talking early stage where you've got a little bit. I keep it together and the an innovation that excites you. And there's not a lot of hats, really. The most important hat is raising money, right? So you need to be able to raise money. You need to be able to have a team that can develop and build the technology. So some guys that have some engineering background, you've gotta have some folks that understand I p and make sure that you've got a good eye strategy and maybe there's a couple of other things that you do, but there's not a lot of things. And so if I wanted to be involved in early stage medical device company, I knew that I had to try to figure out a value and one of those quadrants, so not much really more interesting than that other than I just wanted to work in an early stage company and raising money seemed to be an important piece there. So it worked out really well

spk_0:   33:58
on that note. Mike like, let's chat a little bit about that because it's certainly one of the more challenging things that I think most early stage med tech companies deal with is like how to recognize that now that first round. So what? What, or maybe some of the mistakes or challenges that you helped a lot of those companies overcome when it comes to getting over that proverbial hump.

spk_1:   34:18
Scott, you're in early stage company, and you start to learn who's gonna fund this idea, and you're left with a few groups of people. You've got angel investors, individuals right to are accredited investors meaning that they make over 200 grand a year or have at least a $1,000,000 in net assets, and they invest in early stage companies. You've got angel groups which are formalized groups of those folks who pulled together so that they can look at more deals together and and use their individual expertise to make better decisions on investing. And then your third group is a family office, right? So they're they're kind of hard to find, by the way. And they're difficult to navigate and understand. What are the specific needs that they're looking for from a family office and investing perspective? And then, if you're follow this model, you end up with venture capitalists, right? So where you're probably looking for a larger raise and every one of these starting with that angel investor has their own varying levels of due diligence that they go through and cancers are they don't know who you are, so they don't trust you. They don't know you. They I want to learn more about you. But the fact that they don't know you makes it difficult for them to invest. And so, if you're a seed round company of your early stage. I'm just a firm believer that the best place to go is to people who know who you are. People who trust you have worked with you in the past. Business associates, friends or family called Call them what you will, but devising a system in a process that allows for your message to get in front of his many of those people is possible. And, uh, you know, kind of like I did with you. I'm gonna send you my term sheet now, Scott And so those those of the folks that in my experience are just super important to building the early days of a company. And it's amazing that a lot of entrepreneurs will spend so much time trying to, you know, go through a due diligence or started due diligence with some of those other avenues without fully exploring their existing list of friends and business associates

spk_0:   36:23
in walking early stage, kind of whether it's a founder or a leadership team. Through that process, I'm sure it helped clarify a lot of like the potential targets per se, but what we're kind of the next steps. Once those more clear avenues were ah were identified.

spk_1:   36:39
It's first important to understand why people are not investing. You know what? Why would an Angel group or a family office or venture capital not invest in you? And so then the number one thing if you were to ask 10 early stage entrepreneurs like myself, the number one objection that they might hear from one of those groups is that you're way too early. And so, by the way, if there's an entrepreneur that's listening to this, they're laughing right now because they've heard it right. Everyone here is that you're way too early and it almost doesn't matter how early you are. It just seems to be the most common objection again, I think really, what? What they're telling you is, I don't know. You are I don't trust you. I don't know enough about view, and I don't want to be the first dollars in on a deal where I don't know the person that I'm investing in. And so if you come to that belief and you believe that wholeheartedly, it leads you to wanting to develop a good strategy toe letting people who do know who you are, you do trust you to hear your story. And so I know it sounds. It sounds so simple, but really, I think it is that simple. It's just a matter of if you believe in the project enough, then you should believe in enoughto let your friends and your business associates know about. I'll tell you the only thing more scary about losing your own money is to lose your friends or your business associates money. So I can tell you that has medical. I am humbled toe have some of the my closest friends and closest business associates people that I respect so much have invest. Student has medical, and I'm motivated to see it through for a lot of reasons. But I promise you that a lot of it has to do with the fact that there's no way I'm gonna fail in on my friends and the people who invested in Tasmin iCal and the people who invested in May. So it kind of goes back to those checks and balances, right? It's It's an awesome checks and balance, and it's also a good metric Great. So

spk_0:   38:37
as an

spk_1:   38:37
entrepreneur really believes in their project, they should believe in enough to not just investment themselves, but the feel good enough about it that they're comfortable having, you know, their friends and family invest in their project.

spk_0:   38:50
We just found the official title for this. Ah, this conversation is checks and balances with Michael Tosic. There we go. How to use checks and balances in your in your favor, you know? Ah, no, that's really great stuff. And I love the way you framed up and probably speaks to your you know, kind of your court when your core superpowers being kind of the sales process. But how you sort of, like peeled back the layer of the onion, so to speak, to get out the true need, which most I don't want to speak for. Ah, you know, early stage Med tech founders. But so many miss on the fact that, um, the response that they're often given being you're too early isn't really the rial issue at hand, right? It's more more of a trust issue, and they don't know who you are. And so that's an easy out or ah, easy critique for most people with capital to invest. So I love I love your take on that I think that's super important for anyone to consider.

spk_1:   39:42
So now, knowing what you know when it comes to your neck, Obviously, if you continue to go and you know, want to commercialize and put on Salesforce, you're going to need to raise capital. So obviously it becomes easier probably to get money at that point. But do you go to the institutional investors at that point because you need bigger money quicker or you still keep it in kind of the smaller circles? Or, you know what, your thoughts with that for two, as I can tell you that we're embarking on a series a round. Now that's a $10 million round. So we're seeking a lead investor toe usher that series a round. And so now you know, because of the risk that the early investors made in our seed round and we raised two million and our seed round because of their risk that they took for us, I allowed us to de risk that allowed us toe, get some pre clinical work done to develop our product, get to a design freeze to have our regulatory pathway fully baked and allow us toe really plan for each phase of our company and now venture capital and larger investors arm or interested in investing and has medical. Plus, I thought it also allowed me a couple of years to interact with them, right? So now they do know me a little bit more. And so again, the seed round is I think, obviously the most important runs. If you don't get through the seed round, you don't don't get anywhere. So you can easily say the seed round is the most important round, and it allows you to prepare for the larger rounds, which is to build relationships with these investors and and super important that you congee risk and prepare yourself for the for the larger investors to come in.

spk_0:   41:32
Really good points. Norbert, we're gonna add something else.

spk_1:   41:35
No, no, I was just saying, That's great.

spk_0:   41:36
Yeah, yeah. Especially that that that concept of of de risking further further rounds, you know, it's just so important, so easy to under appreciate as well. On that note, Mike, I want to be sensitive to time, and I know we're kind of up against the clock, so I would love to kind of wrap up the conversation. Maybe with some some rapid fire questions. If you're Ah, you're okay with that? Yeah. Yeah. Okay. Cool. So 1st 1 is what's your favorite business book?

spk_1:   42:00
Well, there was a book called four D X for disciplines of execution. A coworker of mine air. Eric Rue introduced it to me a number of years ago. And I would say that book is my favorite business book, in large part because Eric really helped us to execute on it. So it wasn't just a read, but we actually used the material in the book to advance, you know, in projects that we were working on. So four DX is a Sean Covey book, and it's about focus and engagement and accountability.

spk_0:   42:34
Four D acts like the number four D is a dog in the backseat of the next. Right. Okay, I got it interesting. I've never I've never heard of that. Jotting it down Teoh to look up after we, uh, conclude the interview here. So next rapid fire question. Is there a business leader or mentor that you most admire? One that really stands out from your your career in med sec.

spk_1:   42:53
I'll learn from anybody for sure I'd say I'm currently working with another CEO on a project that he's working on. I'm on their board. His name's Dave Wagner. Dave Wagner is CEO of this company called Inspired Life Medical. And actually, he founded another product called Frog Tape. I'm not sure if any of you your listeners, have come across that product. It's a painting tape, right? And so it's a It's a green tape that you could see

spk_0:   43:20
on the shelves

spk_1:   43:21
of home Home Depot. And so he founded that as well as other companies. He's a serial enter entrepreneur and Dave Wagner. Is that person from a

spk_0:   43:30
branch from frog tape? Teoh Med Tech Company. Yeah, I e

spk_1:   43:36
guess the better question might be for me to say I should provide more color. David Lee leads through Christian principles. You just lead by examples. I mean, he doesn't push his ideas or ambitions. I gave you a name that maybe none of you know, if I didn't give you ah Warren buffet type type name, and so I'll share with you. That is just a great listener. And he's always open to other solutions. That may not be his ideas, and so yeah, ID, say Dave Wagner is is that that person that I most admire his a current CEO?

spk_0:   44:10
Cool. That's good to know. It's another one. I'm gonna happen. Have to do a quick Google search. Ah, after after the interview here Day Wagner frog tape. Maybe I'll find a little bit more information. We'll

spk_1:   44:20
now now would be Dave Wagner. He and his company, they're looking to develop a product that can diagnose or screen probably screen is a better word. Alzheimer's disease meant many years before symptoms occur

spk_0:   44:33
on,

spk_1:   44:33
and so yet he's a super ambitious project, and I actually invested in his company, Tucson. I'm betting on Dave Wagner. He's, uh, I think he'll get it done.

spk_0:   44:43
Cool. Super fascinating. All right, Last rapid fire question. Mike is which or what? One thing would you tell your 30 year old self if you had the opportunity to go back in time?

spk_1:   44:53
I guess I would tell my 30 year old self to not be afraid to take risks, to not be afraid to fail, and I'm really thinking this through. When I was 30 years old, I'd probably also tell myself not to buy a bunch of real estate like I did in 2006 in 2007.

spk_0:   45:13
Instead, you should have invested in fraud shape. Yeah,

spk_1:   45:16
that's right.

spk_0:   45:17
Exactly right. No, that's good stuff. That's good stuff. So, um, I know we're Ah, we've we've kind of reaching towards the end of the end of the interview here. It would be fun. I mean, in in looking at, you know, your background and kind of the notes that we had we had prepared to kind of leading into this conversation. I mean, at some point, you find to do, ah, follow up interview just on kind of what what you'll learn. I would imagine over the next, you know, 1 to 2 years with task medical and maybe any other projects, I guess that you're involved with and, you know, compare and contrast those to the things that you were maybe even teaching or consulting at Kinetics, you know? And I know we didn't get into the We barely touched on your experience at CS I, but you were there for, I think, almost almost eight years in during the early kind of formative years of CS I so be funded. Maybe maybe circle back around in the future and kind of touch on some of those experiences as well. But, um number anything else to add before we officially wrap it up here?

spk_1:   46:09
No, I think that was very insightful. I think the fundraising part of it is, uh, really interesting. I mean, this isn't a conversation that we really have with anybody before, and I think it'll be fulfilling for Tata's medical on Mike. You know, Winnie's after he went through difficult times with the seed rounds to now being able to dictate the terms a little bit more next time. And you determine who's money you take rather than them dictating the terms to you. That will be, ah, probably a much more enjoyable experience for you. Yeah, well, I think so. I really appreciate the interview guys. And Scott, I really have enjoyed your interviews over over the last couple of years. You guys bring a great service, and so I'm looking forward. Toa learn as I'm listening toe other podcasts of yours.

spk_0:   46:59
Yeah. Yeah, I can't. I mean, thanks for the compliments, Mike. And I can't think enough for coming on and sharing a little bit more about your about as medical kind of what you're learning what you're doing there. But also, you know, kind of, you know, some some experiences from your you're MedTech career as well, which is pretty wide ranging in terms, in terms of your experiences. And I'm just gonna just thinking about digesting some of the things that we chatted about and parts of the conversation that really stick out to me is kind of your your general approach. You know, Teoh synergistic approaches called that to your kind of your your soft launch strategy with Chazz and then no, just kind of helping helping would be med tech founders, you know, in their approach to raising money and trying to really get at the underlying the underlying rationale a reason for why you know, they may, you know, they may hear the no right Or they may hear people saying they're too responding with their too early and really trying to ah, to better understand that I think those are some of the things that stand out are in our discussion. So, um, anyway, long story short, thanks a ton for the interview. Mike really appreciate you doing it. Where's the best place to for people to learn a little bit more about about two as medical.

spk_1:   48:03
So we do have a website, calves medical dot com, and you can check us out there or reach me on the Lincoln

spk_0:   48:10
cool and we'll provide, ah, links to Task Medical Its T A s Come, Andy Sam ts medical dot com will fried links to ah to Mike's company as well as is linked in profile in the show notes to this interview at med cider dot com. So, Michael, have you going and hold on the line? Um, as I officially wrap this up, But, um, for everyone listening, thanks again for your attention, as always. And if you want to stay up to date on the ah or learn when the latest to med Center interviews are released, go to med cider dot com and just enter your email address. We definitely won't spam you. In fact, the only time you'll probably get an email from us is when ah, in a new interview, does in fact go live. So thanks again for your attention And, uh, look forward, Teoh. The next time we, uh, record another episode, everyone take care