How to Critically Choose and Develop an Implantable Medical Device
Tammy Gilon is the Founder and CEO of Laminate Medical Technologies, where they are developing solutions for improving vascular access for dialysis patients. In this episode she shares why she became interested in medical device, the systematic and thorough process she followed in choosing a project to pursue, finding a partner, what it is like to found a company and raise money as a young female, the start-up culture in Israel, and the long journey of designing an implantable medical device.
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Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:31
Welcome. When you were in your early 20s, did you know exactly what you wanted to do? Well, I can tell you that when I was at age, I was just trying to figure out who I was and was more concerned with finding a job and paying some bills then figuring out what my career was going to be. And it actually took me a while to figure it out. My guest today, Tammy Gilon took a different path. She actually knew what she wanted early on, and has pursued her passion with the help of a really thriving innovation community in Israel. Tammy is the founder and CEO of Laminate Medical Technologies, where they're developing solutions for improving vascular access for dialysis patients. In our conversation, we discuss why she became interested in medical device and why it's such an early age, the systematic and thorough process she followed in choosing a project to pursue and choosing a partner and finding a partner, what it's like to found a company and raise money as a young female entrepreneur. We talked about the startup culture in Israel, and also the long journey of designing an implantable medical device, and the changes that you need to make along the way. Here's our conversation. Tammy, welcome. So nice to have you join us today. Thank you, Pat, great to be here. Thank you for the opportunity. So Tammy, you focus your career on medical devices and startups from early on from from day one. So was that always your plan? Was that always your your dream?
Tammy Gilon 02:25
Actually, yes, I think that I knew, since I was quite young, that the direction of innovating something new and contributing with with something new with new technology, and that will meet an unmet need is something that I've been interested about. And I was looking at the different alternatives that they had in order to make this happen. And medical device was always an industry in which was that which I was interested in,
Patrick Kothe 02:58
when you say always was this as a as a young child, as someone in
Tammy Gilon 03:04
high school, I think I knew that that entrepreneurship is something that I want to follow and I feel comfortable with I got lots of validation, you know, from it, from my environment that this is what I should do. I mean, so
Patrick Kothe 03:19
was your family involved and innovation medical device, your mother, your father?
Tammy Gilon 03:24
Yes. So my family is very involved with with innovation. And my father is an angel investor in Israel. And that is responsible to over 60 exits in the Israeli high tech industry, including life science. But I have to say that this accelerated the life science part accelerated accelerated since I got into it and then provided access to more interesting technologies. But innovation was something that there was always around me. So if we would sit at a family dinner, I remember when my husband met my family for the first time was probably 13 years ago, we were all talking about startups and new technologies. And this company went public and this company was acquired by a different company. And he just told me you think that this is the norm, right? But this is very unusual. So yes, I had that the right environment, I think in terms of mindset and understanding how these processes look. I have to say that, of course, experiencing this puts light on many other aspects that I could only dream off and then faced me with additional challenges, you know, that I didn't know before. So yeah, this is also an aspiration that I had in mind. And when I was exploring alternatives for my education at the University, following my Army service in their intelligence forces in Israel. I knew that studying engineering, whether it's mechanical engineering, or electrical engineering would be a good base and a background and a core knowledge that would serve me in different industries. In 2005, when I started my, my education journey at the Tel Aviv University, and I started with mechanical engineering, and at some point, when we had to choose different courses, I was able to put more focus, focus on the biology and bio mechanisms. And then physics related subjects that were more around topics that are associated with medical device development. And this is how I got in the orientation and the, the background and be confident that this is an industry that they would like to explore and to be part of.
Patrick Kothe 06:02
So when you graduated from university, what was your entry into the medical space?
Tammy Gilon 06:09
So first of all, by the way, I was always debating between philosophy and history and engineering, which is I know, it's very fun. Yeah. Within the same lines, and so before I started, during the journey, I actually spent a semester in New York at the new school, taking some courses in their philosophy and psychology, and history. And that actually is framed these areas for me as something that I could always do as a hobby or, you know, something, you know, on the side that I'm very interested to learn more about, what they don't see as my focus of my career. So I got back to Israel and and then I started to work for a company which is called valtech cardio. And that developed several solutions for mitral valve repair, was later on, acquired, by the way by Edwards life science in a very impressive deal. And but this was always this was also the place where I understood that engineering and r&d is not my forte, it's nice to have a business background, you know, to understand how the dynamics of the r&d process works. However, I'm much more interested in A to Z gastic, about the business part and the intrapreneurial part of them of the making of new technologies. So what I did, I left the company without knowing what would be their the next initiative that I'm going to be part of. And I started to meet with that, and Kirpa nurses and physicians and students that were studying different things that were again associated with the industry, all in the purpose of finding an unmet need a real problem that needs a solution, where I feel that I can contribute to I think that I was reviewing probably 20 to 25 Different unmet needs and potential solutions that can then that can be provided to this problem. I think that I'm I can tell about myself that I'm not. I'm not easily saying yes to opportunities. And I think that I tend to be pretty critical about new technologies and the market size and the opportunity. Fortunately, I was in rejecting many of the ideas that I had, and other people had, until I met my co founder in laminate. This is a guy who's whose name is Dr. Al Aryan. So he's a physician by education. But he's a serial entrepreneur in medical devices. I have to say that I don't always tend to agree with the terminology of being a serial entrepreneur, but they think that he really deserves this title. And they I was working with them incubation program and in Israel, that is that was called rad biomed and was owned by the Zisser. Family, who are considered to be the founders of the Israeli high tech industry think that they deserve that big of a title. And he was scouting for projects and was doing good business development from his clinical perspective. And he knew very little about AV fistulas vascular access and stage renal disease patients. This is the area where we're at with laminate and he presented the the unmet need to me and we met for the first time through For a third person, and first of all, the chemistry was very good. So we were very, and I would say, speaking on the same level, had the same thoughts about other companies in the industries and then the right pathway to success the way we see. And I think that we realized that there is this thing pretty early on, I would say three to four weeks after we met for the first time, the trigger for that was Al sending me some materials about the problem. So I had to sit at home and in study, you know, the environment and get to know that the dynamics and what what is exactly the unmet need and what we can and cannot improve. And I think that when we met, and we found out that our observations in the areas where we thought it could be improved, are very similar, and that we are very aligned with the way we're thinking about things. And this is how we started laminate in February of 2012. And incubation program, this is a program in Israel that is supported there. It used to be the Office of the Chief Scientist, today's the Israel innovation authority. But basically, we're talking about non dilutive grants from the government, that keeps IP in r&d activities in Israel, fund companies with high risk, you know, like in the life science industry, from early on, when it would be really challenging to raise money either from angel investors, not to think even about VCs at this stage that are not willing to take the risk, it's such an early phase of the program was very, you know, was a good fit for us. This is where we started and graduated in two years after.
Patrick Kothe 11:57
So before we get kind of in depth into the laminate story, I want to go back for a second, because when you described how you were evaluating technologies, and how you were evaluating the problems, it, it struck me that a lot of people don't do it that way, a lot of people will fall in love with the technology and or fall in love with a product before they really do the in depth analysis. So is that something that you learned in school? Is that something that you learned from your father? Is that something that is innate to you as a questionnaire? Or how did you come up with that philosophy and being so discerning with the ideas that came to you?
Tammy Gilon 12:42
Yeah, I think that that this is definitely that I pick up the tome as well. But then, as I was exposed to processes in different industries, and I was reading a lot, you know, since again, I was in high school, I was always following companies and their journeys. And I found out that as you, as you say, many people are in love with technology that does not necessarily have an outlet, and especially in the medical device field, I think that there are so many barriers or challenges that you'll have to go through. So just technology is not enough. I mean, in my opinion, you have to check the box, different criteria that would make sense in order to be successful. And I think that it's starting from, from beneath, and then and the dynamics in the market, is it competitive, or going to be me to device or actually compete against their standard of care that has been done in the same way for the past 100 years. And that would result in educating, you know, surgeons to have been doing the same thing for 30 years on a new technology, which is a big challenge, and also a different challenge in different countries, because the mentality and the DNA, and the acceptance for innovation varies between countries.
Patrick Kothe 14:11
So another way that this has been phrased is don't fall in love with the technology or the product fallen will fall in love with the problem. Is that kind of what you're what you're describing here is really defining what the problem is and then seeing if there's something that can be applied to that particular issue.
Tammy Gilon 14:31
Yeah, I think that the solution should make sense and should be you know, destructive. And then and be above the average and not straightforward as if you have an injury with the plaster you know, it's not I mean, you you have to think outside the box and make sure that you write that you have the right angles to and to cope with the problem, but they tend to agree with what you're saying. I think that if there is A good unmet need, and you have the resources and the right direction of thinking about what the solution should be. And this is, in my opinion, more important, because I also believe that good people together and will come up with a good solution to a problem. So even if it would take one or two, three takes, I think that eventually, if they characterize the problem appropriately, and the solution does not rely on that, you know, technology that will only exist in 30 years. And I think that it's doable. So I think that the combination of the right people, solving the right problem is actually more important in the hierarchy
Patrick Kothe 15:49
of things. So as as, as you're going through this analysis, I'm assuming that you are talking to other people within industry clinicians as well to figure out do Is there really a problem here? What's what's the level of the problem? How significant is it? And can't? Is it a solvable thing? And if it is, what does that mean? You know, does it mean a real change in the way medicine is practice? And as you said, is it going to have a significant impact? Is it a is it disruptive, disruptive? So as you started going down that road with each of these projects that you're that you're looking at? Did you find some some areas that you thought, well, actually, this technology doesn't really fit in, in here, but there's really a problem here? So were you able to, to, as you're digging in to find other types of needs, that you that you didn't know, going into it?
Tammy Gilon 16:43
Yeah, I did. I mean, I think that I was exposed to a couple of needs, that actually still exists, you know, in their medicine world. And however, in this case, as I was looking at different things, for example, how many companies or entrepreneurs have been trying to solve this problem? What solution that they come up with? And where did it fail? And then you see that, you know, lots of resources were invested into multiple solutions that were tried along the years. And I think that this is something that you can learn from as well, because you can see, what is the exposure, the risk that you're taking? So unless you have a great idea, you know, which is completely different than what others did? I would say that there, there are many unknown so so yeah, I think that we know that there are some major and needs. In the in the medicine world, I think that hypertension is a good example, where you've seen many, many, many companies fail, you know, it's finding the right solution, a part of it, is because this is a really a systematic problem that is associated with different, you know, systems in the human body. However, some of the solutions, were only focused on, you know, influencing one of the systems that are correlated with hypertension, then the body has been compensated in other ways.
Patrick Kothe 18:18
So, Tammy, what were some of the other criteria that you're looking at? So, so, competitive trials are, you know, people that have tried things competitively? The the need, how disruptive it is? market size, I would assume, had something to do with that as well. Were there other other areas that you're using other criteria that you were using to help narrow your focus?
Tammy Gilon 18:45
Yeah, I think that the market opportunity was also important. And this is something that I looked at. One good example to this was a meeting that I had with with a woman who is the pediatrician, she's trained in cardiology here in Israel, and a woman that I highly, highly respect. And we were sitting and talking about the gaps that exists in them therapeutic devices for a pediatric medic medicine in cardiology, and the solutions that are available for the adult population. And they're actually some solutions today that are available for adults would be manufactured, you know, in smaller sizes, or with very small tweaks that can be easily theoretically applied for to be applied for children as well. But you know, the world is cynical, and many companies did not have the motivation to invest in clinical trials to validate these technologies because the market wasn't that big. And this is why you know, this is an area where and it will be very Hard to influence on innovation. That's one example. And another example is gynecology, and specifically around the labor and technologies that can assist OBGYN, you know, in there are when a woman is going under labor. I think that the tools that are being used, you know, are tools that have been existing for 2025 years, it's almost unbelievable when you physically see the tools that are being used, and compare it with the graph of innovation that you see in cardiology, for example. And then when I dug into it, I realized that the rain Berkman Aqua system, and is very disappointing, that procedures are paid very small dollars in the US and in other countries as well. So there are no margins, I'm not saying that this cannot be shifted or changed, but this would require a different phase of revolution, you know, to the whole ecosystem of payment. And this is something that I felt that I you know, especially with my first company that they want have control over, it's still too big for me.
Patrick Kothe 21:19
Yeah, I mean, the traditional things, when you look at medical devices and look at opportunities, obviously, the clinical need is is is the number one, but then you start looking at market size, reimbursement business model, how are you going to, to make money, what the regulatory pathway is, what the what the investment is, what kind of clinical evidence is needed to support a change? And how long is it going to take to get that that evidence? All of those things kind of lead lead you into? Is this something that I want to attack right now? And am I prepared to do it? And am I going to be able to get funding in order to do that too, because, you know, it's not just hey, you know, I've got a great idea, money is not an option, or money's not my rope, I'm not in this for the money. I'm here that you know, the better medicine, well, that's doesn't quite work, because, you know, you have to get investment in order to do it, too. So all of these things kind of lead us into is this an investable project, not only from outside investment, but is this something that I want to invest myself the time that it's going to take in order to do this. So it sounds like you found that opportunity. And you found a good good partner. After after doing doing extensive extensive analysis. So let's talk a little bit about laminate to tell me a little bit about what the what the technology is all about. And the problem that you're solving.
Tammy Gilon 22:51
Laminate is trying to help patients with end stage renal disease, who's their kidneys are not functioning and are not getting a kidney transplant for many reasons, you know, either. There, there is a leg you know, and a line of years to get a transplant, or the transplant has been rejected by the body. But the bottom line is that they need hemo dialysis treatments to replace the kidneys and to remove toxins from their blood circulation. And this is a treatment that the haemodialysis that these patients are undergoing, usually three times a week, and for several hours in session, so we will take between four to five hours. That is when these patients are being connected to the dialysis machine that removes dirty blood from the blood circulation and returns it when it's clean after being filtered outside the body. And in order to connect the hemodialysis machine to the blood circulation, there is a need to create a vascular access. We're the most common and preferred method for doing that is called AV fistula. Arterioles. to vent fistula it's a relatively simple surgery that is being performed by vascular surgeons in the arm, there are several locations where you can place the fistula. And practically again, it's a suturing between a van and an artery in order to be able to puncture to calculate the vein. And but this is when the vein would after the vein was connected to an artery and that means that there are higher pressures than use your own higher outflows than usual that can accommodate faster treatment and filtering of the blood circulation. The only problem with this surgery which is again, the standard of care for creating vascular access to these patients, is the failure rate. So there are different metrics and outcomes that you can look at. But the bottom line is that 60% of these procedures Within the first year after the surgery was done, and this isn't an unbelievable number for several reasons. First of all, we're talking about a lifeline for patients. So if a patient does not have this support of dialysis treatment, they immediate risk is his death and the you know, other complications or acute solutions that can be applied. The second problem is that being a heart chronic disease, you know, that brings these patients to the dialysis facility several times a week. On top of it, they also have to deal with repetitive interventions at the hospital that will allow this access to be taped and unusable. And this requires balloon angioplasty, placing endovascular stents and repairing the area with surgical techniques. So actually, in the US, there are different averages for subgroups. But the general average would mean that these patients are going back just to maintain these fistulas on average, three times a year, just to make sure that the fistula is working. Each one of these procedures that are maintaining the fistula, are putting more risks on a patient. Again, this is a sensitive population that has to undergo additional interventions and procedures. And this is what we're solving with laminate, we develop an implant that addresses the root causes that lead to these failures. So when we started that back in 2012, we've been characterizing the failure modes that were well established in the literature, I have to say, because there is a lot of studies that discuss the failure modes of the fistula. And we came up with a design, it's an external support implant, all made out of an IP now, that sits on the junction, the connection between the venom and the artery. And it addresses the root causes for failure, which are the high tension that the vein has to accommodate the shear stress profile that is also correlated with very turbulent flow around the junction area. And then ends demotic configuration, the geometrical configuration, which is impossible to retain post the surgery because they close the skin and there is pressure and one patient puts his arm on the table and one plays football or baseball, so everything moves in there. And the implant just keeps it in place to allow for a smooth human for a smooth thermodynamic profit.
Patrick Kothe 27:49
So to me this, this is a nitinol sleeve that goes around the outside of the AV fistula. And it's it's like a, like a stent type of design, mesh type of type of design. And it relieves the mechanical stresses around that. And as to Moses is Do I have it characterized pretty well?
Tammy Gilon 28:13
Yeah, it's a good definition. Yeah, the results and outcomes that we see a are indeed validating the improvement that we've been estimating, you know, and validates our hypothesis for actually dealing with these mechanisms of failure. And we have several studies that were cleared, peer reviewed, and were published in their most important journals in this discipline, which is their journal of vascular surgery, the American Journal of kidney disease, the Journal of vascular access. I think that today, I'm very proud that despite the fact that we're a small startup company, and in the startup phase, we already have clinical evidence that is published for hundreds of for patients. Some of them also include control groups. So apple to apple comparison, if you will, with the standard of care, that shows significant improvement in the most important outcomes for these patients.
Patrick Kothe 29:15
The design of this product has been a long time coming. As you said, You founded the company almost a decade ago. And we're now at the point where some clinical data is is starting to come out and I'm assuming that regulatory clearance of this device is coming shortly as well. What was the design challenges or what were the design challenges that you had over this almost decade that that you've had to overcome?
Tammy Gilon 29:50
Yeah, so the first day design challenge was inserting an implant to a procedure with no implant and no medical equipment. So, one challenge was to actually explore and examine the surgical field of the physician, and to see how we can incorporate that technology into this without making it too difficult and complicated. Again, for a surgeon who has been doing the same thing for years, you know, for 20 or 30 years. So these were challenges that were resulting, you know, in their usability challenges that we had another challenge was working in different territories with different populations of patients, and making sure that we cover the whole range of diameters and unique anatomies that these patients have, we're talking about patients with very often comorbidities of diabetes. So more than half of these patients are diabetic across the board, you know, in different territories, and patients with heart failure patients with peripheral arterial disease, that reflects on the quality of blood vessels that the surgeons have to work with. And this is why we have to provide them a delicate support that would, again, address the root causes of failure on one hand, but then the other hand would be delicate enough not to crush the area, for example, or kink the area or risk, then, you know, the the surgery itself. So, specifically, kink and crush are things that we had to validate and test and work with different values. And this resulted in they're in the design process in making sure that the struts are delicate enough that the width of the wires of our braving mesh are thin enough that we allow tissue growth in this area that if a patient puts again, the his arm on the table, the blood vessel vein, which is quite superficial, would not crash and block the fistula, and so on. And the third, the last challenge, I would say, is related in in a way to the to the previous one is to address as many E's of Terek anatomical configurations as we can, because, again, on average, these are patients with challenging blood vessels. And if we would focus only on patients with perfect blood vessels, this would probably, you know, minimize the potential market share to 10% of the population. And you want to create the geometry that would capture different esoteric configuration that would be a good fit and a good solution for all patients. And so that was a challenge in terms of the geometry and the design.
Patrick Kothe 33:06
Certainly a lot of challenges. So I want to take you back to 2012. So your 2012 year you're having these conversations with your your co founder, and you put together a plan. Did your plan say that it was going to take you 10 years to get to where you are or what did your plan, say at that point?
Tammy Gilon 33:27
No, he didn't. We were hoping probably to get FDA approval at tier seven. I think that the first steps of getting C approval for Europe were pretty aligned with the plans, I have to say we got the C approval in October 2015, which was three and a half years since we started, which is think that it's definitely reasonable timing for an implant. The FDA, however, planning, setting the right Clinical Strategy, making sure that we're ready to go that the company is ready to initiate a study across 15 centers in the US. high volume centers, Kol centers, academic centers that we have the right network of physicians to initiate such a large study, by the way larger than most of the studies in this discipline, even by bigger companies with way more resources was a challenge. And we wanted to make it right. And this was one of the reasons why in 2016 I relocated with my family, to the US to New York I was based in based in New York. And one of the things that I did is screening these sites and making sure that each and every site that is onboarding to the study makes sense for us and then and meets, you know the criteria of getting into the study. So I think that this process took longer than the plan. And executing the study took also quite quite a long time, we wanted to make things right, without making too many mistakes. So yeah, we've even planned for it to take 10 years, but this is where we're at. And we're still learning every day.
Patrick Kothe 35:26
Again, let's go back to 2012. Because in 2012, you're you're a couple years out of university, you're you're a young woman. And raising money is difficult for anyone. But raising money as a young woman with not a lot of experience in the space and dealing with an implant, a serious medical device. That was I'm sure a challenge. So let's let's discuss that a little bit. Because it sounds like the environment that you're in, in terms of the accelerator, entrepreneurial space within Israel is is very unique. So I want to talk about that. But what was it like raising money as a young woman at that point?
Tammy Gilon 36:10
Yeah, so as you can assume, not easy, because I think that you always have to, almost always have to start from a different point where were men would start and as you said, I was a woman and a young woman. So that was there, a double challenge here, you know, I'm very often hearing or being asked about, I say, I hear people say, Wow, I wouldn't imagine that this guy is working for a woman CEO business sentence that they heard more than 10 times in my life. And I see it actually the same way, you know, is raising money, although there are many differences between the analogies, but actually, I mean, if someone is thinking through our perspective, or they're working with female or a male CEO, and this is the important criteria, so probably this dynamic is not going to work. And I would say the same about investors, you know, if they're, if they cannot isolate the story in the business opportunity, and the confidence that they have in me leading this based on what I did, up to date up to the point that I met with them and asked for additional funding. So actually, I think that it's also a good mechanism of screening, because you know how it is, when you're tied with an investor who's not a good fit for the company, this is not the place that you would like to be at. And I think that you have enough challenges in the business itself. And at least during the night, you want to sleep well and know that your partner is trusted.
Patrick Kothe 37:59
I think I think it's interesting, because when when I think about it, I think about a young man or woman with an with an investable idea. But with two years of experience within the space, that's a pretty difficult to ask for somebody who say is, as this person ready to take on all of the things with a startup at the age of what 2324 Whatever, whatever age you were at, at the point, that's a significant ask for somebody that doesn't have experience, you know, hiring people running teams, etc. And then And then, you know, we'll put the woman piece on top of that, because certainly there's there's plenty of data out there to suggest that it's much more difficult for female to raise money than it is for a male to raise money. That's unfortunately, kind of the world world that we're living in right now. But just at that point, as a young female, at that point, that challenge was going to be a difficult challenge for raising money. So as you started, you said with some non dilutive funding, and how far did that get you?
Tammy Gilon 39:15
Oh, it took us through our first in men, which happened in the UK and in June of 2014. So that was a little bit over two years into the process. And I think that this is the point where little money and poor little dollars that you've been spending and working very lean actually works in your favor. Because after starting get first in human with a non dilutive grant with very little additional money, you can show your accomplishments and it's not day one, you know, back in 2012. It's not it's not the same challenge. I mean, you'll have a track record already, even if it's only two years. You know, throughout the process that you can rely on, and this is how you're going to be measured. So this is the point where people can start forgetting about the past, I wouldn't tell you that six or seven years into the process, it's still not challenging to raise money, as you said, it's challenging for everyone, I choose to look at the other side of things that if on average, we can actually raise less money than the average. So this can highlight our accomplishments even more, because every day when I, you know, read in the newspaper about in another company, who just raised $70 million, the first thought is, wow, I'm jealous. But when I get to think of it for 10 seconds, I'm like, gosh, I mean, that's a lot of responsibility on your shoulders and making sure that you're doing the right thing with them with zero resources. So there's also, you know, a positive parts in working lean with limited resources by definitions and fewer alternatives than the average in case you're successful. And you're not making many mistakes, of course.
Patrick Kothe 41:16
So as a public how much you've raised so far,
Tammy Gilon 41:19
and $28 million.
Patrick Kothe 41:22
Okay. I wanted to talk about the ecosystem that, that you've got within Israel, because it's really unique, and it's really robust. And I think it also helps to support young entrepreneurs. So Can Can you talk a little bit about the ecosystem and how you've played within it?
Tammy Gilon 41:46
Yeah, so the F eco system is very supportive of Intrapreneurs. And I think that they're waking up in the morning and say, I want to found by found my own startup is not is not unusual in Israel. And it can be very unusual in other countries. So I think that this is the very different baseline that we have here. It also result in a sometimes saturation of technologies and companies that, you know, when the markets are overloaded with money, so the money is not necessarily spent, you know, appropriately. But that's another issue. But I think that the mentality and the confidence that people have here in the fact that they can do a lot independently on their own is very unique. The fact that the country is very small, helps as well. Because every day you hear about another exit, and then we always laugh, you know, with the two phone calls, you can get to the person to the CEO, because everyone knows, everyone. So this feels very close to you. It's either your cousin or your neighbor. So
Patrick Kothe 42:58
Tammy, is this is this across all industries? Or is it? I know that there's, I know, the medical device space, and I know that there's a very robust community, community within the device, medical device space, is that is that across everything?
Tammy Gilon 43:12
Everything? Yeah. And there is that always a joke that when you when you look at LinkedIn, 80% of the Israeli LinkedIn scribers are CEO, you know. So yeah, that that's the vibe.
Patrick Kothe 43:30
So what kind of support Did you receive from the community?
Tammy Gilon 43:34
There's a lot of support that you can get from the community. I think that one of the important things that I learned as a CEO is that them you have to hear different opinions from people who are also unlike you, you know, that have different personalities and say, different things in different perspective. But there's a CEO, the important thing is that you have to take sometimes 1%, sometimes 50%, of what you've heard, so you're going to hear many, many advice from everyone from people that you're asked for advice and from people that you haven't asked for advice. And you have to to isolate what is contributing to your business and what is not. And this is mainly based, I guess, on intuition, when you'll have to make the decision of which device you're going to take. So I get different kinds of supports from people in the finance industry on how to build a financial roadmap on r&d. So we've met with different manufacturers and different engineers wanted to tackle the challenges, different ways on how to build your clinical platform in the US so I get many advice from People hear went through these processes. But at the end, you have to make your own decisions and to see what makes sense to you. But there are definitely good people to consult with.
Patrick Kothe 45:14
So you wrist another issue that I like to like to talk about, and that is different cultures and, and the entrepreneurial culture is unique in Silicon Valley than it is in Austin, Texas. And it is in Israel and New York and Boston and wherever everyone's got slightly different. But you also are building teams that are multicultural as well, because population of Israel is what 7 million? 9 million? Yeah, 9,000,090 9 million, 9 million people. So you don't and there's, as you said, there's a lot of industry a lot of choices for people to go to work work with. So you're building teams that are not not only in Israel, but can involve people in other areas as well. So how do you build across different cultures? And how do you build a team, not only just, you know, the time differences, but the cultural differences between different groups of people?
Tammy Gilon 46:15
Yeah, I think that this is probably they're one of the most challenging tasks in our hiring, because the team is definitely what your makes what makes your company successful. So I think that this is the most important decision that you have to make, basically, I'm not sure that I have a great answer to this, I think that it's on top of, you know, the usual answers, you know, like references and seeing what this person did for other companies. I think that it's a lot of intuition you met in person, when I hired my VP sales in Europe back in 2016. So he's his German, he's based outside of Berlin. And the mentality is different. I mean, for both sides. I mean, I didn't don't think that he ever dreamt that he was going to work for a startup company when he joined, you know, for people. And, and we met at a conference in London. And following that, I felt like there was good chemistry and potentially a good, you know, fit for laminate. I invited him to Israel for three days, and we spent three days together. You know, what, most of the time, I think that we did not speak about laminate per se, you know, because there wasn't much to speak about, you know, we were in a very early phase. But I wanted to say his commitment, you know, the real spark that he has in his eyes and bringing, you know, a new technology, how does he choose his team, you know, and the people that were working for him, you know, for previous with previous companies. And I'm also interested in, you know, his take on life in general and different people and how they interact, and at the end salesperson is, has to be a people's person as well. So I think that it's easier to assess if this is what you're looking for, or not. And for me, also, I know that with traveling a lot, at least three COVID, I'm going to spend a lot of time with this person in many conferences with many accounts and dinners. So I want something that I like, and I would enjoy a beer, you know, after a long day at work. So that was also an important criteria for me, and I would feel comfortable with,
Patrick Kothe 48:52
if you're a US company, there's a lot of common culture, types of things within people in the US even though you may live in different states, the culture is is is similar. Being in one country and having to go across country lines, cultures, kind of kind of change, not only different things within your culture, but also the startup culture, the medical device culture, the entrepreneurial cultures are different. Your markets are mostly outside of Israel. So you are definitely moving out into into other cultures. So is as you're making your decisions about where to go and who to involve with the company. How does how does that figure in?
Tammy Gilon 49:39
Yeah, that's a good question. So I want say that the dynamics and culture dynamic is, is a major criteria in our choice. I mean, we try to make the right business choices with the countries that we're targeting is business cases or commercial first commercial users. However, it I do acknowledge the fact that, that we have to work with local people who can bridge between these cultural differences. So, in that case, if we work in countries like Italy, for instance, this is a country where we have a very good distributor. So I think that without this company, actually to bridge the gap, we couldn't have been successful. So I think that you have to find the local solution and everywhere, because as you said, from my experience, at least, each country's very different, you know. And, Renato,
Patrick Kothe 50:40
let's talk a little bit about entry strategies in different markets, because there's something to be said for being, you know, doing things locally. First, there's also a strategy of saying, going for the largest market first. There's also some things about going for the least restrictive regulatory pathway or the quickest to market. So there's, there's a lot of different factors that go into choosing where you're going to go first and where you can go second, how did you approach that?
Tammy Gilon 51:13
So a good question, in my opinion, which we ask ourselves every day, by the way, and we keep having discussions about this. And I have to say, as a disclaimer that I haven't seen many startup companies being successful, consistently successful without making any mistakes, as in the startup phase. So and you don't have necessarily great models, you know, in the discipline that you can, you can learn from so I think that you're on your own when you have to prioritize this. So, first of all, I think that you've mentioned it earlier, the reimbursement barrier and the business model. This is something that we see that is becoming more and more important, and major for entering new countries. I think that what we see across the board in different countries, if 10 years ago, it would be a feasible scenario that the senior surgeon at the hospital would want your technology would go into the Office of the CEO of the hospital and say, I'm going, I'm going to use this product, things are different today, there is more weight on administration and purchasing departments. And very often we say that them surgeons themselves are disconnected from this decision making with the payers with other bureaucracy that is associated with this. So you have to make sure that you can map the average sale cycle at different institutions in this country. And that a simple as that, that hospitals can buy your product, it's not straightforward for us in each and every country. So that would be the first criteria. Second criteria would be a market where we feel that we can can have good control over so if in Germany, for example, we have direct presence at hospitals, and as I said, in Italy, we have distributor in both countries, I don't feel that there is major risk for us as a new technology to be exposed for more and more accounts, because I feel like we're doing it the right disciplined way. And however, in the startup phase, you'll have a lot to, to lose, because if you're not doing things appropriately, you can create major damage to your, to your brand and to your company. So actually, sometimes you're you have more to lose than to gain. And I think that this is a balance that you'll really have to think about when you're entering a new country. And the third criteria would probably be the exposure and value with this will allow your company and technology only for mapping KOLs and podium speakers and people who can publish data and can be markedly there's a are decision makers on the international level or on a on a national level, which is important enough. So I think that this can be good motivation, you know, to start working with them specific surgeons or hospitals, if we feel that there is more value that can, you know, come as a result with them working with these institutions. I think that these are the three major criteria when we look at the market opportunities.
Patrick Kothe 54:47
So Tammy, you mentioned earlier that a lot of feedback comes to you and you have to pick and choose what's valuable to you. And over the past 10 years You've had to pivot some different things, product wise, I'm sure that competitors have come and gone or have come in that you didn't expect, different technologies have emerged as well. And you as a leader, what the plan that you started with back in 2012, probably doesn't look exactly the same as it does in 2021. So can you talk a little bit about keeping your your hand on the on the tiller and keeping your ship going in the in the right direction? When you've got to manage all of these changes?
Tammy Gilon 55:46
Yeah, great question. I think that there is a very thin line and a very important balance between being open minded and having the ability to adjust your plan. And the and the leaning towards, you know, being consistent because things takes take time in our industry. And the fact that the outcome that you're expecting did not happen after one year, does not mean that you certainly have to stop what you're doing. Actually, I've heard something that I that I really liked from one of my investors several weeks ago, who said, You cannot avoid mistakes, you can only define good mechanisms that will allow you to monitor these mistakes in a very efficient way. And where you can realize that you made the mistake as soon as possible. So the idea here is to create these mechanisms that we'll be flagging are alerting that you gone the wrong way. And then you will adjust. Because I think that we can, that everyone can agree that we are going to make more mistakes. And we cannot cannot avoid this. Especially when we're growing and you know, crossing new borders. And
Patrick Kothe 57:13
yeah, it's it's identifying, admitting, and then learning, and then feeding, feeding that learning into you not not making that mistake again. Well, Tammy, this has really been a fascinating discussion. And I really appreciate you sharing your knowledge about the startup world and in the startup ecosystem in Israel. I just like to ask, is there any message that you would like to deliver to your fellow medical device professionals out there?
Tammy Gilon 57:45
Yeah, I think that especially now when we see that the markets are going crazy. And then software companies and cybersecurity companies are created for x 200, or I don't know how much. This can be tough moments, you know, for intrapreneurs, who are trying to raise $5 million for a very important solution for well defined me. But they think that their unique situation in our industry, is that we are working with real unmet needs, with real solutions to that. And even if it takes more time, I think that the way to get there feels very, very important and meaningful, because we have to remember the end goal. I mean, even though we're working daily on our very local and then specific challenges. The end goal of this is either improving patients lives or saving patient lives. This is across the board for most of the technologies that I'm fairly familiar with. And I think that it's important to to keep it in mind and that this is the end goal and and hopefully we can enjoy the journey there. Remember, we have real problems to solve.
Patrick Kothe 59:12
Tam is really got some interesting perspectives. And her leadership style really comes through in in that conversation, a few of my takeaways, first of all, the systematic process that she used for evaluating ideas, setting objectives, and setting the criteria for what she was looking at, and then being objective, truly objective and looking at those. The reason why this is so important is we only have a certain amount of time. And if we waste our time on an idea or a startup that ultimately is flawed. It's just a waste of time. Go on to the next one. Don't fall in love with something. Make sure that you really objectively look at what you're What you're about to get into. The second thing is learning from past companies. Now, if there are several companies that have tried to apply technology in a particular area and have not been successful, you got to figure that those were if those were well funded companies, great people involved in there, that there was a reason that it's that they weren't successful in an area. So as a startup company, are you going to bet your future on you being able to figure out figure it out when other people have not been able to do that, that just raises the risk. The last thing is a way she described the decision making process when you've got a potential change. She called it the thin line between being open minded and adjusting your plan versus being consistent. I thought that that was really a good way to think about that. And then she described the system or developing a system to identify and learn from your inevitable mistakes. If you've got that system, it's going to make it easier for you to justify why you are going to make a change or to be consistent and stay the course. Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the mastering medical advice podcast and Apple podcasts, Spotify or wherever you get your podcasts. Also, please spread the word and tell a friend or two to listen to the mastering medical device podcast as interviews like today's and help you become a more effective medical device leader. Work hard. Be kind
