From the Spark of an Idea to Product Launch - The Journey of a Physician Inventor
Dr. Michael Gorn is a Pediatric Emergency Medicine physician who was inspired to develop a medical device for treating a common ailment - an abscess. Mike is also the partner of your host, Pat Kothe! Our company is call EM Device Lab and the product Mike was inspired to invent is the Quickloop Abscess Treatment Device. In this episode Mike shares how he became interested in the problem, how he built a team and company, sought expertise in areas he was unfamiliar with, and how the team developed the product and are in the early days of launching it in the US.
Links from this episode:
Mastering Medical Device:
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. Well, this is an extra special episode for me, because I get to interview my business partner Dr. Michael Gorn. The reason why we're doing this episode now is we celebrated a milestone this month, and I want to share it with with all of you. And this milestone came about due to Mike's vision for a new product that can help clinicians patients and also healthcare systems. So our company is called em device lab. And that M stands for emergency medicine. And the product that we're introducing is called Quick loop. It's called Quick loop abscess treatment device. And we're gonna get into that quite a bit in this in this episode, and Mike and I are going to discuss how he came up with the idea for the product to treat this common issue called abscesses. So I've been involved with some really high tech products, things like heart valves, and transcranial Doppler ultrasound, interventional cardiology products, just a whole bunch of high tech products. But one of the things that I've learned is that complex products often lead to complex sales, and much more difficult product adoption. And the reverse is true simple products lead to simpler sales, and quicker product adoption. So what we're going to talk about today is a simple device to create a really treats a common issue. And this is more of a meat and potatoes product for for medical device, but a simple product that has a lot of big benefits, which we'll discuss. So when I first started working with Mike started work with him as an advisor. And his idea really struck me because it solves some recognized problems, the market was large enough. And the regulatory pathway was pretty straightforward. And also it was I knew that it was patentable. And, and another big thing reimbursement already existed. So a lot of good things were going for, for this idea. And from an entrepreneur, entrepreneur standpoint, those are all really good things. But most importantly, though, I really like Mike as a person, and I knew that we would be able to really work well together. So in this episode, we're going to take you inside our company, and we're going to share what it was like for Mike, as a physician inventor, to have this idea and form a team form a company, and then get it funded, and develop a product and get us to the starting line that we're at today. So as you'll hear Mike's pediatric emergency medicine physician, he was trained at and worked at some of the premier children's hospitals, and is currently the Regional Medical Director for a pm pediatrics and urgent care that's just for kids. I'm really proud to have Mike join me. Here's our conversation. So this could be a really fun conversation today. We've spent a lot of time together. But what I wanted to do is to share with the listeners a little bit about what your journey has been all about not only from the company standpoint, a product standpoint, but kind of what what your journey has been in medicine, and how it's interesting and bringing a new new product to market. But I really feel that a lot of what we become is affected by where we were and what we experienced as, as youngsters. So can you take us back to you know, your origin story, where you were born and what childhood was like for you?
Michael Gorn, MD 04:21
Okay, that's a great question. I think I need to find a couch to sit on and, you know, you can we can analyze my childhood. But Alright, so I was born in Ukraine, part of former Soviet Union, and I lived there for 11 years before we migrated to the United States. So I had the the typical Russian Ukrainian upbringing and school and childhood, which means that we played outside a lot and, you know, learned our math and tinkered with a lot of different things because I can't say we had too many toys but the ones that we had had, you know, I always, always tinkered with them? take them apart, put them back together. Yeah. And so then we moved to New York, that was about a three months migration process through Austria and Italy. And if anyone's familiar with that, you know, you leave Soviet Union as refugees, and you wait for the United States to accept you.
Patrick Kothe 05:24
So did you come over? Did your dad come over? Or parents come over with a lot of money?
Michael Gorn, MD 05:30
No, no, I can't say that. They did. But you know, they, they were smart. And they, didn't know the language, but they worked really hard. And were able to start a life here, learned language, got jobs, did whatever they could. And they, as you can imagine, stress education with me and gave me the opportunities that I had to, to become a physician.
Patrick Kothe 05:53
So Mike, you're you're an only child? What types of expectations did they have of you? Both before you move to the States, and after you moved to the States?
Michael Gorn, MD 06:07
I don't know if they really had expectations. I mean, they wanted me to do well in school. I guess the expectations that you grow up to be a productive person, right. So whether I mean, they they wanted me to go into medicine, but I wasn't particularly pushed into it. I always had to do well in school. That was a priority. But I basically chose this path myself.
Patrick Kothe 06:29
So let's talk about the path. So you, you went to school out out in the east and decided medicine was going to be B for you. So what excited you about medicine?
Michael Gorn, MD 06:40
Yeah, so I got into medicine pretty early as as a as a high school student, I became an EMT, and I was volunteering at a my town's ambulance Corps and so you know, who was just going out to calls and transporting patients to the hospital. Couple of fairly intense calls, I would say for for high schooler, but it got me interested, you know, I wanted to help people. And so when I went to college, I gravitated towards the sciences. And I was actually lucky enough to get into a seven year program. So so that path was kind of clinched for me, you know, going from college straight into medical school. As part of this joint ba MD program between Rutgers and Robert Wood Johnson medical school,
Patrick Kothe 07:29
you end up finishing up in medical school and then deciding what you want to do you know, what type of residency you want to do. What was that the discussion or what was that decision? Like?
Michael Gorn, MD 07:40
Yeah, so, you know, I, like I said, I always tinkered as a kid. So initially, I thought I was going to go into orthopedic surgery, but I kind of gravitated more towards pediatrics and not general pediatrics, but maybe a sub specialty. So, you know, I started applying for my pediatrics residency with the intention of going into either neonatology, or PICU, or cardiology, ultimately ended up in emergency medicine, but that actually was not a thought and has gone through residency that kind of came about later.
Patrick Kothe 08:18
For how did that come about?
Michael Gorn, MD 08:20
This is an interesting story, because I actually applied for my cardiology fellowship in my second year of residency, but then I was asked to be a chief at my program. So it made me reconsider a lot of things. And when I was a chief, I started working independently and moonlighting and our emergency department and I kind of just loved that jack of all trades, master of none. I felt like I really fit in so so at that point, I decided to go into emergency medicine.
Patrick Kothe 08:52
So that really fit fit your personality, your interests, as well as the excitement of it as well.
Michael Gorn, MD 08:59
Yeah, yeah. No, I thought it was good. I think I think I was to add to go into cardiology, you have to be really smart. And I could do you know, cancer, myself to just a single thing, I guess.
Patrick Kothe 09:14
So for the residency itself, it's an emergency medicine residency.
Michael Gorn, MD 09:19
So it's a pediatric residency, and it's an emergency, it's a pediatric emergency medicine fellowship. So that's an additional three years that you do on top of your residency.
Patrick Kothe 09:29
Do a lot of people in pediatrics migrate into into emergency medicine or is that a pretty small subset of of people?
Michael Gorn, MD 09:40
So it's, it is a fairly well, it was a fairly new fellowship when I started, so this was, what 2005 I think the the field was maybe 15 years old at that point. And so a lot of people grandfathered into it because emergency department is was kind of a place where People want to work between jobs or moonlighting and, you know, it didn't really become a field and a specialty until probably early 90s. For pediatrics specifically, and the fellowship has a research component and it's, it's very structured and you learn both adult and pediatric emergency medicine, orthopedic surgery. And so it really prepares you for the job much better than if you, you know, just worked in the er,
Patrick Kothe 10:30
er, is I imagine quite different and adult er versus a pediatric er, what are some of the big differences?
Michael Gorn, MD 10:37
Aside from the smell, or? Yeah, I mean, so I think in general, adult medicine is focused on people who have lots of problems, and they come in to you with exacerbation of those problems, right. So it's the patients with COPD, heart disease, trauma, of course, a lot of them are not necessarily fixed in the emergency department and pediatrics is different from adult er, because most kids don't have many medical problems and you can you feel like you can help them when they come in. I think it's, it's fairly rewarding to be able to, you know, change a child's life without necessarily putting them in the hospital, you know, or taking a long time to, to do it. Of course, you have kids with chronic medical problems and, you know, very serious problems and you learn to deal with those but, but for the most part, I feel like pediatric er is a much happier place compared to an adult er,
Patrick Kothe 11:38
when you think about pedes, er, physician, you think about a children's hospital, but children show up at regular adult ers as well. So the pediatric er physicians work at large medical centers as well as children's hospitals.
Michael Gorn, MD 11:54
Yeah, I mean, especially now there's many models, there are a lot more children's hospitals now than there used to be, there's a lot of satellite emergency departments that are dedicated to children. But you're right to say that more than probably 60 70% of kids are sent or seen by journal er, guys, and, and for the most part, they're pretty good at doing it, but they don't necessarily feel 100% comfortable doing it. So. So they I think they appreciate having us around with
Patrick Kothe 12:25
an adult that you're dealing with, typically, you're dealing with them as a patient or a spouse as a patient. But with kids, you're not only treating the patient, but you're also treating or dealing with the parents as well. How, how is that in dealing with with them? Or what's that like and dealing with with the parent of a child who's very sick or very injured?
Michael Gorn, MD 12:52
Yeah, so you know, you play with a kid and you treat the parent, right. So, you know, thankfully, most kids, as I said, do well. And so it really becomes a negotiation with a parent and trying to figure out what's best for their child, every parent wants what's best for their child, when they walk into the ER, it's a stressful environment, they probably don't know you as a physician. And so you have to convince them to, to take a certain course and or a certain treatment for their child. And so, so it's a little bit of a being like a parent psychologist and trying to understand what they really want. And we all know they want their child to get better, but how to get them there in the most effective way, I think I think is a kind of a unique skill that as pediatricians and especially pediatric emergency medicine dogs, we have,
Patrick Kothe 13:45
you have treated a lot of different different things within the emergency department. But what we're going to focus on today is something called an abscess, because that's where our company is focused. So can you describe to the audience what an abscess is, what causes it, and how often it occurs?
Michael Gorn, MD 14:05
Yeah, so I never thought I would be passionate about abscesses, but you know, it is a fun procedure, I guess it kind of fell into my lap to to become passionate about it. So an abscess is an infection of the skin typically can be caused by you know, small breakdown in the skin from either a scratch or an insect bite or, or an injury. And then bacteria gets underneath and it accumulates in forms and forms a plus pocket and majority of abscess is there in the skin best treatment is to is to drain the bus. So you got to cut it open and take care of it that way. From the doctor standpoint, it's it's actually a fairly fun and easy procedure to do from the patient's standpoint. It's it's considered to be the second most painful procedure we do in the emergency room. So so it's not fun.
Patrick Kothe 14:59
What's fun about For the doctor,
Michael Gorn, MD 15:01
well, you know, I think it's the immediate gratification, right, you could make them feel better, you know, they, they may not enjoy that procedure. But once you're done with it, they definitely feel better. And for the most part, it's, you know, they heal well, and there's no need to hospitalized patients, you know, 90 95% of the time, so. So it's that immediate gratification and making somebody feel better.
Patrick Kothe 15:22
So it's an infection under the skin feels would pass. And how does the patient present me? Why do they come to the ER,
Michael Gorn, MD 15:30
I mean, they come to the ER, because it hurts. So they get some swelling and, and they could be anywhere in the body, they get swelling, increase redness, sometimes fever, occasionally, they could be systemically sick. And you know, those are the patients that end up in the hospital. But, but for the most part, it's an isolated problem in one area, and, you know, just needs to be taken care of.
Patrick Kothe 15:53
So how big How big are these abscesses,
Michael Gorn, MD 15:56
tiny little pimples, two centimeters to two large collections that are centimeters across that sometimes need to go to the operating room. And you know, we're talking about skin biopsies, but sometimes they can extend into other areas. And that will be one of the reasons why they have to go to the operating room.
Patrick Kothe 16:16
And as you said they can be anywhere in the body, anywhere in the body, from head to toe. And in some private areas as well.
Michael Gorn, MD 16:25
Absolutely. Yeah. I mean, bacteria lice likes closed, moist places. So if you can imagine what those areas are, that's where you get dropsies.
Patrick Kothe 16:34
Yeah, so it's red and inflamed. And they show up in the emergency department. They just wanted fixed. So I imagine some of these show up at primary care, urgent care as well.
Michael Gorn, MD 16:46
Sure, sure. So there's there's a good number of them that show up in primary care. And in fact, majority of them have probably taken care of by family physicians summon pediatric practices and urgent cares facilities. I think coming from the pediatric world, we deal with things a lot more gingerly. And so we sedate a lot of the kids right in the ER before we do their procedures. For the most part, adults are not as lucky and they get some local anesthesia for their procedure and they get a cut open.
Patrick Kothe 17:18
So the numbers in the US there's about 4.5 million procedures done for abscesses in the US and then covers the ED as well as primary care, urgent care. And about 1.7 of that 4.51 point 7 million that 4.5 million Rn end up in emergency department to be treated. So there's a high concentration of procedures done in that in that emergency emergency department. So as you mentioned, you know, the traditional way of dealing with it is called incision and drainage. Right? It's it's taking a well why don't you want to walk us through what the steps are in dealing with it?
Michael Gorn, MD 17:58
Yeah, so the standard way to drain an abscess and this this goes back to like ancient Greeks, right? If there's pus let it out. That's that was the saying. The typical procedure involves making an incision over the abscess cavity, and then getting all the pus out, sometimes you irrigate it, wash it out. And sometimes you have to stick an instrument in in order to break up any pockets of pus, you know, plus can form fibrinous membranes that if you miss it, and you don't get everything out, it can wreak humiliate and and then you need to procedure. The classic way is you cut it open, you wash it out, you break up populations, and then you play some gauze or packing into the abscess that will stay there for you know, a day or two and then the patient needs to return to get that back and remove them to get their wounds inspected. And depending on the site and the size of the app, so sometimes they have to come back multiple times. And if you could imagine, the first time you cut it, you're going to numb the patient, you're going to go kind of slow and ginger. When they come back to you a lot of times the packing just kind of gets yanked out without any anesthesia. And you know, the repacking is done also with minimal anesthesia. So, you know, this this traditional technique, while it's fairly effective, at least follow ups are are fairly traumatic for the patients as well.
Patrick Kothe 19:29
Yeah, I think we've we've all had skin, a skin near a skinned elbow and you have that raw skin you put put a bandaid on it and then you rip that band aid off. Well, that's the same thing you're putting putting gauze packing inside that abscess and then you're ripping it out every every couple of days. Not a pleasant experience for the patient.
Michael Gorn, MD 19:50
Yeah, yeah, no and I know you and I we did some YouTubing for this right looking for the right videos to demonstrate The process and you could see how excruciating that is. Yeah, I
Patrick Kothe 20:04
think the other thing that you described to me too is that your patient comes in and and you're going to numb it up. So you're going to take some lighter cane, put it around around the abscess and numb it up. And then you're going to grab that scalpel. And you're going to say, Hey, I'm gonna slice this open for, you know, an inch to two inches. And open this up. And what kind of looks do you get from the patient's at that point?
Michael Gorn, MD 20:27
Yeah, well, you know, luckily, we sedate our er patients, because they're kids, but in the teenagers, they, they look at you, like you're coming nowhere near close to me with that. And then you got to convince them and show them that their skin is numb. And you know, but but it is a it is a very anxiety provoking experience. And like I mentioned, it's, it is considered to be the number two most painful procedure in the ER.
Patrick Kothe 20:53
Yeah, and the other thing is, how effective that procedure is. So something that's been around, as you said, since, you know, the ancient Greeks, people, people have been doing this type of procedure, we're letting the pus out. But what is what is the failure rate of this procedure? within an ED setting?
Michael Gorn, MD 21:13
Yeah, well, so all the ones that I do never fail.
Patrick Kothe 21:20
You're the perfect physician, Michael. Yes. Yeah.
Michael Gorn, MD 21:23
But but that, you know, but I think that's the reality is, I think, I think, because in the ER setting, you don't necessarily see your follow ups, I think that the incidence of complications for ABS diseases is under appreciated, but but when you look at the data, you know, the numbers are anywhere between 10 and 20%. And, you know, this couple recent meta analysis showed that it's probably ends up around 15 16%, of failure rates for the standard procedure. So so it's not small.
Patrick Kothe 21:54
So we got a painful procedure, we got something that is got a fairly high failure rate, something that physicians, although they liked to do it, they don't like to see the pain on their patients face. And and the other thing that you mentioned is the follow up visit. So with with those follow up visits, talk a little bit about reimbursement and what follow up visits do to do to a practice.
Michael Gorn, MD 22:21
I mean, this is obviously something that I learned much more about once we started working on the device and the company. But I did not realize that when you have an abscess drained, you're covered under a global 10 day code. So the physician gets compensated for the initial procedure, but every time that they come back into the practice to get either a wound check or, or their packing, replaced, that's essentially not reimbursable. Under the current guidelines, if you're a busy practice, that's time loss, that you could be seeing another patient. If we think about registration, if you think about that nurse who needs to take vital signs, if you think about, you know, a room that you see this patient and using some equipment, to either repack rewash, or even just look at the wound and cover it back up. And then you know, you have to have a cleaning protocol for that room once the patient leaves. So that's kind of a lot of work for something that's not reimbursable.
Patrick Kothe 23:24
So we've got a whole bunch of things that we've just discussed, they're all lined up saying problem, problem, problem problem. But in medicine a lot a lot of times what happens is, you're just do it and that's routine, you just continue to do it and you just live with the issues that you that you've got. You're a little bit different, Mike and that you said that there's got to be a better way. So what was the inspiration for attacking this? This problem?
Michael Gorn, MD 23:54
Yeah, and and I think that's what kind of makes er physicians unique. I think we, we are kind of on the forefront of trying to come up with simple solutions for common problems, right. So a lot of your physicians are tinkerers, and always trying to come up with better ways to do things. And so I actually learned what's called a loop procedure when I was in fellowship, and the original author of a paper on that Dr. Guinness, he was one of my attendings and in the ER there and I trained in the Bronx at Jacoby hospitals. We used to call it the Jacoby ring. what he would do is make an incision on either side of an abscess, and then tunnel some butterfly tubing and basically tie it in place. So you're forming a ring or loop through an abscess and that's what you leave in there. So essentially, you make a much smaller incisions and you don't have to repack a they just kind of stays in place until the abscess heals. Now originally This was done For GYN cases for bartholin gland cyst apses, because the alternative what's was what's called a ward catheter, and essentially, it's a balloon that has to stay within this gland that's infected, and it's supposed to stay in there for weeks and weeks. And this problem was associated with, you know, the catheter falling out needing to do another procedure and kind of the discomfort of having the catheter in that area of your body. But after we got that using the Jacoby ring, I mean, I think it was just a better much better experience, both for the patients and for the physicians. So that's kind of where I learned their procedure originally. And then as I went on into practice, I didn't really use the loop procedure for anything other than these bartholin abscesses. And it wasn't until I started working at the Children's Hospital in Austin, that I kind of found the procedure again. And the reason why that happened is one one of our partners, Matt Wilkinson was doing a prospective study in children looking at the use of a loop technique for abscesses in children. So this now was 2015 16. So about 10 years after that original publication by Guinness, and there's actually been a lot of adoption. You know, I think in the early 2000s, we went through a wave of MRSA infections, if you remember, right, methicillin resistant staph and advocacies, were very, very common during that era, and people were looking for different ways to manage them. And the Lu procedure was adopted by pediatrics and pediatric surgeons and an emergency medicine physician. So there's some literature and case reports are coming out suggesting that this is probably the way to treat abscesses in general, you know, because it again, it eliminates packing. And in fact, it showed that it was associated with better outcomes, both cosmetic, and in terms of failure rates, and just kind of patient experience all together. So that kind of got me to 2015 when Matt was doing the study. And then one day I kind of just woke up and said, Well, this technique is cumbersome, the way it's done. Now, let's see if we could connect all the steps of this technique into a series. And so if you think about our
Patrick Kothe 27:22
device, so when you say your walk up, did was that literally did you? Yeah. Thinking about it?
Michael Gorn, MD 27:30
Yes, I literally woke up around four or 5am. And my wife thought I was nuts. And I just sat down, and I kind of drew out a picture of what would be a prototype for this device. And in my mind, there was actually more of a zip tie. And then once I started playing and kind of making little prototypes, you know, it turned into a chain, and then it turned into a catheter, and kind of went from there. But But the whole idea was how do you how do you connect the steps of incision, probing, making another incision fishing the, you know, the loop material through tying it in place? How do you conduct that all into one series and just make a simple device. And that's essentially what the quick loop is, right? Because we have the, the introducer, which is essentially the blade, and then the tubing and the clip, which is the connector for the tubing on a series and makes the procedure very simple.
Patrick Kothe 28:36
So when you got that idea, and you started playing around with it, what were you Was it a real exciting thing for you? Or was it something that you just you kind of sat down and worked on every once in a while? Or did you all of a sudden just jump at it? No,
Michael Gorn, MD 28:51
no, I jumped on. It was just I never, I just thought it was a good way of doing things. And I think once I get something in my head, it's hard for me to let go so so I took a couple of Foley catheters and I took, I couldn't really come up with anything for to simulate the needle until I found one of the hooks for picture hanging, because it's got kind of like this white portion and a pointy portion. So the beaded metal chains that you know, they're used, like for dog tags, right? So so I had the catheter and the beta chain and then you know, I kind of fashioned this hook into, into what resembled a suture needle. And I put it together and I have a video of it. I don't know if I showed it to you of me using it on a tomato. And
Patrick Kothe 29:41
I ever seen that one kind
Michael Gorn, MD 29:42
of trying to figure out and you know, my kids, you know, they were they were fairly little at the time there. You could hear him yelling in the background, Daddy, what are you doing? You know, but that's kind of how that thing was born. And I think it was maybe a couple of days that it took me to put all of that together,
Patrick Kothe 30:01
man, it's really fascinating. I've talked to a lot of different physicians about how they got their ideas and, and the early prototyping that that they utilize. And I was talking to Billy Cohen, who's a famous cardiac surgeon and Donald's done a lot and, and he was doing doing some devices for the beating heart and doing surgery on a beating heart and hit a fork and put the fork down on the on the heart. And so there's a whole bunch of different, different ideas. And it's amazing how people just take things off the shelf and start to prototype.
Michael Gorn, MD 30:34
Yeah, I mean, this is definitely no beating heart. But you know, for me, it was very exciting. And I just, I was like, Well, what do I do next? You know, because I, you don't get trained on how to bring devices to the market and medical school. So I think I was very naive. What I can do right now.
Patrick Kothe 30:53
So let's talk about that. So you go from from an idea. And this is pre company stuff. So you haven't formed a company or just you've got an idea. You start to prototypes and stuff, what it what happens next. I mean, you're working, you're working for you're working at a hospital, you're working for a staffing company. That's what most most emergency departments are doing. But how do you get from here? I've got a prototype to Hey, there's some device here. What do I do?
Michael Gorn, MD 31:25
Yeah, so I mean, I had a tomato. And so I went to I went around, and I showed it to a bunch of people, you know, I think, I think there's two sides to, to an invention, right? There's people that will kind of hold on to it and try to hide it and not share it because somebody might steal it. And then there's the excitement of Well, let me show it to everybody, because I really want to know what they think. Right? So. And I think I was part of that second group. And I kind of went around and talk to my partners and, and show them what it was. And, you know, someone looked at me, like I was crazy, and others saw some potential in it. And so one of my partners suggested that I go to medtech conference. So that was in town, actually, the month that I came up with it, I kind of got lucky. So Austin had a med tech conference, and I just went there and just to kind of listen and see what this device world was all about. I think what I learned is having an idea is great, but to get it to market takes so many moving parts that it's it's almost daunting.
Patrick Kothe 32:32
So a lot, a lot of physicians, when they do that, you say, Hey, I got I've got this idea, and I'm gonna take this idea, and I'm gonna sell it off to some, you know, to somebody that to do it. Did you have those thoughts?
Michael Gorn, MD 32:42
Yeah, so well, you know, so I went to the patent office for the company that I work for. And then I also showed it to the leadership of a staffing company that I worked for, and they did not have much interest in taking it on. And, you know, if you go through the university, the pathway is very slow, painful, and I just, I just didn't see a payoff there. So that essentially what they do is they get you a patent, and then they hope somebody else picks up that patent to develop your idea. So so you're essentially including a middleman into into the process?
Patrick Kothe 33:23
And what would the benefit of Ben and going and doing something with the university because they didn't have any claim to the IP?
Michael Gorn, MD 33:30
Yeah. So and and so that's the other piece of it, it was you know, who owns the IP that I come up with? In my spare time, right. So. So from the university standpoint, there's some sort of a sharing agreement, but they essentially get a royalty and you get 50% of that royalty. And you know, when that comes, who knows if it ever comes, but I got some pretty good advice earlier on. And so when I pitched the idea to both the company I worked for and the university, they were not super interested. So I got a letter from them releasing the IP to me. So there's no, there's no claim later on that could come across and they can't take it back. My guess is the idea. A
Patrick Kothe 34:14
very, very important thing. Make sure your IP is clear early.
Michael Gorn, MD 34:18
Yeah, yeah. And so, you know, at this con, like I said, I met a lot of good people at this conference. And so I, I kind of started thinking about how do I innovate this, you know, and IP was a big piece of it. I spent a little money and had my patent written out by by a professional and submitted. That was a fairly early activity that we did.
Patrick Kothe 34:43
What were the next steps. So So you've got now you've got early prototype, you've talked to some people to get a little bit of Voice of the Customer stuff. And then you've got these prototypes that you know need to be developed. So what was your kind of what was your next step? Were you thinking at that point? I'm going to take it to a company or At what point to just start saying, hey, maybe I should do this and form a company?
Michael Gorn, MD 35:11
Yeah. So I mean, I think I was very young and naive in my ideas of what happens next. But I did engage a local med tech company, you know, they, they're doing their own thing, but they were graciously helpful to me and introduced me to Gary, who's our, our engineer. And at the time, he and I basically sat down and started working up prototypes, you know. So that was a, that was a very fortunate introduction. And then through my patent attorney, I also met Elisa, who was a regulatory person and kind of started thinking about, okay, if I have this patent, and I have this device worked out, how do I actually what do I actually need to bring it to market? And so I think, I think what I learned and as you know, bringing device to market goes far beyond the actual idea of that device. Right? So there's the, you have to assess the market size, is this something that's going to be adopted? Right, so you have to engage a lot of people, so they could tell you whether this is a good idea, right? And then working on the prototype, you also have to consider, is this something that's going to be manufacturable? You know, so this is seemingly a very simple device, but but it took us a long time to perfect that the needle, as you know, and the other components, so manufacturability, and prototyping, and then comes a regulatory piece, right? So is something that needs clinical trials before it can come to the market? Or is it something that's going to be 510 k exams, where we can do all the steps that, that we need to do for manufacturing and, and be able to sell it, and then you know, you got to talk to your customers, and your customers are, of course, the physicians, but it's also the hospital systems, it's also the body managers, it's also the distributors, you know, who who's gonna want to sell or buy your device, you have to figure all that stuff out. Of course, in 2016, I wasn't thinking about any of this. And as you know, I basically just worked on that prototype got the IP. And when we got it to a point where the prototype was good enough to start showing people, that's when we started thinking about forming a company and potentially fundraising. So let's,
Patrick Kothe 37:43
let's talk a little bit about it. So you decide to form a company and need legal legal input into that. And you also have to go through through some education. Okay, who owns it? Am I going to take on partners? Am I going to do it myself? How do you how do you do that? And then then I'm going to need to raise some money. Do I do it before? Do I do it after? So you're, you're you're navigating through the business side of it, as well. Right?
Michael Gorn, MD 38:12
Yeah, yeah. And so so the business side is another piece that I had to learn. You know, thankfully, I had some great advising early on from this guy, Pat imat. But, you know, I think it was some great advice into just, if you're gonna do this, do it right from the start. So spend a little money, you know, do do the due diligence and forming the company properly, and figure out what you who your partners are, and how you're going to share the company. And so, you know, so initially, it was the founders or Matt, Gary and myself, and we kind of had to make the decision together of, you know, how we split it up, and what form what what type of a company we need to form. And the goal really for, for forming the company was that so we could take investments. You know, we were at the point, after we had our early prototype where we would have to start working with manufacturers and spend some real dollars on development. We wanted to make sure that whoever invested in the company was getting true value based on the structure of that company. So so everything was clear and understood. And we wanted to make sure that the investors were able to invest in a proper vehicle. And so there's no problems when you do the first race and then the secondaries and subsequent race to to fund what you're doing.
Patrick Kothe 39:42
At that I'll say from from my standpoint, as Mike said, when we started, he and I started starting having having discussions early on, before the company company was founded, and I've had the opportunity to spend a lot of time with a lot of physician investors and our physician inventors. And some of them are difficult in that they want to do things their way they want to design the product for themselves. They want to hold on to the you know, all of the all of the equity and you selfishly do that. Mike is not that guy, Mike is all about collaboration is all about you doing the things correctly and listening. And just as I would never pick up a scalpel and do one of these procedures, you know, Mike also knows that there are things that he needs to lean on other people to do, there's other people have more expertise than he does. Just like there's more people that have more expertise than I do. So we lean on each other to be able to have a better outcome for the company company itself. I think that's really important at the beginning of a company to recognize where your strengths are, and where your weaknesses are, and areas that you need to bring in, in other people. And I think that that was one of the real benefits that that Mike saw have of involving other people, and in getting getting the company formed properly.
Michael Gorn, MD 41:12
Yeah, and, you know, I guess I always grew up being taught that I should surround myself with people who are smarter than me, you know, and so when it came to some of these areas that I had no training in, you know, I was lucky to, to put this team together. And whereas, you know, we're still all working together. And, and I think that's one of the reasons is because we we all appreciate each other's role in moving this thing forward.
Patrick Kothe 41:43
So So now we've got a company formed, I ended up joining the company after it was formed. And what we've been able to do is we spent a tremendous amount of time on customer validation talked over 600 clinicians through this process, we lined up manufacturing partners, we further develop the product, there's it's a simple product, it's called Quick loop and and what it involves is, there's three components to it. One is a metal component, it's a needle with a with a blade on the back of a needle with a scalpel on the back of it, that's one component, the second component is a tube that has holes in it tools, tube with fenestrations. And then on the back end there is there's a hub, and that hub allows you to close a door and and close that tubing to form a loop and also as a lower lock on the end of it. So that you can hook up a syringe to an irrigate the abscess from the inside out. So it's a fairly simple device. But it's it was complex in April in development. So it took longer than you would think for it for a smaller, simpler type device. But there's a lot of iterations that we ended up going back. And as Mike said, a lot of it not only was the design, but the manufacturing of the product. So it was a little bit more advanced things that we needed needed to do with the product. But we've got it through we've got it to the point now where it it is on the market. We're very happy to say that this month, the device has been started to be used in the US. So we've launched in the US with a with a soft launch. So Mike with the quick loop. Now, what is the procedure look like? How do you how do you do the procedure?
Michael Gorn, MD 43:36
Yeah, so you know, I, the quick lube procedure is exactly what it sounds like quick, you know, I essentially you grasp it as you would a suture needle. So it's a fairly familiar technique for most practitioners who do emergency medicine or any other procedures. And so you basically grasp it as a suture needle and you you puncture the abscess on one side and you push it through and you come out on the other side and then as that needle passes through the abscess, it kind of tried it makes the incisions for you and attracts the tubing into the cavity of the abscess, you know you cut the needle off, you clip the tube together and then you have the option to irrigate through the fenestrations You also have the option to put an instrument inside the abscess cavity to make sure that you get all the lucky relations remember that the membranes that we talked about earlier on and then when the patient goes home they also have the option to irrigate repeatedly through through the quick loop rather than you know the older loop instructions where we would just tell them well take a showerhead and try to run some water along the track of the loop so so the homecare is a lot easier, right you have the both the home irrigation and And then just moving that loop side to side, they don't have to come back for packing changes of room checks for the most part, and they don't even have to come back to get the loop removed, you know, we can instruct them cut one side of an and pull it straight out. The other nice piece of it is, the device has been rated to stay in place for up to 28 days, some of these large apps and C's or absences, an area that are traditionally known for having to come back for repacking multiple multiple times. You're saving those visits, you know, so like a pilonidal cyst that typically will require 567 10 revisits doesn't need it anymore. So, I mean, that's, that's, that's huge for both the patient and, and the providers, I mean, putting the cost and the money piece aside. It's a tremendous benefit to the patient not to have that painful repacking.
Patrick Kothe 45:59
So to kind of sum it up, then Mike, so it's a faster procedure, the incisions are smaller than smaller than a standard ind, you cut the failure rate, and you'll, you'll eliminate these unnecessary unreimbursed revisits for the patient, and it's less painful for the patient. So really some great benefits to the quick loop product. And not only for the patient, but also for the physician in the healthcare facility. So Mike, when those first devices went in, how did you feel?
Michael Gorn, MD 46:38
I think I felt like a proud papa. Right. I mean, that's, I feel like I was pregnant for five years and, you know, gave birth to a device. I think my wife's not gonna enjoy me saying that, but
Patrick Kothe 46:54
well, that that really is, you know, as, as we spend so much time in the development phases of it when it finally happens. It's a big deal.
Michael Gorn, MD 47:04
Yeah, no, I, I felt very proud of, you know, our team, I felt very proud of just everything we went through in past five years came to a head in this moment where the device was being used. Of course, we're all excited. But it's like being in a room and shouting and outside the world is still happening. Oh, what are these guys doing? But yeah, I mean, for us, it was very exciting. And I, I personally still have not used it on on a patient. And I'm really looking forward to that.
Patrick Kothe 47:36
The other group of people that we haven't talked about, that are also responsible for bringing us product to market, our investors, early on, you made a decision not to put a lot of your own money into it, but to look for other other people. So tell me a little bit about the early investors.
Michael Gorn, MD 47:58
Yeah, so So I think, when I started to realize that this may be something that I'm gonna devote a lot of time to go into meetings, talking to industry, people, and you know, spending time with Gary coming up with designs, it was essentially my second job, I probably spent a good 3040 hours a week, on top of my regular job, just kind of trying to move this thing forward. So when it came to investment, I wanted to make sure that people are investing this idea, because they believe in the idea and they believe in me, and I'm not using my own money to move it forward. I think a lot of businesses get started for maybe the wrong reason. So with the wrong motivation, and maybe with the wrong expectations. And so, you know, if you're well off, you could pump a lot of money into it, but if you're the only one that's excited about it, ultimately, I think it fails. So I did not want to get caught up in that. And I really, initially I only wanted to use investor money rather than my own money. And to say that we also applied for grants and so we did get some grant money as well, which was very nice. You know, the first five six people that invested invested in a piece of paper and they basically said, Hey, I know you you're good guy, and you know whether I get it back or not. Here you go, you know so, so I think I had that added pressure to be successful because you know, these people are my close friends and I didn't want to let them down. Part of me use that as a motivation to push myself to, to work harder on this.
Patrick Kothe 49:45
And just to give audience, a little peek behind the curtains. We have brought this product to market with less than a million dollars worth of investment a little bit, you know, 100,000 in grants and about less than a million dollars in investment, and we've got a product on the market, it's a very difficult thing to do to bring a product to market for that little amount of money. And I can tell you that there is a, there's been a lot of a lot of sacrifice a lot of blood, sweat, and tears that's gone gone into this, but a lot of contributions from a lot of different different individuals within our company. And I'd like to spend a couple minutes recognizing some of those individuals. So as Mike mentioned, the original founding team was himself, Matt Wilkinson, who's also a pediatric emergency medicine physician. And Matt has performed our clinical strategy, and really helped out tremendously there. Gary McGregor, as Mike mentioned, was responsible for the early development. Pete Miller is our VP of r&d. And Pete really took that early development and drove it all the way through to the final development and the testing. And Lisa Maldonado homewards, who Mike mentioned, has done a terrific job building our quality system, and also taking us through the regulatory process. Lisa Dennison runs our marketing, and her role is really going to start to expand over the next couple months as we start to, to market market the product. And finally, Kim Taylor has helped us out with finance, and also a lot of the back office processes. So a shout out to these individuals. As Mike mentioned, you know, we would not be where we are without great people. And these are really some great people, in addition to our own team, the investors, as you mentioned, are critical. And also the clinicians who provided us feedback along the way, as Mike said, we've had feedback from over 600 clinicians, and they've helped to make our product better. So Mike, you're looking back over the past five, six years and your entrepreneurial journey? What lessons have you learned?
Michael Gorn, MD 52:11
I mean, you know, now that you're, you're kind of naming everybody that contributed to this company, I think, really, it's the, it's the relationships, and it's building a strong team. I think that's what brought us here. I mean, I truly believe that if it wasn't for our team, I don't think we would have a product right now. So I think, again, just just surrounding yourself with people who, who have the same goal, I think, is key, I was very much hands on in the beginning. And you know, one, one of the other lessons that I was taught early on is, in the beginning, you're doing all the work. And your job in a startup is to fire yourself from all of these different jobs. So I fired myself as the CEO of the company. And, you know, that's your role now, you know, I fired myself as the part of being the, you know, the engineering team. And that's where Pete took over. And, you know, I can't imagine getting it anywhere close to where he got it. Right, because he had the experience to do it. And so I think I think team and surrounding yourself with the right people is key. I mean, obviously, believing in your idea is key and and just getting support from other people as well. You know, I can't say how many evenings I spent talking to investors. And my wife's kind of like, looking at me like, Okay, this is another, this is another dinner you're not participating in, and, you know, thankfully, she's understanding and my kids are understanding with all the time has spent doing that. I'm happy to be where we are. But I thank all the people around me for, for allowing us to get here.
Patrick Kothe 53:57
So this is a kind of a moment of moment of pride for you, what are you most proud of over the past five years?
Michael Gorn, MD 54:03
I mean, personally, I think I'm proud of the learning experience that I underwent, and, you know, just being able to learn from experts in the different areas of device commercialization. I mean, from you from Pete from Lisa, I'm proud of our team. Again, I can't say that enough. I'm proud that we set certain goals, and we were able to accomplish them, you know, so early on, we talked about, you know, we're going to try to do this, in this timeframe, we're going to try to do that with this kind of dollar amount and, and we were able to achieve that. And now that we're out on the market, pretty proud of the way that the medical community has responded to us, you know, so we as you know, as you mentioned, we reached out to many practitioners earlier on to get some feedback on the device and once we had our prototype and we were showing it in simulation labs and cadaver labs, you know, people were excited about it so. So I'm proud of the fact that we can help the medical providers and hopefully make the experience better for the patients. And abscess. drainage is not the most exciting thing in medicine, but it is very common. And if we can release some of the pains and problems that are associated with it, you know, I'm very proud of that fact.
Patrick Kothe 55:31
That was fun. As you heard, I'm really proud of our team. And you know, where we are today, as I said, we're at the starting line. And also really thankful for Mike, and all the physicians like Mike who have the ability to recognize problems, and then the imagination to think about what solutions there are to those problems. And finally, the guts to act on it. So a few of my takeaways from today's episode, first, Mike said, personally, what he's most proud of is the learning experience he underwent, not the end result, but the learning that he experienced with it. And that is really a deep thing, because so often we're focused on what the results are. But we know that there's so much to learn, and the appreciation of what we're learning really says a lot about Mike. Second, the spark of innovation, I just always find is fascinating. So Mike talked about how he woke up and wrote it down. And and then he spent the next couple days developing prototypes on of household items, you're grabbing things off the shelf, and trying to come up with something that he felt represented what his idea is. And then he started to take this out and ask a couple of friends and colleagues, Hey, does this look look like something that, that there's a good idea here? Am I crazy. So just the ability to get that spark, because many of us have ideas. But we don't take that next step. We don't write it down, we don't start working on it immediately. Because that's when you can be most passionate about finding an answer and digging into it. So I really like that that story that he told us Spark, but then the next couple of days. And the last thing is the team. And I can't stress this enough. We wouldn't be here what without the team as what Mike said, That's certainly true. And our team is is a good team, we push each other we communicate, we got competency and different areas. And we allow other people to make sure that their competency is recognized, and they're the they're the expert in that area, we support that. But the other thing is, you're we're all mature medical device people. And we have chosen to work with the people that we like. And we've chosen to work with people who are competent. And that is something that is what we should all strive to do be part of a team that we're proud of be part of a team that we respect the other people and then it's the type of environment that we want to work in to make us more productive, and make us bring products out to the marketplace that are excellent, like the quick loop and that are going to impact patients lives. So a special thanks to Mike for joining us today and for sharing his journey. Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the mastering medical device podcast in Apple podcast, Spotify, or wherever you get your podcast. Also, please spread the word and tell a friend or two to listen to the mastering medical device podcast. As interviews like today's can help you become a more effective medical device leader. Work hard. Be kind
