Ask Me MD: Medical School for the real world

Erik Kulstad, MD - Medical Device Development

August 14, 2020 D.J. Verret, MD, FACS Season 1 Episode 2
Ask Me MD: Medical School for the real world
Erik Kulstad, MD - Medical Device Development
Chapters
Ask Me MD: Medical School for the real world
Erik Kulstad, MD - Medical Device Development
Aug 14, 2020 Season 1 Episode 2
D.J. Verret, MD, FACS

Dr. Erik Kulstad is co-found and chief medical officer of Attune Medical. Dr. Kulstad discusses the process of medical device development from idea through FDA approval and sales. For more information about Attune Medical, visit them on the web at https://www.attune-medical.com/.

If you have questions or ideas for a show, send us an email at [email protected]. Hear the latest podcast at http://askmemdpodcast.com or through your favorite podcast directory.

Show Notes Transcript

Dr. Erik Kulstad is co-found and chief medical officer of Attune Medical. Dr. Kulstad discusses the process of medical device development from idea through FDA approval and sales. For more information about Attune Medical, visit them on the web at https://www.attune-medical.com/.

If you have questions or ideas for a show, send us an email at [email protected]. Hear the latest podcast at http://askmemdpodcast.com or through your favorite podcast directory.

Announcer :

Ask Me MD, medical school for the real world with the MD Dr. D.J. Verret.

D.J. Verret, MD, FACS :

Greetings and thank you for joining us for Ask Me MD, medical school for the real world. I'm Dr. D.J. Verret. Today we have the pleasure of being joined by Dr. Erik Kulstad. Erik is a board certified emergency room physician and co founder and current chief medical officer of Attune medical, a medical device company focused on patient warming and cooling. Erik and I date back all the way to medical school and for disclosure I am an investor in attune medical. After the break, we'll be back talking medical device creation with Erik Kulstad Welcome back to Ask Me MD, medical school for the real world with the MD, I'm Dr. DJ Verret. This afternoon, we have the great pleasure of being joined by Dr. Erik Kulstad. Erik and I go back to medical school. But since then, Erik has had quite the trials and tribulations of taking a medical device from the development stage all the way to a company that has FDA approvals, and on the frontlines of actually treating COVID. So the CMO and co founder of attune medical Dr. Erik Kulstad, Erik, thanks for joining us.

Erik Kulstad, MD :

Thanks, DJ for having me a pleasure to be here.

D.J. Verret, MD, FACS :

So why don't you just for our listeners, since they aren't familiar with your background, why don't you kind of give us a quick you know, 30 second spiel on who you are and where you come from?

Erik Kulstad, MD :

Sure, I actually started out as an engineer, and actually prior to that an auto mechanic, and somehow I ended up leaving engineering to go into medicine. And that's when when we met at UT Southwestern, in Dallas, Texas, and after finishing residency, came to the conclusion that there was a an unmet need in in clinical practice for whole body temperature management, and specifically in reducing body temperature after cardiac arrest. And, you know, back in 2002, a couple of papers came out showing some benefits to doing so. And we were doing it fairly regularly in the emergency department. But the tools that we had to do it were complicated and expensive. And I just remembered from the days back BJ, when we were medical students, one of the things that we used to do was gastric lavosh, in the emergency department for gi bleeding. And the side effect of that gastric lavosh, of course, was patients would get kind of cold. And so you know, leveraging back to the the automotive days and the engineering days, I realized that the heat transfer environment of the esophagus was was pretty robust and thought, Hey, why don't we make something that leverages that environment and takes the idea of gastric lavas makes it a closed loop system, and maybe plugs into existing heat exchangers. So we don't have to reinvent the wheel, but, you know, make sort of a pre existing concept easier, quicker, safer, and and better. And that was the idea. And, you know, lo and behold, 10 years later, here we are.

D.J. Verret, MD, FACS :

What I remember, at one point, you were telling me about the story of actually creating your first prototypes, and I thought that was that was pretty cool.

Erik Kulstad, MD :

Yeah, it's funny, when I first had the idea, I figured, well, it's a good idea, somebody else must have thought it and must have actually come up with a product to do this. And so I spent a little bit of time looking around on the internet and trying to find the company that that builds something like this, figuring it's already on the market and it after looking around, I didn't see anything like that. And so I had the the fortunate circumstance to have a friend in the neighborhood who was a medical device IP attorney, and he sort of gave me the the impetus to sort of take this to the next level and you You know, sort of guided me through how to research, you know, what, what else might be out there in terms of intellectual property. After coming up with, you know, nothing of the type that we were envisioning, he suggested that we build a prototype. And I had a friend from engineering school who had just been laid off from the Detroit catastrophe, back in 2008. And he and many colleagues, you know, were laid off their respective automotive industry jobs. And so he and I spent several days together in in cold Detroit in February, building a prototype out of hardware parts, you know, going to the aquarium store for for heating elements, setting up a human model in his daughter's bathtub, you know, going to Granger and and Home Depot and, and the like, and we spent an awful lot of time, almost not sleeping the entire time, you know, building prototypes, testing them out, you know, getting the pumps just right, and, you know, trying to mimic as best we could, human physiology in a bathtub. And with that, that's

D.J. Verret, MD, FACS :

quite the challenge,

Erik Kulstad, MD :

isn't it, and I've got great pictures from that, from that era, you know, a decade ago, almost now. And we

D.J. Verret, MD, FACS :

pretty successful experiment, though, with where you guys have come.

Erik Kulstad, MD :

It was and it helped for a couple of reasons, you know, one, it just gave us sort of the proof of concept that, hey, this isn't just a wacky idea, I came up with on the back of an envelope, but actually, you know, has the capability to work and the capacity to drop temperature of a large body of water, which which, you know, sort of what we are, and, but it also then provided input to the intellectual property. And if you have, you know, the more data you have in your patent filings, the better and, and so this was, you know, sort of an important first step, to get our very first patents filed and eventually issued.

D.J. Verret, MD, FACS :

Why don't you talk a little bit, because I definitely want you to take us through the entire development process and kind of put 10 years into about 10 minutes. But can you talk a little bit about the intellectual property side of things? What, what do you need? What are you looking for? If you had, if you had another physician in front of you today that said, Listen, I have a great idea. I'm not sure I'm going to develop it, I don't know what to do. What would you tell them about the intellectual property portions?

Erik Kulstad, MD :

Yeah, it's a tricky question. Because you you want to do as much as you possibly can, you know, within the budget that you've got available. And at this, at the typical stage, when you're trying to do the initial filings of intellectual property, you generally don't have a lot of money to deploy towards that, towards that effort. But it is something that you get what you pay for, and you certainly want to have the best most experienced intellectual property attorney you can find doing this. And that means you don't want to get your friend who does commercial real estate law, you know, putting together your patent. Because there's, there's there are subtleties, and, and, and new knowledge that's continually evolving in that in that front, and if if it's not somebody that's doing prosecution of IP on a daily basis, you know, you're you're not going to get quite the same result, at the initial filing of a patent now is particularly important, because, you know, we're now first file, you know, back 10 years ago, we were first to invent and so we were one of the last countries to switch over to, to the, to the, to the rest of the world's approach of first to file. And what that means is that, you know, there's sort of a clock ticking The minute you have an idea, if you if you if you disclose it to others, you know, technically that can invalidate any filing that you make. And whereas before, you could have a notebook that had you know, dates and times of when you were developing things, that that no longer matters. So, so putting in the effort with the right, prosecuting attorney is key and the initial filing itself, it doesn't have to be that expensive. I mean, there's the work to put together the patent. But it's generally a provisional filing. But getting that out there and getting your line in the sand as to when you came up with the idea and you know, what it encompasses? is is is important

D.J. Verret, MD, FACS :

And when you say posecute, just for for those that may not know, he's just talking about the attorney that will actually file the patent for you work through it dealing with the patent office and get it all the way to issuance from the patent office that the lawyers term that patent prosecution.

Erik Kulstad, MD :

Exactly. And it's distinct from patent litigation, where you've got something issued, and now you're arguing over whether somebody may have infringed upon it, or someone might be arguing that you might have infringed upon their patent. So, so the litigating attorneys are generally different from the prosecuting attorneys. And, you know, you the one that you want to have in your in your court, when you're starting off, and court isn't even the right word. the sports metaphors,

D.J. Verret, MD, FACS :

you're on your side that basic,

Erik Kulstad, MD :

yeah, you decided that that is, is the prosecuting attorney who who will, you know, and the prosecute being not not a legal term for?

D.J. Verret, MD, FACS :

of not a criminal prosecution

Erik Kulstad, MD :

the mechanics as you describe them, so,

D.J. Verret, MD, FACS :

yeah. also, how long does it take to get a patent issued? So you you file the provisional patent within a year you file your, your final patent? And then how long is it? How long have you How long has it taken, you guys to actually get patents issued?

Erik Kulstad, MD :

It varies, and there are some new Fast Track approaches that are available that can speed the process up, but you're usually looking at a, you know, minimum couple of years. And, you know, that can go out for quite some time, especially if you if you have an examiner that, you know, find some prior art that they feel, you know, you precludes some of your claims. Because then then you're going back and forth, and having, you know, a dialogue and, and, and that's a, it's a complex dialogue, it's also that's the part that gets expensive is, you know, now you've got your, you know, your attorney, you know, spending time, you know, writing responses or on the phone, with the examiner, you know, hashing out some of these, some of the some of the issues that may come up, and that takes time, of course, so, so, but generally, it's in this sort of, you know, a couple of years or more process before you get to the point of a filing being issued. And, of course, you still have the one year from the time that you file as a provisional to convert it to a non provisional. And so when you factor that in as well, you know, you're often looking at three to four years before you have a, an issued patent. And, and this may be actually come back, and maybe they're gonna have you on the show later, we can go a lot more through patents and your experience with it, because that that could be a whole show unto itself. Absolutely.

D.J. Verret, MD, FACS :

But, but with that in mind, that it's going to be a multi year process, obviously, then you're going to start development of your device in parallel to your intellectual property protections, your patents, etc. So, kind of walk us through what the device development look like for you.

Erik Kulstad, MD :

Yeah, that's when it gets tricky, because, you know, the, you generally need money to do that. You can, you can self fund to a point, but it's, it's a rare person that can take it beyond, you know, just sort of early stage development and what you what you what you need to get the funding at that to take it to the next stage oftentimes, is something like issued patents. And so, there's a little bit of a balancing act that you have to walk on, you know, taking things through the development stage while you're waiting for for IP to issue and the different ways to do approach that but, you know, one of the the things to be aware of is that in the early stages, when you've got something sort of high risk, but but high reward or large impact or big effect size or you know, filling a clinically unmet need, you know, there are sources for funding that are non dilutive and non meeting.

D.J. Verret, MD, FACS :

Yeah, exactly. If you don't mind explain what non dilutive is.

Erik Kulstad, MD :

Exactly. So, ordinarily, you know, when you raise money for a company, you sell parts of the company you sell it in shares or you sent sell it in, in you know, convertible notes that that then will become shares in the company at some later stage. And that money means you know, you're getting money to do what you need to develop your product, but you're giving up you know, ownership of of your your baby. Non dilutive means you get money but you don't give up anything. And the non dilutive funding generally refers to grant opportunities, and in particular for medical devices or pharmaceutical technology, the the grant opportunity interviews are called SB IR for Small Business Innovation Research grants. And these are, these are monies that are set aside from agencies like the NIH, NSF and a handful of others FDA has, CDC has some, and they they dedicate that money strictly for small, high risk startups that are that are, you know, developing technology that are early enough stage where they're not likely to get funding yet. But there's a good chance that, you know, if they prove the concept, if they get to the next couple of milestones, then they'll be in a position to raise money from, you know, Angel groups, venture capital, private equity, family offices, and so forth, the usual places where people raise larger amounts of money.

D.J. Verret, MD, FACS :

So when you guys started the process, so you had, you had your friend's daughter's bathtub, you had your prototype device, what's the next step, then

Erik Kulstad, MD :

we got, after a few tries, now, I'm talking about non dilutive funding is if it's sort of, you know, easy, it's not easy to get, it's a, you know, they're very competitive grants. And the typical rate of success for one of these grants is about 10%. And so, you know, the way I look at that is, you know, you need to file 10 to get one successfully funded. And we filed, I think we filed three or four or five, before we got successful on on on one of them. And with that, you know, that took us from sort of really just idea and concept stage with, you know, very rough proof of concept, I think we had one animal study done, again, you know, self funded, because, you know, we had resources, and we had, we had new contacts where we could do things relatively frugally. Once we got that initial grant, and that was through NSF, National Science Foundation, you know, all of a sudden, it became a real company, and, you know, part of the grant requires, you actually do have a farm, you know, an office, this started out in my, in my house, and, you know, the company address was my home address, and then, you know, all of a sudden, we went from that to Okay, now we need a, you know, dedicated facility, lab space, if you would, and we need to hire people. And so we, we got our grant in 2012, hired our first employee, who was an intern during his graduate training in biotechnology, and so and that employee is still with us. He's actually our Senior Director of Operations right now. So, so that, that, you know, was sort of compressing a lot into into one sort of, you know, big, big moment that that kind of, you know, made this thing from, from, you know, just sort of a hobby in the garage type type of concept to, okay, now, we're a real company, we have to, you know, take this from where we are now to a commercial product. And you know, that the real key there is that you have to, you have to now sort of develop your manufacturing, determine where you're going to do manufacturing, who's going to do the manufacturing for you, and set up a quality control system and entire quality management system, so that you can, you know, get through the regulatory requirements for for a medical device, you know, and, you know, those, of course, vary by the degree of risk of the device. But, you know, the idea is that your device will fall into into some category of risk, and that category dictates the level of work that you'll have to do to, to get your device onto the market. And prior to getting that, of course, you can't sell your device at all. And, and, you know, the the the regulatory process is a that's a whole nother podcast

D.J. Verret, MD, FACS :

is well, in hearing you talk about it. So you started this around? 2008?

Erik Kulstad, MD :

Correct. Right. I think we incorporated into that idea in 2008, incorporated as an LLC in 2009. And then you were talking about hiring employees in 2012. So

D.J. Verret, MD, FACS :

that's four years later. Yep. And that's when kind of your studies first started, how long? How long after that? Did you start the FDA approval process

Erik Kulstad, MD :

with the hiring of our intern that really started the the the route down the regulatory pathway and you No, we took a big chance on, you know, having somebody with, you know, an intern who had not done it before, you know, sort of helped lead that that effort, we happen to get very lucky. I mean, we had our choice of, of who to hire out of the group that was available. And we went with the the one with with certainly the most talent on paper, and that that talent turned out to be a translate directly into into reality and the, the, the pathway of going through into a submission. And in our case, we use the de novo process, which is sort of a risk level in between 510 K and PMA. In other words, it's, it's it's not so low risk that it can be just a class one device, it's probably class two, but there's no predicate, you have no other device out there similar to your device that you can, you can claim as a predicate and and just, you know, do the easier 510 k route. But it's not so high risk, like an implantable device, or level a class three device that would require a full PMA. And so de novo is relatively newer pathway. And, in fact, when we started pursuing the de novo pathway, that was a little bit Renegade in the sense that, you know, a lot of folks, a lot of FDA consultants, you know, had no experience in de novo. And, and so, to our regulatory interns have credit, you know, he took it on, you know, with with, with gusto, and, you know, was able to, to assemble everything that we needed, and basically, with, you know, every device that requires a different level of quantity of data in the submission, we, in talking to FDA determined, you know, what we needed to do, and most of it was related to looking at histopathology, on on animal studies, because that was what they deemed as sort of the highest risk potential. And we

D.J. Verret, MD, FACS :

would, I'm sorry, what the highest risk potential?

Erik Kulstad, MD :

Oh, I mean, there, it's always a The, the decision to grant regulatory clearance on a device is always a question of risk versus benefit, you know, the, the benefit is huge, in the risk is minimal, or negligible, and it's an easy clearance, if the benefit is, you know, dubious, and the risk is high, that won't get cleared. And, you know, most devices, you know, sort of fall in the middle somewhere. And so, so the FDA will say, Well, here's what we think the most risk in your device might be, and, you know, the they were focusing on, you know, does this damage the esophagus at all, because everything else is fairly straightforward. And, you know, we sort of mimic the idea of a gastric tube, which, you know, are used, you know, thousands of times a day, you know, just in any given city. And so, with that we said about getting the, you know, assembling all the information and the data. And we, I think, got our submission. And at the time we were doing this, we also wanted to get into Europe, and Europe, as, at the time had a very different approach to do regulatory clearance, they gave you much more upfront information, to sort of allow you to plan how to how to proceed, FDA, you know, wasn't very good at giving information upfront, they preferred to just see the submission, and then critique it after the fact. And so most people at the time would spend more time getting through, spend more effort getting through the European regulatory process first, because that gave them a lot more insight as to, you know, where, what, what things might come up as you go to the US regulatory? So I think we got our regulatory clearance in Europe in 2014, or 2015. I think 2014 so two years after we started, we got our first regulatory clearance and then we got the FDA several months after that in 2015.

D.J. Verret, MD, FACS :

And, and as a reminder, I don't think we talked about it the whole time. You're still an emergency physician.

Erik Kulstad, MD :

Right? Yeah, I was still working full time. I mean, I'm still working as an as an emergency physician now. But I'm only part time, you know, clinically and in part time, doing some teaching and doing a little bit of research as well at the at the university, you know, unrelated to my device. And I I stayed full time for for a long time and I've never quit You know, at least part time clinically and in part because early mentors of mine who were physician, entrepreneurs and vendors, all of them to a person said, Eric, don't quit the day job. You know, if you do that, what what happens, what may happen is that if your company is unsuccessful, and keep in mind, most startups fail, you know, 80 or 90% of them fail. And, you know, when that happens, you, you need to know what you're going to do next. And if you have been out of practice for more than, you know, one or two years, you almost can't get credentialed again, in most hospitals. And I, I've, I know, one physician entrepreneur, in in, in critical care who had this happen. And, you know, he went full time with his company, left clinical practice, a couple years later, couldn't raise enough money to keep the company afloat, needed to go back to work, and hospitals would not take him back because they couldn't credential You know, when you're out of out of practice for two years. Most credentialing committees, you know, don't appreciate that. And so he he was faced with some awful decisions at that point.

D.J. Verret, MD, FACS :

Yeah, no, I actually said on a couple of credential committees, and I can definitely speak to that. Every now and again, we're physicians, for whatever reason, we're, we're out for a number of years. And it is, it's a difficult call on both sides of the equation. It really is. Yeah. So so you're looking at you. So add everything together about seven years to devise approval for you guys. At that point, how much money had it taken to get to device approval?

Erik Kulstad, MD :

a batch I think we're probably at about our Series B, if I remember, and that I think was on the order of about six or $7 million. Okay, and then our series c added in, you know, our total raise today is, is $22 million. So, we've, we've done things fairly frugally. You know, if you compare, for example, other class to medical devices in the resuscitative space, you know, the most likely comparables, the, the typical time to get to market is sort of, you know, seven plus years and about anywhere from 30 to $90 million, you know, just sort of surveying, you know, the most similar comparables in terms of the class to, you know, level of risk device. And, and so we, we were able to do an awful lot for, for very little in part because we didn't pair so like I didn't pay myself, most of the early years, anything and, and, you know, we, we just were very frugal, and the folks that came on board were just, you know, very committed to doing something, you know, they, they would get way more responsibility than they would get at any other company, if they worked for, you know, any of the large, you know, corporate med device companies, you know, they would not get anywhere near the level of responsibility or authority that they got with a startup and a lot of people just really want to start off. And so, and typically those running the company, yeah, exactly. So I mean, that's where, you know, you get people who, you know, sort of have that similar sort of focus that they wanted, they're just, they're going to work excessively, they're going to work long, hard hours, and it's just, it's a thrill to be able to do that. So. So, so with that, yeah, we ballpark numbers, you know, sort of, in the single digit millions to get to the first clearance. And that's when things get a little more expensive, because, you know, either you get acquired at that point. And that is certainly an inflection point where your, your, your startup may well get bought, in, you know, we had discussions with acquires, at that point in time, didn't see anything that was attractive, but didn't receive any offers that were attractive enough to warrant at that point. You're giving up control of the company. And so at that point, you're faced with, you know, raising enough money to then actually, you know, start going out into the, into the market. And that, of course, takes more people and, and so that's where that's where the larger cases end up happening. Now, you know, we had the virtue of having a device, you know, cleared in, you know, already to go to market. And, you know, when we when we started to bring people on board in on the sales front and, and, you know, that was that was, that was helpful, you know, if you're, if you're sort of anticipating having the device, you know, ready to go to market and you've got a bunch of people on that are waiting for that. And then for some reason you you get delayed, which happens all the time in the regulatory world, your product gets rejected or what have you, you know, that can tank a company. So. So we've been fortunate on that front.

D.J. Verret, MD, FACS :

So unfortunately, we are approaching the end of our time. But I'd like you to kind of condense the next five years in the development cycle and something we were kind of talking about before the podcast, in how you guys have changed direction, in the focus, you have the same device, but the applications of it have changed over the last couple of years as opportunities presented themselves if maybe you can kind of summarize that for us, I think it would be helpful for folks listening.

Erik Kulstad, MD :

Yeah, absolutely. And that's, that's key is being you know, just able to, to, to pivot as as needed as the market reacts to, to what you have and as new opportunities arise. And that's, you know, the advantage you have as a small startup is, you know, you can make decisions pretty quickly. And in our case, we went out to, you know, our initial focus was whole body hypothermia. Once we started getting into hospitals, we started seeing people also using it for for other reasons of whole body temperature the needs for in whole body temperature modulation, including warming people, so you know, warming patients, you know, trauma patients burn patients that have a problem with inadvertent perioperative hypothermia. And so that sort of, you know, added a little bit more to scope to what we focused on. But what then happened was some electrophysiologist started using our device, not for whole body temperature modulation, but specifically for cooling the esophagus during left atrial ablations for the treatment of atrial fibrillation. And the challenge when left atrial ablation is occurring is that the esophagus is right posterior here to the left atrium, directly posterior to the left atrium and when the ablation catheter is forming the intended lesions in the left atrial tissue, occasionally that that thermal energy that heats from the ablation catheter transmits all the way through the wall of the atrium, into the esophagus and causes damage and that damage can progress to something called an H esophageal fistula. Once you have nature esophageal fistula, the mortality is on the order of 80%. And so it's a dreaded complication that that everyone would like to avoid. And the technology that's used before we came on, and it became available, focused on measuring temperature in the esophagus with a typical temperature sensor and reacting to it so that when temperature was elevated, people would then the ablation just the operator would would stop the ablation. The challenge with that, of course, is that by the time you're sensing temperature rise, the damage has generally already occurred. And so a handful of physicians, electrophysiologists, roughly at the same time, had read one of our papers in resuscitation journal, on whole body cooling and thought this would be interesting, because if I could use this during my ablation, I can maybe prevent these figures from getting overheated at all. And they started using it and the sites that had started doing it with an endoscopy afterwards to see how well it worked. and compared it to their prior experience with other devices, we're finding phenomenal effect sizes. And so once we saw that, we, we jumped on that, because, you know, that opened up a whole new area of medicine that was very unfamiliar to us. And, you know, the the data that has since been generated after we identified this as a potential area of interest, have have been very, very impressive. And unlike anything else out there that's currently used for soft geo protection. So, so with that now, you know, we're we're working on getting formal FDA labeling to cover the, the additional aspect of what we're doing, because this is more than just whole body temperature modulation. This is, you know, specific to to an area of the body. I mean, granted, it's it's still body temperature, manipulation either way, but, you know, we want to we'd like to also be able to demonstrate what the effect size is, you know, based on the data generated to date and ongoing studies that are that are reporting data currently. And so, so the the pivot there, you know, now, you know, this is a significant area of focus for us, so we're not abandoning, you know, anything else. This is just sort of one more application for the device. And the I think the key is that as you as you know, think about the product idea that you have meal be prepared for sudden, you know, things coming out of out of the blue, you know, that might be very worthwhile pursuing and, and might be, you know, might require a significant change in focus. It can be hard to do, you know, because is, you know, there's obviously a trade off between where you put your attention, you know, during the 24 hours a day that you have available to work on this.

D.J. Verret, MD, FACS :

And to speak to how good that indication is, I saw there was actually an article in medscape today about your voucher technology. So kudos on that one.

Erik Kulstad, MD :

That was beautiful. We we didn't know it was coming out, you know, the investigator that presented his data, just a matter of several weeks ago, didn't mention that he was being interviewed by the medscape. Team. And so this came out of the blue and just one of those lovely surprises that you like to see.

D.J. Verret, MD, FACS :

And, and quickly to the the other opportunity you were telling me about is actually in, in COVID, with warming patients to decrease the severity of infection. I think you guys, if I remember, right, you're starting some clinical trials in that area as well.

Erik Kulstad, MD :

Exactly, you know, when the COVID, catastrophe started unfolding, and we started seeing all the sequentially from infected patients coming into our own emergency department. You know, the first question we had was, you know, do we have any anything to offer? Is there anything we can do, and in that search, led me to a couple of physicians that you know, sort of pioneering the concept of temperature in sepsis. And they're out of Washington, University of Washington University and Barnes Jewish Hospital in St. Louis. And so professors, Richard Hotchkiss and Andrew Murray. And it's actually the division chief of critical care for Barnes Jewish. And they had been looking at this for quite some time for years. And in fact, Dr. drewery, even completed the very first randomized control trial in warming patients with with sepsis and found on luminary data, evidence of benefit in immune function, immune immune function, stimulation, and enhancement of actual clinical outcome. And so, in, in, in discovering all of their work, I reached out to them got connected through a mutual acquaintance. And we are now actively pursuing the idea of warming applied, not just to sepsis in general, but specifically to COVID. And there's some growing data to suggest that, you know, the SARS, co v2, virus might have a little bit of an inhibition in buyer in entry in cell entry through the h2 receptor, with only a couple of degrees elevation and temperature. And we already know that the immune system seems to operate at a little bit more of an efficient performance level, with, again, a couple of degrees in temperature, which sort of supports the idea that fever might be beneficial in infections, which a lot of people have been saying for 100 years or more.

D.J. Verret, MD, FACS :

And it is funny, catching up with

Erik Kulstad, MD :

us. It is incredible to think that in 2020, you know, the first clinical study was completed at the beginning of 2020. Before, you know, COVID came through and I don't know, I'm not sure why it took so long. You know, there's an interesting backstory to to the warming concept because before antibiotics, that is what they used to do. And they called it Pyro therapy. And it was done through various means. And a Nobel Prize was awarded in 1927 for the concept of hydrotherapy. And then penicillin came on the market and that pretty much when we did it anyways, interesting, interesting warming. Interesting. So we're coming full circle. But, you know, we'll we'll have that concept of core warming and you know, the potential benefits that we think we might see here in the coming weeks or months. Wow,

D.J. Verret, MD, FACS :

that is really exciting stuff. We're gonna take a short break you're listening to Ask Me MD. When we come back, Dr. Kulstad will give his top three suggestions for any physician looking to start a medical device, we'll be right back. Welcome back to ask me, MD I'm Dr. DJ Verret joining us today Dr. Eric Hall stead of a tune medical talking to us about how a physician can go from a medical device idea to a company that's FDA approved and selling devices in the market. So to wrap things up, Eric, why don't you give our audience the top three thoughts that you have for anyone considering to start a medical device company?

Erik Kulstad, MD :

Yeah, thanks, DJ. So distilling it down to three, it's tough, obviously, there's a lot to consider. But in my mind, the first, the first thing to keep in mind is that, it will not be easy, it will take much, much longer than just the coming up with the idea. And I think, when I first started this, I thought, you know, getting having the idea was the hard part, I thought everything else sort of flowed after that. And it's quite the opposite to having the ideas sort of 2% of the effort, it gets much harder. And so you just have to be committed to it, expect it to take a long time. And, you know, be in it for the long haul, and appreciate failure, and especially for physicians, the the, you know, physicians generally have done well, in any educational endeavor, or pretty much any endeavor, in many cases, you know, and they're used to getting 90% Plus, on tests, and so, so when you, when you, when you have things that go wrong, and that fail, it can be jarring. And so you just have to sort of accept that things will will take longer, things will go wrong, and you have to sort of, you know, pick yourself up and accept the fact that they will go wrong. So, so that's all I put that is number one.

D.J. Verret, MD, FACS :

That's okay, we'll, we'll take it.

Erik Kulstad, MD :

Number Number two is learn how to sell it, because that's the other thing that I think a lot of physicians, it myself very much included, didn't have any appreciation, don't have an appreciation for the complexity of and, you know, selling is, is a is a is a is a is an area of knowledge that is hard to learn from a book, and, you know, good salespeople, you know, that's why they make more than the CEO. You know, they, they, they have talents that are that are hard to replicate. And as a startup entrepreneur, you kind of have to know how to do you have to know, at the very basics of how to sell and the complexities behind it, that the 24 seven sort of focus and the incessant attention to detail that, you know, good, you know, sales people have. And, you know, so spending some time on that is worth doing. And then the third one,

D.J. Verret, MD, FACS :

and if I could interject,

Erik Kulstad, MD :

yes,

D.J. Verret, MD, FACS :

sales that you're talking about there, you're having to sell your company to potential investors. And then at some level, you're having to sell your product to customers. So it's

Erik Kulstad, MD :

exactly

D.J. Verret, MD, FACS :

kind of a multifaceted sales approach. Really.

Erik Kulstad, MD :

Exactly. And that's sort of my point number three was learn how to fundraise which, you know, sort of dovetails with the learning how to sell the and and also dovetails a little bit with the appreciate failure, because learning Andres Yes, you know, yeah, I mean, as an example, I've, I've come across folks that, you know, made one investor pitch or two investor pitches, didn't raise money and gave up and, you know, why recount our story? You know, we gave probably 100 pitches before we got our first investor. And at one point, I counted up the total number of slide decks that I had for the various, you know, pitches to Angel groups, angel investors, individuals, high net worth individuals, family offices, VCs, on and on, and it was over 700. And, oh, so. So that's sort of where, you know, you have to sort of, you know, mentally prepare yourself for to, to, to, you know, to go down this route, it's, it's, you know, it gets easier as you go through, you know, once you demonstrate successful attainment of the milestones you predicted you would get with the last fundraise, then the next fundraise gets easier. But the first one is a doozy because, you know, you have a hard time, you know, people are not generally willing to put in a lot of money to the first time entrepreneur that hasn't done it, you know, before.

D.J. Verret, MD, FACS :

Yeah, well, and I can speak to that, as you know, I've invested in your company and I invest in other startups. And that's absolutely true. Investing in a in a good idea from an unproven sources is very difficult. And one of the things that I see in companies is the inability to continue fundraising. So they'll they'll get there first tranche of money, they'll do what's called a series a round or a friends and family round, they'll get that money, they'll complete some milestones, but then they can't find that next batch of money. For whatever reason, the economy may have changed their idea, lost favor, whatever it is, but they know it's a even though it seems to be progressing, okay, they just can't find any more money to take things to the next level. So that's, that's definitely something I think I can see on both sides of the coin from your your side as the entrepreneur and my side as the investor. That's a, I agree with you, I think that's a very, very difficult thing. And something that a physician who's never been involved in the process has, would have a difficult time understanding, I think you might agree with that one.

Erik Kulstad, MD :

Absolutely. Yeah. And it all sort of circles back to the idea of you need mentors, you need, you know, it's a team effort. And, you know, identifying these mentors early. I mean, I touched earlier on the fact that I had physician, entrepreneur mentors, I tended to seek out folks that were, you know, already, you know, clinicians that had sort of gone into this realm, because I figured that most analogous to the path I was hoping to take and, and so, it, you know, anyone that's been through this is, is almost uniformly happy to chat with people and sort of give them the, you know, their their take on things and advice and guidance, and, you know, it's all just paying it, paying it back paying it forward, what have you. And, you know, at the end of the day, it really is what, what drives the success of the economy? You know, it's it's the startups that drive successful economies. And so, so there's, there are a lot of good reasons to put effort into it. And there are plenty of mentors out there. And, you know, that's probably another topic.

D.J. Verret, MD, FACS :

No, I just just just sitting here talking to you, I've kind of jotted down a few other topics. And I'm going to, I'm going to come back and take up some more of your time at some point, because I think there's a lot of a lot of information in there kind of specific things we can drill down on that. I kind of have some broader applications even beyond starting a medical device company. Yeah. So I think it's interesting. Well, EriK, thanks so much for joining us. I really appreciate it. I know, as I said, I've invested in a tune because it really has a good product, you guys have done an excellent job, taking a company where it is and I as an investor, I definitely like the fact that you're able to pivot and you aren't just set on one thing, but until the ship goes down to the bottom of the ocean. you've actually done a really good job on that front. So

Erik Kulstad, MD :

yeah, thanks, DJ. Appreciate the opportunity, appreciate your support and happy to to be honored to be a guest and happy to do so in the future on on any topics of interest that I can offer any any insight.

D.J. Verret, MD, FACS :

Sounds great. Thanks so much. You've been listening to ask me MD we've been talking with Dr. Erik Kulstad of Attune medical, the co founder and chief medical officer, as well as an emergency room physician on what it takes to start a medical device company. Ask Me MD, medical school for the real world. I'm Dr. D.J. Verret. Make it an awesome week. Thank you

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