Helping Medical Device Companies Bring Their Launches to Market Faster

In this episode, Ethan shares his insights.

Not too long ago, the regulatory world was analogue – submissions were made in paper, literature searches were done in libraries, and organization and compilation was done by hand.

The internet has redirected the challenges associated with clinical evaluations. Now, the amount of information available to you is infinite.

So how do you organize and analyze all that information into a coherent submission?

Listen to CiteMed co-founder Ethan and Kelly from Qualio discuss the challenges of information overload in regulatory submissions in this podcast.

https://youtu.be/u1tUyGS9gsE

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Citemed

• Ethan Drower LinkedIn
• CiteMed

Success Made to Last Podcast – Spreaker

• Kelly Stanton LinkedIn
• Qualio LinkedIn
• Website

This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.

[00:00:21] Kelly Stanton: hi everyone. I’m Kelly from Qualio and your host here at, From Lab to Launch thanks for joining the show today. We’ve published over 50 interviews with innovators in life sciences across the world. It’s been so inspiring to hear the stories of perseverance and innovation to improve human health and save lives. If you’ve enjoyed those conversations, please consider subscribing and giving us a review on Apple or Spotify. And if you wanna be on from lab to launch, please see the application linked in the show notes today. We’re chatting with Ethan Drower, co-founder and operating partner of CiteMed, which is revolutionizing the European union medical device regulation, or EUMDR process. Literature search and review is the cornerstone of medical device companies. Clinical evaluation reports. And CiteMed has made this process more streamlined and optimized than ever. The CiteMed team was formed to deliver a high volume of beautifully written and formatted literature reviews on timelines that will enable companies to meet their EU MDR goals.

[00:01:21] Kelly Stanton: CiteMed’s top goal is to help companies get their medical products to market as quickly as possible all while maintaining state-of-the-art compliance with the European commission regulations. Ethan’s been on our show before, and we’re thrilled to have him back and hear all the latest updates with him and CiteMed.

[00:01:36] Kelly Stanton: Let’s bring him in.

[00:01:38] Kelly Stanton: Hi, Ethan. How are you?

[00:01:40] Ethan Drower: Hey, Kelly. Thanks for having me again.

[00:01:42] Kelly Stanton: Thanks for coming back. Uh, so for our new listeners, tell us a little bit about your background.

[00:01:49] Ethan Drower: Well, personally, I’ve always been, you know, I’m a trained software engineer, so I’ve always come from the software side of the house when it comes to building new product. Building new solutions. So that was my, that was my focus in university. And I, I kind of bounced around industries for a while. After that I was in financial markets for a few years, consumer apps for a few years, and then only in the last, you know, five years, four or five years or so, uh, have I really found my home in the regulatory space and specifically that within that medical devices.

[00:02:25] Kelly Stanton: So tell us then about CiteMed and what inspired you to start that business? Um, I think we all recognize the challenge that is CER and clinical experience report. And of course, obviously with EU MDR updates, um, just in the last couple of years, that really expanded the scope of organizations that had to go through those processes were before so many, you know, it was just your. critical type devices, your class threes and whatnot. So, uh, it’s definitely a hot topic in, in the broader medical device space, for sure. But, uh, tell us about CiteMed and, what it is that you guys are doing there.

[00:03:02] Ethan Drower: Right the inspiration for CiteMed, it really was brought on by EU MDR because it was just such a, such a massive shift in focus from a regulatory perspective to heavy on clinical evaluation, heavy on literature review and on pretty much all of your devices, you have to do something, whereas before you could get away with next nothing or, or virtually nothing in a lot of cases. So the idea came to us, um, you know, through it was really, it was really through my father.

[00:03:38] Ethan Drower: This was a, a dinner table kind of startup idea that that came through and he had been in the industry for decades and was recently tasked with coming up with a plan for, for EU MDR and, and completion of hundreds of CER updates. And he was telling me that, he was showing me what he was working on and, and essentially saying, there’s no way we can find the staff.

[00:04:06] Ethan Drower: There’s just not enough labor in the world. To get this done on a cost effective and timely manner. And, um, that’s really, you know, where my background came in, where I said, well, okay, well, what if we built a tool that, that helps people, you know, be 20 times, 30 times faster and, and more thorough. And, from there, we’ve, we’ve really spent all of our time trying to do just that and build tools that support our clients. And, and support our own team with the conducting of this research, conducting of these reviews and delivering these reports quickly and you know, of the highest caliber possible.

[00:04:47] Kelly Stanton: That’s really exciting. And, and also absolutely what a painful process it used to be. Um, you know, with, I can recall subscribing to organizations that just sent you lists and lists of abstracts and people would just sit and read and read and read and then go, oh, maybe we need to request these 10. And sometimes you had to justify even the expense. Of the 10 that you would request. Yeah. And, and then read those and, and yeah, we had a whole head hold departments and that’s all they do all year.

[00:05:18] Ethan Drower: It’s, it’s incredible, especially with, in this industry and you guys know this better than anybody there’s so much work that relies on the brilliance of the regulatory affairs professionals. And they’re always, they’re great people, right? Quality and regulatory people are incredible. Um, and for far too long companies have relied on them to keep track of all of the paperwork and, and do everything themselves without any hope of, you know, making systems or building better tools.

[00:05:51] Ethan Drower: You know, for us, this is really just, you know, it’s been a long time coming and that’s why I love talking with you guys because you share that vision as well. The time to catch up to the, you know, the inefficiencies these regulations have created the time is not. And, and we have the tools to do it. Somebody just has to really dedicate themselves to, to bringing them to.

[00:06:14] Kelly Stanton: Definitely. Definitely. Yeah. You know, you talk about, of course we’re in the E QMS business, right. And, I started my career in this industry when we still had to fill out, um, carbon copied records because one paper, the batch and one went somewhere else and they were all numbered in the corner.

[00:06:33] Kelly Stanton: And if you lost one, oh my gosh. The the stuff we had to go through to go find that piece of paper. Right. Um, and yeah. So from a literature search perspective that’s a whole, wow. I mean, you’ve got the power of the internet driving so much information, but how you sort through it and how do you, I mean, it’s almost overwhelming in a different sort of perspective.

[00:06:55] Kelly Stanton: Now there’s too much information. So obviously, you know, a tool like yours, that’s amazing to, to, to really target the areas, do the filtering, um, you know, make sure you’re getting good, solid information. Wow. Talk about taking the pain out of it.

[00:07:12] Ethan Drower: right. Well, you, you hit the nail on the head. The perspective has changed. It used to be, companies don’t have access to enough information and that’s, it’s tough to make decisions. And now they have so much information. They can’t remember what they looked at a year ago. So the challenges are about organization and optimization. Now, instead of just raw collection, you have infinite amounts, but what are you gonna do with it? That’s actually useful and produces the real world result of a safe device or a good submission, or, you know, whatever your goals may be. Hopefully both of those are your goals.

[00:07:48] Kelly Stanton: Definitely. definitely. How are you finding, adoption too, you know, coming from the E Q M S side, right? There’s still folks out there that just love their paper. They just want that they want that piece of paper. They want the security that comes with that signature. Um, so we see a little bit of resistance in places. I would imagine that perhaps there’s some similar sorts of resistance to, uh, automated tools or, you know, software not maybe trusting that information. Are you guys seeing some of that in, in your, uh, rollout of this?

[00:08:22] Ethan Drower: Yes. That’s a great point. I, I feel there’s too much, especially in the software world, within regulatory, there’s too much over marketing and over promising of what a software system does. And as regulatory people are very astute and they don’t really respond to fluffy. Oh, it’s artificial intelligence. It handles it for you, right? That does not fly in our worlds. So, we believe in building tools that support the RA professionals. We do not build solutions to replace them.

[00:08:57] Ethan Drower: So for us, as, as soon as we get past that barrier of our system, doesn’t it doesn’t make the decisions for you. We want you to make the decisions, but what we don’t want you to do is all of the other nonsense of organizing the data, presenting it, removing all of the duplicates and bad data, spitting it out into documents. We do all of that. So , once a regulatory affairs manager realizes that. All we’re doing is taking away the nightmare of the formatting of these reports. We tend to see that, you know, adoption, it goes much smoother after that. Um, but there are misconceptions, especially with, with companies trying to over promise with these magical, Machine learning based solutions and, we just, we’ve just abandoned that approach entirely.

[00:09:43] Ethan Drower: That’s, that’s not what we’re out to do. We’re out to just build utilities that, that assist the people that we know to be incredible and to be incredibly competent. So, um, I think you can kind of help the adoption curve by presenting yourself in that. light This is a tool. This is not a replacement. This is not a new thing. This is a better way to continue to do what you’re already doing.

[00:10:06] Kelly Stanton: Definitely. I really like what you said there, it’s not a replacement. You know, I’ve had customers or potential customers ask us things like, does your tool do risk management? Well sort of, I mean, it’s a similar situation, but we need you you know it, yeah, we can, we can make the information available to you and we can organize it in a way, but at the end there still requires a human to make a decision.

[00:10:29] Kelly Stanton: And I don’t think we’ll ever get away from that because the machines even smart ones can’t pick up nuance. Right? There’s, there’s always that, element of some other pieces of information, maybe that the machine filtered and said, well, this wasn’t relevant. Right? So I, I love what you said exactly with, uh, this is not a replacement , it’s support.

[00:10:49] Kelly Stanton: It’s doing, it’s doing the grunt work for you so that you can then assess the information and make the best decisions possible.

[00:10:57] Ethan Drower: Right and to be honest, this is not an industry where I ever want to replace the human, because the people that we’ve worked with, they’re incredible, nobody understands these devices and how they function in the marketplace and how they function with their customers, as well as these people and you’re not gonna be able to just replace them with a complex series of logic. There’s no need to they’re fantastic. If, if they were bad and people were getting hurt because regulatory and quality professionals weren’t good at their jobs. Okay. Maybe that’s a different challenge for us to solve, but that hasn’t been our experience. We’ve found incredible people. Let’s just help them

[00:11:38] Kelly Stanton: yeah. Yeah. Give them more tools to, to do the, do their jobs better. Yep. I’ve often said as a QA professional, I’m only as good as the information I have in front of me. Um, and so yeah, this is, definitely a powerful, powerful way to get more information in the places it needs to be.

[00:11:55] Ethan Drower: Yeah. In a useful way.

[00:11:57] Kelly Stanton: Definitely. So, um, I guess to kind of pivot a little bit then, what are some mistakes maybe that companies are making or things that you’re seeing as you’re working with these different organizations? what are some mistakes companies should avoid during the, EU MDR and the post market surveillance process?

[00:12:17] Ethan Drower: We might need another podcast to get through all of them, Kelly I’ll give you my top two, maybe three. We’ll see how we go. Okay. The first, the first is the most obvious and, and that’s around timeline and planning. The submission process is we’re generally find it’s taking two to three times what a manufacturer expect and that’s for a whole host of reasons. That’s because it takes them a long time to actually put their documents together, but it also takes a long time to get a response from the notified body. And that can be, you know, that can be a completely unpredictable chunk of time.

[00:12:56] Ethan Drower: Could be months could be weeks. And depending on your response that you get back, you could be scrambling to fix things, or it could be a see ya in six months type of correspondence. So try to plan. I know that’s hard, but try to plan for as much safety margin as you can with getting these documents done.

[00:13:16] Ethan Drower: And, and don’t try to, don’t try to line everything up perfectly to your deadline and expect. that your tech file is gonna get approved right away and, and everything’s gonna be fine. So, um, that’s probably the biggest, most general one is just setting good expectations to get a little bit, you know, into more of the nitty gritty of, of MDR when, especially in our world of clinical evaluation.

[00:13:41] Ethan Drower: We find that a lot of companies that don’t have a ton of experience, um, in their regulatory departments, they tend to struggle with making and supporting of the claims of their device. And, and by that, I mean, you know, especially under clinical evaluation, you’re making a safety claim about how safe your device is, and you’re making a performance claim. What is it doing, right? How is it helping the patient if it’s helping the patient? And we have a lot of clients struggle with taking their marketing claims of saying, well, my device is better because it does all of these things and trying to put those into their clinical evaluation claims. And that’s where you can really run into problems.

[00:14:31] Ethan Drower: There’s just not, there’s not going to be clinical data that supports all of your marketing claims in the same way. Right? If you are marketing a scalpel that you think is better because of these reasons, the blade is, I don’t know, you know, special or in some way, you’re not gonna find studies that support that what you instead would be able to find more likely are studies that support the fact that it’s a blade. It cuts things and it doesn’t break. Right. So, we have some, it’s a bit of a dance to try to temper back the differentiating claims that you would make in a marketing perspective versus the claims that your notified body or any regulatory agency actually care about, which is, is it safe? Does it actually work as intended within the body? They don’t care about anything else. And you know, that can be tough for a marketing person to swallow sometimes. That’s their whole life is differentiating the product, but regulatory wants it to be the same.

[00:15:28] Kelly Stanton: That’s an interesting, that’s an interesting perspective too. That is such a dance. I mean, going through the design control process, figuring out what you even are going to try to claim, um, you know, as far as your label claim, and then how does that translate to marketing?

[00:15:42] Kelly Stanton: And I hadn’t even thought about trying to tie that into your CER because you’re right. It wouldn’t be comparative. Doctors aren’t doing comparative studies just for fun. They’re just using things and then reporting on what they observe. So how do you turn that into better or different I hadn’t even thought about it from that perspective.

[00:16:02] Ethan Drower: Yeah, that’s been, that’s been tripping up, um, quite a few, quite a few people in the industry. Because you can’t find clinical data to support all of those nuanced things. You can only find it to support the base claims of a specific type of device and how it works in the body or on the body.

[00:16:19] Ethan Drower: Um, so that’s a major one. That’s a little bit, that’s pretty in the weeds. Um, I’ll give you one more quick one and I guess it would be around underestimating, the workload of continued compliance and updates. Most people are just concerned about, okay, how do I get, how do I get my MDR update approved? Right? How do I get my re-certification done? Whatever I gotta put in there, whatever I gotta put in those documents, they just say, go ahead, do what you need to, and it’s a struggle for us from our perspective as advisors to say we can we’ll we’ll get this doc, this document we’ll pass its audit, but this document has a whole list of things that you are now committing to doing every year or every two years consistently in the same process.

[00:17:08] Ethan Drower: And you gotta make sure that you’re doing that. right. Yeah. That’s sometimes an awkward conversation to have, but what systems and processes do you have in place to actually update your literature review every year? Are you doing your vigilance? How are you organizing the data?

[00:17:24] Ethan Drower: These are the same challenges of quality, right? It’s not just about, okay.

[00:17:28] Ethan Drower: I was gonna say, yep. It’s more than just getting the piece of paper. Maintaining is actually harder. Yeah. It is. Yep. And, and if you’ve got multiple devices and you’re a small team, I’m sure you guys have a lot of customers that are teams of one. Right. And that person’s not going to be able to do five of these CER document updates every year on their own. And then still do all the FDA stuff and, and then, and do new product, you know, new product tech files. I mean, So for us, we always try to drive that home is whether you’re gonna use our platform to keep this in line for you or not.

[00:18:06] Ethan Drower: It doesn’t matter what matters is that you realize you need a process and somebody’s going to have to do this. So it needs to be on your budget, needs to be on your mind, um, because it will get you in a, in a few years and then you’ll be having other challenges, right? Yeah, definitely.

[00:18:22] Kelly Stanton: Well, and I can see too, like the year over year, um, for you guys because once you’ve set up. Your search, for example, with the certain parameters and you’re delivering the information and, and you’ve gone through the process and you’ve gotten your approvals, you’ve gotta be able to replicate that. And so if you don’t stick with a tool, um, now you’re gonna have to replicate it manually, and nobody wants to do that. Yeah, there’s, there’s definitely a huge advantage there too, to use a software tool, um, like what you guys have built here to make sure that you’re consistent, or, you know, I’ve been in situations too, where, you know, you see one, you see a new problem happen in the market or in the field, in your area. So now you need to update and add a few new keywords to go do some more searching. Um, I assume, you know, with your tool, that’s a pretty simple process.

[00:19:12] Ethan Drower: We save the protocol that we’re running and you can run it as many times as you want, as often as you want, and you can store and trend all of those results. And it’s always, it’s always saved. Same thing like in the QMS world, you want that audit trail of processes that can be replicated.

[00:19:30] Ethan Drower: And, that’s one of the bigger, um, notified body focal points now. You’ve given us a plan. Can we run the same searches, do the same process, get the same results. And if you’re sending them a whole mess of tangled, Excel files, and you know, zips of hundreds of documents that aren’t named, you know, in a standardized way, it’s just gonna come back to you. it’s not, it’s not gonna work. . I’m sure you, by your, by your laugh I can tell you’ve seen a few of those, a few of those

[00:20:01] Kelly Stanton: yeah. That’s why I’m thinking back like, oh yeah, that, that can be so painful. Well, it’s funny too, cuz you know, so I’m in quality, not regulatory. So my job was always to, basically QC everything before it got submitted. So yeah, some of the packs that got handed to me over the years and I’m just. You know, you just kind of glaze over and how do you, you know, at some point you’re, you’re part way into it going. I don’t even know if I could say that I agree or have seen everything or, or cuz it is, it is such a jumbled mess,

[00:20:32] Ethan Drower: Right I mean, you barely know what language it’s in at first you’re like, is this, is this meant for our department? Or is this something else?

[00:20:39] Kelly Stanton: Yeah. well, and I always, I was always curious too. And then, you know, so you handle that to a regulat. and I wonder questions come back because you know, the regulators, seeing these submissions from, you know, hundreds of different companies per year. And so the first thing they have to do is figure out, okay, what language are these guys speaking right. To use a language analogy, right? Cuz it is it’s all, everybody has their own terminology and, and semantics, right? That, that we all use, right? Oh, we, we do it. We do that, but we call it this. Right. So, so if you’ve got these standardized tools, you know, we can all start to speak the same language that just speeds up your regulatory process as well. I would think to make it easier for them to, instead of waiting through the piles and buckets

[00:21:23] Ethan Drower: that’s an incredible, that’s an amazing point because I think oftentimes we kind of abstract the concept of our regulatory auditors. And we have to remember that these are just people that are, you know, having the same tough days that we are and if we send them documents that are gonna confuse them or, or create more work for them to review it, it’s just gonna, it’s just gonna negatively impact your scoring because who wants to, who wants to do that after lunch? There’s two hours left in the day and you get a jumbled mess of documents. You can’t understand how they’re linked together or how they did it. They’re just gonna flag it, tag it with a nonconformity and, and send it back to you. They’re not gonna go through it. So yeah, to your point, I, I mean, I think, I think this is also kind of a shared vision, but how can we standardize these types of submissions?

[00:22:17] Ethan Drower: So. Everybody’s on the same page, the regulatory agencies know what they’re getting, so they can more quickly and more efficiently process ’em we know what they want and what they’re reading. And so we can more efficiently put them together, which brings costs down, brings headaches down. Um, you know, it’s striving towards that uniformity is, is really, I mean, I, think it’s a noble goal. I think it’s gonna take a while. Um, but somebody has to try to push it forward.

[00:22:48] Kelly Stanton: Definitely. Well, and this is, I was just thinking too, um, you know, you’re talking about uniformity and stuff. This is a great opportunity, uh, for regulatory harmonization around the globe as well.

[00:22:58] Kelly Stanton: Right? Because I mean, you just look at, for example, you know, I have to write a 510K to submit to the FDA and then have to turn around and write a technical file for a notified body, uh, which is a different format and a different layout. And. Mostly the same, but slightly not right. Not, not enough. The same, not enough.

[00:23:14] Kelly Stanton: You could just , you know, not enough, you just take your five, 10 K and start plugging in all the pieces, but anything related to postmarket surveillance, like we all have the same goal, right? The different regulators. We’re all, we’re all in it for safety and efficacy. We want these things to work. We want to change people’s lives or heal them. But, but if we all go about it so differently, then you’re back into that translation game. of yes. How do I write this up and who sees it? Where, and, and, uh, and it it’s astounding. . I wonder too, now that the MDR has gone into effect, you know, I know the FDA has been working a lot on harmonization and we’ve got MDSAP and we’ve got some different opportunities out there.

[00:23:54] Kelly Stanton: I, I wonder. And hope, maybe they’re watching this to see how it all goes and as they start to standardize the medical device regulations that we’ll see some standardization around postmarket surveillance and clinical experience reporting even into the FDA, I hope.

[00:24:11] Ethan Drower: Right. Well, I mean, you can, you can hope for it, but your point is right. We all have the same goal. It’s to put out as many effective and safe devices as possible to help as many people as possible. So my hope is that, you know, technology in, in my opinion, kind of accelerates things to the point of mass adoption. That’s one of the beauties of it. So my hope is that tools like ours and tools like yours can, can get so good that it makes it obvious that they have to be used.

[00:24:45] Ethan Drower: And whether, whether it becomes things that we’ve created or, things that somebody else has created, it’s immaterial. What matters is we’re striving towards the creation of some type of tool and standardized process that is so efficient. You can’t refute it. I mean, and that’s, that’s kind of the dream, right. Um, but that’s, that’s always been my hope with technology because in other industries, that’s really how it’s worked. We’re just a little bit, we’re a little bit slow over here.

[00:25:14] Kelly Stanton: well, well, yes, life sciences. We don’t like change. Change is right, right. oh my gosh.

[00:25:20] Ethan Drower: I have faith. I have faith in the industry. I know, I know we will get there. And when we do it will be a far more, it’ll be a far more researched and, and well thought out solution. So, um, That does that does make me happy.

[00:25:35] Kelly Stanton: I I’m with you on that one. And I’m also optimistic. I was very excited, you know, the, um, good automated manufacturing practices GAMP has been one of those guidelines that we’ve all lived and died by for. As long, well, as long as I can remember in this industry, it finally updated last month and it changes so much about, uh, their goal is really to enable innovation, right? Get us all using these automated tools, really thinking about them from that risk based perspective. And, and, and honestly, I mean, the longer I I’m doing this from an automated tool perspective, the more, I think there’s actually more risk in staying on paper and, moving forward and embracing technology and its ability to, to help us have all the information we need available quickly and consist

[00:26:18] Ethan Drower: there’s opportunity cost. Right? Yeah. That’s a, that’s a great point, especially, um, you know, especially when it comes to the startup world with devices and, uh, you know, one of our other main goals is it’s not just standardizing this process and taking over the world.

[00:26:36] Ethan Drower: It’s how can we make it easier and cheaper? So, The smaller company that has a newer product that still needs some work. They can actually afford to, to get it approved and, and get it out there and helping people. And if it, if it’s gonna cost you hundreds of thousands of dollars to, to do the paperwork, to approve devices, people aren’t going to want to create devices anymore, except for the big companies that, that have the budget and, and, and don’t care.

[00:27:03] Ethan Drower: Right. But if you want the innovators like you do in the manufacturing space as. You, there needs to be a way for them to safely and, and cheaply try things. Right. And, and foster that, that kind of, that kind of atmosphere of creativity. Um, and that’s just one of the benefits of technology. We can make it cheaper and, and, and safer at the same time, which is unheard of.

[00:27:26] Kelly Stanton: Yeah. It really does remove that barrier. Big time. It’s, uh, it’s interesting, you know, in working with different startups and especially in the, in the, the lower risk class, you know, it’s, it’s a very common regulatory approach to go to market and try not to make too many, if any claims, you know, or maybe you have broader claims planned, but your pathway is let’s just get it in the market now. And then we’ll work on postmarket surveillance and, um, you know, expanding, adding on indication studies and those kinds of things in order to get to the indication we really wanna have, because we know our device really can do these things that are amazing, that are gonna heal people or whatever, but, but the pathway to get there and especially with MDR change, uh, that really, that really change. I think a lot of people’s thinking. And so, uh, this is, this is an amazing way to remove one of those barriers. We can make those market surveillance easier and not so scary.

[00:28:22] Ethan Drower: right I mean, how silly is that you can’t, you can’t actually talk legally about the benefits of your device that you’ve spent, you know, years toiling over because you can’t afford to, you can’t, you can’t afford to prove that it actually does the things that you’ve designed. Um, yeah, and to me that, you know, that’s, that’s a tragedy and, that’s something that can be, you know, improved within, within the industry.

[00:28:45] Kelly Stanton: Definitely well, I’m gonna switch gears here for another minute or so, uh, just talk a little bit about, being an entrepreneur

[00:28:54] Ethan Drower: yeah, for me some curve balls, Kelly

[00:28:56] Kelly Stanton: being an entrepreneur, what are some resources you would recommend to others that are just trying to get started?

[00:29:02] Ethan Drower: Ooh. Okay. Good one. I would say it depends on how new you are. I, I think if you’re brand new and you have some ideas, et cetera, the most valuable thing you can do is you can talk to as many people as possible that have done what you’re trying to, or have done something similar. And you’re not necessarily looking for when you talk to those people, which is easier than most would think because especially entrepreneurs, they’re always willing to help somebody that’s that’s down the line, so they will call you and they will talk to you. But what you should be looking for is you should be looking for broader mindsets about how this person, how this person views their business and their team and their product. And you should be trying to embody those mindsets.

[00:29:52] Ethan Drower: The, individual skills that you need as an entrepreneur, you will learn those as you go, right? You will learn accounting, you will learn sales, you will learn marketing as you need to, but the, the mindset of how do I approach this thing as a whole, that’s what’s, that’s, what’s really going to, to be the deciding factor in how successful you are and how quickly, so talk to talk to as many people that have done it, as you, as you can get your hands on.

[00:30:18] Ethan Drower: That’s probably my biggest one. Um, I mean, I can give you some book recommendations, I guess.

[00:30:25] Kelly Stanton: Sure. Yeah.

[00:30:26] Ethan Drower: Let’s see, you know, one of my, one of my recent favorites would be, uh, a book called traction. And it’s a framework for how to run and systematically grow a business. And there are a million frameworks out there. It doesn’t matter that you pick this one. Um, but what’s important is that you start seeing a business that you’re creating as a series of systems and people, right?

[00:30:52] Ethan Drower: Uh, one of the biggest mistakes early entrepreneurs make is they try and do everything themselves. And they just kind of assume that that’s how it’s gonna be forever as an entrepreneur. One amazing exercise should be making a list of all of the things you have to do to make your company run. Deliver the product or a service get paid, et cetera, make a list of all of these things and then start to figure out, okay, how can I hire people and build processes to do all of those things.

[00:31:22] Ethan Drower: And another one of my favorite reads is, um, a book called fire yourself by Adam Anderson, which is, which is a, you know, it’s a, it’s a strong title, but the premise is if you, if you take that approach and you continue to hire the right people. And put in place the right systems that do all of the things your business needs to one day, you should wake up and, you know, call your staff and they’ll say, why are you calling us?

[00:31:49] Ethan Drower: We don’t, we don’t need need you. And, and that’s, that is the day. That is the day you, you really ultimately wanna reach as an entrepreneur. Not that you’re useless, but that you’ve built such a, a collaborative group of people and, and processes. To, to, to grow and, and accomplish your, your actual business goals. So, I think trying to frame it in approaches like that is very effective for new entrepreneurs and we kind of get lost in the hustle, if that makes sense.

[00:32:17] Kelly Stanton: Definitely and that was, as, as you were speaking, that was kind of the thing I was thinking of. It’s, it’s, here’s all the things, but also what, what are the things. I actually am not very good at, or don’t know how to do. And is there, value in me learning them or is that a thing to outsource? Is that a thing to find a partner or find a, you know, an employee or, you know, obviously in the entrepreneur space, you know, you could be perhaps constrained from a resource or finance perspective, but yeah. What, what pieces make sense for you to do now versus later? I guess also spending a lot of time in the startup space. That’s a place where that can make or break you. If you don’t spend your time and efforts in the right places, or you try to do it out of order.

[00:33:02] Ethan Drower: It’s prioritization. Especially if you don’t have a lot of funding to, to take care of all of it at. If you don’t have an influx of capital to say here’s all the departments, I can hire somebody to build all of those departments. Right. That’s the dream. It never works like that. You’re always one month of invoices away from not being able to pay yourself right. And that’s when it’s important to be able to prioritize what are the tasks that only I can do? and I think you’ll find most entrepreneurs think it’s well, it’s everything then, you know, I’m, I’m so special and talented. Um, but you’ll find is you really start to break it down. In fact, most of those tasks you shouldn’t even be doing because you can actually hire somebody that’s better than you at it. And that can be a hit to the ego. But that level of self honesty I would say is, is an entrepreneur’s biggest, um, indicator of success when you can. I can, I can do sales, but let’s be honest, Kelly. I’m not that good. right. Yeah. I’m not that good. I’m not, I’m not a Superman. So maybe I should be looking to find somebody who is, who is significantly better and they can teach me a thing or two, um, you know, that’s a great way to approach it. But like you said, it’s hard. It’s hard to know.

[00:34:16] Kelly Stanton: Definitely. Well, I think we’re coming up on some time here, so where can folks go to learn more about CiteMed and get connected with you?

[00:34:27] Ethan Drower: Um, LinkedIn we’re very active. The, the whole team posts and puts up wonderful, wonderful articles, um, that I take all of the credit for. just kidding. Um, but you can connect with me on LinkedIn. Uh, you can just find my name, EthanDrower I’m the only one. Uh, if you’re interested in, in more about what we’re doing and how our platform works, you can check out our website, it’s CiteMedical.com um, That’s it, you, we’re pretty easy to find and, and we’re always happy to chat, so.

[00:35:00] Kelly Stanton: Excellent. Well, thank you so much for your time, Ethan. It’s been a, it’s been a pleasure chatting with you again.

[00:35:07] Ethan Drower: As always. I’m looking, looking forward to our next conversation.

[00:35:10] Kelly Stanton: Me too. Me too. All right. Thanks.