In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, about her path from a biomedical engineer to an "accidental entrepreneur."

Dr. Parekh shares how her desire to create impactful medical devices led to the development of the COBRA-OS, a life-saving tool used in trauma care, including military and postpartum hemorrhage situations.

The conversation touches on the challenges and victories of securing funding, navigating regulatory hurdles, and maintaining a mission-driven company focused on patient impact. For those interested in MedTech, this episode provides inspiration, practical insights, and a behind-the-scenes look at innovation in healthcare.

Key Timestamps:

• [03:22] – Asha Parekh shares her transition from biomedical engineer to accidental entrepreneur.
• [12:35] – Developing the COBRA-OS and the moment Asha realized the life-saving potential of her product.
• [22:10] – The role of passion in overcoming challenges as a MedTech entrepreneur.
• [35:42] – The importance of securing funding and the challenges of working with quality and regulatory partners.
• [52:20] – How to craft a compelling pitch to secure funding for your MedTech device.
• [01:04:30] – Asha's milestone moments, including the COBRA-OS being used at Formula One race tracks.

Quotes:

• "Passion is what drives you through the tough days. It's what makes the challenges bearable because the impact you're making is worth it." – Asha Parekh
• "Pitching is an art form. Telling a compelling story about your product, especially one that saves lives, can make all the difference." – Asha Parekh
• "You are the expert on your device. Never forget that, even when you're leaning on regulatory experts. Trust your own knowledge of your product." – Asha Parekh
• "The moment I realized that COBRA-OS could save lives, I knew we had to pursue it full-time." – Asha Parekh

Key Takeaways:

Top 3 MedTech Trends:

1. Growing Impact of Trauma Care Devices – Devices like the COBRA-OS are becoming critical in high-risk environments such as military and emergency settings.
2. Regulatory Complexity – Expanding into international markets (e.g., achieving CE mark) requires navigating a web of regulatory requirements.
3. Funding & Innovation – Securing funding is pivotal for early-stage MedTech companies, especially when aiming for large-scale regulatory testing.

Top 3 Practical Tips for MedTech Entrepreneurs:

1. Find a Mission You’re Passionate About – It will sustain you through difficult phases.
2. Master the Art of Pitching – A compelling story can unlock funding opportunities.
3. Be Proactive in Regulatory Knowledge – Don’t rely solely on consultants; know your product’s regulatory pathway inside and out.

References:

• Frontline Medical Technologies – Learn more about COBRA-OS and its use in trauma care at Frontline MedTech.
• Greenlight Guru – For quality and regulatory management solutions, visit Greenlight Guru.
• Rook Quality Systems – Learn more about QMS consulting at Rook Quality Systems.
• Connect with Etienne Nichols on LinkedIn – LinkedIn Profile.
• Connect with Asha Parekh on LinkedIn – LinkedIn Profile.

MedTech 101: Basics of Regulatory Approvals

For new listeners, understanding how regulatory approvals work is essential in MedTech. Devices are classified by risk (Class I, II, III), and each class has specific regulatory pathways. For example, COBRA-OS received Health Canada, FDA, and CE mark approvals, allowing it to enter the market in different regions. The CE mark is required for products sold in Europe, indicating compliance with health, safety, and environmental protection standards.

Feedback Call-to-Action:

We’d love to hear your feedback! Share your thoughts about this episode by leaving us a review on iTunes. Got a topic you'd like us to cover? Send your suggestions to podcast@greenlight.guru.

Sponsor Message:

This episode is brought to you by Greenlight Guru, the only quality management and electronic data capture software designed specifically for MedTech companies. With Greenlight Guru, you can manage compliance, risk, and innovation seamlessly. Visit Greenlight Guru to learn more!

Today's episode is also sponsored by Rook Quality Systems, your go-to experts for building and optimizing quality management systems in the MedTech industry. Whether you're launching a startup or scaling your company, Rook's team of specialists offers tailored consulting services to ensure your QMS not only meets regulatory requirements but also drives business growth. Learn more about how Rook can elevate your quality processes at Rook Quality Systems.

Etienne Nichols: Welcome to the global medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies. Built for med tech by Med tech, Greenlight Guru's EQMS software helps you manage compliance, quality and innovation all in one. Learn more at www. Dot Greenlight Dot Guru are you looking to elevate your quality management system? Rook Quality Systems offers expert consulting and strategic planning services. Their team of specialists helps you design and implement a QMS that not only meets regulatory requirements, but also drives business excellence. Discover the top notch consulting services at Rook Q hey, everyone. Welcome back to the podcast. My name is Etienne Nichols. I'm the host for today's episode. Today, I wanted to address the topic of accidental entrepreneurship. A lot of people may set out or have the goal of being a medical device entrepreneur, or maybe they don't. I don't know. I don't know exactly what the cross section is in the industry, but I tend to think a lot more people stumble into it than who are actively looking to start a medical device company. And so we're bringing on Doctor Asha Perek. She's a biomedical engineer and the co founder and chief is the executive officer of Frontline Medical Technologies, which is a leader in innovative medical devices for trauma care committed to lowering the barriers and bleeding control and resuscitation, her career began with a desire to improve the lives of those in need, and we'll talk about that a little bit more and how her career has evolved from where she started. She and her team stand as the innovators behind the Cobra Os, which is a device that has proven to be an invaluable tool in critical trauma situations, such as on the military battlefield and in instances of postpartum hemorrhage. She also attended Western University, and she has a PhD in biomedical engineering with a medical innovation fellowship that followed that. How are you doing, doctor Asha?

Asha Parekh: I'm good, thanks. How are you? Please, call me Asha.

Etienne Nichols: Okay. Well, it's great to have you on the podcast. I'm excited to share or to learn more and to share with our listeners about your journey, but maybe that's where we should start. How did you get to where you are today? What did that look like?

Asha Parekh: Yes. Thank you so much for having me and for the great introduction. I know that was a mouthful, but we can get into whatever details you would like for that journey. As you mentioned, I did my PhD in biomedical engineering at Western University here in London. Canada, and that kind of followed by a medical innovation fellowship. That fellowship is focused on the commercialization of new medical devices. So that was like, kind of like a little taste because it's about a year long, just under a year. So you can't really get into too many details, but kind of gives you a sense of the different aspects you need to take into consideration. And that's where I met my now co founder and business partner, Doctor Adam Power, who is a vascular surgeon here in London as well. I will. I'll try to cut this as short as possible, but basically, we continued working on a few projects post fellowship. And, you know, it was the year following that we got some funding through a government and local network here, and that kind of gave us, you know, a point where we said, hey, like, should we really try to do this? You know, and I will say both of us had other medical device projects that we were working on as well. And I. I will say from my personal experience, you know, there, there are maybe not all, but most that I would not have chosen to take this leap on, you know, and I think part of that is for everyone is to have those points of critical reflection, like, what. What am I doing with my life? But what do I want to be doing with my life?

Etienne Nichols: Yeah.

Asha Parekh: You know, and, you know, it really draws on that, Drew, at a point. And I always say that reflection draws on passion. Like, because no matter what, I mean, nothing's ever going to be 100% great all the time, right? I talk to people about job satisfaction. It's like if you're expecting 100%, you know, even in a job you love, you're probably going to have days that are a little subpar. But if you're passionate about something, like, generally those are overcome by, you know, over time and you'll still make. Find a way to make it work. And so, you know, a lot of those projects, due to just the nature of the project, I wasn't as passionate about or, you know, and also for me, I mean, I will say since I was young and getting into, you know, ages, where you start thinking about your career, I went through various different, you know, things that I may have wanted to do, but I always knew, like, I wanted to do something where I felt like I was making an impact, whatever that was. I was like, I want to feel like I'm doing something purposeful and making an impact in the world. And this project, I mean, when we got to the point of, like, oh, my God. And part of my language, I hope this is okay. To say, but it's like, holy ****, this could work. You know, it was like, oh my gosh. The potential impact of that really helping to save lives, like that was a no brainer in terms of that. And then the other big part of it is people like, one is the project, your actual, you know, what you're working on. And then the other big, huge part of it is the people that you work with on it, you know? And so again, sometimes that's the deciding factor that gets you out or in a bit. Right. So I will say, you know, even back then, I'm going to call him Adam now. You know, it's doctor Adam power. But even back then, Adam and I were just getting to know each other, but it was a really good working relationship and I, you know, that was a huge part of the decision. And so based on those two factors, you know, we said, hey, like if we're going to do this, we need to put full time efforts into it, you know, if we're still, we both still have other things going on in our lives and no one's focusing on it, next day it wouldn't happen, but it will just take a lot longer.

Etienne Nichols: Right.

Asha Parekh: And so.

Etienne Nichols: Yeah, yeah, yeah. Sorry to interrupt. I have a question. If we go back in time, because I. Maybe we can talk about the product and what you're doing in a little bit, but there's some things that in the moment, they are probably huge stories and now looking back at them, it's like it's a blip on the radar. So we. I went through my PhD program. That's huge. I went through this medical innovation program and that was probably life changing, it sounds like. But, but can we talk a little bit about what led you to that? Because not everybody's going to be pursuing a PhD necessarily, and, and not every maybe will, will be having this medical innovation fellowship. But I do wanna talk about those two different chapters if we could.

Asha Parekh: Sure.

Etienne Nichols: What led you and caused you to pursue the PhD?

Asha Parekh: Yeah, great question. So I did my undergraduate in biochemical and environmental engineering and I loved engineering altogether. It was a really great program. But there was something still pulling me more towards the science and the medical aspect. We did not have undergraduate biomedical engineering program at the time. We do now, which I'm so happy about, but we didn't have that at the time. So my only option was to do that in graduate school. So that's kind of what led me to grad school. And I will say once I got it was really, again, the project that kept me there. I had kind of said to you a bit earlier that I had never planned on staying at one spot for all of my education because I wanted to experience different university cultures. But the project itself, like, overrode that, you know, because I said, what am I going to be spending my day in, day out on? And, you know, I really wanted to do something again that I was passionate about and I knew that I would enjoy and has nothing to do with what I'm doing now. But it was on bioprosthetic heart valves. Also got some industry experience there because I had an industry sponsor working with me, so that was kind of cool. But that's like, really, once I got in, it was just the prospect of, you know, learning more about that project and building on it that that drove me to, you know, do my PhD. To answer a question on that, the story from there to the innovation fellowship is a little more involved, so I'll give you the whole thing and try to close notes it a little bit so it doesn't take the whole hour here. But as I got close to the end of my PhD, you know, my. My friends were asking me, well, what are you going to do? Typically, people do a PhD in hopes of becoming a professor. That's the typical pathway for PhD. And by the time I had gotten to the end of my PhD, I had surveyed a few of the professors and my supervisor and all that, and spoken to them, and, I mean, every single one of them said a minimum of 80% of their time was doing paperwork. You know, like, begging for money, showing your word all about you're not actually doing, like, a lot of, like, it was really rare that I would see any of them in the lab and, you know, not to say, and again, I mean, I did my BGM all for education. I think it's really important. Everybody has their own roles, and I think, you know, they do an amazing job. It just wasn't what I wanted to do at that time. So by the time I was done, I said, you know, I want to do this right now. I can maybe see myself coming back to it if it's an option, like, a bit later in life. But right now, at that time, I wanted to be a bit more involved in the physical doing and experimenting and all of that kind of stuff. And so I decided not to line up a job, per se for when I graduated. Most people in our lab group and in general are like, okay, I need to make sure when I'm done, I have something there. And I thankfully had the support of my family still at the time. And I said, I kind of take the time to really look into what Im going to do next. And again, I knew 100% job satisfaction was probably unrealistic, but I thought at least if I spend a bit more time than rushing to have something right away, the probability of me being happier in that role is higher. Of course, things dont go as planned, and the universe had different things in mind for me. So Im preparing for my thesis exam, like my defense, and I get an email from one of my professors that had taught me at some point during grad school. Hes like, hey, just wanted to see how youre doing. Like, where are you in terms of your defense? And hes like, there is this program, the medical innovation fellowship thats coming out. And he said postdoc. Like its a postdoc. Immediately I was like, because im thinking its a typical postdoc. And, you know, if I'm not going to like, try strive to become a professor, I don't want to do postdoc right now. But I kept reading. And as he starts to describe this medical innovation fellowship, I get more and more hooked ultimately, because the first part of the fellowship was doing a intense boot camp in Minnesota. In Minnesota, like, you know, medical Minneapolis or Minneapolis? Okay, yeah, exactly. University of Minnesota. And spending like, you know, a couple of months there doing intense boot camp. And I was like, okay. Right away I was like, okay, well, Minnesota is like the place to be for this. So, you know, networking alone was a massive opportunity. And then the second part of it is you come back and you get kind of immersed into the local culture with people, either scientists, surgeons, whoever, to derive unmet clinical needs. I will say, and you can probably appreciate this as engineer, that even in grad school I saw so many things that were, as engineers were like, oh, my God, that's such a cool project. And we could spend years working on it. And it's like, oh, let's get this out into the world. Well, and sometimes you don't know if it's useful, but that doesn't make it not a cool project. But, you know, maybe, maybe the whole premise, I guess the point is the whole premise of the fellowship is to go the other way around and say, let's make sure there's an actual unmet clinical need and work and engineer based on that. And so that's what we did. You go and observe in the or and you watch surgeries and you're looking for unmet needs where things can get improved and whatnot. And so I was like, oh, well, that also sounds really cool. Then the rest of the year, you're basically engineering new medical devices, and I'm like, and you're going to pay me to do this? I just sounded too good to be true, right? And I was like, how could I not? And it was just. It's like one year, you know, whatever. And so I'm sitting there going, I don't know how I could say no to this. This sounds like almost too good to be true. And so that's literally what stopped me from just going to find a job after my PhD to, okay, let me try this fellowship, and if nothing happens, it's probably going to be a good experience, and I'll carry on in like, so, again, a roundabout story. But you know that it kind of fell into my lap and things kind of just folded from there. So.

Etienne Nichols: So that's where you met your co founder, Adam.

Asha Parekh: That's cool.

Etienne Nichols: So tell us a little bit about how that worked. And what I'm specifically curious about is you worked together on this project and. Or you met during this, and what convinced you that this was a viable thing? You also mentioned something that maybe you could touch on is you got some funding, which also doesn't sound like a. Just a note of, yeah, we look back like, oh, we got the funny. But I'm sure in the moment it was maybe a bigger deal than we. We make it sound. Is that correct or.

Asha Parekh: Yeah, yeah. So the first part of the question was something about Adam.

Etienne Nichols: Yeah, yeah. Let's take one question at a time. My Adam's getting mad at me for this.

Asha Parekh: That's okay. Just wanted to make sure I answered it correctly.

Etienne Nichols: Yeah. Tell us about how you met him and how you decided that this was a project worth working on.

Asha Parekh: Yeah. So, again, he was one of a handful of people, many handfuls of people that we had met during the fellowship. But again, there's always something. And this goes to, you know, I think, like, there are many ways to put it, but, you know, you're drawn to certain people. You work your energies, connect better with certain people. You work better with certain people. And so, I mean, in all honesty, I didn't keep in touch with everyone post fellowship, there were a couple of people, and he was one of them. And, you know, so that was one of the reasons was just in terms of, you know, personality, people like what, us getting to know each other while working together. You get to know certain things about people. Right. And that was flowing very well. And so you can only make your decisions based on what, you know, at the time, and at the time, it was great. And it's thankfully still great. I will say. I'm not saying that that has changed. And this being one, again, I think I touched on the passion. Part of it is that I enjoyed it from a potential impact point of view. And I was always more on the what we call thought biomaterial side, not like ortho and all that. I had several ortho projects and they were cool. But, you know, it's not like something I get super jazzed about. Like I was more into, you know, the soft vessels and blood and all that kind of stuff. So that was one thing. And the other thing in terms of it being a viable project was just based on what we had already done in terms of bench testing. And, you know, it becoming a viable project was okay. While we have a proof of concept, that is a proof of concept, but again, oh, my gosh, this could actually work. And the potential impact of saving lives is really huge. So that was kind of really, again, it checked all the boxes that you would look at at that point. You know, like, we were like, okay, again, we want to do it. We think there's a potential impact. Then it was, how does this look from IP, regulatory, all of those things, like, is it something that we should devote our time to? And like, everything checked out. So we said, why wouldn't we try the funding piece of it? Yes, you're right. It was, you know, again, I think at the end of the day, as we all know, you can't do anything without money. Like, you can't, like, you know, if you either have it yourself, which is great, but you're still putting your time, effort, money in some way, shape or form into the project. And so this kind of gave us the, like, catapulted boost to be like, hey. And because that really is what made us think about, you know, actually pursuing this beyond, like, you know, a side thing type of thing. So side thing type of thing. I hope you like my.

Etienne Nichols: No. When a PhD who has started a company is able to speak my language, I feel so special, so.

Asha Parekh: Well.

Asha Parekh: Yes. And again, you know, everything has to line up at some point. You know, it's going for us. For me, it did at that point, you know, and then you get to different points where it lines up. I mean, we, again, you didn't ask me this, but I'm just going to throw this in there and fast forward a little bit and say we basically had said we knew we had enough funding to get us through a year. And so we said at that point, we'll reassess again, because then it's like, okay, if it works, it works. If it doesn't, okay, great, we carry on with our lives, whatever. But at that point, we thankfully were at a point where it was like we needed to, in order to move forward, we needed to do our regulatory testing, which was several millions of dollars and going to take several million, several years. And so at that point, again, it was, if we can't do that and if we can't fundraise enough money from whatever means, then, like, we need to really decide what we're going to do with this because it's going to be left somewhere in the middle, or do we try to piecemeal it and move it forward like that? And so, yeah, to the point, I mean, that initial funding, it seems so small right now, but it was like that really was the, you know, thing that got it. And you just kind of keep on going step by step.

Etienne Nichols: Trey, when I hear stories like yours, I think about it's not like going into an operating room and doing a procedure, you know, you would expect and hope that a cardiovascular surgeon knows exactly what he's going to do if this happens. We're going to do this, their checklists and so on. But in your situation, you are reacting to things that are brand new. It's kind of like the definition of projects in project management, something that's never been done before. And so you come to this fork in the road where you're going to have to get funding. How did you respond to that? And it sounds like you're just always learning. It's that accurate. And can you speak to other CEO's who are going through some similar situations?

Asha Parekh: I love that you said that because one thing that I always say is this is literally like a whole other education. I mean, I've done my PhD. I've done, like, all of it, but this, like, constant learning. Absolutely. But that's keeps it interesting as well. Right. At least for me. I love learning and I love that, you know, to each their own, but it makes it really interesting. And yes, of course, that's what also brings you the highs and lows of stress and whatnot. But that's part of the journey. It's part of the education. It's part of the process. Yeah. And so at that. At that point, it was, I mean, one, do we want to do it? I don't think that I'll say that has never changed. We've always, once we started it was, we want to do it, we want to try it. There are so many unknowns. Right. So many unknowns. But again, I think that part of it goes back to you. I had. I had never done anything like this before, nor had Adam. And, you know, we had lots of great advisors and people around us. I mean, I think leaning on your network and people who have done it before, I always say if we can learn from other people's mistakes, like, where that, you know, experiential learning is one thing, but, you know, we're. It's. It's that much better for us if we don't have to go through that. So. So that is one thing, but there's. When you're devoted and passionate about it going back to doing something you want to do, it didn't matter that I had never done it. It was like, okay, I just need to get it done. I need to find out something. Like, I'm going to go and talk to you x amount of people and then make our own decision. Because as we know, and we spoke about a bit earlier, is, you know, you can't necessarily follow someone's footsteps, but you can learn from their journey and make it, you know, your decisions based on. So, you know, I remember one of the. My advisor saying, like, all we can do is share our experiences because that's what he was doing with me. And I was like, yeah, but, like, it's so helpful sometimes. Just to hear somebody who's gone through it, and it's like, that may not be completely applicable to me, but knowing that I can make more informed decisions about how we want.

Etienne Nichols: Yeah. When you talk about the funding side of things, I'm always curious about this because I've watched pitch contests, I've heard different pitches from people, and it sounds like being able to tell a story, especially about how it's impacting the patient, can be really powerful. Is that something you've learned or had to learn? And if so, what are some tips about that?

Asha Parekh: Absolutely. Pitching is a whole art in itself, and it was one of the things that was there pretty early on in terms of, you know, learning a little bit about it in fellowship, but then also putting it into practice when we're going to fundraise. And it very much is the story part of it. I mean, you have to have, I think, as you know, like, critical elements still have to be there. But I found that when you can link and kind of how you can link, I should say, and get most of the people in a general audience, it depends who you're pitching to is, you know, getting them to relate to something, you know, whether it's a patient story, you know, starting with that, because they're like, oh, I know somebody who's been through that or my family member or this or, you know, they can picture it type of thing, that always makes the biggest impact. I find. And again, not to say the other stuff doesn't matter, but storytelling, I think both Adam and I have learned to hone in on our skills for that as well over time, because no matter how much we do it, and we still even just talking to people, telling our story about frontline, you almost feel like you're pitching, but it's really just that storytelling part of it. Like, you know, you might not be getting into the details of funding and all of that, but when people want to know, it really is the story. So I hope I answered your question. I kind of went on a tangent.

Etienne Nichols: There, but, yeah, no, it makes me think of a phrase that one of our internal people says a lot, which is don't bring a narrative to a data fight. But, and I push back to say, I agree, I love data, but data tells a story, and so you can tell a lot of stories with data. And so it's, it's just one big circular loop, it seems like.

Asha Parekh: Yes, absolutely.

Etienne Nichols: Though if we're to move on a little bit into the more operational side of things, I mean, the pitching and the funding is always very interesting to me. But those of us, those who might be listening might, might be thinking, okay, well, I'm in regulatory, I'm in quality, and I'm in a new early stage startup. What are the things that you've seen now from that, from the early days moving into these graduated, you know, at higher levels, wherever you are and currently in the, at the current state, what are some of those growth inflection points that people can be aware of and how can they prepare for those? Does that make sense as a question?

Asha Parekh: Yeah, I can, and I'll try to answer it. It does. But I will say quality and regulatory have probably been like, I mean, it is such a big part of that education we were talking about and learning because, you know, an experiential learning of that has been incredible. One is, I have to say, and I'm sure a lot of, I don't know, actually, if this is a lot of people, but I originally thought, like, quality was something like we could just one and done, okay, we just put these things in place and that's it. Okay, you need these procedures. Okay, we'll do it. And that's it. Oh, my goodness. Now it's like, you realize how big of a deal quality management systems are. I mean, quality, of course, like, as a general concept, we know that quality of our medical device is important and all of that, but in terms of regulatory inequality, you know, that was, that was, it's kind of a funny thing to look back on, to think that we could just put all these things in place and it kind of runs itself. Yeah, yeah, yeah. But so one is, I will say openly that we went through as a small company, you know, we were not at that time looking to bring a lot of people in house and, you know, as employees. And so we relied on contractors, consultants, different agencies to kind of help us fill the gaps on a lot of these things. We went through a few, not quite a handful, but, you know, a few different quality and regulatory agency people. I can't say they're easy to find. And I don't know if that's a combination of different reasons of where we are, who our network was at the time, and all of that. You know, I'm sure there are various ways to find people nowadays, and I keep hearing about these new ways to do that. But finding a right fit for, you know, we're talking about quality and regulatory, but I think in general, on all fronts, whether it's finance, as, you know, finding a good fit for your company is always, you know, a big thing and not necessarily really easy to do. And the other thing here is that from quality and regulatory perspective, we have our class one, class two, class three, all of those types of things that maybe somebody's more experienced with or different types, like if they're in vascular or ortho or things like that, like we were talking about. But every project is so different, right? And so nobody is really an expert on your device until they get into it themselves. And so I think part of that learning was, you know, okay, this is not quite the right fit. These people, for whatever reasons, are not working well with us. So I would say finding a good partner, I know I really haven't really quite said how to do that, but finding a good partner that you work well with that, you know, again, like we said, people, the people part of it is really important. And if they can get the job done for what you need, like from a technical perspective, that's very important. You know, that, that was a huge learning for us. The other part of it that I think for, like you said, other co founders or founders that are out there starting things as well, is if you are using an agency or whoever it is, your regulatory and quality people, you know, one thing we learned, and in some ways, a little bit of the harder way I will say, is that, you know, don't be afraid to look at what they do, like critically as well. Like they're experts in their field, but you are the expert on your device. And, you know, and I will say, like a couple of times, again, we're like, well, they know, they know best because they're, and it's like, no, like, actually, when we changed it to what, you know, we thought it's actually how things went a little bit more smoothly. So, you know, I think, don't take what they say as gospel, like always, always review, you know, and, and keep that in mind that, you know, I mean, unless you're, you happen to have somebody from your core team who's like a quality and regulatory expert, they probably would have a really good view into that. But those are some of the key things that, and I'll be honest, like, it wasn't even just then, like even now because you get to different parts of the journey going into different jurisdictions. Like now we're expanding, like, we just recently announced our CE mark and that we're expanding into other jurisdictions. So it's new regulatory considerations, new things for your qms and all of that. And again, it's, we have to continuously make sure that we're you know, going at it the right way.

Etienne Nichols: Yeah, I think it's important if you're in the medtech industry, I really like the point that you made that you are the expert on your device, but I also think you need to become a part of the industry of med tech experts. So everyone in your company is a medtech professional, ultimately. And so, yeah, to be able to vet those things, that's really good. One other thing you mentioned, you said it's hard to find a good fit for some of those things. And I'm just going to throw out there to those listening. So Greenlight guru does have an extensive partnership program that we vet out our partners using a particular process. So a lot of our customers come to us for, with certain needs and we're able to pair them with people who work, will work, hopefully well with them. That's always the goal. And they have a different few different things that they do to make sure that works. But I had a question for you. How do you define what a good fit is?

Asha Parekh: Yeah, and I will. I will honestly tell you we're probably still figuring that out in some way. We have grown, but we're still a fairly small company, and I talk about expanding into Europe and all that. And you might be thinking we're this company with all these people and we're still relatively small. Our core team is still like six, seven people max. From a day to day operations perspective, it's even less than that. But I will say even with that, for us, if I look at the different aspects of the business and people that we work with, again, it comes down to those two things. Are you getting done what we need to get done? Because that's an essential table stakes, right? Yeah, that's right. Exactly. And then the rest of it is how we work together is how you work similar to how we work in terms of how you give us things, receiving, giving and receiving from information, from a conversation perspective, working well together, I think I will also openly say we mostly work virtually. So in terms of, in this world that we live in and we have people from that core, it is just Adam and I in London, physically in the same spot. It's just the two of us, you know, again, it comes down to the two things of one is, do we all feel like this job is being done well, or at least to what we need it to be done, and how do we all get along with each other? I'm going to boil it down to those two things.

Etienne Nichols: Yeah.

Asha Parekh: Yeah.

Etienne Nichols: That's really good. And I'll edit out any losses of trains of thoughts, because I did the same thing.

Asha Parekh: Thank you for that.

Etienne Nichols: Any last piece of advice for those who might be in a similar situation? Maybe if you look, if you're talking to yourself from five, two, three years, whatever, years ago when you found yourself as an accidental, accidental entrepreneur, is there any advice you wish someone had given you?

Asha Parekh: You know, I've been asked this before and I can honestly tell you, and you can edit this out as a question even if you want, but I don't know that there's anything that I wish I would have known. And I think that's partly because of the whole, this has been an educational journey. Like, if I knew a lot of this stuff beforehand, it wouldn't have been that type of experience necessarily. There's nothing that stands out that I'm like, okay, well, even with that, that would have been very helpful to know right from the start.

Etienne Nichols: Let me ask you a different question. So it sounds like from your journey, there have been step jumps at different points in your career where you had to learn this, you had to learn this. And now you look back, you're like, okay, we got funding. I did this, I did that. And those are probably highlights in my. In your career, I would guess, because that's the way we tend to tell stories. Is there anything that stands out that you're particularly proud of? I did that. Anything that really resonates in your mind?

Asha Parekh: Oh, there are. There are many. There are many. Can I give you the list of things that I'm proud of?

Etienne Nichols: I'm ready.

Asha Parekh: Oh, I mean, you basically touched on a lot of them. And one is, we didn't realize how big of a deal it was to fundraise several millions of dollars. I'll be honest. Like, I think, again, people really resonate with the story of impact and helping to save lives. So one is the fact that we were able to even fundraise, you know, at any given, any given point. And then I think some obvious ones are our regulatory approvals. That day we got our health Canada. That day we got our FDA approval. That day we got our cd mark for Europe. Like, those are huge, but I'll tell you other ones that stand out that would not be so, like, public facing. And, you know, like, that is like the very first day our device was put in a patient, you know, like first life that it actually saved. You know, I think our. And I think, you know, our driving force, and I'll tell you, it still is. Our biggest thing is always thinking about patients first that impact side of things. And, you know, Adams, a vascular surgeon, as I said, he's seeing patients all the time. And knowing as a business, we're a medical device business, we have to keep running. That's there. But at the end of the day, even as a business, from a business perspective, when we're making decisions, that is what we're thinking about. That is how we actually move ourselves forward in terms of what we're going to do next and how we handle anything that comes along the way. Sorry, I went on a tangent there, but I'm trying to think if anything else stands out in terms of.

Asha Parekh: Thank you. I'm going to throw a fun one in there because I think, you know, there are probably, like business related milestones that we could talk about and valuations and funding and all that kind of stuff, which I'm happy to get into, but I want to say, and I remembering this because someone else asked me recently for a different article, but something that I think is super cool in terms of a milestone is, oddly, aside from any of this, Adam and I used to joke about, you know, getting into f one somehow. And like, do we. We would say, oh, when we get approval for this, we're going to have a champagne celebration. But, like, we're like f one fans and even our director of products, all of us have some, like, you know, love for f one.

Etienne Nichols: And just for clarification, Formula one racing.

Asha Parekh: Formula one racing. Yeah, yeah, yeah. And, you know, it was a couple of years ago now. We got approached by someone in f one. No, out of nowhere. Can you imagine? Like, honestly, like that? That's really. That's like the cool milestone. Like, oh, my God. Because it's like that pipeline kind of dream thing we would joke about, and then all of a sudden somebody's contacting us for the device for Formula one. And we were like, this can't be real. How cool. So, yeah, I will say, I mean, f one is a very interesting beast of its own, and we're still connected. But the cobra has been on more than one f one race rack, so that's, that's a pretty cool accomplishment.

Etienne Nichols: Amazing. I love that. And I love that you're, you're talking about your goals, even if they're crazy. Why not? You know, that's really cool.

Asha Parekh: Used to be a joke for a little bit, you know, and then.

Etienne Nichols: Yeah, anyways, that's amazing how some of those jokes come to fruition. I love that story. Do you have a hard stop?

Asha Parekh: I do not.

Etienne Nichols: Okay. I should have asked that. I don't think there.

Asha Parekh: That's okay.

Etienne Nichols: Any last pieces of it? Yeah, go ahead. Go ahead.

Asha Parekh: I was just going to say, if something else comes to mind, that you're like, oh, like we said, because this was kind of an unplanned trajectory. I'm happy to answer any questions or jump on again if you think, you know, it would be valuable. I think we can. We can pull whatever we can for.

Etienne Nichols: Okay.

Asha Parekh: For the best.

Etienne Nichols: Well, asha, any. Where can people find you? If another accidental entrepreneur out there might want advice from a fellow CEO in a similar situation, where could they find you? Can they get a hold of you?

Asha Parekh: Yes, absolutely. You know, I would typically say LinkedIn, but I'm going to be brutally honest and say I do not go on my LinkedIn, hardly ever. So it's a good way to throw people out there if they want to never hear from me, really. So I'm going to just give you my personal email address, which is ashaprontlinemedtech.com. and I am so happy to talk to anyone at any point. I think, I don't know if it was during this episode, but when we were talking, just saying how I do hear from people after, and I'm always happy to connect with people and talk through anything that they might find useful.

Etienne Nichols: Okay, I want to ask one other question, and it was related to culture because you said sometimes it's hard to find a good fit. Do you have advice for people who are trying to reach out to these startups who would love to work at a startup and advice for them on how to pitch themselves or anything like that for people who would love to work at a startup?

Asha Parekh: Yeah, it's a great question and I'll say, obviously, right now we're on the other side of that. But when. When people approach us for work, it is a tough place for them to come from because they don't know what we need. Right. So there may be brilliant people out there that are like, oh, my gosh, like, I'm an amazing accountant. I do this and it's like, okay, well, we need a marketing person right now. So, like, you know, but they could be so great. So, you know, I think one is finding out the best way to approach this company. Like, people, some local people will come to our door, which actually may be the most effective. I don't know, you know, to getting to the right people. But two, you know, not to be discouraged if it's not what we're looking for right now. It may be something that we're looking for in the future. So, you know, again, timing is everything. It may be good for them right now, and maybe later it's going to be the reverse, and then maybe at some point it will work. But, you know, I think to just be aware of that and if you really. I mean, obviously, people probably can't wait around forever either for that perfect opening at the perfect place, but, you know, not to be discouraged by that and, you know, keep in touch with people that you. That's one thing I will say. There are certain people, even if you don't know where or how they're going to, you know, do something or how you'll be connected at some point. There's some people you just keep in touch with, you know, and I did that as an. As a. Even during my PhD in team and fellowships and beyond. You know, for some reason or another, I'm like, I need to keep in touch with that person. You know, like, those are the people.

Etienne Nichols: I'd rather work with anyway. Yeah, exactly. Thank you so much for the conversation, Asha. We'll put a link in the show notes to what you're doing, where you're. Where the people can find you in that email address that you shared and really appreciate you sharing your story. And I think there's a lot of accidental entrepreneurs out there, and I hope they can learn from your story and maybe get some advice from you, too, if that's. If not to overwhelm you or anything. But this has really been fun.

Asha Parekh: Thank you so much, Etienne. Really appreciate the opportunity. It's been great chatting with you. It's been a fun time, and, you know, look forward to keeping in touch as well.

Etienne Nichols: All right, sounds good. Take care. Those of you been listening. You've been listening to the global medical device podcast, and we'll see you all next time. Take care. Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that leave a review button. This helps others find us, and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening, and we'll see you next time.