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Feb 10, 2021 Teena Hart

Funding and Scaling your Med Device Startup with Jen Baird

 


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Getting funding and scaling a medical device business alone is challenging. But challenges don't deter entrepreneurs like Jen Baird. From being disregarded at first from VCs  simply because she was a woman, to then selling her company for $205M,  to today scaling a med device startup with a denovo FDA application, Jen has done it all! If that's not impressive enough, she takes time to write her insights as a startup CEO in her personal blog. 

Jen has founded and led multiple healthcare ventures. Her most successful company to date was Accuri Cytometers which Jen led from inception to global commercialization. She raised over $30 million in angel and venture capital financing, developed a product and achieved more than $12 million in annual sales in just five years. In 2011, Accuri was sold to Becton Dickinson for $205 million, which is a 10X revenue multiple and Jen generated, or a 5X return for her investors. 

Most recently, Jen raised an $11.5 million Series A to found and build Fifth Eye, a medical device software company that detects hemodynamic status from a single streaming lead of ECG. Her career also includes stints in commercial banking, management consulting, and several other previous startups. Jen graduated at the top of her class with a master's in management, from Northwestern University's Kellogg graduate school of management and earned a BA in organizational psychology from the University of Michigan. 

For everyone who's listening and in the trenches of building a life sciences company, Jen has been there many times and has had some incredible exits. 

I hope you enjoy listening and learning from her wisdom and experience. 

Show notes:

Music by keldez 
Jen's Photo credit Leisa Thompson

Transcript

Robert Fenton: 

Hi, everyone. Thanks for joining us for another episode today. I'm really excited to share a discussion I had with Jen Baird, a successful serial entrepreneur and CEO. Jen has founded and led multiple healthcare ventures as CEO. Her most successful company to date was Accuri Cytometers which Jen led from inception to global commercialization. Jen raised over $30 million in angel and venture capital financing, developed a product and achieved more than $12 million in annual sales in just five years. In 2011, Accuri was sold to Becton Dickinson for $205 million, which is a 10X revenue multiple and Jen generated, or a five X return for her investors. Most recently, Jen raised an $11.5 million Series A to found a build FifthEye a medical device software company that detects hemodynamic status from a single streaming lead of ECG. Her career also includes stints in commercial banking, management consulting, and several other previous startups. Jen graduated at the top of her class with a master's in management, from Northwestern University's Kellogg graduate school of management and earned a BA in organizational psychology from the University of Michigan. For everyone who's listening and into trenches, building a life sciences company, Jen has been there many times and has had some incredible exits. I hope you enjoy listening and learning from her wisdom and experience. Let's dig in. I know that you sound like you're incredibly busy and we only have like three minutes to connect today. I, I have so many questions, but. First of all. Thank you for being a customer of Qualio. We're excited to support you. I love what you folks are doing, but for, for people who don't know you and don't know, FifthEye maybe you could just give a brief intro as to what fiftheye is all about and how you think you're you're impacting the world.

Jen Baird: 

Yeah, absolutely. So FifthEye is a software as a medical device company and what we are doing is commercializing a technology that uses a single lead of EKG to predict patient deterioration by measuring hemodynamic status. and in particular, we highlight hemodynamic instability. And so we're a clinical analytics company and we're a regulated medical device. One of the reasons we're customers of Qualio is because we are A regulated medical device that's looking for FDA Denovo clearance any minute. So we're excited to be kind of we'll be able to take our product into the marketplace. And this has been a journey. The technology underlying the company Arkadin 2013 at university of Michigan and out in, and became part of FifthEye in 2018. And now we're on the threshold of, getting ready to launch a product into the world.

Robert Fenton: 

That is so, so exciting. I love speaking with companies like what you're working on because we have this internal thesis at Qualio that there's this new breed of company being born. And this software as a medical device space is a great example of where lots of lessons learned. And I guess the pure software world is not getting applied in healthcare and it's really amazing what can be achieved. And I think companies like you folks, at FifthEye are part of the, the first wave I believe of proving what can be done here. Now. You've been part of a lot of companies. You are a, I guess a serial entrepreneur would be a, a fair word to use. So I always wonder. How you keep that up for so long, it's going back and back and back. So what, what was your path? I guess, ignoring FifthEye for a moment, I looking at a few, Jen, how did you get to where you are in fifth state today? What made you want to do this? And looking at LinkedIn, I think I was looking at your notes earlier. It was, you're now doing this for over 16 years as an entrepreneur.

Jen Baird: 

I've been in the entreprenuerial space for two decades and, I think I always wanted to, well, I've always wanted to lead companies because I love the comprehensive role of leading the entire thing. And that for me, dates back to high school, which is a little weird. I admit, dating back to high school and thinking about your career, but that was the basis. And when I was back in high school. you didn't do as much going straight into an entrepreneurial career. So I got a, an undergraduate degree in psychology, organizational psych went and built on that with an MBA in finance and strategy. Spent some time in management consulting and then jumped into entrepreneurship. And honestly, that background was super helpful to give me that kind of comprehensive view that now I keep them to my startups and I'm very much not the inventor of the technology. I have a partner with many wonderful technologists along the way, and I would consider FifthEye my fifth startup. that I've been involved in and each time I've worked with different technical founders, and, and partners to go through the process. So I kind of feel like my role is to wrap around and help, set strategic direction, make sure we have the resources and are operationalizing things. And then somebody else is doing that deep technical innovation that's required to do venture back startups, which is really my niche. I'm a venture back startup scale, which is a rare thing, actually. I'm not, there's a single digit percentage of female venture backed startup leaders.

Robert Fenton: 

Yup. A hundred percent. Right. And your story is super interesting. I mean, in high school, you said you kind of saw that path. I mean, any other influences looking back over the early years that kind of led you down this path?

Jen Baird: 

You know what, it is not an easy transition to go from management consulting into leading company and being a company CEO. But the background of management consulting gave me a lot of skills in the sense that I had worked with 25 different companies on 35 different projects in a variety of industries. And all of that gave me a huge amount of this thought of how do you operationalize business value proposition. How do you sell that? How do you, in some ways a startup is like a giant project, right? And it, because it's a giant project, all those project management skills and all those sales skills that you need. I have been developing that for. Yeah, 30 plus years. And those skills translate really well into leading startups and having to keep all those balls in the air. so I think sales skills and comfort with that and project management skills and general exposure to different types of businesses, are really good foundations for entrepreneurship and leading an entrepreneurial company. I was having a great conversation with some of my team earlier today. And one of the things we were talking about is, is what did you learn as the chief analytics officer who came out of the university as a professor and, data scientists and jumped into being part of an entrepreneurial company. And he said it was a great story. He says I thought that when you became part of a company, you'd go figure out what the problem is and go get somebody to fix that. So we have a marketing problem and we'd go get somebody to do that. And he said, what I learned is that you actually end up jumping into the deep end of the pool yourself and doing it and doing a lot of it. And you might get feedback from other people, but you don't have that kind of resource. And that kind of entrepreneurial spirit is you do a lot of that actually in consulting sometimes too. And I think that is a really good base. And a lot of times people, especially coming from large companies, don't appreciate how much of you gotta just go figure it out.

Robert Fenton: 

Yup. That's the, the thing people don't tell the oftentimes is nobody knows you got, gotta figure it out. Yeah. I love that. Joining FifthEye in 2017 I think you mentioned that the technology that was acquired in 2018. So when you joined, I guess, what was the mission statement for you joining asCEO? Cause I believe you joined after the company was started or were you, did you start?

Jen Baird: 

Actually, let me clarify that I was the founder for the company. And the rest of the team joined in 2018 when I raised the first money. So what happened between 2017 and 2018 was I was working with my co-founders who? Well, technically I founded the company. They were still working at the university. We worked on the license of the technology. Making a really great business plan and, raising money for that year. And then when I had raised, our initial round of funding, they left the university. So I had three people from the university who left their jobs at the company at that point, along with, another person who joined from one of my prior startups. So that first season was about fundraising, business planning and raising money. And I was the sole employee of the, of the entity that was FifthEye, but I was working alongside the other people that would ultimately become members of it.

Robert Fenton: 

Of course. Okay. Sorry for you for getting that wrong. I made some notes. My notes. Thank you for correcting me. I appreciate that. So why FifthEye? I think that the clinical case you've made is really compelling and I understand intellectually why it's important, but as the person who started this, right, you were the person to kind of say, this is a, this is a big opportunity. Was there a moment or was there something that triggered that for you?

Jen Baird: 

Yes, absolutely. And actually that's probably one of those lessons learned for startup founders is how do you know you got the right idea? and, and the reality is, Mark and Ashwin and Price, who were the ones that the university had, the idea. I had the opportunity to meet them and hear what they had been working on. And at the time I was between startups and I had about a dozen things, I'd already decided I wanted to be in health. I wanted to focus on healthcare for the next, next thing that I did. and so I was hunting for the next thing and I had probably a dozen people that I was talking to remember, I'm, I'm not the inventor. So I, I look for where's this invention need match and that's really good. And when I met those guys, and heard their story, I was like if that's true, then they've really gotten onto something that I spent probably two months. And I talked to 20 people who were in the target customer group and said, what do you think about this? And this is, this is one of my filters. I'm always looking for the people who are coming out of their seats. Who are customers saying, that's amazing. And one of the first things that I heard, from somebody was like, this is Holy grail territory, Jen, if they can do that, that's Holy grail stuff. And I heard that over and over again, and the clinical doctors and nurses that I was talking to instantly got the concept couldn't believe it was possible. And we're super excited about it if it was, and those are all the things I'm looking for when, when I'm looking for somebody to partner with and picking the next opportunity is that kind of, pull an unmet need that exists in the market.

Robert Fenton: 

thank you for sharing. And you said that you said the first season, right was getting ready fundraising. And you also said correctly that females are massively underrepresented and running venture backed companies. Right. But you've done this multiple times. I think it'd be worthwhile, maybe pausing for a moment. And, for whatever you're comfortable sharing about maybe some of the challenges and how you clearly succeeded multiple times and in getting past any, any of those blockers.

Jen Baird: 

I think, being a female, venture backed CEO is. You know, the first time that I was really venture backed as a CEO, is probably more relevant than what I face now. And now I have a track record. I had success. I have a reputation amongst investors. It is infinitely easier. I mean, not easy, but it is infinitely easier to overcome. Some of those barriers because I have those other things, but the first time through, I I ran into venture capitalists who I found out later dismissed me out of hand because they thought, and I quote, Oh, she's going to go off and get pregnant.

Robert Fenton: 

Wow.

Jen Baird: 

You know, those kinds of, of issues, I ran into people who would treat my colleagues as the leader of the company, because they were men and those kinds of things happen routinely. And what how do you overcome them? You overcome them by having other people be on your team, backing you up on that. And having investors who, will take that chance. I had some wonderful female venture folks that got involved in those early days and that helped a lot. but there were many times that I was the only woman in the boardroom. that's mostly my common experience and I try not to focus on it, but I am aware that it's a leap for some people.

Robert Fenton: 

Yeah, I appreciate you sharing that. Jen, do you think it's changed much in the last decade as, as this has gotten more awareness or any advice for people right now who are maybe thinking of starting up, but maybe share some of those concerns?

Jen Baird: 

Well ultimately, Being an entrepreneur means proving other people wrong a lot. You know, there's always naysayers. They will find something to say about it, have to be. And honestly, when I'm talking to somebody who's contemplating entrepreneurship, I absolutely try to talk them out of it. And the reality is if I can talk you out of it, you shouldn't do it. and that's true. It's hard for me to say how much it's changed because the difference in my track record and what my experience is, is confounded with that. And so I don't know how it would be different today. The percentages are still pitiful and because they're still pitiful. I think the barriers are still there, but I experience it less now. And that's just because the second or third time, you're doing a venture backed startup and you've had success. You know, people look for that track record. I mean, that's true for venture investors as well. You know, their second or third fund, they, if they've had success, it's easier on some level. It's now ready.

Robert Fenton: 

Well, our, if you're on your fifth venture backed company as well, which also helps I guess the journey now we are in your fourth year, it was FifthEye and it sounds like things are going really well and getting the. Denova approval is huge. Right? Right. Well, any, any major blockers or obstacles along that path or lessons learned from that journey?

Jen Baird: 

Well, yeah, it's an interesting one. We are forging a new path, kind of in clinical analytics. And I want to distinguish if you look up health care analytics, you get all kinds of things and you get lots of, lots of companies who were doing things for operationalizing healthcare. You get a lot of things. Clinical analytics is a pretty small, small world still. And I think that. Partly that's because you have to get through the FDA hurdle. And we have learned so much about the FDA through this process, we ended up going through three pre-submission meetings with the FDA before we ultimately landed on our Denovo pathway. which means that we don't have the there's nothing really like what we're doing out there. Nothing even relatively close. and, and we had to provide a lot of clinical data. I think that if anything, the FDA process has made us more confident in our product because they have been so rigorous about testing. Does it work? Does it work? Does it work in so many different ways that, by the time we were kind of over the line last year, working with the FDA on getting through this Denovo process. It got to the point where they asked the next set of questions and we were like, well, it's, it's going to come out okay because every time they asked us to slice and dice the data a little differently, it came out okay. And at the end we were like, it really works. I mean, we believed it worked, but we were like, we have proof like eight ways from Sunday that it works and does what it says. the FDA has been a really interesting process and we were talking earlier about I think that people underestimate what it takes to get things through the FDA. I think I underestimated that. And one of the things that, that we've learned, um Qualio has been super helpful to us feeling like we have all the pieces in place for quality management system. we, as a company are really committed to doing kind of things in the right way. and Qualio really has helped that process. And we didn't, we didn't start with Qualio. We tried to do it on our own with some consultants first, and then we landed on Qualio and I am convinced that I don't know the reason we got there is because of all the operational difficulties of doing a quality management system to an FDA standard. Without automation and Qualio provides an out of the box automation that makes it practical. And I was an operations improvement consultant for a long time. And so I'm really sensitive to whether a process is going to produce consistent results. And by the way, that's what the FDA cares about. Right. And I think Qualio has been a big part of that process and a big learning for us over the last year.

Robert Fenton: 

Well, thank you. Thank you for sharing that. There's something that we talk about a lot internally at the moment, then you might see some things coming down the track this year, but the, yeah, the way we describe it as is that quality and velocity should not be opposing forces.

Jen Baird: 

No,

Robert Fenton: 

unfortunately that's not how the world works today. And we believe our mission is to make it so that there you can have both. And I think that companies like yours, right? Software, your software company, you want to move at a certain velocity. And in order to be able to move at that velocity, you have to be able to remove the bottlenecks and still be again, if you think of their promise of quality is it's safe, it's effective, it works consistently. It's like your Hippocratic oath, you take as a business. Right. And that's important to you. I can tell.

Jen Baird: 

That is exactly right. You know, we, we share. I mean, the FDA is the gatekeeper to make sure that we have a safe and effective product. At the same time, we have an obligation. Our product is a lifesaver and if it's wrong, it could hurt people. And so we have a really high standard for that. And you know, I'm thinking about your comment just now about automation and we have a high commitment to automation, but it's funny to think about in the moment of the pandemic, right? Our VP of engineering who has built software as medical device products before has has been a big champion of Qualio and very deeply involved in our Qualio implementation because and we were laughing about this the other day, when we had to sign off on a bunch of documents as a, as a group. Can you imagine a virtual company, which we are virtual right now because of the pandemic, virtual company has to sign off on this stuff and we can use Qualio to send all of those signatures around and get it done almost instantaneously. And our VP of Engineering, Brandon was like, I used to do this, where these things all came to me in a fax, I had to print them all out. I had to sign them all, scan them, get them back in, and he was just contrasting the difference of what we can do now in a matter of minutes. Versus what he had to do before to get a software package of documentation package pulled together. And that was one of the things that we thought was critically important. And in this pandemic environment, it's so much more important because you can't just walk things around the room and have everybody sign them. That whole automation and we've built on top of Qualio. So we have it even more automated than you guys do. Cause we've got it connected to our GitHub and, other CirclesCI connections so that we can the whole thing.

Robert Fenton: 

That's exciting to hear, Jen. I want to sync back with our team. I know you've, I believe you've worked on a case study or something or something maybe come down the tracks, appreciate your enthusiasm. It means a lot. It's when I get meaning personally, speak with people who are having success and if we can be a small part of that, I think that makes our mission worthwhile. So thank you. Without talking any more about Qualio because I could eat all week.

Jen Baird: 

Oh, we could probably talk about it all day.

Robert Fenton: 

Tell me you have a blog. So I was going to ask you for anything you'd like to share. you write a blog, I've taken a look at it. It's a lot of that actually pretty high impact content. So before we finish up, I guess why the blog and what personal mission or change do you hope to make with that?

Jen Baird: 

Yeah. So I do a blog called a StartupCEOReflections.com and I started it in the pandemic. So last May is when I started and it was because I was feeling this, not enough connection with other entrepreneurs because my history has been being quite connected to the entrepreneurial community, but the pandemic was putting such a damper on that. And I felt like I had reached a point with 20 years of entrepreneurial experience where a lot of the questions that I was in conversations I was having I could guess what people were going to be asking me. so I actually thought how do I share and give back and give a handout to all the people that are trying to tackle entrepreneurship. And, and I, I spent a night. I'm thinking one, I thought maybe I could do a blog. And I knew two other people that were doing blogs. And that's what gave me the idea. Like, Oh, maybe I could do that because a couple of people had said, maybe you should write a book. And I'm like, I don't have time to write a book, but I could maybe do a blog. And then I said, could I think of any topics? And I brainstormed for 24 hours and I had over a hundred topics. I'm like, okay, I got enough topics. I could probably talk about a blog. And then I started writing. posts and I wrote straight out of my own experience, which I'm finding is unusual. Like I keep getting feedback on the blog. People are like this sounds real. And I'm like, well, of course it's real. I can actually do these things. This is, this is real. And it's funny because I think there's a lot of content where people are repackaging other people's content and it's less real. and I really tried to treat it like, I'm going to have coffee with you, Rob. And we're going to talk about our experiences leading our startups and what are we going to talk about? And then I try to think about, well, what's a topic that I've often talked about and every one of these topics, I've talked with somebody about some point in time, and now it's just writing it down and making it available. what am I trying to do? I'm trying to help other entrepreneurs, because guess what? This job that we do leading these companies, Is not well taught. There's all kinds of education out there for here's what you need to do. What I'm finding about most of that education is it's it lacks. all the realness of what what a startup CEO actually needs. And that's why I picked the name like Startup CEO Reflections. I'm reflecting on my experience, sharing it with you if it's useful. Great. If it's not good luck that's okay too. but that, that's a very specific intent to just try and say, Hey I was there learning this at one point and I would like to help other people learn it. So many people trying to say, you can monetize your blog. I'm like, I don't want to monetize the blog. It's there to be helpful. And it's in my way of giving back to the people who are starting their entrepreneurial journey and that's, and I've learned a lot the process of writing means reflecting back on what you learn and it makes me a little, sometimes more self-aware of what I'm doing. So I've learned from it. Other people have learned from it and yeah. It's fun.

Robert Fenton: 

Yeah. Well, I think that a lot of people write from a thin slice of experience. You've got a lot of slices stuck together. So I think that would make sense. You've got a depth that you can pull from. So on behalf of the entrepreneurial community. Jen, I appreciate you sharing what you've learned and thank you for being an awesome customer of Qualio. We're excited to support your journey. And again, for your time today, I've learned a lot. You've just got a new subscriber to your blog. So you might not notice me amongst everybody else, but I'm there now, and I'm excited to follow your progress, Jen. Please keep in touch and thank you for joining today. I really appreciate it.

Jen Baird: 

Yeah, I appreciate you as well. Have a great day.

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Published by Teena Hart February 10, 2021