Mark Byrne is an experienced life sciences leader with broad commercial and technical experience in: strategic planning, class II and class III medical devices, in-vitro diagnostics and biotech. He has accomplishments in technology commercialization, leadership, general management, product and business development, identifying new growth opportunities, developing innovative technology, negotiating licensing and financing transactions, planning and executing mergers and acquisitions, and managing product development teams.
Aaron Moncur, host
About Being An Engineer
The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community.
The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us
Mark Byrne is an experienced life sciences leader with broad commercial and technical experience in: strategic planning, class II and class III medical devices, in-vitro diagnostics and biotech. He has accomplishments in technology commercialization, leadership, general management, product and business development, identifying new growth opportunities, developing innovative technology, negotiating licensing and financing transactions, planning and executing mergers and acquisitions, and managing product development teams.
Aaron Moncur, host
About Being An Engineer
The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community.
The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us
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Mark Byrne:Oh, you're very welcome. I'm happy to be here.
Aaron Moncur:Well, what made you decide to become an engineer.
Mark Byrne:So that was a long time ago. And as a high schooler, I was dabbling in electronics, I was fascinated with building and testing circuits, had an engineer for an uncle who kept me in spare parts. So I always had things to pick up when I went over to his house. And like a lot of engineers, I was good at math and science. So it seemed like a natural fit.
Aaron Moncur:You know, I hear quite often when I ask people that question that they had a family member who was an engineer, and that influenced them somehow that was not necessarily an answer that I would have been expecting before doing all of these episodes. But that seems to be a pretty important factor, whether one becomes an engineering not interestingly,
Mark Byrne:yeah, and this particular uncle we were pretty close with. So my family saw his family quite a lot. And, you know, he encouraged me, and also was very happy when I chose chose the field. Wonderful,
Aaron Moncur:wonderful. Well, you own a company called PriMedicus Development, your own business for, I think, nearly 20 years now. What can you tell us about PriMedicus?
Mark Byrne:So I started primitive, because development 20 years ago, to create a consulting umbrella. I was leaving my first startup company wasn't sure what I wanted to do. But I knew I didn't want to relocate for personal reasons. At that time, I had over the course of the first part of my career developed a broad skill set. I also had quite a number of contacts, and decided to go out on my own. For the first three or four years I worked completely solo, largely for small startup companies, as well as some big device companies. Then hired my first couple of employees went down that road for a while. And but for the last several years have been solo yet again, primary focus focuses on the early stages of the product lifecycle, clients hire us, to help them figure out the technology, help them figure out the patent landscape, help them figure out is there a market so typical products that we might deliver projects we might deliver range from prototypes, either the first or second generation prototype of a product? Business plans, strategic analyses, patent landscape documents, things like that. So we're not hired on the other end of the product lifecycle, so we're not in the manufacturing business. We can help connect clients to manufacturers. We're not in the regulatory business, but we can help click Connect clients to regulatory recesses, resources as well. Interesting.
Aaron Moncur:How were the first few years when you went out on your own? Were you able to develop enough business right away or did it take a little while to get your feet under you?
Mark Byrne:I was surprised how fast it went. Within six months, I was full time booked. If if not more, I had in the early stages of my consulting business, a problem managing my workload, I was working way too much. Because as you're, when you're solo, you're doing the marketing, you're doing the sales, you're doing the product execution, the finances, so on and so forth. So that's what led me ultimately, to hire additional people, the first person I hired was a bookkeeper office manager to help with kind of that side of the business. And then I hired another person to kind of do what I was doing, so that I could train them to serve the clients. This
Aaron Moncur:is all sounding very, very familiar. When I started pipeline, 14 years ago, it was just me. And I wore all the hats, sales, marketing, accounting, engineering, project, lead, write all those things. And then eventually, we hired some people to help with various aspects of the business. So very familiar story, let's fire,
Mark Byrne:one of the people they hired was a teenage son, his job was to clean the office. So that was his first paying job. Perfect. He went on to get a PhD in engineering, so I guess something rubbed off on him. Oh, wonderful.
Aaron Moncur:There you go. Another family member influence on an engineer. I remember when Oh, it was probably 12 years ago, or so it was in the first couple of years that I had started pipeline, there was this project. And back then we did a lot of product design, General Product Design. And there was this phone case, it was a phone case for kids. And they had all these wacky avatars were kind of like animal themed phone cases. And there was this one that was a monkey. And it had all these little hairs on it. Of course, they weren't as small as an actual monkey here. But they were added no call a millimeter or so in diameter, and it was all made out of injection molded rubber. And these hairs needed to be placed individually, that there was no other way that we could do it to make it look kind of real, right? Organized, organized chaos, so to speak. And the only way we could figure out to do it was to place it manually. Well, we went through kind of looked at the surface area of this case and the size, or the spacing between different hairs and calculated that it was going to take like eight hours to just replace all of those hair, you know. And so with that, well we I mean, that seems unreasonable to charge our customer for eight hours of engineering time just to click click, click. So we found a neighborhood kid who was like 14 years old or something you know, old enough to run a computer, and just show them how to do it. Hey, just click this thing, and then move it a little bit and click it over and over and over. And he did great. We paid him like 10 bucks an hour or something? Yeah. It'll be very happy. Thrilled. Yeah. All right. Well, you work or have worked with quite a lot of engineers throughout your, your career. I'm curious, what are some patterns or habits that you've seen in the best engineers, the most talented successful ones. And then conversely, what are some things that you've seen in those who've struggled to succeed in engineering.
Mark Byrne:So I think engineers need to have, obviously, technical skills, and the strong technical skills gives them a great start. But in addition to that, they need some degree of communication and interpersonal skills. So I have seen outstanding technical individuals that struggled because they couldn't work with others, they couldn't communicate with others. So you can't underestimate the soft side of engineering. On the flip side, you can have the opposite setup, you can have people that are maybe mediocre or weak engineering skills, but are great at communications, they typically don't do real well, on a hardcore technical project, partially because they get bored easily with the technical minutia, they don't understand it, and they don't appreciate it. And that's why they end up in, you know, non what I call non day to day engineering roles, like sales or marketing.
Aaron Moncur:It does seem like you need to have at least a certain level of engineering intelligence to succeed, it doesn't need you don't need to be the best engineer in the world by any means. But you have to be at least at a kind of a certain minimum level. And then beyond that, I agree. It's really your ability to communicate and a soft skill fit. That can make the difference between being a lifelong individual contributor versus an engineering leader. Not that there's anything wrong with being an individual contributor,
Mark Byrne:but correct. And in today's world, people that can function in teams, teams that are geographically dispersed, are very important, you know, years ago, everybody was in the same room. And, you know, you could easily connect with the other person now you have to reach out electronically or perhaps you're talking to somebody that does not have English as their native language. So, communication skills of all types are critical. And as I've recruited people over the years, whether as employees or as collaborators, I always looked for and valued, kind of a balanced portfolio of skills, if they were really strong in one area, but lacked all the others. That wasn't my top choice. Sure,
Aaron Moncur:yeah. Terrific. You've held several C level positions throughout the years as well, can you give us a sense of what does a C level executive do, particularly within kind of an engineering manufacturing environment.
Mark Byrne:So let me characterize the positions I've held as in early stage companies, because early stage companies are a very different beast, than what I call a mature company that is manufacturing a product. In an early stage company, a C level person is fundamentally responsible for the financing of the company, the product in terms of getting the product defined, developed, and to market, and then ultimately, the financial performance performance of the company. So one of the hats you wear is a very familiar hat, because you're responsible for product. And you either do that yourself, or you delegate it to somebody that you hire, to be responsible for market definition, development, so on so forth. What's new? What's new to an engineer moving into one of those kinds of roles is the whole world of financing, getting other people's money to run your venture, reporting on finances? And all of the things that goes along with that?
Aaron Moncur:How did a background and engineering prepare you for these sea level roles? And then also, did you ever feel limited in those roles? Because you didn't have I'm assuming here, an MBA or a business background?
Mark Byrne:Good question. I'm going to answer them in reverse order. So no, I do not have an MBA other than an MBA from the school of hard knocks. You learned a lot. You know, I learned a lot of unfortunately, in the early and middle stages of my career, I worked for large companies that offered lots of training programs, and whatnot. But it was also at those companies that I was pigeonholed, and viewed as just an engineer, even though I had skills and aspirations to do more than engineering. So for me to scratch that itch, I had to leave a big company, and go to work for a startup, where they valued notch treasured degrees, but everything you could do, every skill you brought to the table was something great because instead of dozens of people, they had a few people. So having an opportunity to learn having an opportunity to gain some skills, outside of engineering is a great developer, for people that are at the front end of their career, because it positions you to take different kinds of roles. And even if you don't take a role like that, you'll understand more the language, you'll understand what's going on around you. Very nice.
Aaron Moncur:Well, one area that you have quite a bit of experience in is market research to to validate new business opportunities or products, can you walk us through a few strategies that you found successful in doing so.
Mark Byrne:So the fundamental method of market research is to talk to customers. And there's lots of ways to do it. So if you're in a large company that has lots of money, they will conduct market research studies. They'll do qualitative research, which really looks at the knowledge, attitudes and practices of customers in a particular segment. Then they'll do concept research, where a proposed new product is shown. Typically, in a blinded fashion, the people in the room that are observing the product, don't know who the potential manufacturer is. And you're either looking at this study on video, or maybe you're behind a one way mirror and observing it. But in both of those cases, you're trying to get customers of all stripes to tell you what they need, what they think, and more importantly, what they don't like about your product. When you move into a small company environment, you don't have the money to do that right away. So you end up talking to customers directly. And you can do that in a lot of ways. One is survey tools that you use online survey monkey and things like that, that you can very quickly send surveys to large numbers of people Those are only good to a certain point, because you're asking specific questions and the, you don't have an opportunity to ask follow up questions per se in that survey. And you really have a hard time showing a product or explaining a product that way. But it's a piece of information, it's a piece of the result, what I found most useful, was either attending a trade show, or finding a way to get face to face with a customer. Show them my product, whether it was a model that I had with me, whether it was a rendering, rather, it was a set of features, you know, your customer, this is a product I'm planning to build, it will have these features and these characteristics. What would you think of that, if I could offer that to you? And then in that dialogue back and forth, you have a chance to ask follow up questions, and you'd learn from the customers questions, the customer will ask things that maybe you haven't thought of, or you haven't considered. So talk to as many customers as you can find, and iterate on that process. So the first generation, you go out, you talk to 20 customers, you learn from their feedback, you make changes, and then you talk to another 20 customers, and so on and so forth, until you're getting consistent, positive feedback that you're on the right track, don't don't do it just once, iterate, and don't rely on third party market research studies.
Aaron Moncur:That's great advice. I love the idea of of iterating. And have you found that, you know, 20 ish people, that's kind of a good cross section of the market to use as your iteration.
Mark Byrne:I would talk to more if I could, you know, it really depends upon economics, and how easy it is to get these customers. I remember, product I was working on a few years ago, we went to a conference and over two days probably had 75 interviews. And by the time that was over, we had a really solid understanding of how the customers solve this problem today, what was their current practice, what they liked, what they didn't like about that. And then more importantly, what they liked about our potential product, and the questions they had for us that we knew we would have to be able to answer as we brought that product to market. Yeah.
Aaron Moncur:So once you have a reasonable understanding that yes, this is a product that the market wants we we've got the features more or less correct, conceptually. How do you go about funding these these ventures? I mean, what are some successful strategies you've used to find funding to commercialize a technology.
Mark Byrne:So you have to find someone that has a problem, and is willing to pay to help solve that problem. So essentially, you need a customer to help fund the first stages of development. That could be through a development contract, that could be through some kind of a license or partnering agreement. You know, I'm developing a product, you see my prototype, you have a huge problem. And you're willing to underwrite in some way, shape, or form the development because you value the solution to that problem. Once I have you and handled that initial customer that is helping, then I'm in a position to go talk to financial investors, whether they are angel investors, or perhaps venture investors, venture investors typically are not the first money into a new startup. So I have to start with someone that find someone that has that problem. So maybe my market research identifies some potential collaborators, partners, what not get involved with them structure, some kind of development agreement that satisfies my needs, in terms of cash satisfies their needs. And there's lots of ways to do that. make progress towards milestones, and then use that progress and that relationship to start bringing in other other investors. That's,
Aaron Moncur:that's really interesting. Finding a partner in the beginning of customer that has that problem and then partnering somehow with them. That's not something I would have thought about. So are you suggesting that finding a customer, let's say it's one of the big strategic medical device companies out there, they've got money to spend, and they have this problem, and we think we have a solution for it. You approach one of these companies and say, we'd like to partner with you, and we want you to pay us to develop this. So in an agreement like that with the the partnering company, pay part of the development cost and then at some point, you go and look for angel investing or venture capital All?
Mark Byrne:Yeah, so part of it depends on the scope of the project. If I'm developing a class three medical device, that's going to take 20 $30 million to get to market if not more, that's a different problem than a class two. But let's use, we'll use a class two as an example. So if I went to one of the large medical device companies, and they get their doors knocked on all the time, I spend time there is on the receiving end of all these calls. And if my solution matches what they agree to as a market opportunity, and it may or may not, then there's the potential to create a development agreement that gives them some licensing or acquisition rights, when the product hits certain milestones. That's hard to do. So the big device companies are hard to sell to, at the very, very early stage, they typically will be more interested when you're further along and have some preclinical data or even some clinical data. But they are part of the development pathway, they are part of your funding opportunities. All of the big medical device companies have venture arms that at some point would be a potential funder as well. But what I'm talking about is finding, you know, perhaps a medical practice, or a group of doctors that have a problem or a smaller company that has a problem, and to step up to the bigger fish as you go. Interesting,
Aaron Moncur:okay. Now, once you have an initial partnership, maybe you're, you're well into development, you've proven that the core technology works, and you're ready to start looking for more money to further commercialize this. How do you go about finding that kind of money? I mean, are you just Googling angel investor capital, venture capital firms? What's the approach that someone who doesn't really have those contacts can can take? Yeah,
Mark Byrne:so that's not the way you do it.
Aaron Moncur:So rule number one,
Mark Byrne:rule number one is venture investing is to always arrive with an introduction. So I'm at the I'm at the point where my product, I have preclinical data looks solid, I have an IDE, and to the SBA, we're going to do a human clinical is going to cost say $3 million. The first thing I would do is research on funds that maybe are interested in this space. So let's say I'm working on a medical device for neurosurgery. Not everybody's investing in neurosurgery funds have specialty special areas. So even within the medical device space, is anybody currently investing in neurosurgery? Do they have, for example, a competitive investment, if they do, they're not going to be interested in me, they'll just take take my ideas and share them with a company they've already invested in. So I have to do my homework, and narrow the field of candidates. And let's say I've narrowed it down to four or five candidates, then I have to find somebody in my network that knows them. That can give me an introduction to them. So I am taken seriously. If I just send a business plan to firm XYZ, nothing's going to happen to it. It has to be it has to arrive with an introduction, then that starts them we get to start the process of talking to them, of them perhaps taking an interest in ultimately making an investment. But it takes a lot of time. And a lot of effort to do your homework before you approach investors. Another way to get there is with perhaps angel investors. So there are lots of organized angel investor groups in the country. They are very active in medical devices, it a number of fields that are viewed as attractive potential returns. Getting angel investors into your deal early can also be a way to get venture investors in later because sometimes they have those personal relationships. Sam knows this firm and he's done deals and referred deals to them. So you're well, you're well received. So and most angel investors work in their kind of community. Broadly speaking, there's every municipal area in the country has angel investor groups. There's the national angel investor, association, Angel Capital Association, I'm sorry. And I've been very fortunate in most of my projects, to have angel investors in the deals and they are a big help, not just with cash but also their connections.
Aaron Moncur:And typically angel investors or private individuals, making relatively smaller investments, I don't know 100,000 Or a few $100,000 Is that more or less the case, but
Mark Byrne:there are more and more angel funds. So I'm located in Ohio, and all of the big angel investor groups in Ohio also have funds. So if I go to one of those groups, they're looking at me with two possible outcomes. One is an investment from their fund, which could be up to a million million and a half over the life of the deal, maybe initially, a half a million or less, and then what's called sidecar investors. So the individuals, individuals in the fund, and there may be 50 or 60 individuals, and some of them may write checks, and some may not. Got it. Okay. Very interesting. That's a very common model throughout the country that angel groups have organized and are starting to look like venture capital funds looks 2030 years ago.
Aaron Moncur:Okay. All right. How about when you're trying to estimate how much funding you need for a venture, I once read in what was Donald Trump's book called Art of the Deal, I think that he would take his contractor's estimates and add 50%. And that's what he used for the budget for our project, any, any rules of thumb that you've used over the years,
Mark Byrne:if somebody gives you a single point estimate of time and dollars, it's wrong. It's always it's always wrong. So. So in that regard, adding 50% is probably a good start, my approach is to do a bottoms up estimate, and a top down estimate. So bottoms up, you know, looking at the manpower, the expenses, the travel, the prototypes, everything you have to do to get from A to B. And that gives you one set of numbers, and then a top down estimate of what would you think it ought to take. So now I have a range between two numbers, and I can explain how I got each of them. And then over time, I should be able to refine that range and get tighter and tighter. But it still is a guess. And investors know, it's a guess, every investor that I've ever talked to said, you can tell me what you think it will take, but I know you're going to be wrong, not nothing against you personally, they just know that the early stages of development, it's an art, and so many things can go wrong. And you can easily burn hundreds of 1000s of dollars, without even thinking about it. So once you have those estimates, you do everything you can to refine them. And then as you get investors in your deal, you continually update them with monthly updates on what's the plan look like? Where are we relative to the plan, any changes, you know, if we suddenly learned that no, you know, some such and such material is going to be very hard to get, we're gonna have to pay 3x market price for it, that that's new information that changes the plan. The other thing that I've learned is that investors are more interested in my assumptions than in the numbers. So in that whole estimate, budgeting process, one makes a whole series of assumptions about the market, about selling price, cost of goods, development time, resources required. And that's the discussion you have with potential investors. It's not, it's $3 million. It's Mark, why do you think it's $3 million? What assumptions did you make along the way? And then they can start to check off? Yes, we believe, you know, cost of goods, we believe there's a sound basis for that, oh, he's way off on price, he'll never get $50 a unit, he'll only get$10 A unit. So that's then you can have a discussion about why one point of view is better or worse than the other. As you as you go through the estimating process, keep rigorous notes on your assumptions, and be prepared to discuss them. Very good.
Aaron Moncur:All right, well, what would have been maybe one of the biggest failures and one of the biggest successes of your career and and what did you learned from those experiences?
Mark Byrne:Well, when you're working early stage product development, you typically have quite a few failures. And I've had I've had my my share of them. So big failure I had recently was a sensor technology that we took out of medical devices and hospital usage and started to explore a food safety opportunity with it so it's a little bit out side my core expertise. And ultimately that company sailed. And it's failed for technology reasons. The market is still there, no one has fulfilled the market need. But we couldn't make the licensed technology work correctly. So what I learned from that was the need to have stronger experts when it's outside my core expertise. So this was sensor technology, part of it was electrical. The part of it was biological. And I'm not a biologist, and I thought I had that covered with biologists on the team. But it turns out that was in insufficient. So the lesson learned there was, don't rely on yourself for everything. And in a project like that, we needed stronger team members and certain roles that we were able to afford the front end, I mean, we were we would have hired different people if we'd had the money. So it gets back to what's the financing strategy. And when do you pull the trigger. And perhaps we shouldn't have pulled the trigger until we had more money in hand to be able to fund those types of individuals. So it's, but that was a failure, very, very big disappointment, especially when the market need is still there. And I know if I had that product today, I could sell it. So very disappointing.
Aaron Moncur:Maybe another opportunity will come around for that one, right.
Mark Byrne:So a big success was a product out of Mayo Clinic, that I was involved in the front end of putting that deal together. licensed technology started a company, it was a genetic test, to help physicians find the right drug and the right dose for behavioral health patients. This was back in the mid 2000s. When no one even knew what we were trying to do. The Mayo physicians were at the forefront of this opportunity. And ultimately, we were able to put a company together, get it financed, had a nice exit out of it. Product is still on the market today. And when I look back on that, I think an important ingredient for success was the relationship that I was able to build with the physicians at Mayo Clinic. There were three inventors, and we spent an inordinate amount of time with them, making sure they appreciated what we were doing so that they could share technology with us they could share. They were all psychiatrists, so the practice of psychiatry, so we intimately understood how this product would fit into the physician's practice. So that I think that was a an example of knowing your customer and knowing what your customer needs. And because of them, we were able to talk to lots of other customers. And so that put a lot of ingredients for success when that project.
Aaron Moncur:What another way of defining that be to say you understood the problem really, really well.
Mark Byrne:Yes, we understood the problem really, really well. And we understood how the solution would impact that problem. Terrific.
Aaron Moncur:All right, well, just maybe one more question here or two, and then we'll wrap things up. Specifically within the context of your role as an engineer, what is one thing that frustrates you, and also one thing that brings you joy.
Mark Byrne:So I have always enjoyed developing other people, and helping people further their careers. And there's two sides of that coin. One side is when people don't respond to the opportunities you give them. And as a result, they don't develop or they miss an opportunity. And I get frustrated. So the flip side of that is, they take advantage of it. They learn and they continue to learn. And I've had people on both sides throughout my career. And it's very gratifying to know that I've made an impact on an individual and help them end up in a better place career wise. Most people are willing and will accept coaching, Coach accept additional responsibilities, some won't, and those other frustrating ones. Terrific.
Aaron Moncur:All right. Well, speaking of joy, one of the things that we find great joy here at Pipeline is r&d and In developing new processes, and so if you have a project where you're trying to develop some new r&d process or some new manufacturing process, give us a call, we would love to talk to you about it. And not only can we help develop that process, but we can also build custom equipment, test fixtures and automation around it to help you ramp up production. So give us a call. Mark? How can people get in touch with you?
Unknown:The best way to get in touch with me is just a direct email Mark@PriMedicus.com. It's spelled PriMedicus. You'll find me on LinkedIn. So you can see more about my background there. But I don't respond to LinkedIn as much as I should. So direct emails always most efficient. Terrific.
Aaron Moncur:And what else haven't we discussed that you think we should we should talk about Before ending this episode?
Mark Byrne:Um, nothing immediately comes to mind. I think it's been a fairly comprehensive interview. I thank you for putting these podcasts out there. I think it will help individuals at all stages of their career. Because no one has all the right answers and learning from other people's experience other people's point of view is a great way to get better. Well,
Aaron Moncur:Thank you so much, Mark. This. That's the intention of the podcast here. Of course, university will prepare you greatly to be an engineer from the technical side. But what we hope to accomplish with the podcast is to give everyone a peek behind the scenes, what does an engineer actually do? What are all the different opportunities for an engineer and to connect different people, such as yourself with the engineering community? So thank you so much for being on the podcast.
Mark Byrne:You're welcome. My pleasure.
Aaron Moncur:I'm Aaron Moncur, founder of pipeline design and engineering. If you liked what you heard today, please share the episode. To learn how your team can leverage our team's expertise developing turnkey equipment, custom fixtures and automated machines and with product design, visit us at Team pipeline.us. Thanks for listening.