Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Apply an Engineering Mindset to Your Medical Device Startup: Interview with Access Vascular CEO Jim Biggins

Episode Date: May 18, 2022

In this episode of Medsider Radio, we sat down with Jim Biggins, Founder and CEO of Access Vascular.Before starting the company, Jim developed innovative products for companies like Boston Scientific, Ocular Therapeutix, and Medtronic. He then spent 18 months shadowing clinicians in real-life medical settings, which led to the creation of Access Vascular's novel biomaterial for vascular access devices aimed at reducing common patient complications.In this conversation, Jim shares the importance of hearing directly from clinicians in the field, how to plan out a clinical research strategy, and the benefit of questioning assumptions when it comes to commercialization.Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors sent to their door at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Jim if you'd rather read it instead.

There's a lot of different ways to sell devices, to sell something. And, you know, I think a big mistake can be, you know, can be making the assumption that you know how to sell it, right? Just because of either past experiences or, you know, following someone else. And so we were very intentional about doing multiple sales pilots early on in the process. And then just continuing to iterate, right? very much like an engineering problem in a lot of respects. Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews.

Now, here's your host, Scott Nelson. Hey, everyone, it's Scott. In this episode of Medsider, I sat down with Jim Biggins, the CEO of Access Vascular. Prior to start of the company, Jim developed innovative products for other strategics like Boston Scientific, Ocular Therapeutics, and Medtronic, before spending 18 months exploring venture opportunities through shadowing clinicians in real-life medical settings. This company, Access Vascular, has introduced a novel biomaterial

for vascular access devices aimed at reducing common patient complications. Here are few of the things that we discuss in this conversation. First, don't underestimate the importance of getting into hospitals and talking directly with clinicians. Nothing beats observing procedures in real-life settings for understanding the actual. need and how your product can address it. Second, randomized control trials may be the gold standard of clinical research, but smaller well-time studies can also tell potential investors and

customers a compelling story about your technology and its applications. Third, don't assume that you know how to commercialize your device based only on past experience or observing others. Test your sales strategies in small pilot groups before scaling up based on your top-performing models. Okay, so before we jump into the discussion, I wanted to let you know that that we just released the first volume of Medsider Mentors, a print-based book that summarizes the key learnings from my favorite Medsider interviews over the past six months. Look, I fully realize it's tough to listen

or read every Medsider interview that comes out, even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider mentors. It's a way for you to learn from the best thought leaders in our space in one central place. Here's a teaser of what you'll see in this first volume.

Gar Hong Kong, founder of Health. Quest Capital teaches you how to successfully pitch your startup. Patricia Ziliak, CEO of Ivansens, discusses what you really need to know about clinical trials. Jared Bauer, CEO of Ionic Sciences, shares best practices for avoiding obstacles in your startup journey. That only scratches the surface, so if you're interested in learning more, head over to Medsider Radio.com forward slash mentors. If you're a premium Medsider member, you'll get free digital access and a print version sent

straight to your door. If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Erica Rogers, CEO of Silk Road Medical, Dr. David Albert, founder of Livecore, and so many others. Learn more by visiting MedsiderRadio.com forward slash mentors. Again, that's Medsider Radio.com forward slash mentors. All right, without further ado, let's get to the interview. All right, Jim, welcome to Medsider.

Hey, thanks for having me. Scott, really appreciate the invitation to talk today. Yeah, and have been watching Access Vascular ABI, you know, from afar. So great to finally have you on the show and looking forward to learning a little bit more about your story, about the journey with your company and kind of lessons learned along the way. So with that said, let's start kind of at the top, right? I provided a short bio right at the outset of this interview. But talk to us a little bit more about your professional kind of background leading up to actually forming Access Vascular. Yeah, absolutely.

So, you know, sort of I've always wanted to be an entrepreneur. So I think that's always something that's in my background that is a constant sort of theme in my career, even, even, you know, when I was younger, going through high school and certainly into college. I ended up going to UMass Lowell for plastics engineering, so engineered by education. And then during that time, I ended up working second shift at a small company called Medtronic assembling devices. with their diagnostics catheters. And so it was really there where I fell in love with the medical device industry and understanding the different aspects

of getting a product from manufacturing and into a patient. So it's a pretty great experience with Medtronic. Then after graduation, I was lucky enough to get actually a job offer for Medtronic in their quality function. And it was through Medtronic really, that I continue to develop my passion for, and I think this is their phrase, certainly not mine,

of doing well by doing good, right, the ability to impact the life of patients and really having a perspective on what you do from a career perspective, anyways, focused on improving patient's lives, and they do a really good job of sort of ingraining that into their culture. You know, from there I ended up going to Boston Scientific, got some experience there, again on the R&D side, more technically challenging devices with their PMA type devices. And then at that point, I ended up really wanted to do a startup, right? So that was always in the background, got connected to the entrepreneur that was running a company called Oculus therapeutics.

It's one of the first 10 employees there. And that's really where I solidified my decision that entrepreneurship in medical device was something that I could and wanted to do. And so there I was able to wear a lot of different hats, everything from, you know, clinical development to, you know, marketing to regulatory involvement. So that's really where I continue to develop my passion. At some point, I ended up getting my MBA and then realized that if I was going to start a company, there were sort of two areas I needed to work on. One was the sales side, right, sell. selling product and getting that.

And secondly, that sort of commercial experience. So started working for a contract manufacturer in the medical device space called Pulse Technologies and took a job there for a number of years while I sort of honed and developed those skills. And then at some point, I figured it would be now or never in terms of setting out on my own and starting a company. So ended up quitting that job and shadowing clinicians in and around Boston. through a program at MassMedic, who you're familiar with. And that program at the time was called the Ignite program.

I think they actually still have it. And that was sort of a pivotal moment that I gained access to clinicians, was able to shadow physicians for about, like I said, 18 months in various capacities and came up with the concept and the thought of starting a company that's now access vascular. Got it. And we're going to spend most of the conversation, focused on kind of access vascular and what you've, you know, really around kind of key learnings that you've picked up along the way. But before we go there and kind of learn a bit

more about like how the idea, you know, where the idea came from to start access vascular, with MassMedic, is that, I mean, would you kind of consider that somewhat similar to like the Stanford biodesign program to a certain degree? So I'm definitely familiar with the Stanford biodeign program. But in a way, it's, it's actually very different. Their entire focus is, at least at the time, I know they have a slightly different focus now, but it was really allowing entrepreneurs to gain access to clinical facilities, right? Watching procedures, which can be very difficult in my understanding now is that it's even more difficult. So that was really the part of the program that was attractive to me,

was enabling that, right, making those connections and allowing me to go see all kinds of cool clinicians and procedures. Got it. Got it. Okay. Good, good to know. I'm somewhat familiar with the the math medic program, but I've never really done a deep dive, you know, in terms of, you know, what that structure looks like, you know, what is it, what is it, you know, really, what does it really entail, you know, when, you know, kind of from start to finish. But maybe that's, that's another discussion entirely. But that serves as a kind of a good, a good transition to learning a little bit more about, like, how this, you know, how, how,

how ABI or access vascular came to be, right? So, talk to us a little bit more about what's proprietary about kind of the platform, right, that you've built. And, you know, how did it, like, where did this idea come from? Like, what did you see that led you to, like, you know, take a swing here? Yeah, I think it, you know, continuation on the story that we were just saying or just telling, which was just observations, right? Like, it really, it's a market-driven concept where, you know, over that course of the 18 months, I certainly came up or identified hundreds of different unmet needs, but it was really the amount of complaints and concerns that clinicians had regarding something as simple as vascular access that really got me to pay attention. And so it was kind of a combination of my materials background, the volume and the number of times that vascular access got brought up during those 18 months.

and then looking at the complete lack of innovation in the space and the size of the markets, I was very compelled to say, we should be doing better for patients and we can, there's got to be a way to sort of resolve some of these major issues. And that was really where I became highly focused on resolving the problems that plague, the vascular access space, which, as you may know, are thrombosis infection and phobitis. And so, you know, access vascular, you know, we are solely focused on addressing the challenges of obtaining and sustaining vascular access, you know, through that clinical treatment. Got it.

And so tell us a little bit more. So you saw this massive need. The problem kept, you know, surfacing. It sounds like over and over again, you know, back in that, you know, 2000, probably what, 14, 13, 14, 14, 15 time frame, something like that. Yeah, that's right. And so what, like, what's different? Like, give me your elevator pitch, right, around what's different about your, you know, your catheters versus bards or, you know, any, any, any other, you know, vascular access catheter. Yeah. So the, so the market, just to give you a perspective, right, the all of vascular access is about a four and a half billion dollar global market.

There is one material that makes up all of those devices. So there's, there is, you know, quite, literally zero differentiation in terms of the base material. Now, we're not the only company that's sort of identified the problem, obviously, right? It's known that these issues exist. And so competitive companies have tried to coat or add something to the base material. But unfortunately, for patients, it didn't really result in anything that was, you know, changed really the efficacy of the outcomes, maybe at a small level, but nothing that was, you know, truly transformational.

And so it was really identifying that there is no differentiation in this space. And again, with the materials background, knowing that there are better materials or at least different materials, right, before we knew we had a solution. At least there was something, there were other materials that certainly could be used. And it was really through that process that we identified and developed the material that we're using today. And it is, you know, again, fundamentally different. We chose to develop and design a different material altogether rather than work with the same base material. And it's different in a lot of ways.

It's not really a, it's not a thermoplastic. It actually retains a high, very high percentage of water. So it more closely mimics the body's natural chemistry. And then we can, and it's extremely lubricious as well. So it's sort of much more compliant with the body's natural chemistry. Got it. Okay. So the core differentiation is like the underlying like material, right, of your, of your catheters versus those that are, you know, commercialized by like I mentioned Bard and I can't remember all the big players, but I think, you know, Cividian was a big player. You know, I remember these, you know, catheters and in the, you know, the COVIDian sort of portfolio and on that tronic. Yeah. So it's, it sounds like it's really like the material is the underlying like core differentiator. That's exactly right. And it's, Scott, I can't tell you how, how difficult it is for people to understand that we change. the base material. Every time I talk to a strategic or I talk to a clinician, it's like, okay, so what's

the coding made out of it? It's like, well, all right, let's start with that premise that it's not actually coding. Because, you know, in the medical device industry, everyone wants to coat everything, which, and there are issues, fraught, fraught with issues in terms of what that means for patients. And so, yeah, we took a fundamentally different approach. Proteins can't penetrate the surface of our material like it can with the other polyurethains that are out there. And that essentially prevents the thrombosis cascade from

occurring in the first place. So that's really, you know, the secret sauce, if you will, the mode of action is it, you know, our material prevents protein penetration and therefore the calling of, of clotting, you know, other clotting agents that leads to all the clinical issues that you see. Got it. Got it. I love this. I was actually just, you know, fairly recently, reading kind of this this background piece on Elon Musk and like his early days right his like prior to PayPal his early days like basically kind of moving in the direction of areas that are just like hard like no one's doing no one's doing them most people don't want to tackle challenges it's uncomfortable and it sounds like you probably had kind of a similar I mean sort of similar dynamic where you've got all of these

big players that are basically manufacturing these catheters at the same type of material and you're like well, we can do this differently. There's got to be a better way here, right? But no one's moved in that direction, right, until, you know, your team at access vascular. So tell me a little bit more about like your thoughts, right, on that topic of like taking on or going into an area that is kind of seems to be like pretty, pretty challenging, right? It's never been done, you know, it hasn't been done before. It's new. You know, most people are probably going to be skeptical, right? So I'm sure, I'm sure you encountered kind of a lot of that dynamic right early on. Maybe you still do. Yeah. Yeah. I mean, there's lots to tackle there, Scott.

That's a loaded question. I think, you know, let's start with the big companies and hopefully I can hit on all the questions that you had. And if I missed one, just let me know. But I think starting with the status quo, right, I think when, you know, when there's a challenge, I live for that, right? When somebody says it can't be done or, you know, it's too challenging or it's not, you know, not something that, you know, a small company. could do. I love that because that means I'm on to something, right? That means that means there's a challenge there that's that's worth addressing. And so if you're a big company and you own a giant portion of the market and no one's no one has introduced to technology, it's it's it's

sort of like, you know, that no one's going to come steal your your lunch. So, you know, why are you going to change your approach, which is, you know, I can see the, the wisdom in that. And so So I think, you know, when you're doing line extensions, most of these large companies, that's how they make their money, right? They tweak one or two things and, you know, they address a concern that a clinician has or something that pops up in the market and then they launch a new product and that doesn't cost a whole lot of money and there's not a lot of risk there. But you also don't get to move the needle, right?

You also don't get to actually address major clinical issues that your patients are addressing. Look, you know, 85 or 90% of any patient that walks into a hospital is going to get a vascular access device, right? That's how ubiquitous they are. 30% of those patients are going to have some sort of a complication related to their device. And so you want to talk about an unmet clinical need. And that's only on the clinical side, right? Everyone at all levels of the hospital system are talking about economics. So think about what the economic impact of all of those delayed.

therapies, extended stays, procedures to resolve DVTs and PEs, maintenance associated with these devices, it's extensive. And so to me, that's where I want to innovate is something that actually makes an impact on patients. And just because, you know, there's not another company that wants to address it or is willing to address it, I mean, you know, sign me up. If I can make a difference and move the needle for patients, that's what I'm here for. And so that was just more encouraging, right?

Size of the market, it's stagnant, it has a massive impact on the economic outcomes for hospitals, especially with fee for service in this country moving towards value-based care. You know, I'm here for that for sure. And we're seeing that in our clinical outcomes, right? We see patients every day that are getting treated with, you know, traditional devices that, you know, are significantly impacted by the performance of those devices. And it's frustrating to an extent because, you know, we've treated 2,000 patients so far with our two devices.

We have, you know, retrospective clinical data that shows, you know, nearly eliminating these complications compared to the control in a, you know, statistically powered way. And so that parts the exciting part. So when people say, you know, how are you going to take on these behemoths or how are you going to make, you know, are you going to get market share? There's a huge clinical need that the hospital system cares about, right? Administrators care about it because it's costing the money.

Clinicians care about it because it's impacting the health of their patients. And no one's doing anything about it. So, so that's what we're here for. Got it. Got it. That's a great summary. And I think that that probably allows us to kind of like transition into kind of where your head was at in the early days of access vascular. And, you know, thinking about that time period,

as well as just the experiences that you mentioned kind of in the world of contract manufacturing, right? You spent some time in that space too. Like, what do you, what do you think maybe are the biggest mistakes that either you made or that you see, right, at that in those early days, right, of developing, you know, prototype, you know, alpha and beta prototypes that most kind of med tech or life science entrepreneurs make at that particular, you know, phase of the company. Yeah. So I would say the two biggest things early on are not getting out and talking to clinicians

and not just asking them for like the purposes of design control. Like, hey, we have to talk to three clinicians about what the product should look like. Let's tick that box off. But like actually, you know, working alongside them, observing and having. that actual input from the real world influenced your design and product concepts. It's not good enough just to sort of scratch the surface for sure. So I would say that's the biggest thing that I see. Because, you know, Scott, like as we discussed, it's also difficult to gain that access. And it's only getting more difficult. So I understand why people shy away from it, but

it's almost the only thing that people should focus on early on. Got it, got it. So it's almost like a mindset shift from your perspective of like viewing VOC, not just to check the box per se, but like viewing VOC to really truly uncover like what is needed here, right? What are the real challenges that they're at hand? Well, but I also, so I would take that a step further. It's not just the voice of the customer, right? It's not just what they tell you because often what they tell you is not accurate, right? It's really, you know, getting in the weeds of, hey, try this. How does this fit in your hand? How does this, how does this, you know, work? in a clinical setting, does it disrupt your clinical practice? You know, what sort of an impact on outcomes would you be willing to accept if we extended the procedure by five minutes, by 30 seconds, and really understanding how the product is going to get used and make sure that that influences your actual design. And then being in making those observations as well, not just taking, you know, not just sending out an electronic survey on different features, but getting in there and

and seeing how it actually gets used. Yeah, getting rolling up the old sleeves, right? Getting your hands dirty. Yeah. Yeah, it's device, right? We live in a physical, physical world, right? We're not designing, you know, maybe some groups are designing apps, but at the end of the day, there's some sort of an interface with a real person in a real environment that needs to be, you know, a focal point.

Yeah, yeah, no doubt. It's interesting that you bring this up. we're, you know, we're, you know, pretty involved with, you know, fairly extensive discussions like this with, with, with, with, with, with, which is where I'm spending most of my, most of my time these days. Um, and, uh, we have a lot of these conversations, right, around kind of asking questions around, you know, some, some, some, some, some cat renders, right? But some, you know, we can't really ask these questions until we actually have something to show, right? Because the physician's not going to be able to, you know, they may, they may, they may be able to make some super superficial, you know, level, level comments around, you know, some, some, some cat renders, right? Right. Right. Right. Right. Right. Right. Right. but it's not really going to be overly interesting or compelling, you know, feedback until they get something in their hands. You know what I mean? So I would completely echo your sentiment. On that note, let's transition to kind of like reg and clinical. Because you mentioned at Axis vascular, you're taking on a pretty significant, you know, challenge in a massive market. But the underlying differentiator here is the, is the material, right?

Which is no small feat from a reg standpoint. So talk to us a little bit more about like, how you've approached, you know, the kind of the regulatory path with a kind of somewhat nuanced regulatory path in your case. Yeah. So your question is very timely. I'm actually flying out to MD&M West next week to give a talk on this very topic. And I think it's a very important one. And if I could maybe sort of adjust the answer or adjust the question and answer that one.

I think there's a lot, you know, obviously a lot going on with the FDA, right, the regulatory bodies, actually not just in the U.S., but OU.S. as well. And I think the one thing that I've learned, right, so if it's sort of, you know, my learnings over the years, I think two things really, really stick out to me as maybe pitfalls that other companies fall into and lessons that we've learned really understand the regulatory process. right, understand what, you know, what is the FDA concerned about? What's the agency concerned about? What are they focused on? What are the hot topics? And making sure you answer those very important questions to them, right? Because they're, you know, they have a job to do. And I think that, you know, sort of the perception that it has to be like an adversarial relationship,

I think we're beyond that, right? I think that's a great thing that the, you know, whatever's causing it in the industry is actually very positive, where the FDA is leading the way in a number of different aspects in terms of how they review, submissions for 510Ks specifically. And the approach that we took was, okay, well, you know, what are the products in this space? What do they take to design, develop, and get through the regulatory process? Some of them are much more complex than others. as an example, dialysis catheters are more expensive and more complicated to get through the

regulatory process. You know, pick lines and midlines are less. And so, you know, we, our material, fortunately, can address, you know, all of the different spaces within vascular access, as we've already discussed. And so our approach was, okay, what is the, what's the agency going to be concerned with, right? They're, you know, what are the safety concerns? How do we make sure we fully address those in a responsible way and give them what they need to feel comfortable, you know, and for us as well. And then what do we need for a submission? So we again, focused on pick lines, relatively straightforward for us. At least we thought that when we, when we started trying to find manufacturing techniques for a novel new material,

even if the overall shape is relatively straightforward, is not as easy as one would hope when you start off with these things. But I think it's just really focused on smart approaches and knowing the regulations and knowing design control and being able to operate within those confines. Some of our most successful R&D engineers here, they know design control as better or as well as they do design, right at being able to navigate through you know the timelines you know areas that they that that might

trip up other people and how do you efficiently go through that process and to me understanding so to summarize understanding the agency and understanding design control has been has been key for us hey there it's scott and thanks for listening in so far the rest of this conversation is only available via our private podcast for medsider premium members if you're not a premium member yet you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan, CEO of Cala Health, Nadim Yared, CEO of CVRX, and so many others. As a premium member, you'll get to join live interviews with these incredible medical device and health technology entrepreneurs. In addition,

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