How to Apply an Engineering Mindset to Your Medical Device Startup: Interview with Access Vascular CEO Jim Biggins

It’s easy to see that Jim Biggins, Founder and CEO of Access Vascular, is an entrepreneur at heart. He started business ventures as a teenager and has since strategically steered his career path to strengthen the skills needed to eventually launch his own medical device company in 2015.

But it’s an engineering mind that Jim has employed to navigate the challenges of introducing a groundbreaking new biomaterial into the $4.5 billion global market for vascular access devices.

Access Vascular closed on a $20 million Series B fundraising round led by TVM Capital Life Science in 2021, and in early 2002, the company opened its new 40,000-square foot manufacturing facility outside Boston.

Jim founded Access Vascular based on a need he identified in the medical device market, and then proceeded to reverse-engineer the solution to a pervasive problem he encountered while observing clinicians through MassMEDIC’s Ignite training and mentorship program.

As his company has evolved, Jim has leveraged a similar framework to complex clinical research, and commercialization processes — designing his own roadmap for developing, testing, and iterating various potential solutions.

In this episode of Medsider, 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.

Guest

Jim Biggins

CEO of Access Vascular

Jim Biggins developed innovative products for companies like Boston Scientific, Ocular Therapeutix, and Medtronic before spending 18 months exploring venture opportunities by shadowing clinicians in real-life medical settings. His company, Access Vascular, has introduced a novel biomaterial for vascular access devices aimed at reducing common patient complications.

Key Learnings from Jim’s Experiences

  • Don’t underestimate the impact of getting into hospitals and talking directly with clinicians. Nothing beats observing procedures in real-life medical settings for understanding the actual need and how your product can address it.
  • Randomized control trials may be the gold standard of clinical research, but smaller, well-timed studies can also tell potential investors and customers a compelling story about your technology and its applications.
  • 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.

Clinical Access Offers Valuable Insights

Jim first fell in love with the medical device industry when he was an undergraduate student studying materials engineering at UMass Lowell and working the second shift assembling devices at Medtronic. Over the next decade, he racked up experience in all aspects of the medical device space — R&D, clinical affairs, marketing, regulatory, marketing, and sales.

When he was ready to take the leap to start his own company, Jim joined the MassMEDIC Ignite program, and for 18 months, he shadowed clinicians in various capacities, listening to their experiences and complaints, and developing the concept that would eventually become Access Vascular.

It was a pivotal moment, he says, as this face-to-face access helped him uncover a huge market need he may have otherwise missed.

“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,” he says. “Looking at the complete lack of innovation in the space and the size of the market, I was very compelled to say, We should be doing better for patients.”

Drawing on his materials background, Jim developed a proprietary new base material for vascular access devices that could reduce the main complications patients experience. In an industry with virtually zero differentiation among existing products, Jim felt that his new solution could move the needle in terms of improving patient outcomes and improving the economic impact of vascular access complications.

Jim credits his real-world clinical access with the idea for his company, and believes that getting into hospitals to observe and speak with clinicians is a missed opportunity among medtech entrepreneurs in the product design stage. It’s a crucial part of the process that goes beyond ticking off the boxes mandated by design controls. And while Jim acknowledges that gaining this access has become increasingly difficult, the experience is well worth the effort.

Rolling up their sleeves allows entrepreneurs to really get in the weeds to figure out a device’s use and impact. This experience can help you understand everything from how a device fits into a clinician’s hand to how use of your device could extend procedure time, and whether that’s an acceptable tradeoff for improved outcomes These are learnings you can’t easily get from sending out a few electronic surveys.

“We live in a physical world,” Jim says. “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 the focal point.”

Uncover Your Clinical Research Roadmap

Jim says that it wasn’t always clear how Access Vascular should approach the issue of clinical research. Lots of people recommend a randomized control trial (RCT) right out of the gate, but that’s an expensive avenue for a single study that may or may not have the desired impact on fundraising and sales efforts.

Thanks to great guidance from some advisors and his own due diligence, Jim was able to reverse-engineer his way to a solution.

He looked at five successful companies operating in arenas similar to Access Vascular and plotted each company’s studies and publications on a five-year timeline. Then he looked to see what sort of clinical evidence they had in place at each pivotal point in the company’s growth. What he found — rather than a single RCT — was a volume of studies put together to tell a compelling story.

This approach has worked well for the company. Jim found that value analysis committees are more than willing to evaluate the product based on these smaller studies that speak to specific aspects of the technology.

“It’s really about knowing what resonates, building that story up and making sure we have the right endpoints and the right sites,” he says, “and then we pull the trigger [to do an RCT] when it adds the correct amount of value.”

Create an Iterative Process for Commercialization

When Access Vascular reached the commercialization stage, the company faced stiff competition from large, well-established sales forces. But instead of trying to hire dozens of representatives to match the size of their competition, Jim started with a handful of small, focused sales pilots.

“There are a lot of different ways to sell devices,” Jim says, “And I think the big mistake can be making the assumption that you know how to sell it because of either past experiences or following someone else.”

Jim approached the sales pilots like an engineering problem from the start, iterating each time he found a representative profile or distribution model that out-performed the others. The company’s go-to-market strategy examined a number of variables including geography and likely early adopters. They also had to consider which hospitals would be willing to open their doors to a new medical device company in the midst of the COVID-19 pandemic.

Now that the company is ready to hire a sales team, they have a much clearer picture of the successful formula.

“As we kept learning, we just kept track — Here’s the pipeline with this sort of profile, with this geography, with this concentration of hospitals,” Jim says. “And then — Who’s letting us in the door? What’s working? What’s resonating? What’s the messaging? All of those things certainly came into play.”

Through navigating each of the processes involved in launching Access Vascular, Jim has kept the company’s mission front and center.

“Ultimately, if you’re doing the right things by solving a real problem, and you’re passionate about that, I feel like everything else will fall into place,” he says.

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