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.

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In medtech, developing novel, impactful technology is often just the starting line. The real race begins when you try to integrate your solution into the often-resistant healthcare system – a hurdle that has tripped up countless promising companies. Here are the key strategies and lessons from five veterans in the medtech space on how to overcome this hurdle.

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