Built by Margin with Laurie Chen

The Risk, Capital, and Regulatory Path Behind Medical Innovation with John Konhilas⁠

Laurie Chen, CPA, MBA Season 2 Episode 48

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0:00 | 36:27

In episode 48 of Built by Margin, Laurie Chen speaks with John Konhilas, founder, professor, and Chief Science Officer at BioXGen, about what it really takes to turn scientific discovery into a product that can reach patients.

John shares his unconventional path from studying art at Duke University to earning a PhD in physiology, spending nearly two decades as a professor at the University of Arizona, and building ventures at the intersection of women’s health, heart disease, microbiome research, and medical device innovation. He discusses the lessons from scaling and exiting Menolabs, including how data, consumer behavior, and timing shaped the company’s trajectory. 

The conversation then moves into BioXGen’s patent-pending single-use cardiac patch, designed to be placed directly on the heart during open-heart surgery to support healing during the highest-risk post-operative period. John explains the technical, clinical, and adoption risks behind the product, why surgeon buy-in matters, and how the company is pursuing an FDA 510(k) pathway to create a faster and more capital-efficient route to market. 

Laurie and John also discuss capital strategy, including self-funding, friends-and-family investment, and BioXGen’s current Regulation CF raise. John shares why he believes in “science for the people,” how AI may accelerate medical device customization, and why founders building serious medical innovations need diligence, partnerships, and the willingness to step outside their comfort zone. 

This episode is a powerful look at how discovery becomes utility — and how risk, science, regulation, capital, and persistence all come together when building something that could change patient outcomes.

Quotes

  • "It’s not always the best idea that makes it to the patient. It takes the right people, the right environment, and the willingness to bring science into the real world." – John Konhilas
  • “Medical innovation is not just a science problem. It’s a risk, capital, regulatory, and execution problem. - Laurie Chen


Laurie Chen

Instagram: https://www.instagram.com/lauriechencpamba/

LinkedIn: https://www.linkedin.com/in/lauriechen/

Risk Worthy: https://www.riskworthy.co/

 

John Konhilas

LinkedIn: https://www.linkedin.com/in/johnkonhilas/

BioXgen: https://invest.bioxgen.life