In this episode of Medsider Radio, we sat down with Kurt Jacobus, co-founder and CEO of restor3d.

restor3d provides patient-specific orthopedic implants using 3D printing and advanced software.

Kurt has over two decades of experience in medtech entrepreneurship, including successful exits to Enovis and NuVasive. Prior to his career in medical devices, Kurt was a consultant at McKinsey & Company. He holds a PhD in Mechanical Engineering and is an Adjunct Professor at Georgia Tech.

In this interview, Kurt discusses how restor3d used the FDA's 520(b) pathway to generate revenue and regulatory proof simultaneously, why self-regulating beyond FDA requirements makes submissions a competitive barrier, and how to approach investor relationships and board construction with long-term thinking.

Before we dive into the discussion, I wanted to mention a few things:

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If you'd rather read than listen, here's a link to the full interview with Kurt Jacobus.

KEY MOMENTS FROM THE INTERVIEW

(03:21) - How Kurt went from wanting to build race cars to 20 years of orthopedic entrepreneurship
(06:03) - How restor3d’s patient-specific implants challenge the “8 sizes fit 8 billion people” model
(15:36) - Why early-stage companies should “ring the cash register” as soon as possible
(17:16) - How a 520(b) pathway helped restor3d generate revenue before full FDA clearance
(31:48) - How restor3d treats every FDA submission like a PhD thesis and holds itself to standards beyond what regulators ask for
(35:24) - What Kurt learned from restor3d’s limited market release
(40:03) - How Kurt raised is last$100M+ round, and why fundraising is really a networking game
(45:13) - What makes a great board, and how the wrong one can quietly derail a company

Why Early Revenue is the Most Credible Proof in Medtech: Interview with restor3d CEO Kurt Jacobus

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Why Early Revenue is the Most Credible Proof in Medtech: Interview with restor3d CEO Kurt Jacobus