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Why Early Revenue is the Most Credible Proof in Medtech

Why Early Revenue is the Most Credible Proof in Medtech

Interview with restor3d CEO Kurt Jacobus

About the Guest

Kurt Jacobus is the co-founder and CEO of restor3d, the developer of 3D-printed, patient-specific orthopedic implants. He brings two decades of medtech entrepreneurship, including multiple successful exits to Enovis and NuVasive. Before 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.

Interview Summary

At restor3d, Kurt is challenging one of orthopedics' most accepted assumptions: that eight sizes can serve eight billion people. After two decades of building and exiting orthopedic companies, Kurt didn’t arrive at personalized implants as a technology enthusiast. He arrived as an operator who had worked inside a system delivering roughly 80% patient satisfaction — and decided that wasn’t good enough.

Traditional orthopedic implants are designed around standardized sizes, leaving surgeons to adapt technique and patients to accept the outcome. restor3d's answer is to design and manufacture implants and instruments specific to each patient’s anatomy, using advanced 3D printing to serve patients from cranium to toe.

Rather than waiting for full regulatory clearance, restor3d used the FDA’s 520(b) custom device exemption to begin treating patients and generating revenue early. This approach generated both commercial traction and clinical data that informed later 510(k) submissions.

The company's most developed portfolios are now in shoulder and ankle, with a patient-specific shoulder clearance expected in Q2 2026. restor3d controls the full manufacturing process from powder to sterile product across two production facilities in North Carolina and Massachusetts. The company has treated more than 150,000 patients and recently raised $104 million to support continued scale.

Top Takeaways

  • Ring the cash register early. It's the most credible proof. Early sales show you can clear regulatory hurdles, manufacture reliably, build a sales team, and convince the market your product is differentiated. That signal compounds and attracts talent, expands your investor base, and shifts the terms of capital. Strong enough growth and you raise when you want to, not because you have to.

  • Self-regulate beyond what FDA requires, then treat every submission like a PhD thesis. Early pathways like 520(b) can generate revenue and regulatory proof before a 510(k). Set internal standards that exceed FDA expectations, and when submissions don’t fully clear, aim for what's commercially relevant now and return later for the rest. This standard builds trust with regulators and raises the bar for competitors.

  • Fundraising is a long game of preparation, not persuasion. Both private and institutional investors run in small networks. Give them a compelling story or demonstrate strong momentum, and word will quickly spread. And remember, decision-making sits with a small group, not the entire firm. Build relationships before you need capital, keep your prospective investors informed, and treat a “no” as a placeholder.

  • Your board is an asset or a liability — build it deliberately. The best board members share the vision, open their networks, and stay engaged between meetings. Problems arise at both extremes: members who overstep into managerial execution, and those who disengage until something breaks. When building the board, prioritize operators who understand how companies are built.

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