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In this episode, Alyssa Huffman, CEO and co-founder of Allumin8, shares the six-year journey behind a first-of-its-kind 5.5 mm porous, 3D-printed pedicle screw. We discussed how Allumin8 earned FDA clearance and why design details matter for fatigue, fixation, and fewer revisions. We also map a path toward therapeutic hardware that integrates orthobiologics without slowing surgeons down.
Critical questions addressed:

Why does 5.5 mm matter so much?

How does Gaussian topography support bone ingrowth?
What are some of the lessons from fatigue testing and post-processing?
What are the additive vs milled manufacturing trade-offs?
What was Allumin8's FDA journey and strategy?
When and how do orthobiologics add value?
How did Alyssa build a purpose-aligned team and investor base?
What are some practical founder advice on equity and boards?
What is on Alyssa's wishlist for the future of orthopedic implants?

Please listen to the disclaimer at the end of this podcast.

Stay tuned for our show notes for relevant links, video highlights, glossary of terms, and more resources to enjoy this episode.

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Chapters

1. Why 5.5 Millimeters Matters (00:00:00)

2. Guest Intro And Milestone (00:01:01)

3. Mission To Reduce Spine Reoperations (00:02:23)

4. From Rep Idea To Inventor (00:07:56)

5. Additive Vs. Milled Screws (00:09:50)

6. Gaussian Topography And Bone Ingrowth (00:16:55)

7. FDA Strategy, Predicates, And Data (00:20:49)

8. Patient Guidance And Surgeon Choice (00:25:15)

9. Cannulation, Fenestration, And MIS (minimally invasive surgery)Plans (00:28:28)

10. Winning Believers: Surgeons And Investors (00:31:20)

11. Personal Adversity And Founder Grit (00:35:54)

12. Roadmap: Biologics And Protocols (00:44:16)

13. Data Collection And Animal Models (00:52:04)

14. Founder Advice: Intuition And Equity (00:55:34)

15. Curiosity, Research Habits, Community (01:00:20)

16. Closing Notes And Disclaimer (01:07:12)

29 episodes