Manage episode 521524852 series 2901571
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?
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About Pitch3D
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