On both the OrthoStreams blog and newsletter and the BoneChat private community we talk alot about what a startup should do, but we don't talk enough about what not to do.
Orthopedic startup success is a statistical anomaly. Roughly 75% of medical device companies never reach profitability, and only 10–15% of ortho ventures ever achieve meaningful traction or a clean exit. In the ortho space, the deck is stacked even higher.
For every Kyphon, there are a hundred Surgaligns and Conformis's.
When we study the "corpses" in the ortho graveyard, we rarely find one dramatic, singular flaw.
Instead, startups usually die from "a thousand small cuts."
Below are 71 of the most common reasons orthopedic startups hit a wall or disappear entirely.
Think of it as a survival checklist.
The Regulatory & Compliance Graveyard
Wrong Predicate Device: Selecting a "substantial equivalent" that the FDA rejects, forcing a De Novo or PMA path you didn't budget for.
The "Paper" QMS: Building a Quality Management System that looks good in a binder but fails a real-world FDA audit.
Missing DHF: Discovering years into development that your Design History File is missing critical early testing data.
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