Lara’s Substack
Lara ZibnersUnderstanding healthcare (and particularly women's health) from the viewpoint of physician, woman, fertility survivor, healthcare entrepreneur, investor, and mother, I aim to translate the business of medicine from both sides of the fence.
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 48 | Founded | a year ago | Last Issue | 6 days ago |
| Active | |||||
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drzibners.substack.comLatest Issues
SaMD
I (Lara) recently wrote a piece explaining FDA medical device classifications and explained odd terms like “510(k)” and “De Novo.” Theresa Neil from Femovate said, “Oh, let’s do one on SaMD.” And that is this piece. Let’s go upstream from t...
Cleared. Approved. Registered. Choose your words like a Federal Agency is watching you.
I’ve written a couple of times now about FDA terminology for device classification and how confusing it can be. The words, “registered, cleared or approved,” all sound similar. Yet they aren’t. Which means I have been trying to explain them...
Disclaimer: cartoon by AI, writing by me
There’s been a lot of noise about the role of AI in generating content for Substack, the suspicion that exists about AI written manuscripts and the fallibility of the tools being used to screen for such bot-work.
Sadly, I’ve had to bid a f...
Ship the Wellness Version, Wait for the Evidence
A 25,000 person waitlist. A perfectly legal route to market months or years earlier than you might face. Women clamoring for more information about their bodies after years of being told to just wait.
Well, why not just get your product to...
FDA "Clearance"
I just love talking about a few things. Duck vaginas are one of them. The world of “continuous hormone monitoring” is another. Sometimes people listen. And comment. Like the time someone from Mira thanked me for bringing attention to the is...
Key Facts
Audience Metrics
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| Subscribers | Engagement | 70 | Monthly Web Visits | ||
|---|---|---|---|---|---|
| Accepts Sponsors | Estimated Cost per Ad | ||||
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Authors
The writers behind this newsletter.
Dr. Lara Zibners, MD, MMEd, MBA, is co-founder of Calla Lily Clinical Care, a British women's health care company, as well as co-host of the popular Unstable Vitals podcast.
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