Shannon Lantzy
How to get a submission through FDA
A few tips when crafting a (FDA CDRH) regulatory submission. Use Q-subs, it's like free FDA consulting Follow directions, get the basics...
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Shannon Lantzy
Sep 7, 2023
Uncertainty != Risk
We can manage risk better than we can manage uncertainty. In medtech cyber, there is a lot more uncertainty than well-characterized risk....
Shannon Lantzy
Sep 6, 2023
Tech innovation requires org innovation
When technology changes drastically, the organization needs to change too Last week I spoke with a colleague who is making a career move...
Shannon Lantzy
Sep 5, 2023
Finding the hidden story for a 510k submission
If you don't toot your own horn, there's no music! Here's a story of uncovering wonderful work already done by a software engineer who...
Shannon Lantzy
Aug 31, 2023
For Better Risk Analysis, Stop Keeping Score
Risk scores often distract from the valuable information needed to make decisions. Instead, use simple, elegant models better suited to...
Shannon Lantzy
Aug 25, 2023
“Optimize” means “make the best of it”
I read an article that suggested people think "optimizing" and efficiency efforts are synonymous with cost-cutting and worker burnout. I...
Shannon Lantzy
Aug 24, 2023
What is Regulatory Innovation?
With my recent change of employment status (from employed to self-employed), people have asked me, "What do you do?" I sometimes answer...
Shannon Lantzy
Aug 17, 2023
Deficiencies in AIs; What We Can Learn
Deficiencies in AIs; What We Can Learn No not that AI. I’m referring to FDA’s Additional Information (AI) letters. Also known as “hold...
Shannon Lantzy
Aug 10, 2023
How Cybersecurity Will Usher Speedier, Automatable Regulatory Decision-Making
I entered the world of medtech cybersecurity five years ago, not because I was a cybersecurity professional (though I play one on TV),...
Shannon Lantzy
Aug 9, 2023
Medtech Cybersecurity Expert Attrition
There aren't enough cybersecurity professionals in medtech. In fact, there aren't enough cybersecurity professionals in general....
Shannon Lantzy
Aug 8, 2023
The critical outside voice: invaluable
I recently took a ride in a driverless car through the streets of San Francisco, courtesy of my friend, a Waymo employee. The car pulled...
Shannon Lantzy
Aug 4, 2023
Thinking about "Luxury" Healthcare
A series of “thinking cap questions” about luxury healthcare, software subscription models, and promoting versus preventing progress What...
Shannon Lantzy
Aug 3, 2023
"Ready to submit" does not mean risk-free
"Get it to market," a friend and colleague said, relating a story about a conversation between herself, her FDA teammates, and a sponsor...
Shannon Lantzy
Aug 2, 2023
FDA’s “New” Cybersecurity Requirements Are a Relief
In January 2023, Congress granted FDA new regulatory authority to require manufacturers to address cybersecurity in medical devices....
Shannon Lantzy
Aug 1, 2023
Are CGMs good for the masses?
Lane Desborough shared this article with me, in response to a conversation about datasets and what CGMs can tell us. The article asserts...
Shannon Lantzy
Jul 26, 2023
We can love new tech, despite its pitfalls
Throughout human history, technology has surprised us with delightful innovations that save, extend, or improve the quality of our lives....
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