Shannon Lantzy
It's not all science; lead with value
Listen to the caring voice, the angel on the right shoulder, the gut feeling. Act on what is not only scientifically right but what is...
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Shannon Lantzy
Sep 29, 2023
To create value (aka $$$) you have to do more than the right thing
Complying with FDA's medtech cybersecurity requirements means doing the right thing. This will create compliance. You can create more...
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 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 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 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
May 23, 2023
Hospitals’ Connectivity Conundrum
Hospitals’ Connectivity Conundrum: Hospitals have adopted the risks of connected tech, without its protections My friend recently shared...
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