Regulatory Innovation

Posts

Essays, Articles, Notes, and Resources

Shannon Lantzy

Sep 5

(Podcast) The Power of Patient-Led Innovation: Insights from Inside MedTech Innovation with Susannah Fox

Welcome to the Inside MedTech Innovation podcast, where we explore the intersections of technology, healthcare, and regulation. Medical...

Shannon Lantzy

Oct 5, 2023

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...

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 22, 2023

"The Golden Age of Medical Device Innovation" and Free Consulting from FDA

FDA used to be the choke point to get to market. FDA accelerated, and now payment is the primary problem. FDA is offering TAP, a free...

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 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

Jul 20, 2023

James Clear's 3-2-1 (Recommended)

I read Atomic Habits on the recommendation of (seemingly) all the self-improver readers I know. It's a great book, short and readable,...

Shannon Lantzy

Jun 13, 2023

The complexities of US drug pricing and why I’m glad FDA stays out of it

The Inflation Reduction Act (IRA) changed the length of time a drug maker can enjoy exclusive marketing rights to a small molecule (e.g.,...