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Summer pause; back in September!
I'm focused on launching my podcast, serving my coaching and project clients, and enjoying the days as they come. I'll be back to regular...

Shannon Lantzy
Jul 23, 2024


MDUFA V, Medtech commercialization, and a puppy preference study
Patient preferences are a tool in the commercialization path; use them well to get patient access Patient preferences are...

Shannon Lantzy
Jun 25, 2024


RegTech's Law (an extension of Martec's Law)
Technology changes fast (exponential), organizations change slowly (logarithmically), regulated industries are marked by inflection...

Shannon Lantzy
Apr 26, 2024
Accelerating AI adoption requires RegTech Innovation
To achieve the promise but avoid the perils of the healthcare AI revolution, we need to accelerate RegTech innovation As technology...

Shannon Lantzy
Apr 19, 2024
Health cyber is solved; I am going to focus on consumer products (like table saws) ***April Fool’s post!***
I usually send out a newsletter and post it on my blog on Thursday or Friday. Today is Monday. Not only is that a better day to send a...

Shannon Lantzy
Apr 1, 2024
Adapt threat modeling for AI safety
Threat modeling could be adapted into a process for developing medical AI with safety-by-design Medical AI developers need to create...

Shannon Lantzy
Mar 21, 2024


For regulatory "reliance," separate science from value (a post-IMDRF thought)
International regulators need and want to rely on each other's regulatory decisions for efficiency but don't want to lose sovereign...

Shannon Lantzy
Mar 15, 2024
GenAI is good for Regulators
How are you using GenAI for regulatory strategy, prep, submission, review, and response? GenAI, ChatGPT, LLMs, oh my! I am having a lot...

Shannon Lantzy
Mar 8, 2024


Health cyber innovators: the HSCC Strategic Plan is a gift
HSCC's new strategic plan is a valuable resource for anyone innovating, offering, or buying cybersecurity solutions for healthcare The...

Shannon Lantzy
Mar 1, 2024
Why do amazing innovations fail to gain adoption in healthcare?
Ease of use and usefulness are two strong predictors of adoption, but they're not enough in healthcare. Valuable innovations often go...

Shannon Lantzy
Feb 23, 2024


Innovators, difference-makers: Are you pitching to the right person?
Entrepreneurs and innovators spend a lot of time pitching people on the value of their solution; that time can be deceptively wasteful...

Shannon Lantzy
Feb 15, 2024
“Is this product secure enough?” is the wrong question
The answer is always "it depends." The better question is: "Is this company managing product security well?" If I am a hospital system...

Shannon Lantzy
Feb 6, 2024
Procurement can solve cybersecurity woes
Health system procurement teams, rather than solely IT, hold the keys to solving healthcare cybersecurity. I recently met a tenacious...

Shannon Lantzy
Feb 1, 2024


Thriving Through Organizational Disruption
Organizations change (if they don't they're dying). In the wake of a major reorg, here's how to thrive. FDA just announced that the...

Shannon Lantzy
Jan 31, 2024
Why is helping healthcare so hard?
The healthcare industry is plagued by problems that other industries have already solved. When solution providers try to help, they're...

Shannon Lantzy
Jan 25, 2024


"Crawl, Walk, Run" is for babies; start running now*
People say "crawl, walk, run" to denote a progression of maturity to reach a goal. Institutions are not babies, and executives aren't...

Shannon Lantzy
Jan 18, 2024
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