It's cool to see another FDA AI Regulatory person on HN. Drop me a note if you are interested in connecting -> chris@medlaunchnow.com
As a medical device company, establishing and documenting your approach to answer these questions can go a long way. More of a policy vs protocol approach.
Hey, I’ve done dozens of similar implementations within Med device companies. Happy to chat -> chris@medlaunchnow.com
This is largely where the art of "labeling/claims" comes into play regarding how explicitly worded a "diagnosis" can be. There is a lot of room to play on the spectrum from truly diagnosing a patient with a disease…
Completely agree, and feeling most of these pain points in the medical device / diagnostics industry as well. There are so many black boxes and unknown-unknowns in this space, especially when it comes to developing…
Great to see someone else on HN enjoying the special nature of medtech (I consult and advise a few as well). Would love to share notes -> chris(at)medlaunchnow.com
The devices they currently market are low risk (across US, Canada, EU, etc) so there is minimum regulatory burden. The "working on it" note regarding a Pulse Oximeter mentions a clinical trial, which I infer to mean…
Thanks for the recommendation! I'm in the midst of a big and culturally/politically challenging engineering project and eager to learn... so much so that I signed up for a library card and checked out the ebook from the…
It's cool to see another FDA AI Regulatory person on HN. Drop me a note if you are interested in connecting -> chris@medlaunchnow.com
As a medical device company, establishing and documenting your approach to answer these questions can go a long way. More of a policy vs protocol approach.
Hey, I’ve done dozens of similar implementations within Med device companies. Happy to chat -> chris@medlaunchnow.com
This is largely where the art of "labeling/claims" comes into play regarding how explicitly worded a "diagnosis" can be. There is a lot of room to play on the spectrum from truly diagnosing a patient with a disease…
Completely agree, and feeling most of these pain points in the medical device / diagnostics industry as well. There are so many black boxes and unknown-unknowns in this space, especially when it comes to developing…
Great to see someone else on HN enjoying the special nature of medtech (I consult and advise a few as well). Would love to share notes -> chris(at)medlaunchnow.com
The devices they currently market are low risk (across US, Canada, EU, etc) so there is minimum regulatory burden. The "working on it" note regarding a Pulse Oximeter mentions a clinical trial, which I infer to mean…
Thanks for the recommendation! I'm in the midst of a big and culturally/politically challenging engineering project and eager to learn... so much so that I signed up for a library card and checked out the ebook from the…