ware_am_i

It's cool to see another FDA AI Regulatory person on HN. Drop me a note if you are interested in connecting -> [email protected]

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 -> [email protected]

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 (which requires the most evidence and carries the most liability) all the way down to gently prompting a healthcare provider to look at one record earlier than another one while reviewing their reading queue.

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 indications and navigating regulatory interactions. That's a main driver of why we built Essenvia (https://www.essenvia.com/#/), which automates the creation and submission of all regulatory docs required for medical device approval. We're expanding next into other aspects of the industry (complaint handling, compliance testing) as well as adjacent industries (environmental, pharma, etc.).

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 that they're considering regulatory requirements for higher-risk or more complex devices.

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 LA Public Library!