ware_am_i

4 ms·

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by ware_am_i 4y ago
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
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by ware_am_i 4y ago
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.
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by ware_am_i 5y ago
Hey, I’ve done dozens of similar implementations within Med device companies. Happy to chat -> chris@medlaunchnow.com
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by ware_am_i 5y ago
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
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by ware_am_i 6y ago
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 navi
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by ware_am_i 6y ago
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
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by ware_am_i 7y ago
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&#x27
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by ware_am_i 7y ago
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