759 karma · joined September 24, 2021
Happy to chat about all things med device!
To escape my spam filter, just put "HN" somewhere in the subject line, I'm over on jeremy@<my username>.com
We're a medical device company with Breakthrough Device status, and it works largely like this. Whenever we submit, FDA has 30 days to reach a decision from time of receipt, and if they don't decide, we automatically get approval. Really helps with keeping up momentum!
I figured it was one of those "founder-has-a-blog-with-very-similar-name-to-capture-new-users" situations. Nothing wrong with it, just something I feel it's important to be aware of. Sorry for the mixup!
Emphasis mine. The reason why this is done in big projects is adding just one more level of abstraction to be able to preserve how userland interacts with your library, but still allowing you to make underlying structural changes to the code.
The process I follow to ensure a clean knot every time:
1. Tie your figure 8, with the tail the same size every time (use your body as a ruler, testing a few lengths to get the perfect size)
2. Pass the tail up through your hard points so the knot is only a few inches from the bottom hard point.
3. Orient your knot so the tail is coming out of the bottom right side
4. This is the most important step! Instead of passing the tail through the inside of the knot when starting the followthrough, pass it in between the tail strand and the bottom right of the knot.
5. Follow through as normal. It should come out almost clean (eg no need to flip strands over each other)
6. For all 4 combos of top and bottom strand, yank them to make the knot very tight. The tighter and cleaner it is, the easier to untie after a whip.
7. If you do this all, the load strand will be on top, so no difficult flipped strands after a whip!
This is just my process, what's most important is doing something that works for you and that you can get right every time.
I went snooping around the internet, and found that there was this magical software called Nix, which would let you have a package manager without root! The Linux computers in the lab didn't have root, but they did have GCC. I started learning all about build systems (mainly that you could specify a custom --prefix and essentially create your own filesystem within your filesystem), and got to work compiling Nix (or, i think, GUIX) from source. It's actually a fantastic amount of work to go from GCC all the way to a functional GUIX, even with access to every source tarball on the Internet
Eventually some admin emailed me about this project and I stopped working on making it happen shortly after, but it was such a formative experience in my tech life that I always think back fondly on it when Nix pops up.
Now, if you closed the loop and used older insulins, you'd have good control and less issues since a computer would bear the cognitive load, but glucose control, especially in the outpatient setting, is ridiculously hard. If you think you can solve it though, give it a shot. It's a multi billion dollar market and a lot of lives you can improve.
I can't speak to drug manufacturing, but I know from experience that when it comes to medical devices, you save almost 10x in up front fixed cost by outsourcing, like California is doing. You spend more per unit, but still profit, so you can build a healthy warchest while you accumulate experienced personnel to build out a more vertically integrated manufacturing process.
Obviously YMMV.