seehafer

15 ms·

91.
by seehafer 8y ago
Here's the problem with CA-brand NIMBYism: it's coupled with faux-bleeding-heart-ism. We could have a state initiative to build Club Med for homeless people in the Central Valley, far away from anyone who could complain, and the s
92.
by seehafer 8y ago
I thought SLT would be a great place for a SW ecosystem due to rising Bay Area costs back in the seemingly-quaint time of 2012. Glad to see some folks are making it happen.
93.
by seehafer 8y ago
There’s a reason the alt-righters have gotten so far with using the term “soy” as an insult.
94.
by seehafer 8y ago
I don’t have experience to say beyond seed stage, but at seed stage, especially given the explosion in funds, this is most definitely true. Even as a YC startup, VC interactions I’ve had have ranged from “I could give two shits about you” t
95.
by seehafer 8y ago
There’s probably a viable business model now in helping US-based startups set up offices in Canada.
96.
by seehafer 8y ago
Texas would beg to differ with this assessment
97.
by seehafer 8y ago
Instructions for Use indicate that in such an event you should immediately go see your physician. A pacer is different than a brain stimulator. And pacers generally try to restart themselves if they can. Brain stimulators, because of the se
98.
by seehafer 8y ago
I used to design these devices (deep brain stimulators). As part of the design process for every FDA-regulated product, you are obliged to perform a risk analysis to judge the severity and probability of risks to a patient using your produc
99.
by seehafer 8y ago
I think Tokyo is a good counter to the nonsense perpetuated in SF that the law of supply and demand doesn’t somehow apply to housing. Homelessness however is more a multi-headed beast, and Japanese culture likely plays as much into a lack o
100.
by seehafer 9y ago
Theranos tried to get their tech bought by the military and used now SecDef, then Gen. Jim Mattis, then a Theranos board member, to shepherd the product through the military procurement process. They were stopped because DoD regulations sta
101.
by seehafer 9y ago
They would have to do biocomp testing. Every 510(k) requires an analysis of device compliance to ISO 10993, regardless of whether or not its predicate is preamendment. The premise of the article is alarmist and acts as if FDA requires no
102.
by seehafer 9y ago
If you’ve been rejected before don’t be discouraged, we were rejected twice before getting in last summer. Stick with it!
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by seehafer 9y ago
Yes. This type of innovation — where you can demonstrate evolution on an existing product class — is very much in our wheelhouse. And, yeah, FDA recently increased the range of condom sizes they would accept, thus enabling the kind of thing
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by seehafer 9y ago
> I totally agree with this. If you could create a software submission which efficiently communicated traceability, verification and validation info, and the other key metrics the FDA wanted to see, that would be pretty huge in terms of
105.
by seehafer 9y ago
> De novos, abbreviated 510(k)s, lesser used pathways. De novo’s definitely, abbreviated 510(k)’s as well (that’s more of a requirements -> standard conformance challenge which a system like ours is particularly suited to demonstrate)
106.
by seehafer 9y ago
Took quite a bit of negotiating to get to a figure we could afford ;)
107.
by seehafer 9y ago
There are a couple of things that are distinct about us contra an incorporation company: 1) Compliance is an ongoing activity regardless of how many new products you release. Think something like HIPAA, but more pervasive. So there’s an ong
108.
by seehafer 9y ago
To your other questions: Registration and listing: harder to automate because information systems on FDA’s side aren’t quite there yet. For GUDID, yes CAPA, labeling, submissions: yes Alternative submission pathways: what do you mean by thi
109.
by seehafer 9y ago
Hi all, happy to answer questions!
110.
Launch HN: Enzyme (YC S17) – Automating FDA Compliance and Approval
42 points by seehafer 9y ago|25 comments
111.
by seehafer 9y ago
Then again, going on CNBC and touting your coin as the next big thing and then selling your stake a few days later... there's a reason we've banned that kind of behavior in securities markets for decades.
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When is it OK to be critical of startup founders?(cbinsights.com)
2 points by seehafer 9y ago|0 comments
113.
by seehafer 9y ago
Just like “peak oil” was undone by fracking this will be proven to be untrue by the wave of drug discovery startups that will decrease discovery time. 1) https://www.atomwise.com 2) https://www.recursionpharma.com
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by seehafer 9y ago
Snow Leopard is arguably the best OS apple ever released
115.
by seehafer 9y ago
Nevada side of Lake Tahoe? Easy. No space. Reno? Easy. No ecosystem, aside from specialized things (Gigafactory etc). I would LOVE to start an accelerator type thing just over the border of SLT, CA. But I would expect everyone would leave a
116.
by seehafer 9y ago
Correct there's some (not necessarily daily or weekly) amount of sync frequency that you negotiate.
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by seehafer 9y ago
You are underestimating the extent to which a finite $200M injection can make it seem like the price is skyrocketing for exogenous factors and therefore yield real money coming in. Classic pump and dump strategy.
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by seehafer 9y ago
Seconding the “source code in escrow” solution as a mitigation about concerns of working with a startup. IMO enterprise customers happy to pay for it and it usually never gets asked about again
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by seehafer 9y ago
I think that actually exacerbates the psychological dynamic that the author of this post is talking about. Not being able to get your money out will drive additional panic.
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by seehafer 9y ago
> CRISPR technologies are like bullets to attack problems This is a correct and useful analogy. Nonetheless, biologists are excited about CRISPR because, to continue your analogy, we were previously working with spears. And now we have b

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