seehafer

21 ms·

181.
by seehafer 11y ago
The FDA quality system regulations seem like nitpicking on their face, and they can be implemented in such a way that is very pedantic, but at their core this is really about an engineering process that is controlled and validated, which is
182.
by seehafer 11y ago
> Starting with the Reagan administration, oversight over medical devices has been greatly reduced. You have a lot of leeway with medical devices, even moreso than with drugs. Citation needed.
183.
by seehafer 11y ago
>but you don't fuck around with the FDA As 23andMe found out the hard way.
184.
by seehafer 11y ago
As OopsCriticality points out above, it's incredibly difficult to judge the potential of Theranos' technology because they have so far refused to perform and/or publish peer-reviewed randomized clinical data comparing themsel
185.
by seehafer 11y ago
The number is closer to 33% as long term capital gains are taxed as income in California.
186.
by seehafer 11y ago
Hahaha, I take it by your first line you have some neural engineering background?
187.
by seehafer 11y ago
"The system" isn't equivalent to "the intentions of the people who built the system"... it's what actually occurs in every day life.
188.
by seehafer 11y ago
I'm willing to accept to a large amount of honest disagreement of how much regulation is appropriate for medical technology. But articles like this, which twist the truth and drop so much context make my blood boil. Some examples: &quo
189.
by seehafer 11y ago
But they do, and for the authors of this op-ed to try and insinuate otherwise is massively dishonest. Most implantable devices are what is known as Class III: the highest risk that FDA assigns. Accordingly, they go through the most stringen
190.
by seehafer 11y ago
One could argue that much of government regulation came about because of massive information asymmetry. In the age of the Internet it is much harder to peddle snake oil cures (though not impossible, certainly, look at anti-vaxxers) than it
191.
by seehafer 11y ago
So much of what the House is trying to do here could be accomplished by making the FDA actually make some real guidelines and stick to them . Like you say, deciding whether not change X is a memo to file, a special, abbreviated, or full 51
192.
by seehafer 11y ago
"But shifting reponsibility from the FDA to a third party is something I'm not sure I'm comfortable with." This is exactly what happens in Europe, though. And it's one of the reasons we generally release products th
193.
by seehafer 11y ago
I worked for MDT Diabetes, and I can tell you the engineers (many of whom are insulin pump users themselves) are just as frustrated as you are.
194.
by seehafer 11y ago
If /r/aww, /r/funny and /r/pics did the same, Reddit's traffic would fall off a cliff.
195.
by seehafer 11y ago
Reddit seems engaged in a test to see how far a company built on a community can attack that community's leaders before everything falls apart at the seams.
196.
by seehafer 11y ago
They're trying that in SF. It's called Flywheel. And it's more expensive than Uber and not as good of an experience, because you have no power to rate down poor drivers.
197.
by seehafer 11y ago
So who is actually running Reddit these days? Because a CEO involved in very high-profile personal litigation likely doesn't have the time to be a very effective CEO.
198.
A Simple Paragraph Every Entrepreneur Should Add to Their Convertible Notes(bothsidesofthetable.com)
56 points by seehafer 11y ago|10 comments
199.
by seehafer 12y ago
The only things I would ask myself in your place are: "Am I being objective in thinking I have nothing to learn from these people?" (it's easy to delude yourself) and "Can I change the room without leaving the company?&q
200.
by seehafer 12y ago
1) Absolutely not. 2) Are you in a position to change the culture? Doesn't sound like it. Generally only execs can do that, and generally only the CEO. Being the smartest person in the room, unless you're a C-level executive, is t
201.
by seehafer 12y ago
Beyond being more efficient, they need to have a shift in thinking as to what constitutes a quality SW development process. Example: as of right now, they still think that a waterfall process is the only process that is "correct".
202.
by seehafer 12y ago
Don't make the mistake of confusing rhetoric with action. Republicans haven't meaningfully shrunk the size of government since Eisenhower. Nixon grew the government substantially (EPA, HHS, Dept of Education), Reagan talked small-
203.
by seehafer 12y ago
To OP's original point, healthcare orgs tend to think in terms of 5 year chunks, at minimum, when planning. They figure that the likelihood of any small podunk startup being around in 5 years is minimal, so even if the product is 10x o
204.
by seehafer 12y ago
It's more appropriate to say free markets work great when they are allowed to work. Health care isn't allowed to function in a free market due to the moral implications of doing so given our prevailing morality.
205.
by seehafer 12y ago
Amen. The collective argument behind our current system forgets the history, namely that our current backasswards way of paying for healthcare originates with a reaction to wage controls during WW2.
206.
by seehafer 12y ago
"And the poor couldn't afford healthcare anymore. Even if it is a well-justified $10,000 surgery. Most people cannot pay this out of their pocket." A free market healthcare system assumes people would be getting back at least
207.
by seehafer 12y ago
FDA loves to talk a good game about independence, but they are far more driven by political trends then they'd like to admit. Case in point: in 2008, the Democratic house jumped up and down about the under regulation of medical devices
208.
by seehafer 12y ago
> Anyhow, to pretend like there has been no deregulation is to be disingenuous at best. True, but then to blame a financial crisis on free markets when no such thing even remotely existed is also disingenuous at best.
209.
by seehafer 12y ago
It does, at least for new approvals post ~2012. Doesn't help existing devices in the field though.
210.
by seehafer 12y ago
Indeed, all pacers I know of don't have Bluetooth comms precisely because of the potential for vulnerabilities. (I used to work for a pacer company)

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