seehafer

21 ms·

151.
by seehafer 10y ago
Nope, this is a big deal. Carreyrou's been pretty even-handed throughout his reporting. Hard-hitting, but he's not telegraphed an agenda other than trying to figure out if there's anything really behind this company or if it&
152.
by seehafer 10y ago
Ironically Holmes might end up getting her wish about all Lab Developed Tests (LDTs) needing to go through FDA approval in addition to CLIA certification, which cover the operation of a lab, not the design and validation of the machines in
153.
by seehafer 10y ago
From the article: “There have been massive recalls of single tests in the past, but I’m not aware of one where a company recalled the entirety of the results from its testing platform,” said Geoffrey Baird, associate professor in the depart
154.
by seehafer 10y ago
Holmes will have to go and be replaced by a perceived 'grown-up' CEO. That's the only way (and even that is a longshot) the company ever recovers.
155.
by seehafer 10y ago
2002. Part of a weather forecast tool to determine where to best place salting trucks during winter storms http://inws.wrh.noaa.gov/page/tou
156.
by seehafer 10y ago
"Pied Piper's product is its stock. Whatever makes the value of the stock goes up is what we are going to make. Maybe sometime in the future, we can change the world and perform miracles and all of that stuff. I hope we do. But li
157.
by seehafer 11y ago
> If you want to "hack" healthcare and fix the problem, get involved in government and get single payer done. So we can turn what health technology gets developed into even more of a political game? Building a board of governme
158.
by seehafer 11y ago
When I first read this headline I was thinking "Uh oh, Theranos must have very badly handled its interactions with FDA". But this is apparently the SEC investigating the company. Does anyone know how often the SEC investigates a
159.
by seehafer 11y ago
Yes, that's most certainly true, but that's b/c not so much because of native water (the Rockies trap a lot), but b/c CO sold much of its water to AZ and CA long ago.
160.
by seehafer 11y ago
Umm... Except for la veta pass Interstate 25 runs east of the Rockies from Denver to Albuquerue. More possible than you think. Denver to SLC, on the other hand, you'd be 100% correct about.
161.
by seehafer 11y ago
>At what point here do people go to jail? Generally the FDA will give companies several outs to fix problems, they only bring out the handcuffs after several ratcheting steps (one of which includes bringing in a US Marshal and a team fro
162.
by seehafer 11y ago
Arizona.
163.
by seehafer 11y ago
> but how else can you characterize voting, multiple times, to not only shut down the whole government but actually trying to make it default on its debt? A last ditch effort to try to bring some sanity to a budgeting process so broken t
164.
by seehafer 11y ago
Some folks on the inside think Google has an ambition to replace the insurance companies. http://medcitynews.com/2016/01/google-biogen-payer-cms/
165.
by seehafer 11y ago
> Between insurance companies, doctors, hospitals, patients, governments, and every middleman inbetween You can eliminate middlemen if you can show cost reductions for a player larger than the middleman. The big players are providers, pa
166.
by seehafer 11y ago
Scary that you're getting downvoted for this comment.
167.
by seehafer 11y ago
> It blows my mind that some people really believe that only white people can be racist. It's like they completely redefined the meaning of the word "racist". That's the point. Redefine words so that it's impossi
168.
by seehafer 11y ago
Thank you for pointing this out. You'd be surprised how many people even within medical device think design control necessarily means some slow-as-hell waterfall development method.
169.
by seehafer 11y ago
Not necessarily to the former. Definitely to the latter. To elaborate point 1: - If the crucial parts of the devices that "were modified to improve accuracy" were modified early on in the study the data could be representative of
170.
by seehafer 11y ago
http://www.fiercebiotech.com/story/roche-wins-fda-approval-n...
171.
by seehafer 11y ago
What's notable about the meat of the complaint sent to the FDA is that it's less "this technology actually doesn't work" and more "this company has no culture of experimental integrity". From the article:
172.
by seehafer 11y ago
Falsifying data to obtain regulatory approval is definitely illegal, and federal regulations allow the government to hold corporate officers personally liable. It has yet to be proven that Theranos did in fact falsify data, though.
173.
by seehafer 11y ago
For current public companies, you're right, because public company CEOs outside of recent tech cos are rarely founders. Healthcare founders almost always have either medical and/or science training.
174.
by seehafer 11y ago
"They never lobby for (or introduce, if they're in a position to do so) bills to actually achieve that end, and in fact usually do nothing and let the status quo -- which until very recently was "keep the discriminatory laws
175.
by seehafer 11y ago
It's not a bad theory, but even the military medical establishment would demand that the tests are accurate.
176.
by seehafer 11y ago
> It's rare to see anyone favoriting a tweet to "reference" it later. A lot of broad statements being thrown around by both the author of this article and the people in this thread. I used favorites in exactly this way, an
177.
by seehafer 11y ago
One addition in terms of how Trek becomes great, from a behind-the-camera perspective: 7. Results from a tension between competing visions between writers and creators. Examples: TNG was campy and unwatchable, mostly, until Michael Piller
178.
by seehafer 11y ago
Your wish is unlikely to come true, as the new series is being written/produced by the head writer of the last two movies.
179.
by seehafer 11y ago
Certainly the pivot-constantly, push-code-daily mentality is not translatable to medical technology. That said, biotech & device companies could stand to be a hell of a lot more agile. Compliance is necessary but it isn't a complet
180.
by seehafer 11y ago
I disagree. Device/diagnostic companies get 483's all the time. What's telling is the scope of these observations. Theranos is failing on most counts of the quality system regulations. Judging by the observations they don&#x2

More ›