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Re:The FDA's notes from its visit to Theranos' labs don't lo... by iandanforth on Wednesday October 28, 2015 @12:09AM (#10462797)
Document numbers? Release dates? This seems more like red tape and nitpicking rather than a substantive challenge to a technology. It's stories like these that guarantee I would never try to start a company in biotech or recommend a friend join one.
Re:The FDA's notes from its visit to Theranos' labs don't lo... by epistasis on Wednesday October 28, 2015 @12:28AM (#10462846)
Unit testing? Source control? Continuous integration? Code documentation? Seems like red tape and nitpicking rather than substantive coding. It's stories like that that guarantee that I would never try to start a company in software or recommend a friend join one.

Just because standard practice seems unnecessary to you doesn't mean that it doesn't exist for good reasons. To anyone in biotech or familiar with what can go wrong with physical products, your complaints come across as ignorant.

Re:The FDA's notes from its visit to Theranos' labs don't lo... by Uhhrrr on Wednesday October 28, 2015 @02:00AM (#10463038)
I've worked at successful companies which did a terrible job at one or another of those, and the customers didn't complain (or die). You can get away with a lot more in software than you can in other disciplines, because in software you can incorporate negative feedback relatively quickly.
Re:The FDA's notes from its visit to Theranos' labs don't lo... by judk on Wednesday October 28, 2015 @11:34PM (#10469105)
The high flying startups you know didn't go to market with the engineering processes you mention.
Re:The FDA's notes from its visit to Theranos' labs don't lo... by seehafer on Wednesday October 28, 2015 @01:35AM (#10462992)
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 isn't, you know, unreasonable if you're talking about products that directly impact people's health.

Document numbers and release dates go toward ensuring everyone at the company is working with the same information. Most computer science students learn about the failure of the Mars Climate Orbiter [1] because one team was using feet and the other meters. Guarding against issues like those is exactly what FDA is trying to do.

1: http://articles.latimes.com/1999/oct/01/news/mn-17288

Re:The FDA's notes from its visit to Theranos' labs don't lo... by jrapdx3 on Wednesday October 28, 2015 @12:33AM (#10462859)
The FDA is a federal bureaucracy, and the "picky" requirements are the usual and customary mode of operation. Documentation of details is important in order to conform to federal law which the FDA implements in its domains.

Having been involved in several pharmaceutical studies, I can assure you the level of documentation detail demanded is extremely picky. Medical laboratory rules are similarly strict. They have to be given the risks to patients if not closely regulated.

The essence of the requirements are thoroughness and consistency. Medical laboratory measurement devices have to be carefully calibrated in order to be predictable, a lot rides on the accuracy of results. Without conforming documentation of calibration and testing procedures, it's impossible to trust lab test results, which is untenable.

It's not "just red tape", if true that compliance with standards is arduous. I have no trouble understanding reasons people might avoid getting involved in biotech enterprises, or recommending it for others.

Re:The FDA's notes from its visit to Theranos' labs don't lo... by hrq on Wednesday October 28, 2015 @12:18AM (#10462824)
TBH the FDA is the least of the various hurdles to get a great biotech going. The FDA has (surprise) largely been spot on. Theranos is just a fraud. If you are not risk tolerant that's fine, it's a reasonable position. But, there are plenty of people who are willing to actually get outside the anonymous video chat / messaging whatever echo chamber and make real inventions happen in the world that make a real difference to real people.
Re:The FDA's notes from its visit to Theranos' labs don't lo... by forgetsusername on Wednesday October 28, 2015 @09:46AM (#10464373)
>It's stories like these that guarantee I would never try to start a company in biotech or recommend a friend join one.

Good. We're in mutual agreement. Because I or my friends don't want people working on matters of life and death who don't care about "red tape" or "document numbers".

Re:The FDA's notes from its visit to Theranos' labs don't lo... by OopsCriticality on Wednesday October 28, 2015 @10:16AM (#10464548)
That's all a part of design control, and it is common among regulated industries (US and abroad). It's not hard to do, it just takes some diligence.

As far as the biotech industry, the funding situation is awful, especially for early companies, and that is a fine reason to avoid this area. Needing to "say what you do and do what you say" doesn't strike me as that much of an obstacle in comparison.

Re:The FDA's notes from its visit to Theranos' labs don't lo... by jheriko on Wednesday October 28, 2015 @12:24AM (#10462839)
when you start a company your approach should be beyond reproach. red tape and nitpicking are things to welcome as part of a high quality bar - as annoying as they maybe - not to write off as inconvenient annoyances.

when you have your shit together in the most basic ways, you simply won't have this level of problem.

Re:The FDA's notes from its visit to Theranos' labs don't lo... by judk on Wednesday October 28, 2015 @11:36PM (#10469109)
Name a successful startup that was beyond reproach.
Re:The FDA's notes from its visit to Theranos' labs don't lo... by jheriko on Friday November 06, 2015 @11:43AM (#10520362)
most people try this tbh. its common sense. its why you do things like register your company, pay your taxes, get legal advice. its exceptionally normal behaviour until recently it seems...

we used to call people who didn't do this 'rogue traders' and the like. they were looked down on like scum instead of looked up to as role models.