4 ms·

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

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.

hrq 11y ago
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.
jheriko 11y ago
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.
- judk 11y ago
  Name a successful startup that was beyond reproach.
  - jheriko 11y ago
    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.
epistasis 11y ago
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.
- Uhhrrr 11y ago
  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.
  - deleted 11y ago
    [deleted]
- judk 11y ago
  The high flying startups you know didn't go to market with the engineering processes you mention.
jrapdx3 11y ago
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.
deleted 11y ago
[deleted]
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 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 http://articles.latimes.com/1999/oct/01/news/mn-17288
forgetsusername 11y ago
>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".
OopsCriticality 11y ago
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.

hrq 11y ago

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.

jheriko 11y ago

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.

judk 11y ago
Name a successful startup that was beyond reproach.
- jheriko 11y ago
  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.

epistasis 11y ago

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.

Uhhrrr 11y ago
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.
- deleted 11y ago
  [deleted]
judk 11y ago
The high flying startups you know didn't go to market with the engineering processes you mention.

jrapdx3 11y ago

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.

deleted 11y ago

[deleted]

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

forgetsusername 11y ago

>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".

OopsCriticality 11y ago

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.