5 ms·

Down-voting my comment will not make the FDA regulations go away. You will not bring any biotech products to [edit: medical] market unless you comply with the F

by mkempe 13y ago

Down-voting my comment will not make the FDA regulations go away. You will not bring any biotech products to [edit: medical] market unless you comply with the FDA (or somehow manage to eradicate it). Health-related products and services are heavily controlled -- in ways completely at odds with the common practices of Internet startups. If you haven't yet had to comply with these regulations, you may want to find out how onerous they are. Here is one example: Quality System (QS) Regulation/Medical Device Good Manufacturing Practices [1], covering: Quality System, Design Controls, and Human Factors. They audit your compliance with their regulations. You have to document everything you do, every decision you make, every change you make. That is not how startups commonly operate. [1] http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...

technotony 13y ago
Who say's biotech products have to go via the FDA? There are all kinds of potential markets with lower or non-existent barriers to market, eg my company which makes Glowing Plants. These are the areas which make more sense initially as you really can take a lean startup approach to them.
- mkempe 13y ago
  Of course, some biotech is not aimed at humans. Anything aimed at humans will have to satisfy the FDA, in the US.
- dnautics 13y ago
  how's that going? You guys said you would deliver in april, but it looks like it's been pushed back to june. There are also very few lab-related blog posts, despite a promise by Mr. Drory in the reddit thread that all intermediate results, both good and bad would be disclosed. Also, he said a budget would be disclosed. I haven't seen one on the site yet. http://www.reddit.com/r/technology/comments/1e5rti/whats_wrong_with_the_glowing_plant_kickstarter/ http://www.reddit.com/r/technology/comments/1e5rti/whats_wro... >This will be totally transparent project - we will introduce a novel concept called "constant peer review" - In academia no one publish things that didn't work - we will publish everything. >We take being a good Steward of our backers funds as #1 priority. Our budget will also be publish online and you can see where the money went. Neither of these two things has happened yet.
  - technotony 13y ago
    Are you a backer? We've been sharing this information in the backer updates. Some of this is also to be found on our youtube channel. With respect to the budget we currently have $230,000 left in the bank. We'll publish the financials when we are ready to ship.
fasteo 13y ago
This is THE hardest problem to solve in a biotech start-up. In the mitochondrial field, companies are going through orphan-drug designation and fast-track approval processes. This is probably to only advantage researching for niche - rare - diseases: You can save lots of money/time to get the drug in the market. If you can then find some off-label use for you drug, much better.

by mkempe 13y ago

technotony 13y ago

Who say's biotech products have to go via the FDA? There are all kinds of potential markets with lower or non-existent barriers to market, eg my company which makes Glowing Plants. These are the areas which make more sense initially as you really can take a lean startup approach to them.

mkempe 13y ago
Of course, some biotech is not aimed at humans. Anything aimed at humans will have to satisfy the FDA, in the US.
dnautics 13y ago
how's that going? You guys said you would deliver in april, but it looks like it's been pushed back to june. There are also very few lab-related blog posts, despite a promise by Mr. Drory in the reddit thread that all intermediate results, both good and bad would be disclosed. Also, he said a budget would be disclosed. I haven't seen one on the site yet. http://www.reddit.com/r/technology/comments/1e5rti/whats_wrong_with_the_glowing_plant_kickstarter/ http://www.reddit.com/r/technology/comments/1e5rti/whats_wro... >This will be totally transparent project - we will introduce a novel concept called "constant peer review" - In academia no one publish things that didn't work - we will publish everything. >We take being a good Steward of our backers funds as #1 priority. Our budget will also be publish online and you can see where the money went. Neither of these two things has happened yet.
- technotony 13y ago
  Are you a backer? We've been sharing this information in the backer updates. Some of this is also to be found on our youtube channel. With respect to the budget we currently have $230,000 left in the bank. We'll publish the financials when we are ready to ship.

fasteo 13y ago

This is THE hardest problem to solve in a biotech start-up. In the mitochondrial field, companies are going through orphan-drug designation and fast-track approval processes. This is probably to only advantage researching for niche - rare - diseases: You can save lots of money/time to get the drug in the market. If you can then find some off-label use for you drug, much better.