Hey guys,Let me start off by apologizing about including you in the video. I'm so embarrassed reading this haha We thought you guys knew what we were doing that day when filming- we didn't mean to step on any toes. We had a lot of issues with the video. We had the camera for a portion of two days, with half of the footage rendered unusable. That left us with so little content that we had to use stock video! The product we have are labeled "for education use only" for legal reasons. Most biotech companies have similar disclosures on their products (ex. BioRad). The first products we released, including the blue light transilluminator, were the first I ever designed or fabricated. The reason they are priced much, in the case of the blue light, on the higher end is 1. starting up we couldn't afford bulk materials making it far more expensive and 2. sourcing materials in the US. This is something I plan to remedy when I have the funds (buying in bulk). For now, I've cut the costs as much as I can and only make a small margin of profit on that item. Lastly, we were vague on the video because 1. The content we did film that went in depth were completely out of focus and 2. We didn't think it would be very interesting to the average indiegogo user. I have talked to Raymond about doing a demo at BioCurious soon.Many apologize for the lack of production value of the video haha. I worked with the time I had and the footage that survived.Cheers,Thomas
Matt, see my comments in-line below.
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cc: diybio, biocurious, tito, indiegogo
(is this a violation of indiegogo terms?)
Thomas:The reason why this is annoying to me, personally, is that you didn't seem to do your homework
...I can't tell how much of your video or your product is directly copied from Pearl Biotech.
...Is Tito Jankowski aware of this?
SELLING that for twice the price to "greater fools" willing to give you money for the work leaves a very bad taste in my mouth.
...Things don't add up.
In my opinion, which you probably don't take very seriously
But this? Does not feel right. Does not smell right. IMO: violates our code of conduct. http://diybio.org/codes/, and that of indiegogo http://www.indiegogo.com/about/terms.
Everyone: how do you feel about this? Are my concerns ungrounded?
Hey Nathan and Patrick,--Thank you for that "warm" welcome haha. I have been working on ways to reduce the price of the transilluminator without buying overseas or in bulk (which I can't yet afford). This will be fixed when sales start coming in. I've been wanting to design a gel imager for awhile now, but the project took a back seat the the microfluidic chips. I'm updating the info on the chips tonight for you guys! I thought it a little confusing for the userbase of indiegogo, but I have no problem sprucing it up for people who are interested.Cheers,Thomas
On Monday, November 11, 2013 3:22:10 PM UTC-8, hbergeronx wrote:http://www.youtube.com/watch?v=TQT-oQVaahg featuring the back of Patrik's head, and biocurious. Anyone know more about this? it's an indigogo campaign, but it seems to be a bit under the radar...http://www.indiegogo.com/projects/lab-on-a-chip-diagnostics-in-the-palm-of-your-handI have to admit i'm a bit skeptible when the video doesn't have any of the prototypes on it...-matt
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Wow, this got really interesting while I was out of Internet reach...
Thomas and Grene Labs received permission to film in the lab and use the BioCurious logo incidentally in the video, showing that's where the demo was filmed. BioCurious is not currently an official sponsor or promoter. Thomas graciously offered to teach a class or make other arrangements (provide equipment at a discount, help us standardize our current setup, etc.) to say thanks to the lab for having a place to film.
(And thanks for the good catch, Cathal - we try to protect use of our logo and brand, without ruthlessly policing it. I appreciate the whole community looking out for us.)
BioCurious is considered a public venue, and we allow people to film with prior arrangement. Reporters need permission. Surreptitious filming is not allowed. It's customary to get permission, either verbal or formal, when filming people for any commercial use. If I'm in the lab, and there are cameras out, and I don't want to be filmed, I ask them to stop or I leave. Or I speak to the staff on duty.
If anyone has serious concerns about being misrepresented in a video that Grene Labs did, please continue to pursue it with Grene Labs directly, but also please let me know.
And, as a matter of course, BioCurious encourages both open and commercial projects, and we encourage proper attribution. We don't have formal policies on any of this - it's more of a Golden Rule / social contract.
I encourage a good, open discussion here, but, hey - keep it civil, folks. That's also a BioCurious community value. And the Internet is like amber for damned foolishness.
That sounds officious. But I wanted to do the transparent disclosure stuff on BioC's involvement.
Now personal opinion:
I'm a funder of the project. I don't know if they can do what they say - microfluidics is harder than it first looks, and this sounds ambitious.
But I see a crowd-funded biotech project, I'm supporting it. Hell, I'm a funder of Glowing Plant, and my personal reservations about the approach there are pretty well known.
I'm concerned because some neat projects with potential to move the needle are going unfunded. Note the Yovivo! project (disclosure: I'm an advisor).
I haven't had a good chance to vet the Grene Labs lab-on-a-chip approach. I'm hoping to. I'd like it even better if we do something as a community to (politely) ask probing questions, and to challenge technical and legal assumptions. Maybe we can get Thomas to do an open meeting on that, in addition to a class, if we haven't welcomed him too warmly already.
Final personal thought - listing the device as educational is not a dodge, but standard guidance and legal practice to help keep it from being used for diagnostics or medical use. Marketing a crowd-funded project as having potential in this area, without over-promising , is just trying to do some good world - saving.
And, see, I almost got through this entire thing without saying anything about white male privilege.
Yours,
Raymond
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Device Investigations Exempt from IDE Regulation
Investigations of diagnostic devices that meet the criteria at section 812.2(c)(3) are exempt from the regulations at 21 CFR 812, with the exception of section 812.119. The criteria at section 812.2(c)(3) include specifying that testing:
The criteria in section 812.2(c)(3) also include compliance with labeling requirements section CFR 809.10(c), which exempts shipments and other deliveries of IVDs from certain labeling requirements if either (1) the device complies with part 812, or (2) the investigation is not subject to part 812 and one of the following conditions is met:
(i) For a product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, all labeling bears the statement, prominently placed: "For Research Use Only. Not for use in diagnostic procedures.''
(ii) For a product being shipped or delivered for product testing prior to full commercial marketing (for example, for use on specimens derived from humans to compare the usefulness of the product with other products or procedures which are in current use or recognized as useful), all labeling bears the statement, prominently placed: "For Investigational Use Only. The performance characteristics of this product have not been established.''
For purposes of this guidance document, "labeled RUO" refers to IVD products labeled in accordance with section 809.10(c)(2)(i); "labeled IUO" refers to IVD products labeled in accordance with section 809.10(c)(2)(ii) unless otherwise specified. Examples of products that meet the criteria for these designations are provided in Section III.
Because these products are exempt from most regulatory controls, it is important that they are not distributed for clinical diagnostic uses.
Mere placement of an RUO or IUO label on an IVD product does not render the device exempt from otherwise applicable clearance, approval, or other requirements. FDA may determine that the device is intended for use in clinical diagnosis based on other evidence, including how the device is marketed.
In general, if evidence shows that an IVD product is inappropriately labeled RUO or IUO, and that the product does not qualify for an investigational device exemption under 520(g) of the Act, and is not cleared, approved, or 510(k)-exempt, the device would be misbranded under sections 502(a) and 502(o) of the Act, 21 U.S.C. 352(a), 352(o), and adulterated under section 501(f) of the Act, 21 U.S.C. 351(f).
Hey guys,I'm bulking up the indiegogo for you guys to make this more clear. That should be done by the end of the day. I only tried to keep it simple for Indiegogo users. As for the "education purposes only" on my electrophoresis products, I understood that "for educational use only" worked also for the FDA (biorad does as well). I talked to them before I put up that disclaimer- but I can also change that to make it more of the standard disclaimer. We have a really small team here. We work to the best of our abilities to do marketing and provide the appropriate information- but it's obviously lacking. I appreciate the critical feedback, truly. We've never engaged in marketing or business before this, we just wanted to take on projects that pushed our design capabilities.The Indiegogo will be updated for all the questions here, and also handed out my personal cell phone to many people on the board.Cheers,Thomas
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Hey guys,I'm bulking up the indiegogo for you guys to make this more clear. That should be done by the end of the day. I only tried to keep it simple for Indiegogo users. As for the "education purposes only" on my electrophoresis products, I understood that "for educational use only" worked also for the FDA (biorad does as well). I talked to them before I put up that disclaimer- but I can also change that to make it more of the standard disclaimer. We have a really small team here. We work to the best of our abilities to do marketing and provide the appropriate information- but it's obviously lacking. I appreciate the critical feedback, truly. We've never engaged in marketing or business before this, we just wanted to take on projects that pushed our design capabilities.The Indiegogo will be updated for all the questions here, and also handed out my personal cell phone to many people on the board.Cheers,Thomas
On Friday, November 22, 2013 8:13:20 AM UTC-8, hbergeronx wrote:
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Hey guys,
I'm bulking up the indiegogo for you guys to make this more clear. That should be done by the end of the day. I only tried to keep it simple for Indiegogo users. As for the "education purposes only" on my electrophoresis products, I understood that "for educational use only" worked also for the FDA (biorad does as well). I talked to them before I put up that disclaimer- but I can also change that to make it more of the standard disclaimer. We have a really small team here. We work to the best of our abilities to do marketing and provide the appropriate information- but it's obviously lacking. I appreciate the critical feedback, truly. We've never engaged in marketing or business before this, we just wanted to take on projects that pushed our design capabilities.The Indiegogo will be updated for all the questions here, and also handed out my personal cell phone to many people on the board.Cheers,Thomas
On Friday, November 22, 2013 8:13:20 AM UTC-8, hbergeronx wrote:
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