[DIYbio] Re: [CCL] lab-on-a-chip

Yet this update seems to reference not your own work, but that of others posted publicly available. You have changed your tune: you are no longer referencing "needing no power", but have gone to electrophoresis and PCR. On the applicability of electrophoresis, I'm not sure how you're planning on doing detection- laser induced fluorescence? Mass Spec? or are you planning on coupling the chip with a transilluminator and your homebrew power supply? If so, you might also need to throw in a fluorescent microscope, since the amount of fluorophore is going to be invisible to the naked eye, AFAIK. And I'm not sure how you're going to compete with Agilent, particularly since there is considerable IP including their own lab-on-a-chip http://www.genomics.agilent.com/en/Bioanalyzer-Instruments-Software/2100-Bioanalyzer/?cid=AG-PT-106&tabId=AG-PR-1001 which (for some applications) seems to be backed by patents, e.g http://www.google.com/patents/US8346486. There's still a big question in my mind what gel you are going to be loading into the chip, what electrode system, peltier, etc. 

Some pictures of the prototype performing basic test separations (e.g. with a ladder) would be welcome.

I'm also not sure why the pictured chip would be needed. You can use PEEK tubing just as easily for the CE separation and get more or less the same effect- a long narrow capillary tube. This is a big element of the design I've been working on. Loading and unloading gel becomes a heck of a lot less of a PITA when you can just swap it out with a few pennies of tubing, no chip needed.

so keep working- I think you've got quite a task ahead of you before you have a viable product. (and I'm, honestly, still not sure how much of this is original work, or stuff plagiarized off the internet. It's great that you've "come up with your own design" for a transilluminator, but as you say, there are thousands of such designs out there googleable and does not actually represent revolutionary tech.)

As far as the patentable IP vs open source is concerned, you're young: by 2023 or so, much of this will be off patent and "game on" for open source exploitation.

-matt

On Friday, November 22, 2013 9:56:10 AM UTC-8, Thomas Warinner wrote:

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:

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253307.htm

Listing the device as "for educational purposes only" is not the same as a part 812 exception. There are very clear guidelines from the FDA on how medical devices must be labeled and marketed. Learning said regulations is an important part of developing medical devices, at least here in the US. 

Offering to send a chip to developing countries for (apparent) diagnostic purposes is incompatible with a declaration of investigational or educational use. 

-matt

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:

• be non-invasive,
• not require an invasive sampling procedure that presents a significant risk,
• not by design or intention introduce energy into a subject, and
• not be used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.

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).

On Friday, November 22, 2013, Raymond McCauley wrote:

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