Quality Matters - a post about commercial biohacker projects

A while back, Dangerous Things introduced the m31 biomagnet
based on a partnership with now defunct Science for the Masses. It was a big
hit, we were happy, and biohackers were happy. I implanted one of the very
first m31s into my pinky finger. Many months went by. We manufactured more
batches. Things were good.

Then we started getting reports of failures. These failures
were tied to physical events like “I smashed my finger” and “it wasn’t placed
properly”.. but still it began to worry me. We started to work with SfM to sort
out a more rigorous test involving acids and other chemical and physical stress
tests we could perform on m31s before they were accepted into our inventory.
Then SfM fell apart, some money and contractual obligations between SfM and DT
were in limbo, and I was left with no choice but to halt all sales of m31s
until better manufacturing and QA testing could be sorted out.

As time went on, just after the 1 year mark, my own magnet
began to fail. It started with a slight swelling and a small amount of pain associated
with the now fully healed implant site. I then tested sensation using my
microwave oven, something I’d done a lot of testing with a few months after I first
got my m31 implant… it was noticeably less sensitive and the proximity I had to
hold my finger to the oven was noticeably closer than previous necessary. I
decided to remove it myself using our PMK and a scalpel. I did a decent job,
but a tiny bit of it still remains in my finger – a dark stain to constantly remind
me that QUALITY MATTERS.

Since then, we’ve tried various new coating techniques and
methods to get TiN on to our magnets in such a way that they will not fail. The
endeavor proved fruitless. We switched materials… we tried straight titanium,
steel, and even a few more exotic materials. Nothing gave us that warm fuzzy
feeling you get when you know you’ve done it the right way… so we soldier on
and continue to pour money into magnet development… not because we think it
will be a big money maker, but because we believe biomagnets are a fundamental part
of what it means to be a biohacker.

On the surface, a magnet in your finger isn’t a big deal… it’s
not really all that interesting beyond doing some party tricks with and sensing
a field or two when you weren’t expecting to. However, having a magnet
implanted in your body literally changes your sense of self like no wearable tool
could. It re-wires your brain to interpret the sensory input coming from those
specific nerves in a new way… that is part of the fundamental essence of what
biohacking is all about… and I don’t want to see any injury befall any of my
fellow biohackers, or see any damage done to this growing community, simply to
rush a product and make a few bucks. That’s why the remainder of this post must,
unfortunately, be a warning regarding the quality of work being put out by a
fellow biohacker.

We have been working on our biopolymer formulation for quite
some time, and once we had it nailed down, we decided to offer the first
product using it – the flexNT - as a private beta for special customers who
wanted to test things on the edge. I had the first flexNT installed in my left
middle finger, and so far about 4 other people have had the chance to test the
flexNT, with the remainder of our beta test customers due to receive their
shortly… but then I got this email…

Someone from this board contacted me and wanted to discuss a
flexible NFC tag they received as part of a beta test from Alex / cyberise.me –
it surprised me to learn there was a flex tag coming out from cyberise, so I
engaged in a lively discussion. Ultimately, this person wanted to trade the
flex tag they received for a flexNT. I agreed, if only for curiosity’s sake. I
received that flexible tag and it sat on my desk for weeks… but yesterday I
finally opened it up and found, to my horror, a device that was nothing close
to what I’d consider to be safe for implantation. The beta test tag Cyberise sent
to this person, with the understanding that it be implanted as part of the
test, was really badly constructed. The silicone used to coat the tag with was mixed
very badly, with air bubbles trapped throughout the silicone coating which
probably contain evaporated curing agent and/or solvent vapors. It also had fibers and hairs
embedded throughout the coating, and dirt and other refuse stuck to the surface
of the coating. But the worst thing was that the tag was tacky when I attempted
to take it out of the pouch. I moved the tag off the paper pouch and it left a
mark on the paper… that means the silicone elastomer was not fully cured and
still had plenty of unlinked polymer… this would have been disastrous to implant.

I hate to call out any biohacker for trying to bring new
exciting things to our fledgling industry, but this is a safety issue that
could badly damage this fragile group who are all operating in the shadows and
grey area of legality. The worst thing for us would be a legal issue arising now
due to a serious health complication from a commercial biohacking device.

If you received a beta flex tag from Cyberise, and it’s
tacky to the touch or has bubbles in it, please do not implant it.

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Comments

  • This looks like someone tried adding another layer. This looks nothing like the quality of the tag I received directly from cyberise.me
  • Interesting. Were you part of the free pre-beta program or did you order a beta tag from the site? Was there a marking on the pouch, a number? Can you post photos?

    I just destructively analysed this tag and it's a simple silicone coating overtop a PET or PTFE substrate inlay. The silicone appears to be the only/initial coating.
  • edited June 2016
    amal
    I've gotta agree, that device should not be implanted.

    The device in your picture appears to one I made before I started using a vacuum pump to remove bubbles, it was a very early prototype and should never have been implanted, I'm glad the person who got it by mistake sent it to you rather than implanting it.

    Would you like me to send you one of my flexible implants to assuage your fears?

    PS to everyone else: If you ever get an implant which looks dodgy from me or anyone else, please contact me, safety has to come first in all types of implants.
  • edited June 2016
    @alex - if you wouldn't mind, I'd like to take a look. 

    Sorry I really don't mean to be a dick I'm just wanting to ensure everyone in the commercial biohacking market is keeping the utmost level of quality possible for the things they ship out to anyone, beta tester or not. I'm currently involved with various legal endeavors to try to open up and legitimize biohacking at various state and federal levels here in the USA, including a potential meeting with the FDA. Industry self-regulation is critical since we're all essentially living and working firmly in grey area at the moment, and I really hope we can keep each other straight (with no hard feelings) so as not to endanger the future of this movement which I feel is so hugely important for humanity.
  • It seems to be one of my prototype devices, but not one which was ever meant to be implanted, I must have made a mistake and picked up the wrong device when sending them out. I don't believe it had been tampered with before reaching you.

    Can you PM/email me your address and I'll send you one of the tags to test/check meets your safety standards. Thanks
  • Ok, well that makes me feel a bit better. Just proof positive that QA must extend to both ends of the supply chain. I considered contacting you directly but ultimately felt the content of the discussion would be valuable for public display anyway.
  • thanks for this discussion, as a new biohacker and someone who doesn't know anything about the technological side of this, i might have tried to implant it or let someone put it in me (Phrasing).

    i will be sure to always double check the quality of any device like this crosses my path, whether its put into me or into someone else. I'm glad this post gave me an idea of what i should be watching out for.

    i know it seems bad, but thank god this was just an honest mistake caught by an expert and not a rookie like myself.
  • I appreciate the info too because it never occurred to me that bubbles might be an issue. That's good info to have for whatever I come across in the future, especially if I try to DIY something.
  • katzevonstich bubbles are only an issue if they are close to the surface. i.e. if you had a 1cm square block of silicone (or other coating agent) with a bubble in the centre, it wouldn't be an issue, if however the bubble was close to the edge, there would be a risk of it weakening the coating, and if the thin wall between the bubble and the outside broke, it would likely lead to fouling.
  • @AlexSmith Thanks for the clarification. 

    FWIW, I figured the tag must have been a fluke or something else. Having read your post about the firefly tattoo design process, I got the impression you work hard on making your implants safe.
  • I received my flex tag from @AlexSmith today, coincidentally.  Here is a pic of mine.  The quality seems quite good and I'm very confident that I will have no issues with it when I implant it tomorrow.

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    As you can see, no air bubbles at all.  The NFC light prototype @AlexSmith sent me was of comparable quality, though the flex tag seems a bit better overall, so I'd say his skills are improving. :)

    @AlexSmith produces quality items in my opinion.  Then again, so do you, @Amal, and I know we all appreciate the work (and money) you put into making sure Dangerous Things sells.  I've got implants from both of you and I've never been disappointed by either of you.  Even when one of my m31s failed after six months, I knew that @Amal had the situation with them already addressed and I look forward to the day when the m36 (or whatever ultimately is made available in their place) releases.
  • @alexsmith in June you mentioned "I'll send you one of the tags to test/check meets your safety standards" ... thanks for sending one. I received it in November but didn't have time to check it until now. Unfortunately it was DOA... the tag was not functional, and the pierced silicone encapsulation negated my ability to perform a full battery of tests. Even though I could only do destructive testing on it, for what I was able to do, it looks like things have improved with the silicone process.


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  • With texas having disallowed tongue bifurcation, i agree that quality control and self regulation are going to be a serious point of keeping the community going. All it takes is one bad apple to ruin the whole bunch with something that is considered so out of ordinary.

    On the op note of m31...i have had mine in for about 2 years now. Should i remove it? It hasn't yet shown signs of magnetic degredation, or any sensitivity. I'm not exactly sure which version i have, but i think i remember it packaged in a business card, from dangerous things. Thin, more than likely the m31 size. Ti coated.
  • It will definitely be easier to remove now than later if it does fail. Forward me your order information (reply to the order email) and I will put you on the list for a free replacement. All of our implantable products carry lifetime warranties.
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