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Hi

brobnett
brobnett
October 2013
edited February 2015
in Everything else
Just a quick hello and a little about me. I've been interested in the biohack/grinder/h+ movement since meeting Steve Hayworth last year at XFF. I am the Director of Regulatory Affairs & Quality at a medical device manufacturer (cancer therapy) and I have 20+ years experience in medical device design, testing/validation, and regulatory approvals.


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  1. ThomasEgi
    ThomasEgi
    First Anniversary Second Anniversary Third Anniversary Fourth Anniversary Fifth Anniversary Final Anniversary First Post 10 Posts 100 Posts 500 Posts You Look Familiar Paging Mr. F Welcome Committee We Have Touchdown
    October 2013
    Be welcome. Since you posses good knowledge i want to encourage you to add a section in the wiki. So everyone can access the information on demand.
  2. DirectorX
    DirectorX
    November 2013
    Hello @Brobnett, welcome! XFF was fun. Chaotic, but fun. I have a speaking gig in Feb at a medical device trade show in Anaheim. Since you are in the industry and (I assume) communicate with the FDA on a regular basis, I'd like your opinion on something. Do you see recreational/cosmetic/non-life saving implants (like the Circadia implant from Grindhouse) being accepted by the FDA any time soon?

    I don't see some of these implants, many of which are class 3, being approved any time soon given the current red tape. I suppose it is possible, but going through the current approval process would definitely be cost prohibitive compared to the expected return. I'm wondering if it looks as bleak from your point of view?
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