Regulatory Open Forum

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  • 1.  personal lubricant applicator

    Posted 10-Feb-2016 19:53

    Hello all. My co. manufactures personal lubricants & one of our investors has recently asked about putting our lubricants into a squeeze tube (see photo for an idea of the type of applicator I'm referring to) so that users would not have to "touch their genitals" when applying the lubricant. I see a number of issues with this, the most concerning being the risk of infection, as the applicator tip would be in direct contact w/ the genitals/mucous membranes. The risk would still be there even if the product was applied to the fingertip first. Aside from this issue, can anyone else give me any ideas that I can use to kill this idea? Thanks so much everyone.

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    Lauren Parker
    CA
    United States
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  • 2.  RE: personal lubricant applicator

    Posted 11-Feb-2016 07:51

    The easiest way to talk management out of this idea, in my opinion, is to make the argument that it won't be profitable. Has anyone at your company done a market analysis? If not, then it might be worth a little bit of your time to take a look at the market size, competitive landscape, cost of goods, etc., and do a rough calculation of how much profit you're likely to make. If there's not a big potential upside, then you shouldn't have much trouble convincing people not to take the risk.

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    Michael Hellerstein
    GeoVax, Inc.
    Smyrna GA
    United States

    Original Message


  • 3.  RE: personal lubricant applicator

    Posted 11-Feb-2016 08:39

    Lauren, a statistician (or a microbiologist) may be able to calculate infection transmission risk based on rates of transmission of STDS, for example.  However, contamination of the "applicator" seems the minor risk compared to the direct person-to-person contact if one of the persons is infected.

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    Mark De Rosch
    Vice President, Regulatory Affairs
    Akebia Therapeutics, Inc.
    Cambridge MA
    United States

    Original Message


  • 4.  RE: personal lubricant applicator

    Posted 11-Feb-2016 09:10

    One other argument could be, if this would work, it would have already been on the market.

    The idea is not so revolutionary that is unlikely to have come to others too...

    :-)

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    Sorin Alb
    Project Manager, Regulatory Affairs
    NUCRO TECHNICS
    Scarborough ON
    Canada

    Original Message


  • 5.  RE: personal lubricant applicator

    Posted 11-Feb-2016 10:13
    Lauren,

    I don't know your function in your company. But I would assume you play a role in RA.

    Technically speaking, in reference to your words "personal lubricants....risk of infection...kill this idea..."

    It is for personal use.  There are personal lubricants, which are inserted into the vagina, or applied directly to the vaginal area or even to the device being inserted into the vagina. Thus, risk of infection is minor.

    To kill the idea as an RA pro, you've got to be on top of the issues (a full and complete understanding of technical issues including business and regulatory risks, etc.).  Otherwise, please take some conservative position. 

    At this point, it is recommended you can softly raise an issue by saying "we need to look at all other similar devices on the market and see if there is any potential risks to be facing (e.g., an increased risk of infection....)."  

    You've done enough at this point with the statement recommended above.

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



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    Original Message


  • 6.  RE: personal lubricant applicator

    Posted 12-Feb-2016 14:32

    I don't see a huge risk - "personal toys" would pose a similar risk and yet there is a market for those. Would it just be a matter of making sure the product is labeled with instructions on how to keep the applicator clean after use? 

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    Christine

    Original Message