Regulatory Open Forum

 View Only
  Thread closed by the administrator, not accepting new replies.
  • 1.  Medical Technology trends

    This message was posted by a user wishing to remain anonymous
    Posted 19-Aug-2019 11:38
    No replies, thread closed.
    This message was posted by a user wishing to remain anonymous

    Wanted to see RAPS community's thoughts on these:

    1:  What is a trend we are seeing in medical technology? and

    2: What is a trend we think we are going to start seeing in the next year for medical technology?


     



  • 2.  RE: Medical Technology trends

    Posted 20-Aug-2019 09:17
    No replies, thread closed.
    Asking these questions anonymously is in poor form

    ------------------------------
    Gail Sauers RAC
    Regulatory Affairs Manager
    Wake Forest NC
    United States
    ------------------------------



  • 3.  RE: Medical Technology trends

    Posted 21-Aug-2019 09:04
    No replies, thread closed.
    I don't think it's in poor form to ask a question anonymously.  Asking questions can be intimidating for some people, especially if they're new in the industry or are learning.  RAPS gives members the option to remain anonymously and to respond if we choose to.

    ------------------------------
    Delhy Arias ASQ-CQA, BS, MS
    Regulatory Affairs Manager
    Miami FL
    United States
    ------------------------------



  • 4.  RE: Medical Technology trends

    Posted 21-Aug-2019 09:12
    No replies, thread closed.
    One good reason to ask anonymously is taking into account the people who receive the question. For example, a competitor may like to know that a company is having an issue. I have no doubt that people from FDA monitor this list looking for indications of potential problems. I do know that there is a group that looks at company websites to determine if the company makes medical devices but has not registered and listed. These show up in Warning Letters on occasion.


    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------



  • 5.  RE: Medical Technology trends

    Posted 21-Aug-2019 16:48
    Edited by Julie Omohundro 21-Aug-2019 16:59
    No replies, thread closed.
    Yeah, this clearly isn't that kind of question (i.e., the kind that a newbie might shirk from asking nor the kind that reveals information about a company or its products.)  It isn't even a regulatory question.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 6.  RE: Medical Technology trends

    Posted 22-Aug-2019 15:53
    No replies, thread closed.

    Since I first saw the comment about anonymous questions and queries I was giving some thought to how to respond.  As long as the society (RAPS) permits the use of anonymity there is an expectation that that is what we will see.  The obvious reasons are; I don't want to search it out for myself, there is something proprietary to my company in the question, I am new to how to obtain information and therefore can be embarrassed, the fear of the question eluding to something which from a regulatory standpoint is concerning, etc.  From my own perspective being old school I think it is professional to use one's name and affiliation.  As pointed out above anonymity implies something negative, I assume in most cases, and therefore there is this wish to hide.

    I have on several occasions answered the anonymous question privately and have yet to receive a response.  Therefore in my judgment to request information anonymously and at least not acknowledge the response is unprofessional.

    Under most circumstances I personally do not favor anonymity.

     



    ------------------------------
    Robert Schiff PhD, RAC, CQA, FRAPS
    CEO
    Schiff & Company, Inc.
    1120 Bloomfield Ave., Suite 103
    West Caldwell, NJ 07006
    rschiff13@aol.com
    973-568-3361
    ------------------------------



  • 7.  RE: Medical Technology trends

    Posted 22-Aug-2019 16:26
    No replies, thread closed.
    Thanks Robert of your take on the situation. I appreciate that you felt comfortable letting me know.
    Everyone should be allowed to do what they think is best. But at the time I read that posting I felt the need to let anonymous posters know it's not always the best way to ask for help. I usually keep my opinions to myself, some days it doesn't work.








  • 8.  RE: Medical Technology trends

    Posted 23-Aug-2019 11:49
    No replies, thread closed.
    I guess I am a bit nuanced on this. I can see situations where someone wants advice but is concerned about being new or less informed. I can also see situations where there is concern about implying (whether true to not) there is a situation at your company that the company may not want revealed. I am ok with people making the anonymous posting in those cases (though I myself likely would not do so).

    However, I am less good with posts that appear much more of a "we need to do a paper on this topic for my class and I am trying to take a short cut and get you to help me with it" type. If you want to do that, and have others share their knowledge to help you with an assignment of some sort, the very least you can do is identify yourself.

    g-

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------



  • 9.  RE: Medical Technology trends

    Posted 23-Aug-2019 16:50
    No replies, thread closed.

    Hi Everyone,

    We appreciate having read through all your concerns and opinions; your feedback is important! It really helps RAPS think about how anonymous posting is being used. Because the discussion is off topic from the original question, we are going to close this thread.

    Again, we appreciate your feedback. 

    Thanks,
    Emily

     



    ------------------------------
    Emily Stamm
    Community Manager
    Regulatory Affairs Professionals Society®
    regex@raps.org
    ------------------------------