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.
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Robert Schiff PhD, RAC, CQA, FRAPS
CEO
Schiff & Company, Inc.
1120 Bloomfield Ave., Suite 103
West Caldwell, NJ 07006
rschiff13@aol.com973-568-3361
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Original Message:
Sent: 21-Aug-2019 16:47
From: Julie Omohundro
Subject: Medical Technology trends
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.
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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
Original Message:
Sent: 21-Aug-2019 09:11
From: Dan O'Leary
Subject: Medical Technology trends
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.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 21-Aug-2019 09:04
From: Delhy Arias
Subject: Medical Technology trends
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.
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Delhy Arias ASQ-CQA, BS, MS
Regulatory Affairs Manager
Miami FL
United States
Original Message:
Sent: 20-Aug-2019 09:16
From: Gail Sauers
Subject: Medical Technology trends
Asking these questions anonymously is in poor form
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Gail Sauers RAC
Regulatory Affairs Manager
Wake Forest NC
United States
Original Message:
Sent: 19-Aug-2019 10:22
From: Anonymous Member
Subject: Medical Technology trends
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?