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    Inevitably, being a technical support contact, you are going to have to speak to a client, whether it's being the first point of contact and they have called you to report a problem, to get more information about a particular problem, or to let them know an issue has been res
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    olved. Unfortunately, in my experience, most technicians do this the absolute wrong way.

    What's the wrong way, you ask? Well let me explain. For the purposes of this article, I will define a "user" as someone who has between 0 and 10 hours of total training of a particular p
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    roduct. Whether this means that they went to a night course on how to use Microsoft Word more effectively, or they looked at the sticker on their phone that tells them how to get their voicemail is irrelevant; they are not power users by any stretch of the imagination, just s
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    meone who knows enough to get by. Also, for our purposes the words "client" and "user" can be used interchangeably.

    Problem Description: User calls the helpdesk and says "I can't save my document to my network folder."

    What I almost always hear the technician ask is somethi
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ng along the lines of "Ok, and what server and share is giving the error?" There are so many things wrong with that sentence, I don't even know where to begin.

    1. As much as it may pain you to do so, empathize with your client, but don't sympathize. Start out replying by say
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ng something like 'I understand how that can be frustrating, now let's see what we can do to fix it.' Letting the user know that you relate to the problem will let them know that you have formed some sort of personal attachment to their issue. Also, most users will realize th
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    at the problem isn't your specific fault, so emphasizing that you're willing to help them fix it actually lets them know that you are taking personal responsibility for the problem and will invest all of your resources into fixing it. The reason I use 'we' is to set the custo
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    er expectation that they will be involved and that you need their help. This is something I think is critical in setting customer expectations and allowing them to feel involved in the process. (Setting customer expectations is something we will discuss more in depth in a lat
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    er article.)

    2. 'What server and share...' assumes that the user first of all knows what a "share" is, and secondly what server this 'share'-thing is on. Never assume that your user has any technical knowledge beyond what they've just explained to you in whatever technical o
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    non- terms. Ask more user-friendly questions like 'Where are you trying to save to?' This will allow the user to respond in whatever level language they feel comfortable in. Also by listening to their response, you should be able to make a good guess as to their technical co
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    mpetency and tailor your next questions accordingly. The initial call is an excellent time to learn client lingo and educate the client on proper terms. While educating a client on proper terminology is something that we will focus more on at a later date, it is very importan
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    t at this stage to note that the use of the exact words used by the client should be noted to determine where the issue lies. This is often how the user and technician get confused.

    3. She didn't say anything about an error, so don't assume one is showing up. Feel free to as
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    'Is there an error message on your screen?' but don't assume that there is one just because something isn't working. Maybe she had a mapped network drive that is no longer showing up under My Computer in a Save As dialog box. That would satisfy the criteria of not being able
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    to save to her network folder, but not having an error, would it not? You must play detective for the users and realize that more often then not they have left out information inadvertantly, as they're really not sure what to be looking for in the first place. Ask more probi
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    g questions like 'What is the title of the window that you're currently looking at?' or 'Can you describe what buttons you have available to you?' More often than not, even something as simple as knowing that there is a certain button available on the window she's looking at
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    will help you immensely in narrowing down what the user is looking at.

    Now, that's three major problems in a 10 word response; that's pretty bad, if you ask me. Never mind that 2 out of the 3 issues could be resolved by not assuming anything. Being a proficient help desk tec
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    nician requires more than just being able to solve a technical problem, but also to be able to tailor your responses to the client so that they feel comfortable doing what you're asking (e.g. converting 'geekspeak' to 'normalspeak').

    I can tell you that 99 times out of 100,
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    if you are able to communicate on the same level as your client (whether that means dumbing things down to the point of using Winnie the Pooh characters or whether you're communicating back in forth in binary), you will be able to get them to listen to you, as well as get the
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    to do what you're asking, with little resistance. You have to remember that computers, while not necessarily a new thing in the workplace, are still mysterious machines that at the click of a button can make incredibly huge calculations and at the same time play the latest s
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ong from Britney Spears. The more comfortable they feel around them, the less worried they'll be about potentially breaking something.

    Next week, I'll continue this article by going more in depth about how to explain technical issues and terms to users who might not "get it"


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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