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  • Advice Pool - I Didn't Hear You, Can You Repeat That

    Pardon? Say what? Come again? Say that again? Eh? Can you repeat that? Sorry? You what? Aye? I missed that? Hmm?

    It doesn’t matter how you say it,
    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
    they all mean the same thing: you didn’t hear what was just said.

    I’ve been thinking recently about how often I don’t hear what someone has said and how o
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ften I ask them to repeat themselves. In some situations I will ask repeatedly, no matter how many time it takes, until I hear. In others, I will only ask o
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ce or twice. And, in others, I will not ask at all.

    With family and close friends I am happy to ask repeatedly; most, if not all, of them know I am partial
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ly deaf and they are usually happy to repeat themselves until the cows come home. Sometimes, and I guess it depends on their mood, they don’t want to repeat
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    themselves - this annoys me quite a bit, if what they just said is not worth repeating why was it worth saying in the first place?

    The people I really stru
    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
    ggle with are the quietly and soft spoken ones. Some people just refuse to speak up and it will not matter how many times I ask them to repeat it, I will ne
    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 hear them properly! I find myself avoiding speaking to people who I know speak really quietly, just to avoid the hassle - I wish I didn’t do this because
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    I’m sure it looks rude to them and I’m no doubt missing out on some good conversation. The obvious answer here is to tell them that I have trouble hearing
    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
    hat they say; I really don’t feel comfortable doing that and I can’t remember a time when I ever have done. I really should make the effort to start in futu
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    re.

    In the opening paragraph I said that in some cases I will never ask the person to repeat themselves. I used to do this a lot - I used to be too embarra
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ssed about my hearing loss, I tried to hide it as much as possible - I would either try and guess what they said based on the odd word I’d heard or the cont
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    xt of the conversation or simply nod, laugh or give a short answer like “yes” or “no”. I realised some years ago that this was a stupid thing to do, I cring
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    e at the amount of times I must have given stupid and meaningless answers. I’m sure a lot of people do this exact thing all the time, it’s an easy way out.
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    It’s rarely uncomfortable to ask someone to repeat themselves in a one-to-one conversation; a group conversation can, on the other hand, be very difficult.
    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
    It is a good idea to position yourself somewhere where you will have the best chance of hearing; this is something you can do when you know that one person
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    n the group is going to be doing most of the talking: the teacher at school/college, someone giving a presentation to a group, and so on. It’s not so easy w
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    hen you don’t have a single person to concentrate on: when you are chatting with friends or in an office meeting, it is particularly difficult if there is a
    .

    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
    so background noise such as background chatter or office air-conditioning. It is too easy to loose the conversation when you are having to listen for voices
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    coming from all directions.

    Read more articles like this at www.deafness-and-hearingaids.net


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