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    We make assumptions when we don’t fully understand a situation. It is a natural reaction to immediately fill in any missing information by making up our own story. We do this becau
    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
    se we like to try to make sense of people and situations. The problem with this is that most of the time our story is incorrect which causes all kinds of complications. The fact is
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    we don’t know what the truth is unless we ask.

    As much as we would like to think we know what others are thinking, we simply can’t read minds. Sometimes we think we have the super
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    power to know the reasons why people do the things they do (without asking them) which is pretty presumptuous. Remember, not everyone sees the world the same way you do (shocker, I
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    now, but it is easy to forget).

    Need another reason to stop making assumptions? Try turning it around, do you believe that other people can read your mind? Would you rather that s
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    meone makes up a story (an assumption) about what you are thinking and feeling? Or, would you prefer if they ask you?

    When you ask instead of assume, you may not always get an answ
    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
    r you like or expect. Still, asking is much better than making up your own story because then you are in the position to make an informed next step.

    Asking questions seems like an
    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
    asy thing to do so why don’t we do it more often? Why do we sometimes become paralyzed when it comes time to:

    - Contact a client to find out why they haven’t responded to a phone c
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ll or e-mail

    - Ask a partner if they are satisfied with the way you work together

    - Ask a colleague if they still plan to make that introduction for you that they promised

    It goes
    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
    something like this. Let’s say you see a prospective client at a networking event, he sees you too but when you try to approach him for a chat he leaves abruptly. That is all that
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    appened, you don’t know why he had to leave and yet your mind starts making up a story, an assumption.

    You might think he doesn’t like you or that he isn’t interested in your busine
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ss. That may or may not be true but why bother thinking negative thoughts when you don’t really know the reason he left.

    If you want to know the reason, ask! You may find out that
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    he just went outside to put money in a parking meter, that he had a family emergency, or something else which was not related to you at all.

    So how do you do it? When asking questi
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ns, do so in a non-judgmental way with the intention to discover the truth. Stick to the facts and use a neutral tone when asking questions verbally.

    If you’re still not convinced,
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    here are seven reasons why you, and your business, may be suffering because of assumptions. Making assumptions is bad for business because doing so can:

    1. Cause unnecessary stress
    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

    2. Waste time and energy

    3. Create misunderstandings

    4. Cause you to miss out on great opportunities

    5. Lower your confidence and create self-doubt

    6. Lead you to offer the wron
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    product/service

    7. Create obstacles that don’t exist

    Hopefully it is clear why assumptions are not good for your business and you are willing to stop making them. Making assumpti
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ns isn’t good for any relationship which means you can apply this to your personal life as well. After all, you do have a life outside of your business right?

    My challenge to you i
    .

    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 start paying attention to your thoughts and become aware of when you are making assumptions and then get into action and ask the right questions.

    Asking questions is simple, and
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    not always easy. Find the courage to do what may feel difficult and just ask. Ending assumptions is like any skill, it takes practice. The more you do it the easier it will become


    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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