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    I have just come back from completing some one on one coaching sessions with
    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
    some managers of a high street financial institution and many of them found
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    it difficult to give feedback to others in a constructive manner.

    Usually,
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    they would either say nothing at all and just bottle up all of the frustratio
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ns and feelings they had inside.

    Sometimes, what they would say would come o
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ut all wrong and then they would be labelled as aggressive!

    Then there were
    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
    others who would give the feedback in a very aplogetic nature and in the end
    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
    backdown and dillute how they were feeling!

    So, say someone has done someth
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ing that you are not happy with. How do you tell them?

    Well, I recommend tha
    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
    t you use the EXAMPLE, EFFECT, CHANGE method.

    Here's how it works:

    SCENARIO
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    1

    Example WHEN YOU DON'T ARRIVE AT MY MEETINGS ON TIME...

    Effect IT REALLY
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    DOES UPSET MY BUSY SCHEDULE FOR THE ENTIRE DAY...

    Change IN FUTURE COULD WE
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    AGREE THAT WE START PUNCTUALLY?

    SCENARIO 2

    Example WHEN YOU DON'T LOOK AT
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ME WHEN I'M EXPLAINING SOMETHING TO YOU...

    Effect IT MAKES ME FEEL AS IF YO
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    U ARE NOT LISTENING TO ME...

    Change IN FUTURE COULD YOU TRY TO LOOK AT ME W
    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
    HEN I'M TALKING TO YOU?

    SCENARIO 3

    Example WHEN YOU STOP ME FROM TALKING BY
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    INTERRUPTING WHAT I AM SAYING...

    Effect IT MAKES ME FEEL AS IF YOU DO NOT
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    VALUE MY CONTRIBUTION...

    Change IN FUTURE COULD YOU PLEASE LET ME FINISH WIT
    .

    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
    HOUT INTERRUPTING ME?

    Can you see how you could use that at work?

    Think ab
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    out the common occurances where that technique would come in handy and use 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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