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  • Top Adding - Should I Lead with the Business or the Product?

    That's a popular question.

    Some people insist you lead with the business (and
    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 tell you to offer the product as a last resort only if the prospect says
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    No to the business); others say they'd rather lead with the product.

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

    there is NO best way for all. Just like there's no product for everyone.

    He
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    e are five questions to help you decide what YOU should do.

    Remember, you're
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    he one leading, so choose what suits YOU. And no, it might not be the same wa
    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
    y your upline tells you to lead. But the two of you might not have the same t
    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
    ste in music either, and that doesn't bother anyone, does it?

    The questions:
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

    1. What really excites you more: The product or the business?

    2. What do yo
    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
    identity with more: the product or the business?

    3. What do you believe you
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    an do better - talk about the product (and your experience with it) or the bus
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    iness?

    4. Where do you have more credibility and believability? With your pr
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    duct experience or your business (this or previous business) experience?

    5. W
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    hat is your tolerance for rejection? It's 10-50 times more if you lead with t
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    e business than the product.

    There is no best way. There is only the what wo
    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
    ks best for you way at this time. So follow your inner voice. Once you have
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    given that an honest try, you can always experiment with another approach.

    Af
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    er all, isn't the entire thing an experiment? We don't know the outcome for s
    .

    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
    ure, do we? So start with as many advantages as you can: Know yourself, act o
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    that information. Then you will have given yourself the best chance possible


    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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