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    Many business people wonder why they have such a difficult time launching a new produ
    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
    ct or service. Most do not invest time researching two key issues: whether or not the
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    re is a viable market for what they want to offer and what the competition is already
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    doing to satisfy the market.

    Why would an experienced businessperson ignore that vit
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    al step?

    1. Ego: They have a “great idea” and figure that all they have to do is adv
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    rtise and customers will line up to buy.

    2. Ignorance: They think they are the only
    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
    one to offer what they offer and so they have no competition.

    3. Poor Planning: They
    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
    do not have enough capital to get the job done adequately.

    In order to avoid these
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    istakes and plan for success, ask yourself the following questions:

    --What is your a
    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
    ctual, specific, detailed market?

    --Do the prospects already understand what you are
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    offering?

    --Are there enough customers out there to support a profitable business?

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

    Following aspects would a
    --If prospects are out there, how do you reach them with specific sales messages and
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    make it easy for them to buy?

    --If you have to educate prospects about the benefits
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    f your product or service, how much time and money will that education cost before yo
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    u make a sale and gain an income?

    --Who are your competitors from your customer’s po
    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
    nt of view, not your point of view?

    --How are you going to effectively compete with
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    all of those competitors?

    If you take the time to answer these pointed questions bef
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ore you launch that new product or service, you will have a much better indication of
    .

    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
    the risk of your venture. And the possible return on that risk as well. If you are wi
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    lling to take that risk, you can at least make sure the deck is stacked in your favor


    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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