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  • Your Space - Organizing - Nature Versus Nurture

    The First law of nature is about self-preservation; every man for himself and le
    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
    t the devil take the hindmost.

    The nature versus nurture dichotomy is part of t
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    e cultural area; culture is about what people and groups have learned, additiona
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    lly from what they have "inherited" from nature initially. You could still fin
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    this dichotomy in organizations if you concentrate on the preferable way of org
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    nizing activities: individually based or by means of teamwork.

    If the first law
    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
    of nature is still valid, than the “natural” way of organizing activities will
    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
    e the individual way. This is however a very cultural topic and the cultural bac
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    kground will bias the outcome.

    But workplace culture is just about this. About
    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
    he balance between giving space to the individual “hero” and in the meantime pro
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ote teamwork. To establish this balance, the manager should use his or her artis
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    tic and creative powers:

    If you give too much space to the heroic activities of
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    the individual you will end up with a lot of loose end solutions that are not su
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    pported by the rest of the organization.

    If you put too much emphasis on the fa
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    t that the result must be carried by the team, you will take the risk that the r
    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
    sult is indeed carried but no longer agrees the initial requirements because of
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    the amendments of the members (in order to achieve consensus). The average bias
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    etween these two is pointing to the first one. So the second needs on average mo
    .

    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
    re attention.

    The least you should know is which side is your organization on.
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    he rest is making sure that you are not going for the ultimate.

    © 2006 Hans Boo


    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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