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    The fundament of any corporate culture is based on productivity. So it is the main productivity focus of a company that influences much of
    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
    the corporate culture.

    To see this relation, just imagine an investment company. A company that is dedicated to investments either in mu
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ual funds, venture capital or managing third party investments. The company’s main productivity focus is in dealing with risk -- exchangin
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    g risk between different partners. And this main focus will influence the culture of the organization. "Take risk, but in a calculated way
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    " could be a organizational rule.

    Now think of the same company and the decision of the company to handle insurance products. The main bu
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    siness of insurance is also to do with risk, but in a different way -- focused on avoiding risk.

    What would be the impact of this decisio
    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
    on the culture of this organization? And why is this important?

    Two Airplane manufacturers will -- by sharing the same kind of business
    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
    productivity -- exhibit similar cultures. Engineering is an important factor, and the professional airplane environment is another factor
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    hat both will share. There will also be differences, for example when one company is European and the other American. One is Airbus, the o
    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
    ther is Boeing.

    Think of these companies at one moment in time, having both this similar business culture. Than take the impact of both c
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    mpany’s strategic focus on the culture of each organization. The first strategic focus is set on speed (by Boeing) the other strategic foc
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    s is set on Size (by Airbus).

    Airbus was the first company that took the risk of redefining its strategy. The feedback loop -- the time t
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    o develop and construct a new model is quite large. The initiative from Airbus to develop the new A380 model was (therefore) quite a chall
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    nge. It was a brave strategic move that required a even more serious implementation. And this implementation is where we -- especially the
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    Arab Emirates --are still waiting for. And at the moment it becomes clear that the implementation of the strategy is causing problems.

    T
    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
    is is however not unique for Airbus. Any company that is remodeling its business strategy will face implementation problems. In the case o
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    f Airbus these are very visible for the world, not in the last place for the long feedback loop.

    What is unique to the Airbus case is the
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    possible impact on the corporate culture. When the new A380 airplane will be finished and launched it will certainly be an enormous event.
    .

    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
    Yet at a cost of arriving too late. And (Just In) timing is key in the airplane industry. The strategic focus on size is in this case a b
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    t unfortunate. The cultural impact on the organization in developing the A380 is therefore significant. But irreversible.

    © 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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