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    A person who has a lazy, slow-moving gait tends to look less commanding than someone who walks with a good posture that exudes confidence. Likewise, the way the company is organised can help
    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
    it position for future growth.

    The world has changed dramatically. These days, being internationally competitive is the name of the game. With the dissolution of the international trade barr
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ers and the evolution of a new global economy, many companies have gone through a continuum of transition from being international (stressing an export-import orientation), to being multin
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ational (having major operations abroad that are concentrated on specific, relatively protected markets) to being global (looking at the entire world as a market). The new and total global e
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    onomy has come of age.

    There are three organisational structures:

    Multi-local The overseas affiliates are given full autonomy with little interference from the headquarters. This structure
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    is suitable for organisations that require high customisation, flexibility and speed to respond to the market place. Examples of industries requiring such structures include the retailing, a
    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
    uditing and consulting businesses etc. The downside is that there are wasteful duplications and low cost efficiency. However, in industries that require ground knowledge, the trade-off for e
    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
    onomy of scale and duplications is speed and flexibility.

    Global The overseas affiliates are given little autonomy. The headquarters make all the major decisions. The organisational struc
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ture is by functions, with each function such as the sales and marketing, financial heads of the subsidiaries reporting to the headquarters’ functional heads. In some companies, the function
    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
    are grouped by product lines and major customer accounts reporting back to the heads for the product lines and multinational accounts. If worldwide efficiency is required, then this structu
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    e is more appropriate. Examples of industries requiring such structure include electronic chips, consumer electronics etc. The disadvantage of this structure is the erosion of local respon
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    siveness as it entails very centralized control.

    Transnational In some cases where both local and global know-how are important, the transnational structure may be appropriate. The organisa
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ional structure is based on a matrix with dual reporting and the achievement of consensus as the key driver. Depending on the nature of your business, you should adopt an organisational stru
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    cture that enables you to meet with your business objectives, and which will provide flexibility and room for future growth. The common thread in the above three structures is the concept
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    f ‘flat organisation’.

    The phrase ‘flat organisation’ is now overworked and misunderstood. It is an oxymoron, a contradiction in terms. Any organisation that exists for a purpose needs a spin
    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
    of decision-making accountability. This applies to private corporations, public institutions, voluntary organisations and cooperatives.

    A good organisation structure is one with the optima
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    l number of layers of leadership, which demonstrably add value to the work of the others. This includes the design and delivery of mission and strategy. It provides space and challenge for i
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    dividuals to achieve, continue to learn, grow and enjoy their work and be duly rewarded for their performance.

    The theory is clear. The problem for managers is how to design it in practice.
    .

    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
    How many vertebrae should there be in this spine of accountability? What are the key functions? How are they identified? What is the impact of removing a function from this spine? What im
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    act will this have on the development and motivation of the incumbents? Surprisingly, at the beginning of the 21st century this is still an area of guesswork and fashion in most organisation


    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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