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  • Digg It - Does Your Organization Have a Learning Disability - Disability # 5 - Slow Change Kills

    Disability 5 – Change? Really? Where?

    By now most of us have heard the parable of the bo
    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
    iled frog. He’s the poor fella that gets cooked. OK so they say that if you dunk a frog in
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    a pot of water he’ll jump out quicker than he or I can say “ribbit”. Rightly so. Now if we
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    were to place him in a nice comfy pot and turn up the heat he will enjoy his spa bath unti
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    he reverts to soup.

    Apparently the frogs internal apparatus for sensing threats to survi
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    val is geared to sudden changes in his environment, not slow gradual changes. Sound famili
    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
    r?

    In business we live life in the fast lane. Everything is frantic, zooming by in a blin
    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
    ing flash. Giving us barely enough time to blink, let alone think, make a decision and kee
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    moving.

    What changes have occurred while we were caught up in watching the action but mi
    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
    ssing the plays? In business today there are some amazing strategies being employed to ens
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    are top positions by companies that were not even in the arena five years ago. How was IBM
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    to know that by owning an operating system an industry would be born? How did Apple move f
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    om being a PC manufacturer to the hippest new tech toy creator? But where does it end? Is
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    the PC redundant and the cell/combo unit do it all through some main server?

    How did the
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    apanese auto manufacturers take over the US market and what about the Korean models? How d
    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
    d the big three slump so badly?

    Interesting how the S&P is reorganized. Top southern reta
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ler Winn-Dixie struggles in Chapter 11. Delta and Northwest file for bankruptcy? What does
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    that mean for Southwest and other smaller airlines actually making some smidgeon of an in
    .

    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
    ome?

    How do we avoid the fate of the frog? Slow down, smell the coffee, pay attention to
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ubtle changes as well as the dramatic. It’s the subtle changes that will kill our business


    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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