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    There are 8 carefully planned steps which are bound to boost an organisation. Develop a situation to act u
    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
    pon, form a dynamic guiding coalition, create a vision, communicate the vision, empower people to act on 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 vision, plan and create short-term wins, find improvements to change and finally, utilise the new approa
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    hes. These are the steps the management team should consider in elevating the company to the next level.

    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ) Develop a situation to act upon
    Study the current market and the realities of the competition. Ide
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    tify and discuss crises (including potential crises) and major opportunities which can be capitilised on.
    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
    2) Form a dynamic guiding coalition
    Garner a group with sufficient expertise to bring about the chan
    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 effort. Encourage the group to work as a team and synergise their efforts.

    3) Create a vision
    Cre
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    te a vision to help lead the change effort in the right direction. Come up with strategies on how to go ab
    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
    ut achieving that vision.

    4) Communicate the vision
    Use every possible means to communicate the new
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    vision and strategies. Teach new behaviours by using the example of the guiding coalition.

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

    Following aspects would a
    ple to act on the vision
    Move obstacles out of the way in order to change. Change systems or structu
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    es that pose hinderance to the vision. Encourage risk taking and unconventional ideas, activities and acti
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ns. People must be taught to break away from the norms whenever and wherever appropriate and necessary.

    6
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    Plan and create short-term wins
    Plan for visible performance improvements. Create those improvement
    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
    . Recognise and reward employees involved in the improvements.

    7) Find improvements to change
    Use i
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    creased credibility to change policies, structures and systems that do not fit the vision. Hire and train
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    mployees who can implement the vision. Breathe life into the process with new projects, themes and change
    .

    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
    gents.

    8) Utilise the new approaches
    Articulate the connections between the new behaviours and orga
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    isational success. Create the means to ensure leadership development and sustainable competitive advantage


    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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