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  • Just Other Articles - A SMART Way to Turn Your Business Wishes into Reality

    Have you ever wondered why New Years resolutions typically don’t work? It’s worth exploring, because it’s the same reason why most business leaders miss their performance objectives more often than they’d
    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
    like.

    We commonly accept New Years resolutions as being personal in nature -- we want to exercise more, get organized, quit smoking, etc. But, whether we realize it or not, as business leaders most of u
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    make -- or at least think about -- business resolutions as well. Common business resolutions include:

    -- “I want to sell more this year,”
    -- “I want more satisfied clients,” and
    -- “I want to
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    mprove the quality of my team.


    So why don’t they work?

    Simply put, this is a conversation about goal setting. The reason that most resolutions never make it past the first week or two is that they
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    re worded as hopes, wants, or wishes. None of the examples above are goals -- they are just very general desires. Unless those wants are converted into goals, the odds of disappointing or status quo resu
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ts mount.

    To turn hopes into goals, you can use the following 5-component SMART test. Your goal statement must be:

    -- Specific (Can you clearly visualize the outcome?)
    -- Measurable (Can you object
    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
    ively measure the outcome?)
    -- Achievable (Is the goal within the realm of reality / possibility?)
    -- Realistically high (Is the goal too easy and not enough of a stretch?)
    -- Time-bound (Wh
    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
    n will the goal be accomplished?)


    When we convert the resolution examples into SMART goals that pass the 5-component test, they might sound like this:

    -- We will increase 2007 revenue by $275,000 – w
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    th half of the increase from new accounts and the other half from add-on business with existing clients.

    -- We will reduce client complaints in 2007 by 30% through a combination of improving product quali
    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
    y and customer service.

    -- By September 30, 2007, we will research, select, and engage an outside professional to implement training and development processes for management, sales and customer service.

    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    MART goals are easier to plan and easier to execute due to the specificity of how they are worded. Setting goals is a daunting task, however. It’s even more daunting to review them regularly, execute the
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    action items, and complete them reasonably near the due date that was originally set.

    That said, there is a process called an Annual Goals Review (AGR) you can use to improve your batting average, and th
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    refore the impact of your business goals. The AGR is a simple process that consists of the following 6 steps:

    -- Revisit your organization or department Vision Statement (you cannot achieve that which you
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    can’t envision or believe).

    -- Review the results of your previous year’s goal accomplishment (or lack thereof). Are there any goals to carry forward into next year?

    -- Evaluate your organization or dep
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    rtment performance improvement status (this will help you identify areas of need).

    -- Create a list of Critical Goal Categories (CGC’s). These are areas of focus that are absolutely essential to get the
    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
    esults you want -- try to limit yourself to 5-8.

    -- Write SMART goals for each CGC. Be sure to determine the rewards that will accrue to you for completing each goal, the consequences for not completing
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    the goal, the obstacles that could prevent you from completing the goal, the possible solutions and actions steps to be taken, and dates for each step.

    -- Assign goals and action steps to individuals for
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ccountability and tracking.

    Goal setting and goal planning provide focus and a spark of energy. Without SMART goals and a plan to achieve them, your professional activities are much like arrows shot up i
    .

    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
    to the air -- you really have no idea where they will land. When you convert your business resolutions into goals, it's a lot easier for you to visualize the outcomes, to plan for them, and -- importantly
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    -- to communicate them in a clear and actionable manner to your team.

    You’ll find yourself on a path to much more predictable results and to numerous other celebrations of your success throughout the year


    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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