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  • Advice You - The Five Stages of Change for Small Business Owners

    Change is a tricky thing. If you are someone contemplating the changes that will occur by becoming a successful small business owner, it will be helpful for you to have a bird's eye view of where you are along the continuum.

    To that end, Dr. James Prochaska and Carlo Di
    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
    Clemente developed a Transtheoretical Model of Change in 1982 that has been applied to everything from weight loss to drug addiction with great success and acclaim. Though their model has never before been applied to those considering starting up a successful small busin
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ess, it is a very relevant model that will help take the pressure off individuals thinking they should be further along than where they are, and provide a compassionate understanding of where each person is along the scale.

    Three Great Things about The Stages of Change

    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    Prochaska and DiClemente's Transtheoretical Model of Change identifies five stages of change: precontemplation, contemplation, preparation, action, and maintenance.

    The Precontemplation Stage (Not Currently Considering Change)

    This stage could really be called "the pre
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ursor-to-change" stage. This is the stage when individuals may not even be thinking about becoming small business owners. In fact, in this stage, they may not even be aware that it would be beneficial for them to make a change, though other individuals around them may b
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    e thinking that they should. This stage's motto is: Ignorance is bliss.

    How to know if you are in The Precontemplation Stage:
    1.You're not really thinking about starting up a small business.
    2.You are basically okay with how things are.
    3.Others may b
    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
    e voicing their concerns about the hours you are keeping, the stress you seem to be under, or how much you need to take a vacation.

    Those in this stage do not intend to take action within the next 6 months.

    The Contemplation Stage (Thinking about Change and Researching
    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
    ptions)

    In the Contemplation Stage, individuals are aware that a change is needed and they actually desire to make a change. Although they are seriously thinking about change, they have no clear plan of action because they are feeling ambivalent about change. This stag
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    e's motto is: Just sitting on the fence waiting to see what will come along.

    How to know if you are in The Contemplation Stage:
    1. You find yourself doing on-line research, and thinking about what it would be like to be a small business owner.
    2. You seek ou
    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
    t the perspective of others who have "been there, done that."
    3. You find yourself attracted to journal articles about entrepreneurship and small business ownership.

    Those in this stage are considering taking action within the next 6 months.

    The Preparation Stage
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    Ready for Change and Making Plans)

    This stage of change is readily apparent by the amount of activity, decisions, and overt action that is taking place in preparation for a small business start up. This is a time of planning how and when the start up process will begin.
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    This stage's motto is: I think I can, I think I can, I think I can.

    How to know if you are in The Preparation Stage:
    1. Your small business start up coach has become your best friend.
    2. Your white board is getting a daily workout as you look at every aspe
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ct of small business ownership.
    3. You are regularly experiencing both excitement and fear.

    Individuals in this stage are intending to take action within the next month.

    The Action Stage (Making Change and Taking Charge)

    This stage is characterized by a considera
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ble amount of steady, forward movement. All the necessary paper work is filled out, business checking accounts opened, company name registered, business cards selected, web site developed, and strategic action plans mapped out. The motto for this stage is: Carpe Deum.
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    How to know if you are in The Action Stage:
    1. You are in full-out action mode.
    2. You're spending most of your day focused on your new small business, and loving it.
    3. You are committed to seeing your actions through.

    Individuals in this stage are tak
    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
    ing action.

    The Maintenance Stage (Continuing Forward Movement toward Goal)

    By this stage, individuals are firmly ensconced in the forward movement and momentum of launching their new small business. Continued commitment to sustaining the forward movement of their smal
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    l business success is the goal of this stage. The motto of this stage is: Westward, ho!

    How to know if you are in The Maintenance Stage:
    1. Your business is running smoothly.
    2. You have begun cycling back through the stages of change to further develop and
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    expand the growth of your small business.
    3. You are actively looking for new opportunities for change and growth.

    Individuals in this stage are continuing momentum.

    In Praise of Prochaska and DiClemente's Transtheoretical Model of Change

    As has been demonstrated
    .

    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
    , Prochaska and DiClemente's Transtheoretical Model can be easily adapted to the stages of change that occur in small business start ups. Individuals considering whether or not they are ready to become small business owners need no longer be left with the question of "if
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ." Rather, they can easily find a clear answer to where they are along the change continuum. As a result, they themselves become powerful and effective agents for change. What's more, they learn that change, while life-altering, can be life-affirming and life-enhancing


    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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