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  • I Suggest - Your Business And The Universe, What Do They Have In Common?

    If you do what you usually do, you get what you usually get Or what the Universe and your Business have in common.

    Those who know me, know I have a penchant for soapboxes. I have a large variety of these wonderful contraptions and can get very excited about all of them (no
    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
    t always appropriately I might add)

    One of my favoured soapboxes revolves around this question:

    Who do you need to be, to have the business you want to have?

    I have done a lot of reading, studying and reflecting over the last few of years, and it has become abundantly clear to me that th
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    re is no such thing as “I”.

    Some of you might have seen “The Secret, and the Law of Attraction” recently or that mind boggling movie “What the bleep do we know” and come away with a frown on your forehead; Or some of you might just have observed at times that what you thi
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    nk about somehow becomes real.

    Telepathy and LoveHow many of us have been in love at some time in our life and it seems uncannily as if you are telepathically connected to your lover; Suddenly it seems as if they can read your thoughts, they ring up moments after you flash
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    on them, and you find yourself finishing your lovers sentences. These are merely some of the most obvious real-life examples of the concept of our connectedness, but there is no reason to believe telepathy only works when we are in love.

    Have you ever wondered how for some people things al
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ways just seem to happen? While for others, nothing ever works out.

    The simple truth is that we don’t exist in isolation from everyone else or from the world at large, we are an integral part of it, and where “I” starts and stops is simply not a discussion worth having anymore.

    The eviden
    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 for this statement is clear, all branches of science have started to come around to this view of the world and us in it, especially in the last 10 years and new evidence is piling up by the day.

    What does it mean?So what do we do with that as business owners in 2007? Wha
    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
    t does that mean? How does that make a difference to us? There is never enough time in a day as it is, without taking up navel gazing as well.

    There are many implications of these thoughts but as business owners I would like to focus you on one implication in particular: The idea that your
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    business is a reflection and an expression of you. In other words, your business is what it is precisely because of who you are today. The state of you and the state of your Business are inextricably connected. (By the way this statement is equally true for everything that you are a part of
    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
    ; for example your relationships are what they are today, because of who you are today, etc)

    If you accept that statement, there are 2 obvious questions that follow:

    1. Who do you need to be to have the business you want to have?

    2. What does your business need to look like to
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    be a reflection of who you are?

    Hence my soapbox: To work on the growth of your business, you must at the same time work on your own growth. If you want to have a business that is twice as big, twice as efficient, twice as much fun, twice as well organised or twice as profitable
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    , you have to make the matching shifts in your own brain at the same time.

    Helen’s BrainThis explains why in small and medium business especially the traditional “business consulting” approach often fails. Business owners and consultants as a rule do not appreciate this co
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    cept of the intricate connection between the owner and his or her business.

    Let’s take a business owner named Helen; the process goes something like this for Helen: We have a problem or a challenge in my business; let’s get a consultant to tell us what to do. The consultant looks at Helen’
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    s business and its challenges and makes his recommendations. Often this involves proprietary systems and tools owned by the consultant. There are templates and processes for Helen and very clever IP. Developed in and for other businesses and based on the latest research and management scien
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    e. All great stuff, but it misses out on the vital ingredient, namely, Helen’s brain and the connection between it and her business. Invariably, what worked for John, John’s brain and his business, is totally inappropriate and unworkable for Helen, Helen’s brain or her business.

    The first
    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
    step in any business change process must therefore be for Helen to be ready to step up to the next level. Helen has to appreciate that there will be no business change in isolation from her own change.

    Threats of violenceA friend of mine hits me whenever I make this statement: “If you do w
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    at you usually do, you get what you usually get” and although I appreciate her point that clich?s can be nauseating, there is real value in this particular one for us as business owners. You simply can not continue to work, behave and think as you are if you want your business to be somethi
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ng more than it is now.

    This article describes the "New Perspective" of New Perspectives Business Coaching. It is this approach that explains how my clients achieve so much more in their business when they work with me and how they sustain their growth.

    Further Reading and resourc
    .

    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
    s:
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    essor Fred Alan Wolfe

  • “The Hole in the Universe” by K. C. Cole

  • “The Mind of God” by Professor Paul Davies

  • "Science and the Akashic Field" By Ervin Laslo

  • "The Field" by Lynne McTaggart

  • "A Brief History of Time" by professor Hawkins



  • 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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