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    The U. S. Department of Defense (DOD) owns and operates the Global Positioning System (GPS), including 24 satellites, each orbiting the earth every 12 hours, as the graphic above illustrates.

    GPS, a navigational system, computes t
    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
    he position and velocity of things in a highly detailed, three dimensional way.

    The GPS costs $400 million annually, and it is essential for our national defense.

    Civilian GPS usage is increasing rapidly. For example, many newe
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    cars and boats have GPS navigation systems to show where you are, where you want to go, and how to get there.

    There are hand held GPS devices, too, priced around 100 dollars.

    Let’s apply this GPS principle—positioning--to your
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    business.

    How broad is your present market positioning? Local, regional, national, international or global?

    What are your Business Plan goals? In what direction, and at what velocity, are you moving toward attaining your 21st C
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ntury business goals? And how are you getting there (strategies and tactics)?

    In most cases, your business should be moving toward a global position.

    Why limit your business to a neighborhood, town or city, region or just one na
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    tion? In the 21st Century, that’s neither necessary nor desirable.

    Everything moves and happens much faster in the 21st Century. Now is not a time for dithering slowpokes, indecisively whiny people, and those clinging to, and liv
    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
    ng in, the past (specifically, the 20th Century).

    Brian Tracy says that knowledge doubles and triples every two to three years. If you don't keep on learning, you will know less and less of total available knowledge as each new da
    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
    y dawns.

    "The global society demands the latest information anytime, anywhere, using any device. Mobility is the key," says Stratton Sclavos, CEO, VeriSign.

    Yet many snoozing people ignorantly and erroneously claim that everyth
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ng is just the same as 100 years ago, preferring just to market locally, as they always have done.

    What a shame when tradition, provincialism and/or xenophobia (fear of foreigners), and myopia limit or impede great global busines
    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
    s possibilities.

    In the book "The Lexus & The Lemon Tree," the author, Thomas L. Freidman, recalls being in Japan, attending a major corporate event and riding on a new high speed train.

    While riding on the train, he read a newsp
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    per, which reported on a small incident in an ages old, petty feud between Palestians and Israelis over ownership of just one lemon tree.

    Absurdly enough, we live in a world where some invest their time and talent in the high qu
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    lity, highly automated, products--while others waste their time in petty, unresolved squabbles over a single tree.

    Position your business globally. "Think Big. Live Large," says "The Donald" (Trump).

    After years of research, au
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    thor Steve R. Covey wrote "The 8th Habit: From Effectiveness To Greatness."

    The 8th Habit doesn't replace his book, "The 7 Habits Of Highly Effective People." Rather, it takes people already proficient and effective in all seven
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    habits to their next level of excellence, which is greatness.

    While the 20th Century required lots of physical work, 21st Century work provides increased opportunity to gain long term fulfillment, to experience passion, to contrib
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ute to society, and to develop higher levels of human genius as a "Knowledge Worker."

    This requires a "new mindset and a new skills-set," Covey explains.

    In the 8th Habit, you discover why you're here on planet earth, how to ex
    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
    ress this "why" as your personal passion, "finding your voice while inspiring others to find theirs," as Covey describes it.

    In the 20th Century, only 20 to 30% of value added goods and services came from knowledge work.

    But in t
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    he 21st Century, 70 to 90% of value added goods and services come from knowledge work, which unleashes and utilizes human potential.

    The choice here is yours. Move your mind into the 21st Century and succeed or stay stuck in the
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    0th Century and fail in business.

    Determine your business global position now--and where you will take it in the next three years. Rewrite your plans to capitalize on 21st Century opportunities worldwide.

    Don't leave yourself behin
    .

    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
    d in the previous (20th) Century.

    Remember the movie "Kate & Leopold?" Leopold was a royal person from another era, unable to comprehend modern times. He fell in love with Kate, and they went back in time together, living happily
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ever after in the past.

    That kind of stuff happens only in the movies. You don't get the option of living in the past. You can't return there, as Kate & Leopold did.

    Your only choice is to position yourself globally into the future


    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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