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    I grew up in a really great little town by the name of Dallas, GA, a rural community 32 miles northwest of Atlanta. I grew up in the 1940s and 50s in economic times that were far less robust than they are today. Many of the folks who
    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
    lived in what we called the "out in the country" were farmers who had to work 12 to 14 hours a day to barely scratch out a living. In those days, many farmers didn't own a car or truck, so it was not unusual for them to ride into Dall
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    as on a farm tractor or in a wagon hitched to a workhorse to pick up provisions for the coming week.

    To give you more of an idea of what economic conditions were like back then, the minimum wage was well under $1 per hour. A worker w
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ould toil an eight-to-ten-hour day in the local cotton mill for $40 to $50 a week. Yet in my hometown, in communities "out in the country" and in other communities around the country, there were individuals who were did extremely well
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    . They bucked the economic trend.

    Isn't it like that in your community: there are business owners who are starving to death, but there are also those who seem to always do well regardless of economic conditions.

    I'm reminded of a fa
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    mous quote from Wal-Mart's founder, Sam Walton. One particular year when a recession was predicted by virtually everyone in the news media, Mr. Sam commented to a reporter: "If there's a recession coming, I've decided that I won't par
    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
    ticipate."

    Walton is also well known for another applicable quote: "High expectations are the key to everything."

    Every entrepreneur I ever read about seemed to rank "high expectations" way up there when commenting on how they achie
    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
    ved such lofty levels of success. When I started Lee Resources in November, 1987, I remember sitting down and writing a BIG number on the bottom line of my profit plan for 1988. It was more than double the amount I earned in my last y
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ear as a corporate officer in my former company.

    It even scared me a bit staring at such a BIG bottom line number, but I put my fear aside and moved on to the next step: planning how many billing days I needed to sell and how much I
    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
    had to generate in product sales to make the profit plan come true.

    The final step was coming up with what marketing activities I would implement to sell the billing days I needed to meet my income goal. It was actually a fun process
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    Then came the hard part: implementing my plan, which required a lot of personal discipline.

    At the end of 1988, I exceeded my income goal by about 20%. Wow! I thought. This planning stuff really works. That experience gave me the co
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nfidence I needed to convince my clients to follow a similar profit planning process.

    Now, 2007 is just around the corner and I am still following the same process.

    How about you? What are your expectations for 2007?

    Have you devel
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    oped a game plan?

    If a slowdown is predicted for your market, are you going to participate or are you going to buck the trend and figure out how to get a larger share of your market?

    Step #1: Begin by writing down the amount you wan
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    t your business to earn in 2007.

    Step #2: Ask your salespeople to list each existing customer and each prospect on a spreadsheet and predict how much they believe they will sell in 2007.

    Step#3: When planning operating expenses, beg
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    in by listing each of your people vertically on a spreadsheet. In the next column, list how much they earn right now and in the next column, how much you plan pay each employee in 2007, and for the ones you plan to give a raise in pay
    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
    , plug in the new level of pay in the month the raise will go into effect.

    Step #4: Review operating expenses from 2006 and estimate how much you plan to spend in each expense category in 2007.

    Step #5: Now back in to gross margin.
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    In other words, if you know how much you are planning to earn, how much you're planning to sell and how much you're planning to spend, how gross margin will you have to have to make the plan come true.

    Step #6: Hammer out a marketing
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    plan that will give your sales force the support it needs to achieve the company's sales goal.

    Yes, there is something magic about high expectations. And frankly, I don't totally understand it, but when you think big, bigger things
    .

    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
    happen to you than you think small.

    I believe one of the biggest deterrents to success in life is down deep inside not believing you deserve success. Or that you are destined to struggle financially. Or that double digit profit margi
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ns are for other business owners and managers, but not for you.

    I can speak with confidence about this planning process from firsthand experience.

    I guess that's why David Schwartz entitled his famous book, The Magic of Thinking Big


    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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