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    The misconception stall is particularly harmful because some of your best people already realize that you are operating on faulty assumptions. Since actions based on those assumptions are folly, these key employees are losing faith in the future of the organization and the quality of its leadership. Soon, you may find recovery from your mistakes is made more difficult as your most talented people seek other opportu
    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
    nities.

    MISCONCEPTION: The Danger of False Assumptions Abounds

    How is a misconception stall different from a disbelief stall? A disbelief stall is based on something that was once true, but no longer is. A misconception stall is based on a belief that was never true. Here are some examples of harmful misconceptions:

    • The future can be accurately forecast.

    • Competitors will stand still while we make rapid prog
    ; 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.

    • Agreement among colleagues means that issues are understood.

    • Customers will make the decisions in the same ways they always have.

    All long-held assumptions and beliefs should be questioned. Ask yourself:

    • Is it really true?

    • If it isn't true, why do people believe it to be true?

    • What's needed to persuade people to change their beliefs?

    Round Out Your View

    When only an experiment will do, cross-
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    heck your idea in other ways to get a better sense of what you are about to try. Consider Columbus. While some feared sailing west across the Atlantic believing they would fall off the edge of the Earth, Columbus knew better. He had made a point of studying the early Viking explorations of North America. In fact, in 1477, 15 years before heading toward the Caribbean, Columbus visited Iceland to learn more about the
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    northern "islands" across the Atlantic.

    Apply Sophisticated Thinking

    In his wonderful book, The Unschooled Mind (Basic Books, 1991), cognitive psychologist Professor Howard Gardner argues that people usually think at three different levels. Gardner defines the five-year-old's mind as the first level. Five-year-olds usually live in a world where others take care of them and keep them safe from harm. That belief p
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    rsists when most people become adults and prevents many from becoming independent, fully functioning adults. Overprotection after age five makes matters worse. Another common example of the five-year-old mind is that confident people falsely believe that they are superior in every way to others. Ask any roomful of five-year-olds if they are terrific at something and almost all will agree.

    The second level of think
    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 develops when training, usually in high school and college, gives teens and young adults a grasp of sophisticated concepts that are counterintuitive to the five-year-old's thought process. Here's the problem: The student memorizes the concepts long enough to pass the examination. But Gardner argues that relatively few adults reach the third level of thinking where they can apply the sophisticated concepts to rea
    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
    l-life problems. In the absence of that faculty, almost everyone reverts to the five-year-old's misconceptions for making decisions.

    The person who can apply the principles learned in school to a real-life situation becomes a disciplinary expert. But those effectively working minds are few and far between in most organizations. Imagine what could be accomplished if you consciously shed your five-year-old's misconc
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ptions, applied sophisticated adult reasoning to expert knowledge, and questioned common assumptions of the prevailing five-year-old mind.

    I'LL GET RIGHT ON IT

    Even if people attempt to apply sophisticated thinking, they will still jump to conclusions too often. If service was slow the last two times you went to a given store, you may decide this store will always offer poor service and don't go back. Two experie
    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
    ces do not constitute a trend. It's possible that the manager was away on vacation on both occasions and the rest of the employees took it easy.

    The executives of one award-winning multibillion-dollar manufacturer were clearly intelligent, well educated, and widely admired for their decisions. Ever curious, these managers wanted to measure the quality of their decisions. They knew good decision making has to refle
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    t solid statistically based data, and they wondered what statisticians would say about their decisions. Statisticians were assigned to follow the executives around for six months to watch them in action. Almost without exception the executives treated random events as representing what was typically occurring in the business.

    Executives were constantly trying to eliminate these few random variations in performance
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    . All this scurrying around kept the executives from having time to work on more promising opportunities for gain. Despite learning this profound insight, the organization faltered by continuing to mistake the actual trends. The lesson: Be sure you are focusing on the areas where action will do the most good.

    This example also shows how wide the gap can be between perceptions of management quality and actual effec
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    iveness, another example of misconceptions. You have probably noticed the frequency by which "widely admired" companies rapidly fall from grace as performance plummets.

    When the CEO Speaks, People Take Action

    Management authority Peter Drucker told us that one of the most dangerous beliefs in organizations is that an increase in brains comes with being promoted. Here's verification of that observation: Executive
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ssistants at selected companies were asked by us what was the single, most important thing their CEOs could do better. The aides spoke almost as one in reporting that anything the CEO said was treated as gospel. Underlings, for instance, scramble to make changes even when the CEO was only asking an innocent question. The CEOs assume that the response would come at little or no cost from someone who already had the
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    answer. Some executive assistants estimated that 25 percent of executive and managerial time in their companies was taken up with answering such casual inquiries and making changes that hadn't, in fact, been requested. The assistants wished someone would advise their CEOs to stop asking casual questions and making off-hand comments because the rest of the organization operates on the misconception that these words
    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
    re major priorities on which careers will rise and fall.

    STALLBUSTERS

    Encourage Unmasking False Assumptions

    A company had assumed for decades that advertising would work only when demand was highest for its seasonally consumed food, yet others promoted similarly seasonable foods all year around. Eventually, an advertising test was run during the lean part of the year, and sales promptly took off.

    Here are quest
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ons to help you avoid making such false assumptions:

    • What are the things that your organization assumes will almost always work?

    • What are the things that your organization assumes will seldom or never work?

    • What are the things that your organization assumes will probably happen?

    • What are the things that your organization assumes will be unlikely to happen or will never happen?

    • On what beliefs are the
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    se assumptions based?

    • Have those beliefs been checked recently?

    • Are those beliefs still true?

    Identify the False Assumptions That Need to Be Immediately Challenged

    Some misconceptions require more immediate correction than others. Here are questions to help you set priorities for where to turn your attention first:

    • Which false assumptions have large potential consequences?

    • Where can your organization'
    .

    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
    actions make the largest difference in offsetting false assumptions?

    • When would you need to act to get the most benefit or avoid the most harm?

    • What is the minimum evidence to indicate that you should act immediately?

    • Use Assumptions That Reflect Actual and Critically Sensitive Conditions

    • Open your mind to new ways of thinking about a volatile, unpredictable future with these questions:

    • What assumpt
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ons have worked best in the past for organizations that operated in circumstances somewhat like yours?

    • Which of these assumptions fit your organization's values and style?

    • Which of these assumptions would be received enthusiastically by users of your offering, customers, employees, partners, suppliers, shareholders, lenders, and the communities you serve?

    Copyright 2007 Donald W. Mitchell, All Rights Reserve


    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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