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  • Just Other Articles - Managing Reality - Learning to Love Our Mistakes

    Too often I see and hear the impact of leaders not managing what lies in front of them. Rather, they manage what they would like to see or imagine is there. The consequence is usually underperformance. Characteristics accompanying it include
    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
    crisis management, poor and late decision making.

    When leaders manage what they would like to see, they filter and interpret data to support conclusions already made in their own mind. The Iraq war is an obvious case. People from a wide vari
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ety of leadership roles, filtered and interpreted data to give the predisposed conclusion required to take their favoured action.

    In business, non-profit organisations and government, we do this every day. We begin a project with a view to 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.

    hat we want to achieve. We analyse the data available and search for new data to help support the project. It is rare that a project is aborted during the analysis phase.

    Marketers interpret focus groups and quantitative research in its best
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    light to support their pet product introduction, refresh or campaign.

    Research groups interpret data favourably to give support to their theory, especially if it is linked to a commercial outcome.

    Public policy is often formed under a dire
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ctive based on an ideal. The interpretation of data collected is made to fit conclusions fitting the ideal.

    Sales figures are interpreted in the best light to support the notion that sales are on target. Head office need not worry, and by th
    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 way, can leave us alone.

    Costs are interpreted within the narrow confines of a sub-cost centre or the overall costs of the organisation, depending on which looks better.

    The impact of missing a deadline on a critical path for project deli
    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
    ery timelines are smoothed over. Not because a plan has been developed to get the project back on time, but so as not to give bad news.

    Managers take a liking to a particular management theory and interpret all around them within the confine
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    s of the theory. The fact that the theory only works in a narrow range of parameters is not taken into account. The desire to make managing unwieldy things like people, simple, takes over.

    What creates this inability to see what is in front
    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
    of us for what it is? What stops us working with reality instead of a norm we want to see?

    In my experience in comes down to fear. There are at least two direct sources of fear.

    For some people it is the fear of failure. Having set out a pl
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    an of action they cannot accept data which shows the plan to be failing.

    The fear is personal. It may be reinforced by organisational attitudes to failure, but the driver of the fear is based on personal yardsticks of worth.

    To be right is
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    good. To be wrong is bad.

    People hold deep seated phobias of failure built from their interactions with family, friends and school at very young ages.

    From birth, people are fearless. It only takes a few years of pre-school and school to le
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    arn that being "right" gets rewarded positively and being "wrong" gets rewarded negatively in most cases.

    For others, it is the fear of not being accepted. The organisation's view of failure is, in this case, the key driver. When failure is
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    not accepted, it is less that people see failure is bad than that they worry about their status. In some circumstances they also worry about their continued employment.

    Managers are not likely to highlight shortfalls in their department when
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    doing so is perceived to carry a negative consequence.

    Managers hide things or contest findings from audit rather than fix the faults. They pad out sales figures by arranging for a sell-in campaign to distributors rather than accept that sal
    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
    es are poor. Others cling to a theory from a business book they read to assume credibility by association from a well known business identity.

    All of the above happens in an effort to be accepted by their superiors, peers and subordinates.

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

    Professional from academic institutions, pharmaceutical industries, health care indust
    To turn around the tendency of not facing reality requires action from the leaders of the organisation.

    The first action is to always face reality oneself. Demonstrating that it is preferable to own up to a mistake and correct it rather than
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    perpetuate it sends a powerful signal to subordinates. A signal they are apt to copy.

    The second action is to demonstrate that mistakes are to be learnt from.

    The third action is to anticipate that things will go wrong and decisions made i
    .

    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
    n good faith will be seen to be poor in hindsight. Use contingency planning and performance measurements to know when things are going wrong and take corrective action.

    The fourth action is to celebrate limited success in difficult circumsta
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    nces as much or more than good success in easy or fortuitous circumstances.

    Leaders who encourage their organisations to face reality squarely will reap the rewards of a candid organisation; high levels of productivity, innovation and morale


    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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