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  • Main Subject - Performance Measures - The Good, The Bad And The Ugly

    There are lots of so-called “measures” that people choose to monitor business results. Some are good, some bad and some downright ugly! This
    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
    is one of the most colossal mistakes I see people making with performance measures: to claim as a performance measure something that absolu
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    tely is not a measure of performance at all.

    Here are three of the so-called performance measures that I really dislike most:

    "win the Bla
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    hBlah Award"

    The award might be a customer service award, or environmental award, or workplace health and safety award. Why do I dislike aw
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ards as measures? The winning of an award is an event, and can’t give regular, ongoing feedback that can inform decision making and improvem
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ent - to use it as evidence of business performance assumes that the criteria for the award correlate directly to the business’s priorities
    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
    and strategy. And just think about the kind of behaviour and culture this kind of "measure" would encourage... everyone aiming to impress th
    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
    e judges of the award and taking their eyes off their real stakeholders.

    "complete BlahBlah Project by June 2007"

    Projects such as impleme
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nting a customer relationship management system, or upgrading a maintenance facility, or running a new employee training program are typical
    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
    ly put in the KPI column of business plans. They are next to useless as evidence or feedback about business performance. Finishing a project
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    by a particular date is an action, not an outcome, and thus provides no evidence whatsoever of the result that the project should have achie
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ved. But they are the most common type of "measure". My theory is that it's because we are an activity culture - we have been duped into the
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    false belief that as long as we do things (and finish them on time and to budget) then we have succeeded. A little more scientific thinking
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    would go a long way: we need to use measures to test our hypotheses that the actions we have chosen in fact do produce the results we inten
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ded. So in reality, measures like these are actually strategies - the means we have chosen to achieve the results we want for our business.
    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

    "Annual BlahBlah Survey"

    The survey could be an employee survey or a market survey or a community reputation survey - who knows? Irrespect
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ive, surveys are just data collection processes, not measures. The measures come from the data the survey collects and the measures must be
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    very clearly designed and defined in order to ensure the survey collects the right data. Way too much money is wasted on surveys that ask ir
    .

    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
    relevant questions, and collect data that is never used. I guess having my foundations as a survey statistician makes me particularly frustr
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ated by measures of this type. I'd just love to see more people demonstrating that they can discern the difference between data and measures


    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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