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    I recently came across W Edwards Deming and have since been doing some homework to discover why there is so much resistance to what is essentially some very basic philosophy.

    Deming’s early work on statistics
    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
    and quality was built around an ability to analyse complex systems and the use of that analysis to predict complex outcomes.

    Deming was a statistician and his work very soon leaves the basic philosophy and b
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    comes bogged in the complex use of numbers to define complex systems.

    The very complexity of his approach deters many students but there is a more fundamental problem with complex systems that was identified
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    y the later work on chaos.

    There seems to be two approaches to the world.

    There is the modern Digital approach where every action and interaction is controlled at the microscopic level by single bites of inf
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ormation.

    Below this level it is not possible to go because a single bite of information is not divisible.

    But we know from chaos theory that below the level of that single bite of information there is a who
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    e world of complexity that has huge and unpredictable outcomes.

    The flaws occur when we begin to realise the limitations of the start point digital data.

    When the weather centre at Bracknell decided to tight
    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
    n up its long range forecasting ability with the purchase of their first computers the reaction of the computers was completely unexpected.

    The computers told the forecasters that they should stop issuing lon
    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
    g range forecasts because the probability of a correct forecast was no better than chance.

    Natural events are far more complex than a digital approach can ever define.

    We can take a digital picture that look
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    great but when we blow it up we start to discover its limitations.

    By trying to try to define complex systems in this way we are building in errors that become evident in the variation we encounter and are m
    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
    gnified massively whenever one complex system encounters another.

    The second approach is the Analogue approach.

    In nature the interaction of complex systems occurs all of the time without any trouble at all
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ecause when a wave hits a beach what happens, just happens.

    If we try to define what happens to the wave or the beach in a digital way we will probably end up concluding that nature is at fault.

    The digital
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    approach to managing process's and operations will always have the same built in errors when it contains these complex natural components.

    The component that causes most trouble is the human operator whose ac
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ions and interactions may be the most complex on the planet.

    When treated in this digital way the complexities cannot be resolved.

    The human being has to be treated in natural way that instead of trying to d
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    fine the complexity of the condition simply creates the environment that allows the conditions to interact and come to a natural conclusion.

    In this way we avoid the impossibility of trying to define a comple
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    x system and instead concentrate on the result when the two systems combine.

    Try to define sex.

    What is it, what starts the thought processes that lead to it, what are the physical changes that must precede
    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
    t, how do we feel during and do we have to smoke afterwards, what about the partner, what appealing characteristics, body type, skin tone hair colour etc.

    There are an enormous number of questions before we c
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    n define the act in a digital/analytical way and an even bigger number of answers to those questions.

    The complexity of the analysis puts us off the act.

    If however we appreciate the possibility of the act t
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    hen all we have to do is to create the right environment for the act to take place and ignore the complexities because it is what people want to do.

    The right environment could be as simple as a darkened room
    .

    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


    In the same way, if we assume that people want to be able to do a good job we simply have to create the environment that allows them to do a good job.

    The right environment could be created simply by listen
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ng to the workforce and finding out what they need to be as good as they can be.

    As Deming said, "Remove the barriers that stop people from being as good as they can be and count the smiles on Monday morning.


    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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