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  • Useful Advices - What Do We Need To Change?

    In order to create a performance improvement we have to do something different from what we do now. If we don’t do something different how can we possibly expect to make a change?

    The first problem we have is finding out what the thing is that we need to change.

    Many management models have been t
    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
    ried all with varying levels of success, from Kaizen to Six Sigma, TQM and a host of others.

    These models are not wrong, but they all suffer from the same failing.

    Somewhere in each instruction book there is a phrase that says something similar to,

    “The key to the successful implementation of thi
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    s model is ownership”

    Then we turn the page and begin the new chapter without ever coming across the instruction that tells us how to create “Ownership”

    Ownership is a word that has been used and abused for years but very few people are able to give it a meaningful definition. Without understand
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ing what it is, how is it possible to create the conditions to allow it to happen?

    I prefer to think of ownership as the way that we feel about something.

    If it is mine, I own it, I will take care of it.

    If it is not mine I won’t take care of it, why should I? I don’t own it!

    The problem we have
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    just created is that we have just defined ownership as the ability to care about something.

    That concept may be very well in a soft pink cuddly way but it hardly has a place in a Business conversation. We want to talk about percentage points, hard savings, value added and other assorted sexy busin
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ess type words. Businessmen don’t want to talk about caring.

    But wait a minute!

    How many people ever wash a hire car?

    Not many.

    Why should we?

    If the hire car doesn’t belong to me, why should I care?

    And yet most of us take care of our own cars. They don’t come with washing instructions and
    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
    nobody tells us to wash them, but we do wash them, we maintain and look after them.

    We take care of them because they are ours.

    After two years the hire car that we did not wash has a residual value of practically zero because nobody will buy a car that has been driven for two years by people who
    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
    did not care for it. The hire car company has no option, the hire car is scrapped.

    But your own car has got a residual value after two years. After two years your own car is worth ten or twelve thousand pounds. You can realise that value by selling the car or you can continue to use it reliabl
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    for another ten years.

    Suddenly the care that we gave the car that we owned has got a financial value. We can now say that the value of the care that we gave our car is the cars residual value of ten or twelve thousand pounds. A residual value that the car we did not care for does not have.

    Now
    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
    we have a solid measurable effect on the bottom line that is directly attributed to our ability to care.

    The suggestion at the beginning of this article is that we have to first understand what we have to change before we can figure out how to change it.

    I suggest that what we have to change is t
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    he way that people feel about their work. We have to allow them to start to care about what they do.

    The first reaction to the suggestion that we can change the way people feel about their work is that it is nonsense. How on earth can we change the way people feel and where is the profit in it?

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

    Following aspects would a
    We have already seen where the profit is, and changing the way that people feel about their work is something that happens every day and is as often as not reported on the news, except that we don’t recognise it for what it is.

    Several years ago I was watching TV and I saw an interview with Rod Edd
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ngton, the Chairman of British Airways. He was understandably complaining about the market share that he had lost to Ryanair, Easijet and the other budget airlines. But he was also being quite bullish about it. He said that in the previous 3 years he had reduced British Airways operating costs b
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    y five percent.

    What he didn’t say was that in those same three years he had made Sixteen Thousand of his staff redundant.

    The question that I have to ask is, How did the people who remained working at British Airways feel when they found out that 16,000 of their colleagues had been made redundant
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ?

    Did they feel good about it? Did it make them feel Secure? Did it increase their trust in BA? I don’t think so.

    But think back a few years to the time before the redundancies. Think about the sort of person who used to work for British Airways. Their staff was made up of people who had dreame
    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
    d at school of being the pilot in the Raybans relaxing in the big seat at the front between Tokyo and Paris, or the stewardess whose flip answer to the question “Where are you going for the weekend” was truthfully and smugly, “Barbados”. British Airways staff were good people who had competed for t
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    eir jobs and having won, were living their dreams and getting paid for it. They were proud, motivated, and they cared about what they did.

    Three years later and the redundancies had changed the way that every member of staff who had not been made redundant felt about their jobs.

    This is the sort
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    of change that occurs with monotonous regularity in industry. A caring and productive workforce is changed by what is done to them by their managers into one that turns up for the pay check and has no other interest in being there.

    British Airways changed the way their staff felt about their jobs
    .

    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
    . But they changed in the wrong direction.

    They are not the only organisation to have done so.

    To create a sustained performance improvement we need to change the way people feel, but we have to do it in the right direction.

    We have to allow them to start to care about what they do.

    If this sou
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    nds difficult, consider, most people want to do a good job, they want to care about what they do.

    The only thing that stops them from caring is what is done to them in the work place.

    To make the change all we have to do is to find out what is stopping the workforce from caring, then stop doing it


    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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