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  • Top Articles - The Art of Negotiation in 535 words

    I want to get better at negotiation, but where to start?  UK Amazon currently has 2332 books on negotiation.  Google indexed nearly 4 million relevant (yeah right)
    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
    pages.  All I need is a simple, straightforward model that I can put to use now. 


    Phased by the glut of information, I went within and remembered the wise teach
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ings from a senior manager in my early working life.  So, come closer, listen up, because he was very wise indeed…


    He said “Do you know your LIMits?”


    “My what
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ? said I cautiously, wondering if he was asking about my drinking capacity, driving speed or something equally off the wall.


    Being worldlier than I, he noticed m
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    confusion and helped me out.


    “Lyndsay, if you want to be successful in life, you need to know your LIMits.  Let me explain.  What would you Like to have?  What
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    do you Intend to have?  What Must you have?  What are your LIMit’s?”


    Slowly it dawned on me that he was talking the strange management language of mnemonics.

    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

    He wrote down the word for me like this.


    L
    I
    M
    I
    T
    S


    And next to the letters he wrote


    L – like to have: your number 1, top of the pile, bes
    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
    outcome
    I – intend to have: your realistic, shoot for the stars but reach the moon outcome
    M – must have: your bottom line.  Deal is off if this is not met.
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically


    (The I,T and S are irrelevant, just convenient additions to prevent asking what your LIM are!)


    Testing the Theory


    And so ended his lesson.
    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
      Off I scampered like the eager young graduate I was, itching to put this into practice.  Thinking about a possible secondment opportunity I wrote the following:
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

    Like – 10% bonus, new laptop, mentoring with new senior manager
    Intend – 5% bonus, attendance at special course, return to new job after secon
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    dment
    Must – same pay, relocation expenses paid, credit in my appraisal


    The final deal I struck landed somewhere between Like and Intend, with a few
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    perks I had not even considered, so I felt it was a success.


    Why Negotiation Works


    There are a couple of reasons why simple models are useful
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    but often forgotten. 


    The LIMits negotiation model encourages flexible thinking in that there are 3 potential good outcomes.  Compare this with the most common
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    alternative - success or failure – and you can see there is only 1 measly good outcome.  You don’t have to be a gambling pro to work out which approach is best!  Th
    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
    e secret of the LIMits model is if you don’t meet all the criteria for success, then the opposite is not failure, just a different outcome. 


    The other benefit o
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    f using the LIMits negotiation model is it forces you to prepare, gaining you vital spare capacity when you are in the thick of the negotiation.  You will be clear
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    bout your position and better able to get that across. 
     
    Information overload


    As I demonstrated, simple models are forgotten because we
    .

    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
    seek out newer, shinier ideas in books, the internet or from other sources.  Reduce information overload by re-using what you already know or recycling an old idea
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    into one that works today.  Old knowledge is not always redundant.


    So, negotiate that new job, better deal or contract.  All you need is to know your LIMits.





    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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