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  • Useful Advices - Assumptions - How Accurate Are Yours?

    How many times a day do we assume?

    How often do we verify the accuracy of our assumptions?

    Listed below are examples of common as
    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
    sumptions:

    • You already know that your customer can't afford to buy what you're selling - so, why bother.


    • You know without aski
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ng that the person you're talking to is the only one making the buying decisions - so, why qualify?

  • You know that your boss is mad at y
  • lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ou by the way he is acting - so, you avoid him/her hoping it will all go away.

  • You know that you're never going to get that promotion -
  • here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    so, why try?

  • You know your significant other so well you don't need to ask him/her what's wrong when they seem bothered.<
  • d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    /li>

    Its human nature to assume. Each and every one of us engage in a number of assumptions daily. Then we hold our assumptions to be 'accurate' and con
    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
    duct ourselves according to our 'assumed beliefs.' Think about the impact of that. What if our assumptions are wrong?

    How many Sales ha
    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 you missed or lost because you assumed you knew something? How do you 'benchmark' the accuracy of your assumptions? Wouldn't it be important to know if the
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    y are accurate?

    What if:
    • You spent the next 24 hours evaluating your assumptions?
    • You applied dogged determination to know for sure if your
    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
    assumptions were accurate?
  • You found out during that time that some or most of your assumptions were wrong?


  • To exemplify this thou
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ht - what if your assumptions have been wrong over and over again on the same issues until your assumptions formed an "unbreakable belief system."<
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    /i>

    • You assume you know what the customer wants - do you? How do you know? Or, are you just assuming?


    • You assume the custome
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    r can't afford what you're selling. How do you know? Did you ask or assume?

  • You assume you'll never get that promotion. How do
  • cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    you know if you haven't even tried? And, if you tried and didn't get the promotion, at least you will know what to do differently to get the next one
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen


  • You assume that your significant other just had a bad day at work. How do you know, did you take the time to ask?


  • You assum
  • 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 you know what motivates your current cusomters to buy but you haven't made the sale. Why? Maybe your asssumptions are wrong.

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

    Professional from academic institutions, pharmaceutical industries, health care indust
    ng>I'm sure you've heard this statement before but if you haven't you need to:

    ASSUME NOTHING


    When you assume nothin
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    you ask lots of questions;
    When you ask questions you get responses;
    When you get responses you qualify for accuracy;
    When you qualify for accurac
    .

    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
    y you're better prepared to understand your customer;
    When you truly understand your customer the better your chances of making and keeping the sale;
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    - And if you don't make the sale, at least you'll know for sure why you didn't.

    Stop assuming and start asking! You'll be amazed by the results.

    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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