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  • Advice You - Do You Know That You Don't Know? (For Business Owners And Managers)

    I've spent one third of my working life presenting sales training courses to engineeri
    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
    ng and scientific companies. 600 times so far.

    It has surprised me to find that the h
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ghly intelligent, well-qualified people that come to my events are ignorant about some
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    thing which has a direct bearing on how well their organization does.

    I ask a set of
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    uestions to make the point, 'How important do you consider ability in sales and market
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ng to the success of your company?"

    The usual responses are, 'Essential / critical /
    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
    vital etc '. So then I inquire, 'How long did it take you to have the technical knowle
    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
    ge which is necessary to do your job?'.

    And they reply, 'We're still learning'. But i
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    f I press the point and ask, 'How long was the formal education in your science subje
    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
    ts?', 'What unit of time would you measure it in; days, weeks, years?', they tell me t
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    at it's years. That's obvious, isn't it?.

    Now I've got them set up like that, I hit t
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    hem with my bomb. 'Ok if ability in sales and marketing is critical, and if you've ta
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    en years to learn the technical know-how to do your jobs, then tell me how much time y
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ou have put into learning something about selling.

    There's a room full of blank faces
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    as the realization dawns. 'Duh, nothing, no time at all, nada, a big fat O'. Then so
    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
    eone usually says, 'The ten minutes we've been on your course so far'.

    It's a bit of
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    a paradox; conscious awareness that sales ability is desirable yet a frank admission t
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    at they have done nothing at all to acquire it.

    By the way, this characteristic of 't
    .

    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
    echie' companies has been the same in the 9 countries I've presented the 'Selling for
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ngineers' course in so far.

    So can I ask you again, 'Do you know that you don't know?


    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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