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  • Digg It - The Most Important Thing To Do This Year Is Develop Your USP

    How long can you go just being the same ol', same ol'? Have you considered changing things a bit
    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
    ? You should.

    The most important thing to know about being in business for yourself is this: Be
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    unique. That's Shakespeare paraphrased, "To thine own self be true." Remember that high school
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    nglish class you deplored?

    You must develop your USP. Unique Selling Proposition. Write it down
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    . Use it. On everything.

    Your Unique Selling Proposition is the one thing that sets you apart f
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    om other businesses in your field. Do you know what that is?

    What do you enjoy more than anythi
    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
    ng else? That's a good place to start. Write it down.

    Now, answer me this. What are you best at
    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
    ? Write it down.

    Don't forget the competition. Evaluate them. Who are they, where are they, wha
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    do they do well? Have you written it down?

    Starting to get the picture? Your business plan sho
    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
    uld be in writing. The USP is a critical part of the plan. Write it up and down on everything. T
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    en tell everyone you know.

    Take those two lists: What you're good at and love to do; who are th
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e competition and what do they do well. Those lists! Now, compare them. Are they the same?

    If y
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ou notice too many similarities between your business and its competition then there's something
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    missing from your USP. It's time to delve deep into that shell of yours and do some brainstormin
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    g.

    Don't settle for mediocrity. Find a niche. What are your competitors leaving undone? Have yo
    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
    asked their customers? Or yours? When all else fails, ask those who will use the goods. Ask, an
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    d you will receive.

    Got an elevator pitch? Write it down. Rehearse it. In front of the mirror.
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    Rehearse it again. With a tape recorder. Did you include your USP? Why not?

    It's really not har
    .

    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
    . Think of something you enjoy and do well, figure out what the competition isn't doing, then mo
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ve to hole and make it yours. Own it. And, you guessed it, write it down. Tell everyone you 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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