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  • E-Folder - Your Unique Advantage

    You have a unique advantage, an edge no one else has. When you put that unique advantage to work for you -- when you take the time to develop it as you would strengthe
    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
    n a muscle -- you get something that reduces perceived risk and triples your chances for success.

    That something is called Informed Confidence.

    In fact, research in
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    progress by the SBA Office of Advocacy (http://www.sba.gov/advo/) shows that confidence is the number one success factor when starting any new venture. But confidence
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    alone is not enough. You need the kind of confidence you get only by doing the footwork.

    How do you turn your unique advantage into the edge called Informed Confidenc
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    e? You do it by identifying your unique value and assessing opportunities that allow you to put that unique value to use in service to your ideal customers.

    Identi
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    fying Your Unique Value

    Your unique value is a combination of your chosen principles and the thing you do best. Defining your principles requires you to examine y
    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
    our goals. It forces you to examine your personal beliefs about money, people, reciprocity, relationships, and time.

    Knowing what you do best takes more insight than
    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
    most people realize. Yet what you do best can be easy to identify if you'll ask yourself these questions:
    • To what sort of problems or situations am I most a
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ttracted?
  • What sort of problems or situations are most attracted to me?
  • One of the best ways to work out the answers to these questions is to fre
    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
    e-write your answers. That is, sit down and let your mind rest on each question for a moment, then starting writing about it as quickly as you can without judgment or
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    editing. You can also draw mind maps of the answers, or sketch an image of those answers. Use any technique that feels comfortable for you.

    No matter what technique y
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ou use, you'll find that if you trust the process you'll get results -- some of which you may not have expected.

    Assessing Opportunities

    Once you identify you
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    r unique value and have articulated the sorts of problems you're naturally inclined to solve, study the problems. Become a student of them and an observer of the peopl
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    e who have them. Be open to where your unique value can help solve problems -- and identify facets of the problem that may require application of unique value you your
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    self do *not* possess. Then either find others who possess those unique values or develop the skills required to deliver additional value yourself.

    For example, your
    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
    unique value might lie in identifying market opportunities. Perhaps you're a little weak on the specification side, however, so you might decide to partner with someon
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    e who is skilled at translating vision into clear marketing specifications.

    Your Informed Confidence

    Once you are able to perceive opportunities from the pers
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    pective of your unique value as seen through the eyes of your ideal customers, you have developed a level of Informed Confidence. The more you observe and refine your
    .

    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
    understanding, the deeper that confidence becomes.

    Your unique advantage is the union of your perception of the problem and the special perspective you bring to solvi
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ng it. Bring that union into play in relationship with your customers, and you'll find that they will find their own unique advantage.

    Informed Confidence in YOU!

    **


    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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