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  • Useful Advices - Is Competition Really the Problem?

    The undercurrent in U.S. business today may well be one of fear and even desperation. It would be easy to make such an assessmen
    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
    t based on the number of words that have been written on the subject of competition. Businesses in the United States have lost t
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    heir edge, if the flood of articles and reports on the subject are to be believed.

    But is the problem really competition for cu
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    stomers or a share of the marketplace? Or is it something else?

    A Focus on Scarcity

    We could make a case that the real
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    enemy of any business today is the focus on scarcity driven by fear. Fear of losing "the edge," of losing perceived global leade
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    rship, of losing profits.

    Of losing the business entirely.

    When fear is our focus and scarcity our attitude, our perceptions o
    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
    f the world around us are skewed. We gather incomplete data about conditions because we have conditioned ourselves to see only a
    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
    small part of the total picture. Poor decisions are the result, diverting our attention from the business's right and proper fo
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    cus.

    "But what ABOUT the competition? Those people are really out there, you know, and they are stealing our customers!" I actu
    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
    ally heard someone use these very words just last week. Yes, what about the competition?

    If we focus on what our "competitors"
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    are doing, we shift our attention from the real work and service of our businesses. In reality, incorrect focus causes us to los
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e more customers to those we label as our competitors.

    So...

    What Is Right Focus?

    We define right focus as:
      dd to the challenges in developing combination products:

      Which markets to tap where the combination products can do fairly well?
      Which combination prod
      >Attention to the needs of those you serve.
    • Being clear about why you're in business to begin with and about your busi
    • cts are meaningful and rational?
      Which therapeutic categories to select?
      Which Combinations can address unmet needs of the patients?
      Do combin
      ness principles.
    • Knowing and practicing what you do best every day.
    • Devotion to customer relationships and d
    • tions increase the patient compliance?
      What would be the developing cost?
      How to tackle the risks encountered during combination product developmen
      elivering value.
    By focusing on strong relationships with those we serve, we understand the problems they face that
    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
    require solution. We listen and hear the needs of our stakeholders. Not just our investors, but the investors attended to in co
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    llaboration with our customers, employees, and the community in which we work.

    Another Look at Solutions

    There's no que
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    stion that U.S. businesses need the sorts of skills that well-educated people deliver. So, yes, let's inspire more students to s
    .

    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
    tudy the sciences and technology. And while we're at it, let's ensure they receive the sort of well-rounded education that helps
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    them focus understanding problems and being of service to others.

    For service is, in the end, what business is all about.

    ***


    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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