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    One of my favorite things to write about is the topic of leadership and one of my favorite business theorists is Peter Drucker. Peter Druck
    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
    er has authored more than 35 books and is considered by many to be the founding father on the study of management practices. In this blog p
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    st I will breakdown one of my favorite “Druckerisms” which states that: “managers do things right while leaders do the right things.”

    At f
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    rst glance the above Druckerism might not seem to be all that insightful, but I believe it is very powerful observation that highlights the
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    difference in philosophies between most managers and leaders.

    Doing things right is a trait that causes managers to be focused on security
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    and security is most often underpinned by fear based motivations. Doing things right will cause managers to be safe and politically correct
    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
    in approach. It is this fear based motivation that causes managers to protect turf as opposed to gain ground, to control as opposed to insp
    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
    re, and to refine as opposed to create. Doing things right leads to comfort zone management that completely inhibits the ability to innovat
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    .

    Doing the right things is a trait that causes leaders to be guided by their instincts, principles, values and desire to achieve. Leaders
    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
    motivated by doing the right things are not risk adverse, rarely politically correct and they thrive on shaking things up. It is leaders do
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ng the right things that innovate, motivate, create and inspire. Doing the right thing is often times controversial, but true leaders are n
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ot daunted by the thought of conflict as are most managers. Leaders guided by doing the right thing are willing to step-up and make the big
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    decisions that open markets, exploit opportunities and drive innovation.

    If you’re not sure whether you are doing things right or doing th
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    right things take yourself through the following personal assessment:

    1. When was the last time you witnessed something that you didn’t a
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ree with but kept quiet on the issue to protect yourself rather than voicing your concern in order to protect the enterprise?

    2. When was
    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
    he last time you rocked the boat by design? Rocking the boat by default or by mistake doesn’t count…

    3. When was the last time you drove i
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    novation? Hint: purchasing a new software application is not innovation…

    4. If a survey was taken of your peers and subordinates would the
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    refer to you as a leader who inspires, motivates and mentors or a manager who exercises authority and control?

    It is important to realize
    .

    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
    that everyone has fears. Ask anyone who has ever been in combat and they’ll tell you that it is being in touch with their innate sense of f
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ar that kept them alive. However as important as it is to be aware of your fears, as a leader you cannot allow yourself to be ruled by them


    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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