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  • Advice You - Effective Leadership: Three Indicators to Measure Yourself

    Am I the most effective leader I can be? Is my organization well led? Do I always have to be present for my organization to get the job done? These are questions that every leader should be asking himself. The truly honest answers
    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
    may not always be pleasant.

    For smaller to medium sized organizations/departments that are part of a larger enterprise, my three key indicators of effective leadership will enable a leader to determine if he is being effective. For th
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    e senior leaders of large enterprises, such as Fortune 500 companies, more indicators, such as increasing shareholder wealth, would be needed to assess effective leadership. However, large enterprises should use these three indicators
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    to measure the effectiveness of their junior to middle level leadership. All three must be present to indicate truly effective leadership.

    The first indicator is Proficiency which I define as the “the organization knows the job thorou
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    hly and does it well.” Proficiency is a result of both individual and group training. All organizations know that individuals must be trained, but individual training should be tailored to improving the organization’s effectiveness.
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    An individual’s training must contribute positively to the organization.

    Additionally, in my book, Small Unit Leadership, I advocate group training whenever possible, even as a conference room exercise if necessary. Athletic teams and
    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
    military units use individual training to get to a common language/understanding and they then train as a team for maximum effectiveness. Why can’t other organizations? It might require some creativity, but that’s not a bad thing.

    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
    so, a leader must never assume proficiency. Train as necessary, but always inspect for proficiency. Many potentially great leaders never moved forward in their careers because they failed to exercise one of my principles, “Inspect wha
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    t you expect.” This includes inspecting for proficiency.

    My second indicator of effective leadership is Organizational Discipline, which I define as “In the absence of the leader or key personnel, the organization executes well and in
    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
    itiates appropriate action.” Many leaders believe that to be effective, they must be present nearly all the time. They believe that when they take vacation that their organization will struggle without them. However, when a truly eff
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ctive leader takes vacation, his organization can run for a period of time without his physical presence. This is because he has set clear standards and expectations and has ingrained a sense of responsibility in his people. His peopl
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e understand what has to be done and they go about doing it without him being physically present. This is a truly effective leader.

    Clearly understood standards and expectations are key. Without them, an organization will only do wha
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    t it is told to do on a recurring basis. With no one physically there to tell them what to do, it will flounder. An effective leader sets clear standards and expectations allowing a well-trained organization to function effectively du
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ring his occasional absence.

    I’ve frequently heard workers say “We work better without the boss; he only gets in the way.” However, the truth is the vast majority of workers want their leader to succeed and be effective. Part of that
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    success is your organization being able to survive your occasional absence without a drop-off in effectiveness. A department with organizational discipline succeeds despite the occasional absence of its leader. Additionally, your boss
    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
    should notice the well-trained, disciplined team that you have developed when you are away.

    My third indicator of effective leadership is High Morale, defined as “Employees exhibit a positive state of mind; they are proud to be part o
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    f the organization.”

    High morale indicates that proficiency and organizational discipline are well received, indeed, expected by the people in the organization. Organizations can have proficiency and organizational discipline without
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    igh morale, but the proficiency and organizational discipline will come from fear or another negative leadership trait. Experience tells me that negative leadership works for only short periods of time.

    Conversely, for a time, there c
    .

    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
    an be high morale in an organization without proficiency and organizational discipline. However, a lack of proficiency and organizational discipline will eventually lead to chaos, never allowing the organization to reach its goals and
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    objectives.

    High morale by itself will not allow an organization to attain its goals. However, it will confirm that, if the organization is meeting its standards and expectations, then the leader is using positive, forceful leadership


    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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