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    Team leaders have three functions:

    • to get the team to perform a given task to the satisfaction of the customer
    • to allow for individuals to find job satisfaction and sufficient motivation to
    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
    want to continue in the team
    • to develop the team so that, with the same people and the same resources, a higher performance can be obtained.


    The triple concerns of Task, Team and Individua
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ls mean that the team leader is constantly faced with dilemmas and paradoxes: should task come before the team or team before task? Should the leader meet individuals one-to-one or only meet with the
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    team as a whole? These dilemmas mean that effective team leadership is a series of checks and balances rather than a simple question of implementing the rules.

    "Teamwork is like riding a bicycle. Y
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ou can only move forward if you stay in balance."

    1. The Task. In the balancing act that is team leadership, the task becomes the team's number one priority whenever the customer's needs are u
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ppermost in their minds. Working on the team's task may mean putting the team's team and individual needs on hold. It may also become necessary to work on the task if the team has spent too much tim
    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
    e on its people needs and needs to re-discover a balance.

    Some of the features of the task-oriented team leader are:

    • she rules with an iron fist
    • she talks about how much should be done
    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
    • she asks for sacrifices for the good of the whole team
    • she sees to it that people are working to their limits
    • she stresses being ahead of competing work teams
    • she decides in de
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    tail what needs to be done
    • she emphasises deadlines
    • she emphasises quality of work.

    2. The Team. In their position of being either slightly outside the team or wholly outside it,
    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
    team leaders are the best people to see the team objectively as a team. They are able to give the team its shape and reality, making the team more than just a collection of individuals.

    They can do
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    this by:

    • meeting with the team as a whole, involving the team in discussions and reaching team decisions
    • making selections to the team based on what newcomers can add to the team
    • rem
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    oving from the team anyone who unbalances or disrupts the team
    • sensing the team's energy and making the necessary interventions to help it move forward
    • fostering team spirit
    • givin
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    g the team its unique identity.

    3. The Individual. The route to all effective teamwork lies through managing the individuals in the team. Only through one-to-one contact and management can a
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    team leader develop people who have the skills, motivation and inspiration to fulfil the task needs of the team and develop the team as a unit.

    The areas a team leader needs to address in managing th
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    e individuals in the team include:

    • appointing newcomers to the team
    • building up individual skills and realising personal potential through training, coaching, and mentoring
    • getting to
    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
    know individuals well enough to be able to make sensible adjustments to who does what in the team
    • individual rewards, pay and conditions
    • personal performance appraisal
    • dealing wi
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    th individual performance problems through counselling and discipline.

    The team leader's concern for balancing task, team and individuals may be likened to the human functions of hand, heart and head
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    :

    • the hand represents the mechanical or technological way a task should be performed.
    • the heart represents the inspiration that can unite a team and achieve more than you can measure.
    •
    .

    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
    the head represents the sensible and logical way individuals should be managed.

    When hand, heart and head are all properly cared for, not only is there a whole, but also a healthy balance.

    "A man w
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ho works with his hands is a labourer; a man who works with his hands and his brain is a craftsman; but a man who works with his hands and his brain and his heart is an artist." (Louis Nizer, 1902-94


    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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