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  • Main Subject - Power Questions that Turn Trouble Makers into Problem Solvers

    Here she comes again into the office to complain. First it was about everyone else abusing their breaks, and then she accused you of playing favorites by not h
    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
    onoring her seniority, now she’s unhappy with the rotation. You think to yourself: what now?

    Some complaints are valid and others are annoying. One of the big
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    gest stresses on management is the squeaky wheel that never gets enough grease. If you have one of these noisy irritants you can transform your troublemaker i
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    nto a problem solver by asking these power questions:
    • Does everyone else feel the same?
    • What do you suggest?
    • Are you willing to write up a
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    proposal with your ideas?

    Suppose you are a supervisor in a manufacturing department and “Connie Complainer” comes to you with the grievance that the rotation
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    is unfair. You rack your brain and it seems that there is no solution. Before shooting from the hip and saying “I haven’t heard anyone else complain,” inste
    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
    ad try the power question, “Does everyone else feel the same?”

    This positions you as a good listener and you might just get valuable information. If others 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
    e secretly complaining, it’s to your benefit to be aware. Perhaps Connie is the only one with the guts to approach you. If so, Connie can be a great resource o
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    f information for you. After all, if everyone is complaining and you don’t know it, there will be repercussions. However, if no one else is complaining, now
    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
    you have narrowed it down to one person’s problem and you can work with that person to find a solution for her or him.

    The second gut reaction when a worker c
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    mplains is “There’s nothing I can do.” And perhaps from your viewpoint, that is the reality. A better approach is the power question: “What do you suggest?”
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    Now you are teaching your employees to think like problem solvers, giving them ownership of the process. You might be surprised how creative your employees ca
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    n be if given the chance to help you with the solutions. The beauty of this question is that it eliminates the chronic complaining and takes the monkey off of
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    your back.

    The benefit is that you present yourself as open minded instead of controlling or power hungry. If it is a question of policy, where there really
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    is nothing you personally can do, educate your employee as to the policy and direct him or her to the appropriate person.

    One way to document and keep track o
    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
    f complaints and suggestions is to ask the third power question: “Are you willing to write up a proposal with your ideas?” This is an excellent way to develop
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    leadership in someone who otherwise might be contrary. How far is that person willing to go when asked to make a real commitment to helping solve the problem?
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    Is she willing to put her ideas to paper or make an informal presentation? If so, then you have given her the opportunity to develop leadership skills and tak
    .

    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
    e ownership of the problem.

    Be prompt in your follow up once your employee has written the proposal, otherwise it hurts your credibility and you risk losing t
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    rust. Strategic use of these questions puts you in the driver’s seat and empowers your employees to being a part of the solution instead of part of the problem


    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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