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    We draw conclusions about people through observation, their behavior, past experiences, other people’s comments, etc. We assume who people are, what they think/need/want with such
    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
    speed we fail to recognize how our own viewpoint colors the way we connect with and relate to people and situations. We even hold assumptions about ourselves!

    Let’s focus for a
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    moment on verbal communication. Making assumptions has become a part of the way we communicate (or don’t communicate) with each other.

    During my coach training, one of the points
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    that class leaders focused on was the value of listening to people with curiosity. What that means is hearing what people say, being present with them, and having an innocent, op
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    en, genuine interest to learn about who they are without judgments or preconceived attitudes.

    In my work, I consider myself to be an empathetic listener. I’ve become accustomed t
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    o asking questions and quickly grasping the essence of what people are saying. Focusing on staying in curiosity, I was astonished to observe the subtle ways I quickly shifted into
    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
    making assumptions in my desire to understand. Saying things like " Tell me more about that, what does that mean to you, how would your life be different if you had.." brought me
    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
    back into curiosity instead of jumping forward into planning strategies or problem-solving. I realized that by making assumptions, I was missing (stepping over) important informa
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    tion that would help me to be fully present with my clients.

    How often do you believe you understand the other person only to find out you have a miss – understanding??? To what
    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
    extent do your assumptions cause conflicts? How often do you make a decision and/or take action based on your assumptions. What happened?

    So why don’t we ask questions for furthe
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    clarification? When I ask this question, people tell me:

    * It’s such an automatic response. I don’t think to ask for more information.

    * I wasn’t totally sure but I was uncom
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    fortable asking – like I should have known.

    * I didn’t realize I misunderstood until…..

    * I didn’t want to appear stupid (misunderstanding is better?).

    What’s your answer?

    F
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    or example – people often say they want to be supported. What does that really mean? I know what feeling supported and being supported means to me but I don’t know what that means
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    to anyone else. What are people really asking for? Seeking clarification (get specifics!), about what people want/need/expect invites you to show up and respond (to that need for
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    support) from your heart. Win-win. (Note. Using this example, don’t assume that people need the same things in every situation.)

    Here are some tips to begin moving out of uncons
    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
    cious assumptions to conscious curiosity:

    1. Look for opportunities to practice being curious instead of "knowing." Choose some situations that would benefit from eliciting furth
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    er information. Pay attention to how you are responding to people.

    2. ASK QUESTIONS!!!!!!! Say things like – "tell me more about that", "I know what that means to me, what does t
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    hat mean to you?" Consider what you’d really like to know.

    3. Reflect back to the person what you hear them say and what you believe they mean. This is active listening.

    4. Be w
    .

    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
    illing to look silly or be uncomfortable in an effort to understand.

    5. Recall a past experience when you made assumptions that had negative consequences. Looking back, what assu
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    mptions did you make that you can learn from now? How can you apply this information to become more open and receptive?

    What else can you think of?

    Copyright 2003, Lorraine Cohe


    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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