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  • Useful Advices - The Power of Not Knowing: Understanding Your Adversary

    Most of the time, your eagerness to get your point across guarantees that you won't. It seems the hard
    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 you push to be heard, the harder they push back.

    How do you create a willing listener? It's eas
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    y: be one.
    Being heard is exactly what the other person wants, too. So give what you would l
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ke to receive and see what happens.

    In aikido, I physically align with my partner as he attacks. I mo
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ve to face the same direction, unite with the attack energy, and redirect it toward mutual safety and
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    esolution. We become partners in a flowing, cooperative dance.

    In a difficult conversation when I
    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
    want to get my point across, I create alignment through "Not-Knowing." I pretend I don't know anyt
    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
    hing about this person or their goals (I actually don't), and I try to learn what's important to them,
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    what they're really going for, and how what I'm offering might fit with their goals.

    I enter the L
    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
    and of Not-Knowing. When I remember how absolutely little I know about this other human being, I r
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    lax for a moment. I become interested. It's quite a lovely place to be: undemanding, stress-free, a pl
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ace of no expectations. I get to just sit there and be a learner, a child at play. Why do I need to pr
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    etend I know everything anyway?

    How to do it? The easiest way to move from critic to curious is to
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ask a question you don't know the answer to. Get the person talking about something they love to t
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    alk about - even if it's the opposite of what you want or believe. Watch their expression, listen to t
    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
    eir voice, and notice how they change when they can talk without worrying about being stopped or judge
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    d.

    To listen without judgment is an amazingly powerful skill, even more powerful when you don't ag
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ree with the speaker. Observe what happens when you find this power. Remember that listening does
    .

    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
    ot equal agreement, and that you will have a chance to deliver your message, too, possibly with more s
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    uccess now that you've heard what's important to your partner.

    Good luck in all of your communication


    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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