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    Jane and Bob have been working with their teams for a couple of months, and they've really paid attention to putting the right people in the right roles. However,
    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
    other problems can arise that don't have anything to do with teams, leaders, and workstyles.

    Differences in communication styles or the communication styles themsel
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ves are often the cause of problems, rather than the content that's being communicated. Often we see these problems occur when the topic is difficult; no one has tr
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ouble communicating around the success of the project, the awards ceremony for the team, and the overall good health of the company!

    What if the topic is difficult?
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe


    When Jane and Bob need to discuss a problem, a broken commitment, or a difficult situation, they use the following formula.

    CPR


    * Content
    * Pattern
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    * Relationship


    Content


    The first time a problem occurs, talk about the content – what happened. Usually it's a single event, and it only involves the here
    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
    and now.

    Pattern


    The next time the problem occurs, talk about the pattern – what has been happening over time. Patterns acknowledge that problems have histor
    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
    ies, and histories make a difference. Frequent and continued violations affect the other person's predictability and eventually upset trust and respect.

    Relationsh
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ip


    If the problem persists, talk about the relationship – what's happening to us, and why does this keep recurring. Relationship concerns are bigger than conte
    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
    nt or pattern. The string of disappointments has caused you to lose trust in the other person. You doubt his competency, you don't respect or trust his promises, a
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    d it's affecting the way you treat one another.

    Clearing the air


    Jane and Bob make communication work for them by being clear about their expectations as well
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    as about problems that come up. You need to do the same. Don't be vague!!! Be specific about what you want and by when.

    Vague: "I need this finished right away.
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    " Clear: "I need this research document complete and to me by Wednesday."

    Vague: "It's important for you to play well with the other departments." Clear: "In ord
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    er for your department to work effectively with _____ department, you need to discontinue bad-mouthing or gossiping about the ________ department and their problems
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    to your staff. Discuss any issues you have with that department head or with me."

    Don't assume that because you made a statement or request the other person has ag
    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
    eed. Ask her! "Monica, I'd like this project completed and results to me by next Thursday. Is there any reason you can't deliver it by then?" Confirm with her th
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    at she not only will deliver what you requested, but also by the date needed.

    Tying it up


    At the end of the conversation, ask the person to explain to you what
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    he believes you want. This provides you the opportunity to make sure he heard you correctly, and, if not, to change or modify what he thinks.

    Often, the gap betwe
    .

    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
    en your request and what you receive is because of misunderstandings about the specifics.

    Armed with the CPR (Content, Pattern, and Relationship) and understanding
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    the necessity of being clear, Jane and Bob have the tools to build and maintain an effective work environment with individuals who understand what's expected of them


    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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