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  • Advice Pool - Thinking Outside The Box - Where To Start?

    Are you ready to start thinking outside the box, and generating new ideas? You've probably heard the expression enough, but what is the box, and how do you get outside of it?
    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
    You can start with the following technique.

    A Metaphorical Box

    Time to play with the metaphor a little. Imagine you are actually in a box, and written on the cardbo
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    rd walls around you is a description of the world outside. It could be a very detailed and accurate description of the world in some ways, giving you a good idea about what 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.

    s out there. Perhaps you could even use this knowledge to create some useful ideas.

    Of course there is a problem here. The world is larger and more complex than any descript
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    on can capture - no matter how detailed it is. This means that if you stay inside this box, your thinking will be very limited. To really know the world, and to make your thi
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    king about it more productive, you need to be outside the box, right?

    Getting Outside The Box

    All of us are "in the box" at times. The "box" consists of our habitual
    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 limiting ways of thinking and solving problems. This is easiest to understand with a simple example.

    Suppose that Beth hates her boss, in part because he has been unfai
    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
    and rude to her. Beth's first approach to this problem was to go above his head and complain. She hoped he would be fired, but this didn't happen.

    She considered transferri
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ng to another department, or perhaps even quitting her job. This made her angry. After all, why should she quit, when he is the one causing the problem? She even started to t
    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
    ink about revenge, which made her smile, but she knew it would only mean more trouble.

    Beth finally decided that her thinking wasn't very productive. She needed to start thi
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    king outside the box, but how could she go about this? To begin, she identified key elements about her approach - the assumptions she was making - and she challenged these.
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a

    For example, she was assuming that her boss was the problem. You might say that this was part of the description written on the inside of the box she was in. Perhaps it was
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ccurate, but it wasn't helping, so she asked the question, "What if I was the problem here?" She considered what was she doing, and what she could do differently. Now she was
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    thinking outside the box.

    Looking at it this way, she saw that she was dwelling on his unfair decisions and rudeness. When she ignored those, she realized, she actually sti
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    l liked her job. When she stopped focusing on his behavior, she didn't seem to have much of a problem with her boss.

    She also saw that she was making herself a target. Her g
    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
    tting upset seemed to make her boss act even worse towards her, so she started answering his rudeness by smiling like she knew some secret. He seemed confused, and he stopped
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    making as many rude comments to her.

    In her box, she realized, this situation was painted as a battle between her boss and herself. But did it have to be a battle? She cons
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    dered what would happen if she tried to help him, and she laughed, mumbling to herself, "Yeah, help him find another job somewhere else." This might be a good idea, Beth deci
    .

    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
    ded, so she found his resume and secretly sent it to a corporate "headhunting" service. The next month her boss had a job offer and he left the company. Beth was even promote
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    to fill his position.

    There are many ways you can start thinking outside the box. But one of the first to try is to challenge the assumptions that the box is constructed of


    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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