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    As engineers and technical professionals we are all trained to be logical and rational and rely on proven fact
    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
    s in making decisions. The approach with engineers is to vigorously apply the blowtorch to any concept which i
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    s rather nebulous and stick to solid engineering design practise. However as Margot Cairnes, an Australian le
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    adership strategist recently pointed out: ‘This often means being conventional, boring and underperforming (w
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    hen creating solutions to difficult problems). In a changing world, creativity is essential, not only to keep
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    pace with change but to be at the crest of the wave’.

    I am sure you have been in numerous engineering meeting
    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
    s which grind on and on regarding some trivial but critical design issue. Important, perhaps, in many cases. B
    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
    ut we submerge our creativity under this overwhelming conventional but safe engineering thinking. It is stagge
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ring how many brilliant and effective products are out there which were created through creative thinking and
    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
    “thinking foolishly”. These range from products as varied as the 3M Post It note, the Kreepy Krauly pool clean
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    er, the iPod to the ubiquitous telephone.

    Here at IDC we brainstorm foolishly at times when designing new ser
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    vices or products. Initially my rational engineering mind is irritated and uncomfortable. However, when creati
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ve impulses intrude, the barmy content which appeared illegal, unsafe and even dangerous, can, with a more cha
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    otic and lateral vision begin to appear quite stunningly brilliant. The trick, when the ideas are flowing, is
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    to get other people to comment on them and to turn them around and see whether they can be made useful and pro
    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
    ductive.

    When you are engaged in another meeting examining a difficult problem; be foolish. According to the
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    Entrepeneur magazine, the following framework is recommended:


    * Pose an initial question to get the “show
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    on the road”
    * Identify a challenge which you want to solve
    * Suspend criticism of all ideas that a
    .

    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
    re presented
    * Postphone evaluation whilst the ideas are being presented
    * Build on others’ ideas in
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    a fast paced manner
    * Do not risk life and limb, but as Steve Jobs says: ‘Stay hungry, stay foolish’



    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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