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    Investors, like the rest of us, have different tastes. One investor may love a conc
    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
    ept and/or business plan while the next may hate both. It is important to understan
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    this as business plans are working documents and are always undergoing iterations.
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.


    Management teams must not rush to incorporate each potential investor’s comments.
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    Instead, have several investors, partners and other business colleagues review the
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    lan and provide feedback. Then incorporate common concerns and probe other comments
    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
    to determine if they are valid.

    Always try to understand the rationale behind an i
    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
    nvestor’s comments. For instance, an investor may poke holes in a business plan if
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    t doesn’t have enough funds to fully fund the opportunity. In this case, the invest
    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
    r’s criticism is solely for them to save face.

    However, if you are hearing the sam
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    feedback from multiple investors, it is probably valid. In such cases, be humble.
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    Tell investors that you appreciate their feedback and modify your strategy and pla
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    appropriately. You may then be able to re-approach these investors with great succ
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ss.

    Many investors have significant operating and investing experience and can qui
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ckly and expertly find potential flaws in a business plan. Seek out investors who h
    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
    ve such experience, and be open to their suggestions. Just don’t take one point of
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    eedback and blindly follow the advice. It is also important to note that even the m
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ost successful and largest public companies have Boards that provide similar feedba
    .

    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
    k and advice, so don’t take criticism and feedback as a sign that something is wron
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    with your venture. Rather, use it as a launching pad for an even stronger business


    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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