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    I think one of the biggest challenges facing companies at just about any timeframe of its corporate life is focus. The focus I am referring to relates to a number of areas within the company. First is the notion of culture. Does your company have more of a sales-driven culture,
    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
    (which represents a majority of companies)? Or is your company an engineering driven culture? Or is it a marketing-driven culture? In my experience, a small percentage of companies are based on a marketing-driven culture, more than half are sales-driven, and for technology, th
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ey are generally engineering-driven. Not being a marketing-driven company is big challenge to maintaining consistent focus.

    What I mean by marketing-driven is looking from the ground up at everything you are doing as a marketing opportunity. So, for example, looking at your sa
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    les strategy. Is your sales guy running the show? This is very common. The sales guys come in and they want the sale, no matter the cost. And that cost is what I call a "seat-of-the- pants" approach where there is a frenetic environment and the sales guy turns on a dime dependi
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ng on his customer. And features and benefits of the products are sometimes even adjusted for that one customer. That is a lack of focus.

    What most companies are not doing is starting from scratch, looking at the market opportunity, looking at the market need, looking at what
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    pain their product is going to solve in the marketplace. (That’s actually a key issue: "product myopia" - benefits versus features… this will be covered in a future post).

    In an engineering-driven culture, it’s kind of a "if you build it, they will come" type of approach. They
    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
    focus on "that little knob over there can create this really cool GUI which really is, like, cool". Versus creating a product that is actually going to meet the needs of the customer. Sometimes in an engineering-driven environment, the product marketing person will meet with c
    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
    stomers and will clearly see the opportunities for product improvement… that the engineers will resist to their death.

    What is needed is a different way of thinking; my credibility branding model helps because it offers a system to walk through the business and marketing strat
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    egy process. But in general empowering your marketing executives and departments and using your marketing brand when making business decisions is really important. For example if resources are limited and you have the choice of pursuing several different customers but can’t ser
    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
    vice them all, don’t just go for the money, go for the one that will meet budget expectations but also add credibility to the company and product. For example a well known brand will add far more credibility and make the sale process easier than a bigger sale to a no names comp
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    any. The sale to the no named company will go easier when the brand name is on board. This is a process of focus.

    The discussion of focus also goes to the opportunities that come from success. Sometimes there are things that are in the marketplace that you don't realize are op
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    portunities until you introduce the product. One example is Avon’s skin lotion that was created for dry skin. Users discovered that it actually stops mosquitoes from biting, which is now how it is used. This is a rare case of a new product focus that worked (and Avon was quick
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    enough to capitalize on it). Most of those opportunities however, are not real, they just look like they could be real.

    So many companies fall into the trap of going out and losing the initial focus of the current market. It’s that idea of customer acquisition. Every one knows
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    that it’s a lot cheaper to pursue your current customers and increase their spending, but they sometimes forget that it’s also a lot less expensive to go after new customers in the same marketplace rather than pursuing all sorts of new market opportunities. With current target
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    audiences you have good evidence of success; you also have proof of concept that the products benefit users. You have customers that validate how they use your product. While, some of these new market opportunities are definitely important, the majority are not. I have seen to
    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
    o many companies fail by going after these new, sexier, market opportunities that just take their focus away from their core competency.

    Core competency is an important concept as well. Do you know what you core competency is? If you don’t there is a pretty good chance that c
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ustomers, industry influencers and shareholders also don’t know. This is not a chastisement. It is easy to lose perspective on what this is. As a company and its products move through the market sales cycle the definition of the core competency inherently changes. And if you ar
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    e doing your job well as a marketer then you are influencing a change in the marketplace of what your product category is and how the new category benefits users. The messaging around the core competency will need to be adjusted over time but the essential elements will remain
    .

    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
    the same.

    Here a couple of questions that can help you understand what your core competency is:

    -- In 10 words or less what does your company do?

    -- Who do your products serve and how do these products serve them?

    -- Describe your customers, who are they, what is their job
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    description, how has your product impacted them (how have they benefited)?

    Once answered you will likely have a better idea of what your core competency is. Now with these answers in hand, review your marketing materials and programs. You may see opportunities for improvements


    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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