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    Having been involved in sales for most of my career, I can attest to the many successes and failures of various colleagues. In trying
    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
    to determine the root of those that had problems selling, it can be summed up in a few words; lack of preparation. These poor people
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    would knock on a door or make a call with almost no idea of what they were going to say or how the sales call should go. What they n
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    eeded was an outline and some general knowledge of the company regarding whom they were calling. With the advent of the Internet, thi
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    s is inexcusable. The ability to research a specific company or industry has become as easy as clicking a mouse.

    In my day, I had to
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    read journals, look in the phone book, or ask around to get even a glimmer of information. But I would arm myself with whatever was
    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
    available before entering the business. If not, I might look like a fool. Suppose I was going to see a dentist. I was a Yellow Page s
    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
    alesman at the time and now consider this dialog.

    ME: “Hello Dr. Jones. I’m here to sell you a Yellow Page ad in our directory. I fi
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    gure that most of your new patients would use the book to find you.” HIM: “No, they wouldn’t because I don’t take any insurance 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
    I charge the most in town.” ME: “Then how do you get new patients?” HIM: “I don’t. We aren’t accepting any new patients.” ME; “Oh.
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi


    If I had done my homework I would have known what to expect and not looked like an idiot by going down the wrong path. This was a u
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nique dentist, but even he could have been sold using the right technique. If I had been prepared, I could have taken a different pat
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    h. For example, listen to this new conversation. ME: “So, Dr. Jones, I understand you’re closed to new patients. Then what do you do
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    about the ones that move away or die? Each year that’s about 20%, according to my industry figures.” HIM: “Really, I didn’t know th
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    at. I really just want to maintain my current practice without any trouble or expense.” ME: “Well, I have an ad that would only attr
    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
    act the most profitable customers to help replenish your base. And all for a minimal investment of your time and money. Would you all
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ow me to show it to you?” HIM: “Well, I do have a few minutes. What have you got in mind?”

    Do you see the difference even a little
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    preparation can make? I had a few statistics up my sleeve and designed an ad based on what I thought he might need. So, instead of 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
    wasted call, I end up with a good sale and the respect of someone who might now normally have given me the time of day. The moral: do
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    you due diligence, know your customers, your product, and their industry before the call. It will make all the difference in the end


    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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