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    I recently had an experience with a small business that reminded me of the power of "the extra mile" principle. The "extra mile principle" is the act of going above and
    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
    beyond expectations; going out of your way to provide an uncommonly high level of service to another, whether a customer, a friend, a relative or even a stranger, not
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    because you HAVE to, but because you WANT to.

    Here's what happened: I went in to a neighborhood mailing place called Mostly Mail to send out some packages on a Saturda
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    . I arrived after the last mail pick-up had already been made for the day. But the owner of the store, an incredibly nice guy named Bill, volunteered to go the extra mi
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    le on my behalf. "No problem," he told me. "I'll make a special drop at the post office myself to make sure your packages get out in the mail today."

    Now he certainly
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    idn't have to do it. I'm a relatively new customer. I don't even rent a P.O. box at his store, and the volume of my business is miniscule. But he has a customer for lif
    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
    e in me and a walking, talking advertisement for his business as well, all because he chose to go the extra mile! I go into his store every chance I get, to buy stamps
    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
    or send out packages, even though it costs me a few cents more than it would to go to the post office. He sells other products too, both business and non- business, and
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    while I could buy mailing envelopes and business supplies, or even candles more inexpensively elsewhere, because he consistently goes the extra mile for me, I prefer to
    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
    spend a little more money buying from him and supporting his business.

    Then a few weeks ago, Bill did it again! When my new book 101 Great Ways to Improve Your Life,
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ol. 3 was released, I took a copy in to show him, and he shocked me with his "extra mile" spirit by offering to place several books in his store for other customers to
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    purchase. Did I mention that he has me as a customer for life??

    I hope you've been fortunate enough to have an "extra mile" experience somewhere recently. But more imp
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ortantly, I challenge you to make a point of providing an "extra mile" experience for someone today and everyday. It doesn't matter whether you own a business or work f
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    r someone else, whether you're a manager or a worker bee, or whether you even work at all. We live in a world where "it's not my job or my problem" seems to be the stan
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    dard operating principle. Sadly most businesses, large and small, lose valuable customers everyday due to this lack of personal responsibility. But you and I always hav
    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
    the choice: either do just enough to get by, or go the extra mile to make someone else's life more pleasant or easy.

    And if you want to have more "extra mile" experie
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    nces, start by making the commitment to give more "extra mile" experiences to others. The old adage, "what goes around comes around" applies. Today, be like Bill and ma
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ke someone's day by going the extra mile. If you run a business, model the "extra mile principle" with employees and customers alike. And encourage your employees and c
    .

    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
    - workers to live it too. I guarantee the rewards will come back in more loyal customers, greater cooperation among staff, and a more positive working environment.

    Wha
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    t a world it would be if everyone took the "extra mile" attitude in life and business! Let's get the trend started right now. Who will you go the "extra mile" for today


    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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