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    You've probably heard the saying that good things don't always come to you the way you expect them to. That's why it's best not to get too focused on "how" something is going to come about, but more on what it
    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
    is you want to create or achieve.

    My goal, like yours, is to grow my business, so I constantly explore avenues and possibilities for expansion.

    Sometimes acting on certain opportunities have brought me to d
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ad ends.

    And sometimes they've taken me miles away from where I thought I'd end up, but surprisingly, to a much better place than I ever imagined.

    Here's one such example...

    Because I conduct my business pr
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    marily over the telephone and Internet, I never made an effort to integrate into my own community. Coaching was, and still is, virtually unknown in these parts.

    A year ago, I decided to open a chapter of a na
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    tional women's business group in my city. The organization has a solid platform and is rapidly expanding across Canada and the U.S. It provides national exposure, training, networking opportunities, and suppor
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    and resources for entrepreneurs and executives.

    Through this alliance, I saw the potential to integrate myself into my local business community while providing my fellow business owners with the venue to lea
    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
    n, connect and grow their businesses on a much larger scale.

    I envisioned a large gathering of passionate business owners who would embrace the concept and opportunity as heartily as I had.

    Unfortunately, on
    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
    ly a select few were able to think bigger and bolder than the masses. The majority of business owners were satisfied with their businesses remaining "as is". They were comfortable with where they were.

    After
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    lmost a year of attempts to build the group from the small number I had enlisted, I decided to let it fold. The efforts were taking me away from focusing on my own business and the dismal results gave me the a
    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
    swers I needed.

    This was something my city was not ready for. At least, not just yet.

    When I first envisioned the dream of one hundred or more local business women embracing the concept and helping each othe
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    grow their businesses, I was excited and couldn't see how anyone wouldn't want to be a part of it.

    And, based on the failure of this attempt, I could be frustrated and remorseful for taking the chance, but t
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    he experience brought me far more than I expected or hoped for.

    Because I took a chance, I put myself in front of many highly respected and successful business women I may never have met. I've since formed bu
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    iness relationships with several of them that will bring me several thousand dollars in added revenue this year.

    I was invited to join a local mastermind group made up of some of the brightest business minds
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    know with wide circles of influence.

    I was invited into a "by invitation only" group of business owners who share leads and resources with each other. At the last meeting I received over 34 leads from just o
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ne person alone!

    I receive regular phone calls from local business owners inviting me to lunch, to learn more about what I do, looking for help in expanding their thinking and businesses.

    All because I took
    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
    chance and put myself in front of others.

    I didn't fail. I just created an entirely different result than originally planned.

    And I honestly have to say, I'm loving how everything has unfolded.

    I'm sharing
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    this because I want you to embrace the possibilities.

    As you build your business and explore opportunities, by all means, do your due diligence to ensure you take responsible risks.

    You may land on your butt
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    from time to time, but that comes with the territory.

    The important thing is - when you come across something that you think might have teeth, take action. Sometimes you will create the results you were hopi
    .

    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
    g for and that's great, but don't let a detour break you.

    Sometimes those detours will take you down a path that you never knew existed, one that is far better than you could have envisioned on your own.

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

    Companies that provide selfless information through particip
    your eye on your vision, but always leave that back door open because oftentimes your greatest opportunity will slip through, waiting for you to turn around and notice it.

    2007 © Laurie Hayes - The HBB Sourc


    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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