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  • Just Other Articles - Changing the Paradigm - A Mother's Guide to the World of Entrepreneurialism

    Point #1: It all starts with an idea.
    Many people think you need an MBA, PhD, or even a college degree to become a successful entrepreneur, and you need to be knowledgeable in certain business areas. Let's debunk that myth right away, it is true that those thi
    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
    ngs help you, but they are not a prerequisite for definitive success. The last time I checked you didn't need a degree from an accredited university to come up with a brilliant concept, service, or product. Ideas are the foundations of success. You could know every
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    thing there is to know about business, but if you have to offer, you have nothing to sell. If you have an idea to improve a product, offer a service that is needed or desired, or have a ground-breaking idea that companies, governments, or individuals are willing to
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    exchange money for then you have the foundations for a successful business venture.

    Point #2: Leverage your current skill sets
    As I said in Point #1, you don’t need to necessarily have the business skills and knowledge that is taught in business schools and p
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    rograms to be successful, but it helps greatly to know someone who does, we’ll talk about this a little later. First it time to look internally at your own hidden skills. We’ll start with your networking skills, they’re essential for business because it always help
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    to know people. You have these skills already; you just have to identify them. You meeting your neighbors, those you attend church with, your hairdresser, your child’s teacher, etc. Your social skills are the beginning of networking, which is essentially creating
    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
    a roster of people you know who you may need to call upon. You have sales skills… yes you do. Getting your child to take their medicine, do their homework, do their chores, or to do anything they don’t feel they need to do is selling, same concept, just a different
    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
    purpose. You have management skills, keeping your children in line, getting them off to school, managing the house, and all the errands and chores take management skills, you’ve already got them. Another skill is creativity, this cannot be taught. Coming up with so
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ngs to sing to your children, games to play, and creative outlets for them all takes an innovator’s and inventor’s mind a key skill when running your own company.

    Point #3: Determine your goals
    Your company can be whatever you want it to be, and for whatever
    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
    urpose. You can make just enough to pay for a new outfit a month and a trip to the spa, play for Johnny’s and Susie’s college education, or become the next corporate giant. Your venture can be full-time, part-time, seasonal, day, night, etc. Your company’s strategy
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    , focus, and direction are determined by your goals, so whatever you decide upon simply stick to it. Success does not mean a certain annual revenue, or company size, or market share. These are only definitions of success if that was the initial goal, meeting and/or
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    exceeding your goals defines success.

    Point #4: Take an inventory
    This portion has to do a little with marketing, finance, strategy, sales, etc in business but within the context of who you know. You have a plethora of people who are potentially in your targ
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    t market (those who you are in business for, whose needs you want to meet). You call them play groups, church groups, fellow soccer moms, the PTA, etc. If your business is a business that caters to other mom’s you already have a group of people you know to run your
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ideas by. You can sample your services, product, or can weigh in on your idea to see if it’s feasible or not. These same people have skill sets that may benefit you, or know people who can help. Take an inventory of who you know, and of what organizations you belo
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    g to, you may find some hidden gems that can be beneficial to your business idea.

    Point #5: Exploit technology to help you
    Technology doesn’t have to become a burden, being able to use it to your advantage can ease some suffering and solve many problems. Most
    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
    web hosting companies offer templates of websites that you download and change, not much more difficult then using a word processor. There are services you can use for a small fee that can collect payments for you, and help run your business. If you have a child o
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    er the age of 10, chances are they can set-up all of your technology for you. Generally all you need is a computer and a broadband connection, they can do the rest. Don’t be afraid to use them, besides you’ve cleaned up after them, stayed up all night with them, ti
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    me for them to return the favor.

    Point #6: Know when to use outside help
    Sometimes you face a challenge or task in business that is beyond your knowledge. This is when you want to look for outside assistance. Depending on whom you know (see Point #4) or your
    .

    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
    ow much your making you can always bring in outside help. You don’t have to hire employees; some people will work pro bono or on a contract basis. There are also government resources that can assist you. Visit your local Small Business Association (www.sba.gov) the
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    y offer a wide variety of free services, some even cater to women in helping them level the playing field. Bringing in someone to help doesn’t mean you have to give up control or change direction. Remember this is your idea, your vision, and ultimately your company


    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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