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    Have you unintentionally set your business up for failure?

    No one sets out to fail! Most business owners read all the statistics (maybe more than once) before they open their doors. Many know the reasons why businesses fail. But some businesses operate u
    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
    nder this paradigm: "failure can never happen to me because I know better." Is that you?

    What most business owners miss is looking at the reasons for business failure and turning them into action steps to help overcome the odds of failure. How do I know?
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    I once thought I knew better, too!

    Bear in mind that even "adolescent" businesses fail. According to the SBA statistics, 90% of small businesses fail within the first five years. Many businesses aren't producing enough income because the business owner
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    aren't "business wise." They may be excellent at a specific task - consulting, programming, massage therapy, web site design, copywriting, etc. Or they have a great product. But wise about the "business" of business, they are not!

    In the past five year
    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 of my business, not one client (including those who have been in business for more than 10 years) provided me with a business plan to review. Not one! Two of 100 clients have had marketing plans, but marketing plans don't work without a business plan a
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    d other focus type tools, too. The other common (95%!) mistake I see (and help my clients correct) is pricing their services very low as a way to gain market share and new clients. So low, in fact, that a potential buyer will perceive the service or pro
    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
    duct as being cheap and of low quality, even when the provider offers years of expertise. NO ONE wants to hire a business that is cheap! Inexpensive - yes; affordable - yes; cheap - no, no, no!

    The most common problems business owners experience stem fr
    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
    om simple functions like streamlining, organizing, information resourcing, marketing, planning, visioning, languaging, communication, technology and ecommerce. Example: If you know that most businesses fail because they don't have a usable business plan,
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    develop your own business and marketing plans and use them daily; don't create one that gathers dust on a shelf. I use the One Page Business Plan Book or Interactive CD by Jim Horan. It helps business owners create very realistic, focused, and well thoug
    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
    ht-out business and marketing plans, including scorecards to help you anticipate and avoid business problems.

    Example 1: Recently, a client turned down an opportunity to teach computer classes on a subject she could easily teach. Using teaching to marke
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    her business is on her marketing plan. So why not? Well, the proposed classes weren't going to help her get business for her primary business, they weren't going to attract her ideal client, and the pay was much lower than her usual hourly rate. She fel
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    t confident about declining the offer. Of course, that same week, other new business - the type she really wanted - came her way!

    Example 2: New client knows she wants to create a business plan. She also has a strategy of increasing her income by joinin
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    g four organizations with networking opportunities for her to meet her ideal clients. She joins the first two groups - total cost: $400.

    As she starts her business foundation work, which includes the One Page Business Plan, she realizes that her ideal c
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ient isn't whom she originally thought it was! Some clients might be found in the two groups she's already joined, but not her ideal clients. As a new business owner, she wants to spend her time around her ideal clients, first and foremost. Planning just
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    a little more for her business would have saved her $400 in membership fees.

    What other simple things can you do to build a solid business foundation?

    · Use a one-page plan daily to create your to-do list and monitor your business.

    · Create an Ideal
    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
    Client Profile and Elevator Speech and define a niche for your business.

    · Read one of the "E-myth Revisited" books by Michael Gerber.

    · Go with your strengths. Hire individuals whose strengths ARE your weaknesses to "fill in the gaps."

    · Remember that
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    there is no need to repeat the SAME mistakes others have made.

    · Know what your business exit strategy will be.

    Most business owners don't know what they don't know. Get assistance by hiring non-biased professionals who help you realign with your vision
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    , create plans and financial scorecards to monitor your business. Look for someone who can suggest resources to help you and your business grow. Someone who's been in your shoes and succeeded. Start looking at how having a partner - a business consultant
    .

    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
    coach, counselor, strategist, organizer or planner - can help you grow your business.

    Ready to learn more about business success? Take a look at the articles I found on business failure that are posted below, (elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ia.com/articles/succeed.html">http://www.coachmaria.com/articles/succeed.html). Learn to overcome the costly (both in money and your time) errors that other business owners have already made. Give your business a fighting chance to continue to succeed


    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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