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    According to the Small Business Administration, over 50% of small businesses fail in the first year and 95% fail within the first five years. This is further supp
    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
    orted by Harlan Platt, author of “Why Companies Fail, who claims that a business fails every hour in the United States. It’s a harsh statistic but a reality for m
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ny new entrepreneurs. The numbers are not meant to scare you away from starting a business, but underestimating how difficult it can be to start and run a busin
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ss is one of the largest obstacles that new business owners have to overcome. Businesses tend to fail because they have:

    An unrealistic or inadequate strategic 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
    an
    Many new business owners fail to develop a strong strategic plan or to set realistic business goals. Be sure to create specific goals that include deadlin
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    es and a formalized plan to achieve them. Revisit your business plan on a regular basis.

    Poor customer service
    Customer service is no longer a benefit. It
    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
    s an expectation. Failure to provide a strong focus on customer service can easily spell doom for your business. This is particularly true for fitness providers
    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
    that are service-oriented businesses. Take the time to educate and train your employees to provide great customer service.

    Insufficient Marketing
    Advertisin
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    , promoting and selling to potential customers is an on-going commitment. A marketing and advertising campaign must occur year round in order to prove effective.

    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
    Poor Employee Training
    Under trained or poorly trained staff can frustrate customers. It’s a no brainer to assume that frustrated customers leave and go else
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    here. Invest the necessary resources and time in training your staff.

    Excessive Spending
    Evaluate your expenses and ask yourself some hard questions. For
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    example, do you need to purchase the newest equipment or can you buy used? Also consider developing some type of control system that will track and monitor your e
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    penses.

    No Cash Reserve or Working Capital
    When times are going well for your business, set aside some of your resources for a rainy day. Consider investing
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    your spare capital in a money market or mutual fund. That way it will be there when you need some working capital.

    Poor Financial Record Keeping
    Ultimately
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    it is your responsibility as the business owner to know how much money is coming into your operation and how much money is going out. Maintaining detailed books
    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
    nd an appropriate financial statement of your business is necessary. Always keep your records current and detailed.

    Tax Problems
    Whether you want to or not,
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ou are going to have to pay taxes. So, follow the rules and pay on time. Getting behind with Uncle Sam can only result in unnecessary government pressure, penalt
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ies, and late fees. Over time, this can become an overwhelming amount of money.

    A Lack of Business Knowledge
    Operating a business involves more than just sa
    .

    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
    es and great customer service. As a business owner, you owe it to yourself to become more knowledgeable about operating a business. Take the time to read books,
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ake courses, and seek professional advice whenever needed.

    So, ensure you heed the advise of the many businesses before you as to not end up one of the statistics


    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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