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  • Digg It - Don't Name The Lobsters - Nurture The Right Relationships For Your Small Business

    Small business, at its core, is about one thing and one thing only--success. How does our capitalistic society measure success? Dollars, my f
    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
    riend, cold hard cash. Now before you start emailing me about "relationships" and "making a difference" stop to consider that without positive
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    cash flow, your entire enterprise can shrivel up and die right before your eyes.

    It is imperative that you separate you and your intentions f
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    rom your business. Put another way, your business is not you and you have no right to impose your needs, financial or otherwise, on it. The
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    strong>survival and health of your company should be your driving force, so be very careful what decisions you make.

    Another name fo
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    "relationships" and "making a difference" is "naming the lobsters". Have you ever walked into a fine seafood restaurant and observed the Lob
    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
    ster tank? Inside are large lobsters waiting to be chosen for your next meal. In that moment--you make a decision. Will I eat them or not? If
    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
    you let yourself emotionally connect to the Lobster, you will never be able to have them for dinner. The same principle holds true for your b
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    siness.

    Naming the lobsters is the lack of separation between an owner and their business and it becomes apparent to me when
    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
    clients say things like:
    • John's been with me from the start, yet he loses more sales than he makes.
    • I charge this client less
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    because they can't really afford my fees, yet they really need my help.
  • Our kids went to school together so I sell to them at cost.
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    >

    If you emotionally connect to people and customers, you will not be able to make the difficult but essential decisions that will ultim
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ately determine the health of your business. Unproductive employees, less than profitable customers and abusive relationships
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    weaken the very core of the enterprise. DON'T NAME THE LOBSTERS! Terminate relationships that don't nurture your business,
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    o matter how painful it may be.

    Think about this. Relationship building is the core of business building, yet--what happens when you have an
    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
    employee that becomes detrimental to the relationships you've built? What happens when you have a client relationship that demands a lot of
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    our time but gives little in return by way of purchases or profit? That employee and that non-profitable client relationship: Lobsters. Don
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    t name them! Toss them back. One bad apple can truly spoil the whole bunch.

    Owning, caring for and nurturing a small business
    .

    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
    ng> requires true leadership ability, and can be a lonely road to travel. It is filled with difficult decisions and sleepless nights. I know
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    I've been there. Trust me; if you fail to embrace the truly hard decisions and you continue to name the lobsters, you are risking everything


    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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