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    My video duplication company has been a reliable and responsive supplier. They should be – I have spent more than $62,000 with
    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
    them in the past few years.

    I received a complaint from a customer about one of my video programs that ‘skipped’ during playba
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    k. I thought it was an oddity and immediately replaced the disc. But the next month another complaint arrived about the same si
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    uation.

    I contacted the duplication company right away. They ex-plained this problem may have affected a small number of discs
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    from their supply of blank stock. They apologized profusely and promised immediate replacement. I removed all remaining invent
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ry from my office and warehouse and sent the discs back – a few hundred pieces from the most recent duplication.

    Then I got a
    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
    essage from the company offering to replace only ‘verified bad discs’, and not all the discs I had returned.

    What am I suppose
    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
    d to do, watch every disc and look out for those that ‘skip’? Or wait for my customers to notice the problem and complain, and
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    hen exchange those discs one at a time? Of course not.

    The better course of action is to simply – and quickly – replace them 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
    l. I told them so in a follow-up message.

    To their credit, the duplication company responded to my second message in an entire
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    y appropriate manner. They have agreed to replace all the discs promptly and at no charge.

    They also promised to put extraordi
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nary care into my future duplications to ensure the highest quality standards.

    That’s a smart business move. It guarantees ano
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    her $62,000.


    Key Learning Point
    --------------------------------------------------------------------------------
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    > When the service you provide jeopardizes your customer's relationship with their customers, you need to respond with twice t
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    he speed and twice the recovery effort. After all, now your upset customer has upset customers!

    Of course there will be costs
    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 consequences and perhaps some aggravation, but leap to it right away. Be the supplier who takes immediate action to set the
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    rong things right.


    Action Steps
    --------------------------------------------------------------------------------
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    r> Who are your customers' customers? How do your actions as a supplier impact your customers' customers' satisfaction? If thi
    .

    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
    gs go wrong, how will your response and recovery affect theirs?

    Meet with your customers to discuss this on a regular basis. D
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    velop a clear understanding and positive action plans. Make sure your customers, and your customers' customers, are well served


    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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