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    I spent one whole day in the vacuum cleaner business.

    And it was long enough—to learn one of the best lessons.

    The fellow I
    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
    was attached to for my training day was a rumpled dumpling. He was the exact opposite of what you’d expect the company’s top s
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    lesperson to look like. He wasn’t cleanly shaven, didn’t speak well, and appeared in every single way to be pathetic.

    He drov
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    e an ancient Chevy sedan with torn seats. If this guy was a moneymaker, a top earner, number one in commissions, then I was Su
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    erman, or so went my teenage thinking.

    We knocked on doors, until someone answered.

    Soon enough, a housewife straight out of
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    Stepford, greeted us. He asked if he could have the privilege of vacuuming her living room—free of charge—simply to dramatize
    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
    the amazing Power Nozzle attachment that was exclusive to his machine.

    She nodded, looking at me as if to ask, “Where did you
    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
    get this partner, you poor boy?”

    He revved up the one and a half horsepower motor and glided from one corner of the living ro
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    m to the next, making small talk that no one could hear.

    Then, he shut it off and said, “You keep a very tidy house, don’t yo
    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
    u?

    “I try!” she beamed.

    Unlocking the back door of the hot dog shaped appliance, he deftly retrieved a full bag of soot and
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    wiftly plopped it in a pile in the center of her rug.

    This demo knocked the wind out of her, she became woozy, overcome by th
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    revelation and humiliation that there was a ton of hidden dirt that her old standby vacuum was leaving behind.

    “Oh, my gosh,
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    look at that!” she gasped, reciting her role perfectly in this domestic drama.

    Suffice it to say, he sold her this Cadillac
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    f cleaners, and I walked with him to the curb, in a daze of my own.

    We drove back to headquarters, and he and the big boss de
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    riefed me. What did I think? Could I do this?

    I said I’d think it over, and as we all parted company, I noticed that the frum
    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
    py salesman had changed his worn jacket for a snazzy cashmere sweater, and he suddenly looked two feet taller as he put the ke
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    into his off-hours car, his real driver: A brand new Cadillac.

    His entire sales persona was a masterpiece, carefully calcula
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ed to make buyers feel sorry for him.

    And it worked beautifully.

    Although I didn’t feel I could do his act, I did walk away
    .

    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
    knowing one thing about selling: it is an art, a performance art, and some of the savviest practitioners don’t let their offst
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ge identities interfere in the least with their onstage personalities.

    That’s one powerful lesson.

    Dr. Gary S. Goodman © 200


    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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