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    I first met Roland (not his real name) in 1972. He was a high school student working a summer job in his father’s business.

    “We’re teaching him the business from the ground up,” h
    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
    is father told me proudly as he introduced me to the tall good looking kid. We shook hands, exchanged a few words, then Roland jumped on a fork lift and was off to stage another de
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ivery.

    The next time I saw Roland, he was approaching 40 years of age and had served four years as company president.

    The business was located in a fast-growing metro market, but
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    under Roland’s leadership, sales had not kept pace with the growth of the market. His father, now retired, suggested that he bring in a consultant to take a look at the business.

    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    e met at my hotel for breakfast. In many ways, he had not changed all that much. He was wearing jeans, a red flannel shirt, and a pair of cowboy boots. His image was far from tha
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    of a company president.

    Roland got immediately to the point, “What do you need from me to get this project started?”

    “Let me begin by asking a couple of questions,” I answered, “
    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
    What is your vision for this business?”

    “How do you mean?” Roland asked.

    “What are you trying to make happen here? When December 31st rolls around, what evidence do you look for
    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
    o determine if you’ve had a satisfactory year?” I said, trying to clarify my question.

    “Well, if you’re talking about strategic planning or budgeting, things like that, I don’t do
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    any of that,” he responded bluntly.

    “How do you personally spend you time every day,” I asked, trying a different approach.

    “It depends on where I’m needed,” he said. “Sometimes
    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
    ’m doing the buying, but other times, like when the warehouse foreman doesn’t show up, I’m working out back.”

    “How much time do you spend in the office?” I probed.

    “As little as p
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ssible,” he fired back with the hint of a smile.

    “Sounds as if you don’t like office work,” I asked in a feeble attempt at humor.

    “You got that right.”

    “Your dad says that sales
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    haven’t kept pace with the market. Do you have an explanation?”

    “Yeah, I can’t find decent salespeople.”

    “Who’s in charge of recruiting salespeople?”

    “I am!”

    Roland didn’t have
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    a clue what role a CEO should play. He had graduated from college, but with a meaningless degree. When he rejoined the family business, he received no preparation for taking over
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    the reins; he had grown up working with his hands and that is still what he enjoyed most. When he was made president, it was in name only.

    I interviewed a couple of salespeople wh
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    m Roland had been unable to hire. They told me that they didn’t want to work for a man like Roland, and referred to his lack of sophistication and his abrupt communication style.
    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
    heir image of Roland was not that of a leader, so they each opted to take jobs with more progressive businesses in the area.

    At the end of my visit, I suggested that Roland hire a
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    general manager who had the talent to perform the essential business functions that Roland hated so much. To my surprise, he didn’t resist the idea. He was not stupid; he knew ful
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    well that being a company president was not his cup of tea.

    Today, the company is growing and earning more bottom line profit than ever before. Roland is the happiest he has been
    .

    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
    in years.

    Lesson: If the owner doesn’t have the talent or the willingness to prepare a strategic marketing plan or hammer out an annual capital expenditure budget and an operatio
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    s budget, hire someone who does. There is no rule in business that says the owner has to be the general manager.

    Management acumen is not always passed down to the next generation


    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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