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    Watching the Chicago White Sox win the World Series for the first time since 1917, I was struck again how wondrous this beautiful sport still can be. The purest American game,
    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
    baseball teaches so many of the values we appreciate in all areas of life. Hard work, doing the little things, hustle, overcoming adversity and never quitting are lessons we
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    learn playing Little League baseball.

    My firm specializes in small business development and boot strapping entrepreneurs. The virtues we see in every baseball game are direct
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    y applicable to success or failure for inventors and companies. The Chicago White Sox, and one player in particular, are wonderful endorsements for the baseball/success ethos.
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    Scott Posednik is the poster boy for every virtue essential to positive entrepreneurial achievement.

    It Took Nine Long Years

    Scott Posednik was born and raised in tiny West
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    , TX. West is a hamlet, founded, and still principally inhabited by Czech immigrants. No great sports traditions here. As a 150-pound outfielder, Mr. Posednik was drafted and
    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
    layed minor league baseball for nine, very long, frustrating years. Every year in spring training, Mr. Posednik would be returned to the minor league camp, traded from team to
    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
    team and generally stuck with the label “not a prospect”.

    Several times he considered giving up and seeking another calling. Nevertheless, he knew, believed in his heart, th
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    at given a chance he would be a success at the Major League level. Three years ago an injury opened a spot on the Milwaukee Brewers. The team took a chance on Scott Posednik,
    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
    elieving he would be a back-up player until the injured star returned. This was the chance he dreamed about since Little League in West, TX. He never looked back.

    Rookie Reco
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    rd Breaker

    As a 29-year old rookie, Scott Posednik hit over .300, scored over 100 runs and stole over 50 bases. He played the game with drive, hustle, smarts and courage. Mr.
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    Posedniks value has rapidly escalated and during the off-season he was traded to the White Sox for power hitting Carlos Lee. The White Sox had not won the World Series in 88
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ears. Hitting in the key leadoff spot, stealing bases and playing sparkling outfield defense, Scott Posednik is the emotional leader of the new champions.

    A Model for Entrepr
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    eneurs as Well

    Scott Posednik heard the dreaded word “NO” for years. Every business start-up, inventor or entrepreneur faces the same hurdle at various points in time. Mr. Po
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    sednik did not like hearing the cursed word, but it did not deter him from seeking and attaining his goals. It is the same for every successful entrepreneur. “NO” has to be ha
    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
    dled as a temporary roadblock, not a final, death knell for opportunity.

    Success is very seldom linear. Setbacks, stumbles, mistakes happen, will happen and must be handled a
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    s challenges, not disasters. Thomas Edison performed over 1000 experiments before perfecting the electric light bulb. That is a lot of “NO”! He never thought of stopping his
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    pursuit of success, and no successful entrepreneur ever let NO stop the drive to succeed.

    The Chicago White Sox are champions because they do the little things better than an
    .

    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
    team in baseball. A team with virtually no stars vanquished other squads with more All-Stars and much higher payrolls. This is a template that every inventor can use as a pos
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    itive example. Creativity, effort, diligence and determination can overcome almost any obstacle. Scott Posednik and the Sox are real world models we can all admire and emulate


    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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