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  • Digg It - The Power of a Group

    You are the leader of your team, your department or your organisation. You are the owner and amongst you all, no one can do the job; ru
    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
    n the place, like you do. We all know that and have been there.

    It's tough because someone has to do it.

    In fact it's a struggle and
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    because you are building something worthwhile, someone once told you that you don't get anywhere without hard work.

    Period; full stop;
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    whatever.

    In fact there is a lot of research now that shows you are wrong. Not just a bit wrong. Horribly wrong. In 'The Wisdom of
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    Crowds' by Robert Surowiecki, he quotes a number of sources of information. Like, if you compare the performance of a team
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    of experts with a team of half experts and half not experts, which gives the best results?

    It's the second one.

    If you have a bunch o
    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
    f people working on a problem will they find a better solution than just one person. They will. In fact as long as they have the follow
    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
    ing attributes:-

    Diversity of Opinion - each has their own private information

    Independence - from other decision maker
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    s

    Decentralisation - can take into account local (and hence diverse from the big picture)

    Aggregation - the capacity to
    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
    bring together all this variety of opinion

    A crowd will always generate the best result - even if they are disparate and not connecte
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    d in any way!

    So, how can you go about getting the best from a group of your people, to enhance what you do?

    The findings that Robert
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    Surowiecki brought up are no different in your business and organisation than the many examples he shares. Such as elections, marketin
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    g, gambling etc.

    There are dozens in the book. Yet, how many organisations truly involve their people in making vital decisions about
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    how the business can do better?

    So, as a starter for 10, try asking them.

    Next time you face a problem or challenge in your business,
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    gather a group of people - as random a group as possible and give them these three tools and let them get on with it.

    Ensure that the
    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
    y are different, empowered and encouraged to contribute. From the evidence from Surowiecki's book, your people are
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    almost definitely going to produce a better result than you alone ever could. Then you have to go with that flow.

    Remember they must
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    generate a solution that works, that doesn't generate new problems and is cost-effective. If you give them their head, it is almost a g
    .

    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
    iven that they will do just that.

    The challenge for you is not whether they will do well; more that you are willing to let up your own
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    control and give them the opportunity to test their solution.

    And that's a big ask for you - not them.

    The book is a worthy read too


    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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