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    1. Most leaders die with their mouths open.

    I recently read an article in Fast Company magazine about the issue of leadership. In it, they quote Ronald Heifetz, the
    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
    founder of Harvard's Center for Public Leadership, who made the above comment back in 1999. He followed it up by saying, "leaders must know how to listen - and the ar
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    t of listening is more subtle than most people think it is. But first and just as important, leaders must want to listen."

    You'd think this is simply basic stuff, ri
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ght? Like what all managers learned in Management 101. I doubt there's an exec in business today who wouldn't say they 'know' this already. But in my experience, mos
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    leaders seem to think it no longer applies to them when they start moving up the ladder. They seem to get to the stage where they think they really know it all.
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro

    But yet, executives and professionals at all levels frequently tell me that they themselves don't feel 'heard' by their superiors. And here's the really interesting
    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
    thing about it - I hear this frustration cited by people at every management level! Therefore, managers throughout many businesses are busy looking 'up' the org
    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
    anization chart for someone to listen to them - but they're not giving their own managers and the staff 'below' them the same benefit.

    So you have managers going a
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ound telling subordinates what to do & how to do it; rarely asking those people for their input. And then being cranky because their boss treats them the same way
    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
    ! How dumb is that?

    2. Our North American companies are pretty inefficient

    OK - this is a random poll: Please raise your arm if you believe your company is efficien
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    t. At least 90% efficient.

    Based upon what I hear from clients, there aren't many arms raised out there. In fact, most tell me that their own organizations are act
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ually inefficient. Many are concerned that their employer is getting less competitive on a global scale. Some worry about cutbacks or reduced investment spending wh
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ch may result.

    At the same time, they'll tell me that they are bored, unchallenged, stale, and losing interest. So, let's review.

    Inefficient businesses:

    - no one i
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    s listening to those who are close to the real

    action.

    - stale managers who are worried about global

    competitiveness.

    Coincidence? Not likely. We can fix this situa
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    tion, though. And it's not that hard.

    Remind yourself about that lesson of Management 101. Become a better leader by becoming a better listener. Simply start asking
    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
    - and here I mean showing that you really want to hear your team members' ideas about making your department / organization more efficient. Make it clear that you a
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    e on a new mission and you want to make 'listening' a priority. When your direct reports start to believe that you are serious - watch out.

    I guarantee that you'll
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    start to hear new ideas which will kick-start your organization's success. With that will come renewed enthusiasm for the job. And the cycle of success will build fr
    .

    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
    om there.

    You don't need to die with your mouth open.

    3. Today's Tips

    1. Give your team credit for having the same basic needs and

    expectations as you have yourself
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    .

    2. Once in a while - just shut up.

    3. Ask your subordinates how they'd deal with a problem or

    situation.

    4. Get enthusiastic about the game again. It's contagious


    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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