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    Business management, when will you ever listen? Your business management approach should be so different. I mean, really, they
    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
    seem to already have their answer to any question or proposition you may present. This really is a reason nature gave us 2 ears and on
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    y one mouth: To Listen More. So, hey, boss man, just listen to us and we may be able to achieve for the company what you are responsib
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    le for. For starters, do we really need all of these people around here? Have you ever done any sort of time study on their jobs? I di
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    one at a manufacturing plant the other day, and within 1 hour of measurements, saw we could eliminate 3 positions in the plant. This
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    is a savings of $250,000 a year, all in just 1 hour. The employees would just be reassigned to where we are currently staffing persons
    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
    How simple was that? But when you take it to management, they want to schedule a meeting with the other managers to get everyone’s op
    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
    inions. Opinions on what? We are talking about $250,000 a year. Maybe it is because it was not their idea.

    How about delegating a few
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    items? We really do not need all of the micromanaging. Just tell us what to do, and we will do it. Don’t worry about how we get from A
    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
    to B, just as long as we get there on time. When you micro manage, it takes away from the many skills the people in the company have.
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    You do not give them a chance to shine, to come up with something, or to just find a better way to build a mouse trap. This will free
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    p so much more of your time to do more important things, like schedule the meeting for the staffing changes (sorry, could not resist).
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    Delegating is a good thing.

    Maybe we can actually ask the employees what they think. Ask them if they have any opinions or ideas on
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ays to better the work environment. They are the ones out there fighting the battles, so they are the experts on this. Yes, you will g
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    et the occasional ridiculous idea from the wise guy, but just ignore it. You will get many more positive responses than negative ones.
    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 do not stop there, actually go out there and implement them. Put them in place, and watch the morale of the employees increase. If
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    you do something for them, they will do something for you. Amazing how this actually works. But for it to work, you need to get out a
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    d meet the people, and let them know who you are. Getting employees involved gives them the sense of importance, and this weighs heavi
    .

    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
    ly with the work force.

    So, if management would just listen a bit, they can actually make a huge impact with the employees of the com
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    any. And happy employees make an excellent and thriving company. So, maybe you can try a different business management approach


    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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