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    Delegation -- one of the critical determining factors for everyone who wants to be an effective leader or manager. And for those of us control freaks, lac
    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
    k of delegating skill can be a real show stopper.

    Because the harder you try to hold on to things, the faster they can get away from you, and if you want to extend your r
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    each beyond your ability to do everything at once, you must delegate some things to other people.

    In my business coaching practice, and in our franchise for business coac
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    hes we find that delegation is simply frightening for many people.

    Why?

    First of all, you may enjoy doing the thing you have to delegate...

    You may think you do it bett
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    r than anyone else. You imagine it won't get done properly...

    And you know it won't get done your way. You might even believe if you don't do that thing, you won't have e
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    nough to do.

    Know this: whatever you keep to yourself instead of delegating will get shorter shrift than it deserves. These things become bottlenecks in the continued suc
    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
    cess of your business .

    There are four keys to effective delegating.

    1. Give the job to someone who can get it done - someone who eithe
    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
    r has, or has access to, the skills, knowledge and resources needed. Also, give the job to someone who has time for it. Don't dump your projects onto someone who has neith
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    r the wherewithal nor the availability.

    If you do that you are simply setting them up to fail and setting yourself up for disappointment. Don't just hand your task to the
    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
    next warm body. Get buy-in from the delegate. Are they okay with this thing? Are they enrolled, or is this just more work for someone who is already overburdened?

    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    g> 2. Communicate your conditions of satisfaction. Have you ever asked someone to do something, and when they came back you said, "Oh. That's not what I wanted a
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    t all"? Be sure you have mutual agreement on the critical requirements that define how this job must be handled, and what the outcome will look like.

    Use SMART goals to c
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    arify the desired outcome along with a timeline for its realization. Also, if necessary, set up a measurement system that will help you and your delegate know whether thin
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    gs are on or off track.

    3. Work out a plan. Depending on the complexity of the delegated task, you may ask that the first step be a plan for how to get
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    the rest done. In other cases, the request may be simple and a plan not necessary. But think this through.

    If you are uncertain as to how something needs to get done, bu
    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
    t want to make sure it will occur according to some guidelines - get a plan.

    4. Finally, you need a communications protocol - how are you going to get
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    pdates and give feedback or advice? When are you going to speak or meet? How frequently? Will they send you an email, or a formal progress report? Create some pre-defined
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    mechanism to keep you informed, and to give them an opportunity to seek guidance if appropriate.

    There is a big difference between delegating and abdicating. When you abd
    .

    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
    icate you are saying - I'm neither responsible nor accountable for the results. When you delegate, you are still accountable. You are asking your delegate to do the work,
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    and therefore be accountable to you.

    "Never tell people how to do things. Tell them what to do and they will surprise you with their ingenuity." - General George S. Patto


    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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