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    Introduction

    Structuring techniques help overcome limitations of human problem solving. Effective structuring analysis techniques logically organize the elements of a problem to help us analyze each element separately, systematically and sufficiently. In this article you will learn one of the most powerful problem solving too
    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
    l to solve real-world problems. It is called as Problem Restatement.

    Problem statement that defines a problem must take causes of a problem into account. It must distinguish between problem and symptoms of the problem. The quality of the solution depends on the quality of the problem definition. This is due to the fact that a
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    alysis of a problem leads us in a certain direction towards a particular solution. Therefore defining a problem in terms of its symptoms will lead to a poor solution to the actual problem.

    So it is important that we understand the difference between causes of a problem and symptoms of a problem. A problem statement that takes
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    into account the causes of a problem makes it easier to consider and evaluate all the alternatives to a particular problem and results in a superior solution.

    Example

    How can I stop my headache? Vs What is the source of my headache?

    First question fails to distinguish between causes and symptoms. It leads to solution
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    such as taking medicine, using headache balm etc. Whereas the second question leads to solutions that could address the real problem such as allergy, lack of sleep etc.

    What is Problem Restatement?

    Problem Restatement is a technique that is used to broaden our perspective of a problem. Redefine the problem in as many differ
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ent ways as possible. The key to doing this is to get into divergent mode and generate as many restatements as possible. You must suspend your judgment during this process.

    Problem restatement helps us to identify the core issues and alternative solutions. However it will not solve the problem. It only points us in the right
    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
    irection and the outcome of the analysis will resolve the problem.

    The poorer a problem is defined harder it becomes to redefine the problem. In such cases, we must clearly define the problem.

    Most of the time restatement of a problem will uncover several problems. Sometimes it will point to a solution.

    Example of Problem R
    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
    estatement

    Mr. Commuter got a new job in a metro area that pays $60 / hr. He commutes to work everyday and spends 40-60 minutes in driving. Mr. Commuter thinks that he has a problem because he spends 80 – 120 minutes everyday commuting to work. He has to drive 44 miles everyday to commute. He also feels that his commuting is
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    aking him feel tired. He pays $59 / night for accommodation. Reducing the miles increases the room rate.

    The initial problem statement identifies wasting time and getting tired as the main issues.

    Problem Restatement: How can I utilize my time during commute? , How can I get more energy?

    The question: How can I minimize 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
    commute time? Can lead to the following options:

    · Carpool

    · Take advantage of the fact that Hybrid one driver cars are allowed to drive on the carpool lane.

    · Drive during non-peak times.

    The alternatives that are listed above are generated by analysis of the situation. What is the real problem here?
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    Who is the culprit distance or time? The symptoms are long commuting time and tiredness. The causes are traffic congestion and diet/exercise.

    When you are using this technique on behalf of someone else, it is better to work in the presence of that person. This enables you to focus on the concerns and key issues of the stakeho
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    lder(s). It also facilitates agreement about the actual problem and helps us to guide our analysis towards the solution.

    Causes of Poor Problem Definition

    Vague or broad definition that lacks focus. Too narrow definition with misdirected focus. Assumptions in problem definition. Solutions in problem definition. Examp
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e for cause number one: What should we do about cars on the highway?

    This fails to identify the problem.

    Example for cause number two: Mr. Commuter’s time is wasted. How can we get him to drive faster?

    Driving slow may not be the problem. If it isn’t, forcing Mr. Commuter to drive faster may lead to other problems.

    Example
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    for cause number three: How can we make politicians aware of our traffic congestion problems?

    By assuming that politicians are unaware of the traffic congestion problems, the statement defines the problem narrowly. When the assumption is not valid, the problem statement fails to direct the focus of the analysis in the right
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    irection.

    Example for cause number four: How can we persuade the politicians to build more highways to reduce traffic congestion?

    This problem statement is narrow and assumes a solution. In the case of inappropriate assumption, it misdirects the analytic focus.

    6. Ways to Restate Problem

    Paraphrase

    Initial statement: How
    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
    can we minimize commuting time?

    Paraphrased statement: How can we keep the commuting time from increasing?

    This puts a spin on the meaning and leads to new perspectives and insights.

    Opposite View

    How can we reduce the traffic congestion? Becomes

    How can we increase traffic congestion?

    By either increasing the number of
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ars or making more cars commute during the peak traffic congestion period. One solution would be to have higher toll charges during peak traffic. Better solution: Dynamic pricing of toll charge based on how fast the traffic is moving.

    Broaden the focus by using a larger context.

    Should I start my own business?

    How can I ach
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ieve financial security?

    Initial statement boils down to a yes or now whereas the second statement generates alternate options.

    Change Focus

    How can I quit my job and start my own business? Becomes

    How can I generate multiple streams of income?

    Ask why repeatedly till you get to the essence of the real problem.

    How can I
    .

    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
    get to work quickly?

    Why? Because, instead of wasting time on commuting, I want to spend it on building my business.

    Restatement: How can I spend the commuting time on business? (Answer: Listen to CDs during commute)

    Why? Because I want to setup profit making business quickly.

    Restatement: How can I setup profit making bus
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    iness quickly? Delegate, enroll in mentorship program etc.

    Conclusion

    This divergent technique reveals important perspectives and issues that we must consider during solving a given problem. Use simple, positive, and active voice sentences to restate problems. This makes it easier to grasp and analyze the problem.

    Author Bi


    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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