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    You can not imagine being able to organize the enormous amount of data and manipulate them as easily as you would be able to do without data collection tools. Then a
    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
    gain, the task is not easily done unless you have selected the right kind of tool appropriate for the project. You need these data collection tools at all steps wher
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    you generate numerical data.

    Six Sigma Data Collection Tools

    The data collection tools are mostly in excel format and come as Macro Plug Ins, barring a few except
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ions of stand-alone applications.

    Initial Raw Data Collection Tools

    1. Operational Definitions Sheet- This sheet defines the metrics so that data collection across
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    the board is consistent.

    2. Voice Of The Customer Data Collection Tool- Collect data from internal database, surveys, interviews, listening posts and observations a
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    the point of sales and use and organize them systematically

    3. Worksheet For Customer Segmentation- Worksheet for segmentation is essential to identify and concent
    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
    rate on the demands of main and sub-segments which helps get down to finer details

    4. Check Sheets- Very handy in collecting smaller sample data of different attrib
    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
    tes or counts for use in defining problem areas or substantiating the outcomes.

    5. Data sheets- These plain and simple datasheets are used to gather small amounts o
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    f measured or variable data to for the purpose of defining a problem or substantiating the results.

    Data Assessment Tools

    Data assessment tools are not decision-ma
    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
    ing tools such as the Ishikawa Fishbone Chart or the Thought Map Relation Diagram.

    1. Customer Requirement Translation And Analysis Tool- Analysis of customer requi
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ement is done to translate to an understandable and an unambiguous language. The translated and interpreted customer data converts into measurable functional require
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ments thus strengthening the operating team's capability to deliver products and services that customers will immediately identify and really relish.

    2. SIPOC Diagr
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    m- SIPOC diagram is rather a presentation diagram and an analysis tool at the same time. It provides an "at a glance" like overview of various processes, and helps i
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    dentify the venders, inputs and outputs of a process and customers by critically contrasting the input data against each other

    3. Pareto Chart- A Pareto chart is he
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    pful in identifying those small numbers of problems which cause about 80% of all the troubles. This is a tremendous help in reducing or eliminating the avoidable was
    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
    e of efforts so that you can channelize your improvement efforts on continuous productive applications.

    4. Production Scheduling And Actual Scorecard- The simple pr
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    oduction scheduling and actual score card comes handy to evaluate the production schedules and operations & sales planning as opposed to actual results. This is the
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ame template which is used for Pareto chart, schedule to actual comparison and the checklist for quality.

    5. QFD House Of Quality Chart- Quality Function deployment
    .

    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
    house of quality is an all in one tool. It helps identify customer requirements vis-a-vis products or services, develop an effective blueprint, formulate strategies
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    to eliminate faults and failures and finally implement new design.

    It would be futile to work without tools, either PC based or otherwise in a Six Sigma environment


    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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