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  • Main Subject - ABC: Digital Dictation

    According to Dictaphone®, in 1952 recorded dictation itself was established as "a time saver over handwriting and stenography among attorneys, physicians and other professiona
    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
    ls". In fact, it was in 1973 that the first mini-cassette recorder was marketed, making analog dictation the technological equivalent of listening to music on an 8 track tape
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    !

    There are several options to capture dictation files, once you have decided to upgrade. They include:

    I. TELEPHONIC OR DIAL IN DICTATION
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.



    A toll free number is dialed, a pass code punched in and work is dictated into the receiver or speaker of a standard telephone, using the key pad to control the rec
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ording functions (play, rewind, insert, etc.). Upon completion of the call, the digital file created is routed through the internet to a secretary, virtual assistant or trans
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ription company.

    Dial in dictation has many benefits, including:

    no capital expenditure for equipment or software;

    no learning curve for portable recorder or dictation soft
    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
    ware;

    24 hour service availability;

    ability to dictate from anywhere there is a phone, including while traveling;

    works as well for single professionals as it does for larg
    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
    e corporations.

    II. PORTABLE RECORDERS

    Portable digital recorders can be located in any electronics or office supply store, catalog
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    or website. They range in price from as little as $50.00 to $500.00 and up. Along with the recorder, software is provided for the transfer of the digital file created by th
    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
    e unit to a computer, generally through a USB cable or a cradle. A user guide and software included with the recorder usually contain instructions and a tutorial.

    Dictating
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    s fairly straight forward and quite similar to an analog (tape) recorder. When purchasing a unit, note button size, shape and location. Be certain that the unit is not so sm
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    all, or button placement so awkward that it is uncomfortable to use. Also be certain that the recorder has all the functions needed. Some less expensive models, for instance
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    , do not have the ability to insert – that quick rewind to go over what you just said to say it better. Research all the model’s functions before you purchase!

    Once a digita
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    l file is created and uploaded to a PC, it is ready to be sent through a company’s network, direct upload to a transcription service provider or over the internet to a virtual
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    assistant. Many portable software units require the purchase of separate transcription software and equipment such as a foot pedal.

    III. DI
    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
    ITAL DICTATION SOFTWARE

    As with many types of software, development of digital dictation applications range from basic to the extremely comprehensive and industry sp
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ecific. Most dictation software has a free trial period (usually thirty days) and can be downloaded directly from a developer’s website. In a nutshell, digital dictation sof
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    tware turns a computer’s microphone, speakers, mouse and monitor into a dictation machine. Just as with a portable unit, when the file is complete, it is ready for transfer t
    .

    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
    hrough your company’s network or over the internet to your transcription provider.

    Should you invest in a portable recorder, PC-based software, or use a transcription service
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    and toll free number? Each situation is unique and requires consideration of many factors, including your company’s needs, size, volume of work and technology comfort level


    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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