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    Rapid prototyping is an intensive process of collecting information on requirements and on the adequacy and functionality of fairly new
    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
    product designs. Model prototyping is an important data resource during the different stages of product development. Model prototyping m
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    akes use of various kinds of rapid prototyping techniques to provide the right model types used for different testing procedures. Such t
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    echniques may require the use of requirements animation, incremental, and evolutionary prototyping.

    1. Requirements Animation- is the m
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ethod used mainly to demonstrate functionality in test cases that can be easily assessed by users. Software tools are used to produce re
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    presentational prototype models that are built using animation packages as well as screen painters.

    2. Incremental prototyping- enables
    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
    the development of large prototype system models installed in phases in order to avoid delays between product specification and its fin
    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
    al delivery into the consumer market. Once the customer and supplier have agreed on certain core features, the installation of a skeleto
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    n system is applied as soon as possible. Important requirements can be checked out as the model is being used, enabling changes to core
    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
    features while in operation with extra and optional features can be added later.

    3. Evolutionary prototyping- considered as the most in
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    tegral form of prototyping. It acts as a compromise between production methods and with that of model prototyping. Employing this techni
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    que, a model prototype is initially constructed that is then evaluated as it evolves continually and becomes a highly improved end produ
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ct. Many designers believe that more acceptable systems would result if evolutionary prototyping were interconnected with periods of req
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    uirements animation or rapid prototyping. Here the tools are the actual facilities resources where the final system will be implemented.
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen


    The use of different model prototyping techniques can help do away with the uncertainties about how well a final design may be able to
    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
    fit into the end user's needs. The different model prototyping techniques help product designers make the necessary decisions by obtain
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ing information from initial test users about the effective functionality of a certain product prototype.

    Model prototyping can also be
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    an effective aid in determining how effective and ideal the features and the overall design can be for proposed users. Model prototypin
    .

    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
    g and the subsequent testing procedures can provide useful representation information that can reveal possible design flaws, effective f
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    eatures as well as useless functions that can either be corrected, enhanced or done away with on the next stages of product development.


    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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