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    Almost everyone who has had the task of motivating and training organizations in the lean principles has experienced a set of barriers, especially when dealing with people who are reluctant to buy
    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
    into the Lean principles and Lean thinking.

    How often have we not heard; "Well it sounds all right in theory but it will never work in real life!"

    To a certain degree these people have 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
    point. I have had to listen to numerous consultants and teachers who are preaching Lean principles, but without the ability to link the great theories to the real world.

    And when they are challen
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ged, the response often is: "Well it does work, just look at Toyota!" Guess what? That is not going to convince a sceptical production manager with many years of experience in a traditional batch p
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    roduction.

    In my experience it is extremely important to be able to let the trainees see and feel how the lean tools can actually be the answers to many common challenges.

    It is also a common fac
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    , that people have different ways of learning, some are able to learn just by reading a text, while others need visual input - and Power Point slides are not the answer!

    To deal with this, we have
    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
    had great success in using Lean games as great way of demonstrating that the Lean tools and principles actually work in real life.

    Actually our evaluations from our fundamental Lean training sess
    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
    ions were improved from just above average to top scores every time when we integrated lean games!

    How to use a Lean game in a training session

    The way we use it, is to initially
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    train the students in the fundamental tools, not into great detail, but just a brief introduction.

    And then move on to a Lean game session, where we simulate a production based on traditional bat
    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
    ch principles.

    Then we introduce some of the lean tools into the setup, and now everyone experience how each tool is affecting lead time, work in progress, quality and profitability.

    Between the
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ifferent game cycles it is important to get some valuable discussions on what the effect was of the changes.

    It creates great involvement and motivation from the students, and even the greatest co
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ncrete heads are normally growing into lean manufacturing preachers.

    As a side effect it's great fun and gives a lot of good laughs. This is also an important factor if the students in the session
    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 know each other. Or use it as a team building tool, in the team you learn, you create ideas together and you have fun together, a common experience that improve the team feeling.

    W
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    hich games are available?

    There are different lean games available in the market. They all have different qualities and it is important to select a game that gives you the positive effect
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    s without being difficult to facilitate.

    There is a new shop on the net with Lean games which are the exact games that we are using in ou
    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
    successful training session.

    In a later article I will touch on the subject on how to assess what Lean game suits your needs best.

    But you should at least consider some of these criteria:

      <
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    li>- What numbers of participants are required?
  • - Is there a detailed and effective guide for the instructor?
  • - Playing time
  • - Which Lean tools are applied during the game?<
  • y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    /li>
  • - Setup time for the game
  • Further possibilities

    There are many other situations, besides training sessions, where you can use the Lean games as a great tool. A go
    .

    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
    od example is in the work with continuous improvements.

    It is also a good idea to try to relate the game situation to the kind of products that the students are familiar with.

    In this article I h
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ave only spoken about Lean games as a tool for teaching Lean principles in a production environment, but new games are evolving also for teaching how to apply lean tools in administrative processes


    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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