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  • Useful Advices - The Monster Garage of eLearning

    Have you seen Jesse James on the Discovery Channel's Monster Garage?

    Each week Jesse and his handpicked team create a customized vehicle to dazzle and amaze you. So what does this hav
    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
    e to do with eLearning? Read on...

    Big boys like big toys

    Did you see the episode when the Cadillac Escalade becomes a tailgate party? or...

    The DeLorean is transformed into a hovercraft?

    WOW
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    they were great... and it got me thinking...Jesse's approach to monster car design is directly related to leading successful training programs. Here's why...

    Each episode starts with a sketch of the "d
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    eam machine" and Jesse's verbal description of what he expects the machine to do. Just like Jesse's articulated vision, the training project leader has to be able to articulate the program vision and ex
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ectations to his boss and the team. If you can't describe the training purpose, it's time to re-think the project!

    The Monster Garage rules are simple:

    1) When completed, the monster machine must appe
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    r to be stock.

    2) The team can spend no more than $3,000 cash for parts.

    3) Jesse and his crew have only seven days and nights to design, build and race the machine.

    So let's relate this to your trai
    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
    ing team... Have you taken time to create a simple set of rules for your team? Maybe you should take a lesson from the Monster Garage pit crew and make this a priority!

    For the record, Jesse doesn't ta
    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
    ke NO for an answer, and whining is NOT an option. Hmmm... yet another good project management tip!

    Each Monster Garage project starts with a day of planning Even though the team is running on a very
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    short time schedule, the first full day is set aside for PLANNING. Then the construction begins.

    How often have you been tasked with developing a huge training project and no one really bothered to sch
    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
    dule time to PLAN? Using the Monster Garage analogy, if you are planning a 5 week development process, a full week should be devoted to planning. This is a good rule of thumb with about 20% of the proje
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    t time should be spent in planning.

    Why? Because you can clearly articulate expectations, conduct essential research, collect information from a variety of stakeholders and produce a solid strategy for
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    achieving the stated objectives. Keep in mind if you fail to plan, you plan to fail...

    Just like the Monster Garage creations, online learning projects are big beasts and require a team effort. Jesse a
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    sembles his "dream team" based upon individual areas of expertise. He has welders, mechanics, fabricators and custom air-brush painters. His team must make the transformed vehicle not only look good, bu
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    "deliver on the promise" of functionality.

    Likewise, the training project manager sets the scope with clearly defined roles and responsibilities for each team member:

    Researchers determine existing c
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ontent to leverage and competitive information as well. Instructional designers look for ways to create standardized templates that facilitate the learning process. They create the instruction sequence
    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
    and determine the best way to create meaningful activities for accountable training.

    Programmers must produce solid error-free code.

    Developers take raw content and create lessons while the graphic ar
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ist adds visual elements with graphics, animations and color cues.

    The tighter you define roles and keep people on-track, the better. When it all comes together, a training project is truly a work of a
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    t.

    And finally....the moment of truth and accountability happens...will the monster creation work? Jesse always takes "the dream machine" out for that victory spin. Just like the monster's moment of tr
    .

    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
    th, it is inspirational when the AHA moment (light bulb) happens for your students in your beta test. It is fun to see students demonstrate proficiencies from the training you created.

    When your traini
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    g team is successful and your training customer are happy, it's a win-win!! You accomplished what you set out to do. We thank Jesse James and the Monster Garage for his inspiration on project management


    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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