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  • Mattie718 replied to the topic Scope Creep in the forum Project Management Process and Medical Device Development 6 years, 7 months ago

    I can see how this could be a common problem in industry, especially when Project Managers get requests from stakeholders not directly involved in planning or executing the project. One day you are on track, have a budget established, and have a product on its way towards being released. Then upper management all of a sudden makes a request which they do not realize how much work it would actually entail. Releasing something internationally sounds like it could be its own project entirely, not just some add-on. There are biological differences, regulatory differences, and supply chain differences among other things when attempting to supply your product to a different country. My company produces a certain product line for Japan which has completely different dimensions than the US product line simply due to the fact that Japanese people have different body structures. Also in the European Union they have different medical device regulations than the FDA in America. Best option for something like this would be for the Project Manager to attempt to say “no” to this type of scope change, and recommend an entirely different project for this.