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srg36 replied to the topic Discussion Topic: Project Management in a medical device setting in the forum Intro to Project Management 7 years, 11 months ago
Many of the posts above mention the regulatory aspect of project management as a greater challenge in the medical device industry. I do agree with this, but I would like to expand on what ao242 mentioned about globalization. Many companies develop medical devices to sell globally, and in that case, not only do they have to conform to FDA standards, but they also have to conform to the regulations of whatever country they plan to sell their product in, and they may need to do additional work in order to launch their product outside the US. I think this adds a level of complexity which a project manager for the construction of a new building would not have, since they would only have to abide by the building code regulations for the specific country that they are building in. I also agree that the competition in the medical device industry poses a significant challenge to managing a medical device project. Speed to market in this industry is absolutely critical to the success of a project, as product lifecycles are quite short. What this means is that any slip in the project timeline could ultimately lead to the cancellation of a project, and depending on the phase that the project was in this could be a huge loss for the company.