Some of the challenges for doing project management for medical devices compared to building a skyscraper are; the requirements of highly regulated medical device industry and the level of collaboration that need to be orchestrated across the project team.
There is a well known saying within the medical device industry “if it is not documented, it did not happen” that serves as reminder to the level of rigor and expectation of the FDA when it comes to documenting development of a product. Firms must establish procedures aligned with regulatory requirements and follow them in order to market a product successfully. This is a challenge to project management of medical device opposed to civil engineering industry which is not as highly regulated.
Collaboration is key during medical device development projects. Project teams are composed of many functions within their areas of expertise and a challenge of project management is to ensure that the work gets done through a collaborative approach, resolving conflicts without straining relationships between team members for a better outcome and engaged team members.