Of course one main challenge that comes with project management for a medical device company would have to be adhering to FDA regulations. This, in turn, presents a multitude of challenges. For the most part, medical device companies involve several different teams to collaborate and provide the resources required to efficiently meet the milestones for a given project. This in itself already adds on to the existing challenge of adhering to FDA regulations because everyone involved must be familiar with and consider the specifications of the final product in order for it to be acceptable. The use of the wrong material or the production of an unacceptable geometry for a part, for instance, are factors that must be avoided in order to successfully finalize a project on time. With the restrictions that the FDA enforces, project managers must plan ahead and consider the unique resources and time it may take to drive the project down the right path. For instance, a colleague of mine is currently involved in a new project and due to the unique geometry of one of the parts, they are now required to order a new device to accurately measure certain aspects of the part in order to confirm that it was accurately produced. This device, unfortunately, costs a good amount of money and may take a number of weeks to arrive to their facility. This increase in cost and time was not entirely accounted for at the start and the team has been compressing in order to meet their deadlines. On top of the challenge of properly judging how long each milestone will take and the cost of the resources needed, there is also a challenge in gauging how many tests is sufficient to validate parts of a project, as well as how much room for error is acceptable. This is especially a challenge for medical device companies that produce class II and class III medical devices which have more stringent regulations.

All in all, these challenges can be overcome with experience, guidance, constant communication, and acknowledgement of nearly every aspect of the project and how they may adhere to FDA regulations.