The biggest difference, in my opinion, between a project manager for a medical device versus a that of a construction project is the customer, which in most cases, is a patient seeking medical aid. Along with making sure the device is “audit-ready” using GMP/GDP, there is also a concern of ‘who’ that device is going to. Questions asked by a project manager for a medical device should be: “Is this device going to improve the quality of life for the patient?”, “Is it feasible/practical for the patient to obtain?”, “How is project going to take?”.

The project manager also has to make sure that whoever will be manufacturing these devices is fully qualified and/or has the proper training, especially if the device is something that will interact directly with the human body.
For example, I work with a newly developed cell/gene cancer therapy where we “re-engineer” t-cells, expand them, and re-infuse them into the patient. If this therapy is going to be successful, the project manager in charge would’ve had to make sure that the manufacturers have the proper experience and background knowledge. Also, because this would be going directly into a patient’s blood stream, there needs to be some sort of sterility testing that is implemented prior to re-infusion. A project manager would also have to have contingency plans for instances where some aspects of the project may fail. For example, if sterility testing were to fail, is there still a chance the cells could be re-infused.

Of course, these problems will overlap with those of the construction project. However, with regards to project management in a medical device setting, there is usually people’s lives on the line.