The word project, and hence the term project management, is both broad and somewhat abused in the sense that the words are used to mean many different things. In some organisations, there is a “project manager” and a “project” as soon as something is done, no matter how small it may be (when it is really more a question of someone having been given a task).
A more traditional and suitable sense of the word can be taken from A Guide to the Project Management Body of Knowledge (PMBOK): “The application of knowledge, skills, tools, and techniques to project Activities to Meet the Project Requirements.”
Definitions are not what makes a project succeed, but in this case one can understand a few things; that the project manager if he/she is going to lead a project must have the knowledge, skills and tools to do it. At least if one is to meet the requirements of the project.
Project management for product development and medical device is often about developing a new product or improve/change an existing one. It is almost always urgent to develop the product, and resources are almost always limited. The major challenge for the project manager is to meet the requirements on the product as quickly as possible, using as little resources as possible.
With a realistic plan, skills, knowledge and processes in the organisation, this is possible. Another essential component is that the steering committee must function with the roles and responsibilities they have.