I believe that when forming a project team, one must always start with subject matter experts. Technical knowledge is critical in the early phases of a project. Even if the knowledge is not complete, at least knowing where to look and in which direction to start can prove invaluable. As the project gets underway, in addition to subject matter experts, i would also wish to involve people from the other facets of the project, including but not limited to : regulatory, quality, logistics, manufacturing. By getting input and advice from members within each of the arms of any medical device company, the project manager can then help navigate the research and development of the project to meet all the requirements.