The additional perspectives raised by Aby and Shreya highlight another important point within the product life cycle of medical devices that I overlooked, organizational alignment and operational exec...

Product life cycle in medical devices is shaped far more than just technological innovation, but more by the stringent regulations behind it. Regulatory factors, post market performance and strategic ...

A DHF that is assembled only at the end of a project creates significant risk, as FDA auditors are focused on whether or not design controls were followed throughout the development of the project, an...

The PM does indeed still have a role post-market, but it is important to be careful on where that role ends or blur on who actually owns the rights to the completed project. Once a device is created a...

Vansh does bring up a good point with what roll a PM should take with FDA regulatory compliance, however as Jacob and mmk brought up, the PM should still have a great deal of involvement with a main r...

As a project manager, the responsibility is to keep long development timelines and large budgets under control by proactively managing regulatory uncertainty, particularly for Class II and Class III m...

Many of the points raised about regulatory, quality, and systems engineering skills being the strong foundation for a PM are essential. Yet, the regulatory or QA aspects shouldn't always be the primar...

The emphasis placed on shifting the focus away from personalities and back onto the project itself is really good point that was made. To seg28's point, clarifying expectations and roles early is huge...

@vanshamin I actually disagree on the premise that interpersonal skills far exceed the need of technical skills for a PM. I haven't personally been on the side of project management, however I have be...