Both a project manager who is adamantly committed to a single solution path and a project manager who consistently says "yes" to new requirements are failing to regularly balance their current course ...

Maintaining vendor relations is one of the most important aspects of business that any company needs to attend to. Having had personal experience dealing with and interacting with dozens of vendors in...

The sunk cost fallacy is one of the biggest cognitive traps that companies can fall for in situations like this. PMs can have tendencies to justify more additional rounds of testing to justify the mon...

Trials should both be planned liberally upfront, and adjusted constantly throughout. Upfront planning should be liberal in the sense that buffers need to be deliberately built into enrollment windows,...

I think the question of whether or not the model of accepted risk can become the new norm for medical devices is worth examining, even with the plethora of differences that exists between vaccine deve...

One of the most important reasons why a company would outsource their clinical trials is cost efficiency. Building and maintaining clinical operations within a company is expensive depending on the re...

The reason scope, time and cost feel so central is that they're the most measurable. You can draw a Gantt chart, run a variance report or point to a budget number. But integration management is what d...

To Dev's first question, I think it's rarely a matter of intentional deception but rather displayed as a form of optimism bias that gets integrated into most layers of the project. The team pitching t...

Sami's point on leveraging change control documentation for budget justification is a great point that I want to delve further into. PMs in the medical device development industry can take this a step...

@qbs2 The point about planning assumptions is one that I think gets overlooked a lot in practice. When a project plan is built, the sequence of activities developed based on several decisions regardin...

Actively listening to resistant stakeholders and working towards a collaborative solution is really the foundation of good stakeholder management. Resistance is not always irrational, as sometimes a s...

The phase based approach to leadership is something that does not get discussed enough and the points you make are very insightful. Most conversations about PM leadership treat is as a fixed trait rat...

The board of directors should operate at a strategic level, rather than an operational one because it highlights an important structural dynamic within medical device companies. Their power lies not i...

As other members of this discussion have mentioned, one of the most most effective ways of anticipating and combatting delays is to actually embed them into your project plan. It is almost impossible ...

Treating monitoring as a dynamic and on-going process is one of the best methods for a PM to catch any deviations early, when corrective actions are cheaper and less disruptive to the overall workflow...