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 with the project’s stated objectives. In my opinion,…   Read more»

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 my line of work at a hospital, it…   Read more»

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 money already spent, even when the…   Read more»

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, site activation timelines, and regulatory approval estimates. Experienced PMs in this space…   Read more»

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 development medical device development. With vaccines,…   Read more»

One of the most important reasons why a company would outsource their clinical trials is cost efficiency. Building and maintaining an clinical operations within a company is expensive depending on the research being conducting. This way, a company can not…   Read more»

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 determines whether individually driven…   Read more»

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 the project genuinely believes in it,…   Read more»

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 further by integrating tools such as ‘Earned…   Read more»

@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 regarding resource availability, technical dependencies, and readiness gates…   Read more»

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 stakeholder pushing back can be due some information or concerns that the project…   Read more»

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 rather than something that should evolve alongside…   Read more»

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 in executing the work, but in setting the boundaries within where…   Read more»

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 for a project to go entirely smooth,…   Read more»

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 of the project. Tools like earned…   Read more»

Jacob, your argument about status review meetings as one of the most important tools for effective product execution brings up really strong points. While systems and procedures are necessary, they are only as effective if the team communicates properly during…   Read more»

Dev, I think you made a really good point about connecting each team member’s task to a measurable output and to the next stage of development. When people understand how their work fits into the bigger picture, especially in something…   Read more»

Although I do not have direct industry experience, I have found both from my senior capstone experience and the examples shared here are helpful for understanding how project plan execution would actually work in practice. Regular status meetings is one…   Read more»

The distinction you are drawing between surface-level deviations and foundational assumption failures is an extremely important judgement call a PM and project team have to make, and often does not get enough structured attention in most developmental processes. The challenge…   Read more»

The point about Design of Experiments is one of the more underutilized tools in this kind of situation. The advantage of a DOE approach over one variable at a time testing is exactly what was described by many of you,…   Read more»