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»

The tendency in most PM frameworks is to define stakeholders in fairly transactional terms: the people who fund the project, the people who approve it, and the people who use it. Expanding that definition to include anyone who experiences the…   Read more»

The WBS is arguably the backbone of any project plan, but in medical device development it carries greater weight than a typical engineering project. In a regular engineering project, you are primarily dealing with technical deliverables and business milestones. With…   Read more»

Slack should definitely account for uncertainty, but that doesn’t mean padding every individual task estimate. There’s a real difference between quietly inflating each task “just in case” and deliberately building contingency into the broader project plan. The problem with padding…   Read more»

@dev-doshi You make great points in avoidance, as it is not always the dominant or most appropriate strategy to use in the development of medical devices. If we truly avoided all risk, we would never build implantable devices, never develop…   Read more»

@aca your challenging of the idea that the DHF is the PM’s ultimate deliverable. If a PM’s mindset becomes to produce a perfect DHF, they risk placing too much focus on compliance instead of acting as a proper strategic leader….   Read more»

Krish and Shreya both bring up good points on something that goes deeper than surface level degree or certification. Krish, you make a good distinction that certifications signal good tool competency while degrees shape how someone thinks. Something like obtaining…   Read more»