Quality assurance and quality control are closely related concepts in project management, but they differ in focus and timing. Quality assurance is a proactive, process-oriented approach that aims to prevent defects by ensuring that the right methods, standards, and procedures…   Read more»

You’re right to recognize the tension between cost control and meaningful team development, but it is not strictly a choice between cheap and effective. The most important step is to evaluate what the team actually needs based on project performance…   Read more»

From a project management standpoint, it may seem efficient to skip cross-team alignment in order to give teams more time to meet deadlines, but in practice this often creates more problems than it solves. When different groups work on separate…   Read more»

Resource availability issues are one of the most common causes of negative schedule variance. In the CaPoss simulation, you experienced this when Chris revealed that Manufacturing couldn’t make prototypes for six months due to departmental scheduling conflicts—work that should have…   Read more»

As a Project Manager, successful project execution depends on several key factors that work together to keep the project on track and deliver results. First and foremost is clear communication, which means establishing regular touchpoints with your team, stakeholders, and…   Read more»

You raise excellent questions about multi-PM structures in large medical device projects. In practice, there are several common approaches to navigating these dynamics. The most common structure is a Program Manager overseeing multiple Project Managers, rather than co-equal PMs on…   Read more»

You raise a great point about keeping the design team engaged post-launch for those critical first months when production scaling often reveals issues that didn’t appear during pilot runs. Beyond that support period, other important considerations during design transfer include…   Read more»

Gantt charts are particularly valuable in medical device development because this field involves highly regulated, sequential processes with strict dependencies that must be documented for FDA and ISO compliance. They visually show the required design control phases (planning, design inputs,…   Read more»

As a project manager, there are several tools and practices I’d use to thoroughly monitor the device throughout development, including regular status meetings with clear agendas focused on progress against baseline, variance analysis to track schedule and cost performance using…   Read more»

I completely agree that revisiting earlier phases isn’t a sign of failure but rather a necessary part of adaptive project management, and I think your packaging update example perfectly illustrates why planning needs to be both thorough and flexible. The…   Read more»

The “everything is about risk” syndrome refers to a dysfunctional pattern where risk management becomes so all-consuming and bureaucratic that it actually paralyzes progress rather than enabling it. What this means in practice is that teams or project managers become…   Read more»

That’s a really thoughtful question about how to fairly evaluate team performance when a project succeeds but goes over schedule or budget. I think the ratio of positive to negative aspects in personnel evaluation should heavily depend on why those…   Read more»

One of the most critical preparation steps is establishing a clear checklist and timeline well before the actual meeting date. The project manager should work with the design team to identify exactly what documentation is required for that specific review…   Read more»

One category that’s easy to miss is regulatory bodies and compliance officers. Even though they’re not directly funding or benefiting from your medical device, they have enormous influence over whether your project can move forward. The FDA, notified bodies in…   Read more»

I think one of the most effective strategies is creating a culture of knowledge sharing where team members regularly teach each other their specialized skills. This could be through brief “lunch and learn” sessions, pairing junior and senior staff on…   Read more»

I think the answer really depends on the type of project and what phase you’re in, but if I had to choose an overall preference, I’d lean toward having a mix of both rather than going all-in on one approach….   Read more»

Slack is really important because it gives you flexibility and breathing room when things don’t go exactly as planned and let’s be honest, things rarely go perfectly in any project. It acts as a built-in buffer that lets you absorb…   Read more»

The key to minimizing schedule risks lies in understanding and managing your slack time, which is the difference between your earliest and latest dates. Tasks with zero slack are on the critical path, meaning any delay directly impacts your project…   Read more»

Yes, it’s definitely possible to recover the project, but it’s going to require some tough decisions and proactive adjustments. The first thing I’d do is figure out exactly why we’re behind schedule and over budget. I’d look at what tasks…   Read more»

I don’t think penalizing people for missing deadlines or going over budget should be the default approach, because like you said, there are so many factors that can push a project off track and many of them are outside anyone’s…   Read more»