Career satisfaction in clinical trial project management, or really any field, isn’t just about checking tasks off a list or hitting deliverables. Over time, if there’s no room to grow, no new challen...

Totally agree that communication plans don’t always get the attention they deserve, even though they’re such a big part of what keeps a clinical trial running smoothly. Once a trial moves into the exe...

Balancing cost, time, and quality in clinical trials is definitely a tough equation, especially since quality really isn’t something that can be compromised. Between regulatory requirements and the re...

Reading through this discussion made me think about how protocols work in different settings. I'm not 100% sure in real life how clinical trial protocols and project management protocols match the pro...

Reading through everyone's replies, I appreciate how much emphasis is being put on understanding the root causes of underperformance. From my own experience, both as someone who’s noticed underperform...

Something that ties into it all is how mental health and burnout can creep in during long projects, especially when people feel like their concerns or frustrations are going unheard. Sometimes it’s no...

Scope management can get complicated fast, especially when project goals shift or new requests come in from leadership. One approach that helps handle this is how Agile frameworks deal with scope. Ins...

Many of the tools mentioned, like FMEA, RCA, and scenario-based simulations, are essential for safety-critical projects, especially regarding systems-level risk management. But what often gets overloo...

The risks and trade-offs of duration compression in medical device projects are complex. Both crashing and fast tracking can offer time savings, but the potential impact on cost, quality, and complian...

I really appreciate how this discussion emphasizes the importance of long-term responsibility in medical device management. One thing that stands out to me is how quickly science, society, and patient...

There’s a lot of great insight here, especially around how SV and CV can be distorted in the complex and evolving landscape of medical device development. One thing that’s helped in projects I’ve been...

These are all great insights, and I agree that preparation sets the stage for a smooth and productive design review. One thing that I think also helps a lot in building a regulatory readiness checklis...

In biomedical device development, I feel like managing scope changes after execution starts can be especially tricky, not just because of timelines and budgets, but due to the regulatory and validatio...

This seems like it would be classified as a major change from a project management and regulatory perspective, especially since it affects a functional aspect of the device and involves different inte...

One area I think could be further explored in managing change fatigue is how we track and reflect on it beyond anecdotal signs. While we often “sense” when teams are fatigued, it might help to introdu...