Scope management can get complicated fast, especially when project goals shift or new requests come in from leadership. One approach that helps handle...

Many of the tools mentioned, like FMEA, RCA, and scenario-based simulations, are essential for safety-critical projects, especially regarding systems-...

The risks and trade-offs of duration compression in medical device projects are complex. Both crashing and fast tracking can offer time savings, but t...

I really appreciate how this discussion emphasizes the importance of long-term responsibility in medical device management. One thing that stands out ...

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 developm...

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...

In biomedical device development, I feel like managing scope changes after execution starts can be especially tricky, not just because of timelines an...

This seems like it would be classified as a major change from a project management and regulatory perspective, especially since it affects a functiona...

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”...

Project execution is inherently dynamic, and adaptability in project management is key to ensuring success, especially in industries like medical devi...

In my experience, ensuring product quality starts well before a device or test reaches the market—QA isn’t just about final products but also about re...

In my experience, the best way to communicate really depends on the size and nature of the team. I worked on a small project with just two or three ot...

Getting a medical device project off the ground is never easy, especially with the many moving parts involved in the initiation phase. One of the bigg...

A well-designed verification protocol is essential for ensuring consistency, reliability, and ultimately the success of a project. One major issue wit...

I definitely agree that emails can be overwhelming, especially when important messages get buried. Setting up filters and scheduling time to check ema...