For me, one of the strongest motivators has always been career advancement. I’m someone who thrives when I can see a clear path ahead—whether it’s gaining a new skill, taking on more responsibility, o...

Clinical trials are long, demanding projects, and keeping teams motivated and engaged over time is a major leadership challenge. Managers aren’t just responsible for timelines and deliverables—they al...

In high-stakes projects like medical devices, I think one of the best ways to convince management about investing in contingency planning is to speak their language: risk vs. cost analysis. Instead of...

One of the biggest challenges in clinical research is maintaining team motivation throughout the long and often repetitive phases of a trial. Clinical studies can stretch over several months or even y...

In clinical research projects, one underperforming team member can affect not just productivity, but also team morale. This is especially critical when the timeline is tight and regulatory standards a...

You bring up a great point, clinical trials are uniquely unpredictable compared to other types of projects. In addition to IRB approval delays and patient health fluctuations, other common challenges ...

I think it's true that focusing too much on just meeting regulatory requirements can limit the full potential of quality management. Regulations are important for safety and consistency, but they’re o...

I recently came across the 2019 recall of Allergan's BIOCELL textured breast implants. The FDA requested this recall after data linked these implants to a rare cancer called Breast Implant-Associated ...

Effectively communicating the trade-offs between time compression methods like crashing and fast tracking, and the risks they pose to cost and qualit, requires project managers to be both strategic an...

Using procurement as leverage to encourage suppliers to adopt environmental and social policies can be ethical and effective when handled responsibly. The key is balance, ensuring transparency, fairne...

Project management software significantly simplifies and enhances the accuracy of project planning and execution. While these tools do not fully automate setting dates and budgets without human oversi...

In 2015, Medtronic encountered major regulatory trouble over its SynchroMed II Implantable Infusion Pump. After nearly a decade of inspection findings, the FDA concluded that Medtronic repeatedly fail...

When managing medical device projects, understanding where our project stands in terms of schedule and budget is important. This is where Schedule Variance (SV) and Cost Variance (CV) come into play, ...

Hello everyone, in the complex world of project management, staying on budget while effectively tracking performance is paramount. Earned Value Management (EVM) is a powerful tool that addresses these...

In medical device projects, where precision and clarity are paramount, combining formal and informal communication methods often proves most effective. A strategic mix of these methods can address the...