The BoneFix pouch project shows how scope creep can occur in even simple projects if not properly managed. Initially, the goal was clear: create a pouch to modernize the FusePack 2000’s appearance. Ho...

Although the BoneFix team found an excellent primary supplier (CamTech), they did not sufficiently vet the vendor beyond visual inspection. Smell issues were only discovered after production, when it ...

One takeaway from the BoneFix pouch project is the role of risk management early in project planning. Initially, the project seemed easy with just sourcing a pouch. However, skipping a thorough risk a...

One of the complex areas in clinical trial management is handling protocol noncompliance - understanding the line between a deviation and a violation. While violations can jeopardize the entire study,...

One element that could be sometimes undervalued in clinical trial management is the Communication Plan. During the Executing phase, consistent and strategic communication with site coordinators can ma...

The project management triangle (Cheap, Fast, Good: Pick Two) takes on a level of complexity in the context of clinical trials. Regulatory compliance, patient safety, and scientific rigor limit the ab...

In cost management, one of the most important decisions is choosing the right estimating method: analogous (top-down) or bottom-up. Each has trade-offs between speed, accuracy, and level of detail. An...

Time Management is about developing a schedule that reflects real-world complexities and uncertainty. Tools such as the Critical Path Method (CPM) and Program Evaluation and Review Technique (PERT) pr...

One of the important components of project management in medical device development is Project Scope Management, and at the heart of this lies the Work Breakdown Structure (WBS). The WBS is more than ...

When a potential issue arises near the end of development, deciding whether to modify the product or the process can be challenging. A change in formulation, for example, might fix a biological compat...

Different test labs, even when following the same standard (like ISO 10993-5), can produce different results. Differences in sample handling, extract conditions, or equipment calibration can significa...

One of the challenges in medical device development is managing the tension between technical readiness and market enthusiasm. It’s exciting and validating when a client expresses early interest in a ...

The Closing Phase of a project is more than just finalizing deliverables and wrapping up contracts, it’s a critical opportunity to capture lessons learned and improve future project performance. Many ...

Change is inevitable in any project, but how it is managed determines whether it leads to improvement or chaos. The Change Control System ensures that modifications to a project - whether to the scope...

Monitoring & Controlling ensures that a project stays on track in terms of scope, budget, schedule, and quality. Without proper monitoring, teams may not identify potential risks or deviations unt...