The rapid development of COVID-19 vaccines did appear to defy the traditional "fast, good, cheap — pick two" paradigm, largely due to unprecedented gl...

You bring up such an important aspect of clinical trial execution that often doesn’t get the spotlight it deserves. Communication plans are the backbo...

Both of you raise excellent points. The project management triangle becomes especially complex in clinical trials because compromising on quality is n...

These are all excellent points, and I completely agree that a strong foundation of staff training and clear definitions is essential for managing prot...

The Allergan BIOCELL breast implant recall underscores the critical need for proactive, comprehensive quality and risk management in medical device de...

When deciding between speed and accuracy in cost estimating—especially in high-uncertainty projects like those in the medical device field—a hybrid ap...

Project managers can make informed decisions about using crashing or fast tracking by conducting a thorough risk-benefit analysis, assessing cost impl...

To develop a project team on a low budget, focusing on cost-effective strategies that still promote growth, collaboration, and motivation is essential...

When deciding on the number of alternative vendors, several key factors must be considered to strike a balance between risk mitigation and operational...

Effective time management is essential in biomedical device development due to the industry's strict regulations, rapidly advancing technology, and th...

When a critical team member changes positions or leaves mid-project, it can significantly disrupt the project's timeline and productivity. To mitigate...

Familiarity with each other’s work is a critical factor in ensuring project efficiency, reducing risks, and enhancing overall collaboration. While it ...

Both bottom-up and analogous estimations are essential techniques in project cost management, each suited to different project phases and contexts. Bo...

Effective project plan execution in medical device development requires a combination of proactive planning, real-time adaptability, and efficient res...

Switching the sterilization method of a medical device from gamma radiation to ethylene oxide (EtO) to meet European Medicines Agency (EMA) requiremen...