The rapid development of COVID-19 vaccines did appear to defy the traditional "fast, good, cheap — pick two" paradigm, largely due to unprecedented global collaboration, government subsidies, and exis...

You bring up such an important aspect of clinical trial execution that often doesn’t get the spotlight it deserves. Communication plans are the backbone of operational cohesion, especially in decentra...

Both of you raise excellent points. The project management triangle becomes especially complex in clinical trials because compromising on quality is not just a theoretical risk—it can have real ethica...

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

The Allergan BIOCELL breast implant recall underscores the critical need for proactive, comprehensive quality and risk management in medical device development. While regulatory approval is essential,...

When deciding between speed and accuracy in cost estimating—especially in high-uncertainty projects like those in the medical device field—a hybrid approach truly offers the best of both worlds. Start...

Project managers can make informed decisions about using crashing or fast tracking by conducting a thorough risk-benefit analysis, assessing cost implications, timeline constraints, and potential impa...

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

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

Effective time management is essential in biomedical device development due to the industry's strict regulations, rapidly advancing technology, and the need for precision and accuracy. To optimize tim...

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

Familiarity with each other’s work is a critical factor in ensuring project efficiency, reducing risks, and enhancing overall collaboration. While it may seem counterintuitive to spend valuable time f...

Both bottom-up and analogous estimations are essential techniques in project cost management, each suited to different project phases and contexts. Bottom-up estimation, with its task-level detail, of...

Effective project plan execution in medical device development requires a combination of proactive planning, real-time adaptability, and efficient resource management. One critical aspect is implement...

Switching the sterilization method of a medical device from gamma radiation to ethylene oxide (EtO) to meet European Medicines Agency (EMA) requirements would be classified as a major change from both...