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 existing research infrastructure. Emergency Use Authorizations (EUAs), overlapping clinical trial phases, and…   Read more»

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 decentralized, multi-site trials where coordination across time zones and teams is…   Read more»

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 ethical, financial, and regulatory consequences. I agree that Risk-Based Monitoring (RBM)…   Read more»

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 one of the most impactful strategies is fostering a culture…   Read more»

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, it must not be the sole benchmark for safety. Companies should implement tools like…   Read more»

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. Starting with analogous estimates allows for swift decision-making and early-stage planning, while…   Read more»

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 impacts on quality and compliance—especially crucial in high-stakes medical device projects. Collaborating with cross-functional teams,…   Read more»

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 lunches, peer-to-peer knowledge sharing, and regular team check-ins can be powerful tools….   Read more»

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 risk management are critical. Having multiple vendors reduces the dependency on…   Read more»

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 time management, several key strategies should be implemented. First, leveraging project management methodologies…   Read more»

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 proactive and flexible strategy. First, cross-training team members is crucial to…   Read more»

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 familiarizing team members with different components of a project, the long-term benefits…   Read more»

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, offers higher accuracy and reliability by aggregating individual cost components. This makes it ideal…   Read more»

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 implementing a Work Breakdown Structure (WBS) to divide the project into smaller, manageable tasks, ensuring clear…   Read more»

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 a project management and regulatory perspective. Since the sterilization…   Read more»

The ideal frequency of project update meetings depends on the project’s size, complexity, and pace. For most projects, weekly or bi-weekly meetings strike a good balance, allowing teams to stay aligned on progress, address issues, and prepare for upcoming deadlines…   Read more»

Capturing and applying lessons learned during the project closing phase is a vital practice in project management, particularly in medical device development, as it drives continuous improvement and enhances future project outcomes. By systematically documenting both successes and challenges, teams…   Read more»

During the execution phase, maintaining accurate and up-to-date documentation is essential for effective project management and decision-making. Using version control software (e.g., SharePoint, Confluence) ensures that all stakeholders work with the latest documents while tracking changes for accountability. Real-time collaboration…   Read…[Read more]

Altering or omitting the sequence of activities in a project can have significant consequences on its scope, timeline, and overall success. The sequence of activities defines the logical order in which tasks are performed, ensuring that dependencies are properly managed…   Read more»

The frequency of project update meetings largely depends on the project’s size, complexity, and pace. For most projects, weekly meetings strike a good balance, allowing teams to stay aligned on progress, address issues, and prepare for upcoming deadlines without becoming…   Read more»