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»

Usually projects that start off will consider similar projects that were executed beforehand and learn about what worked well and what didn’t. Otherwise something that could be implemented is a dashboard of projects that were completed with supporting documents and…   Read more»

For many products, companies are required to follow GLP and other good practices as mentioned previously. These good practice rules give companies an outline on standard protocols to follow when it comes to the study itself and record keeping of…   Read more»

In biomedical device development, I feel like managing scope changes after execution starts can be especially tricky, not just because of timelines and budgets, but due to the regulatory and validation implications that even small changes can trigger. That said,…   Read more»

For determining the duration of each task, it’s good to have an understanding of the team members performing the task, and what resources they have access to. Resources team members have access to determine time spent on the procedure. More…   Read more»

This seems like it would be classified as a major change from a project management and regulatory perspective, especially since it affects a functional aspect of the device and involves different international regulatory requirements. I’d assume this would trigger steps…   Read more»

One area I think could be further explored in managing change fatigue is how we track and reflect on it beyond anecdotal signs. While we often “sense” when teams are fatigued, it might help to introduce some change fatigue metrics,…   Read more»

Within my experience, a key aspect of project plan execution is checking the feasibility of the project plan before making an effort to follow through on it. Some of my work is incredibly time-sensitive and requires costly resources. Keeping this…   Read more»

Altering or omitting sequence activities will lead to project inefficiencies, cost increases, and overdue completion.  Every activity is planned to come after the previous one so that there is unimpeded project execution.  Disrupting the sequence may also affect resource allocation, delaying dependent tasks. Moreover, risks in the proj…[Read more]

Project update meetings are a great way of getting an entire team onboard with the projects occurring, seeing who can help out for certain trouble spots, and making plans for future work based on everyone’s feedback. However, for long term…   Read more»

One way I think it is best to organize a meeting is to get straight to the point. I have been a part of meetings with introductions to people or topics, Q&As, or unrelated company updates at the beginnings of…   Read more»