Effective project management requires balancing scope, time, and cost while remaining flexible to unforeseen challenges. Another of the biggest threats to project success is scope creep, where uncontrolled changes expand project deliverables beyond the original plan. To mitigate this, project…   Read more»

To ensure the Work Breakdown Structure (WBS) is detailed yet manageable, project managers should focus on striking a balance between granularity and simplicity. Start by defining clear, high-level deliverables and progressively break them down into smaller tasks, ensuring each task…   Read more»

Project managers can effectively communicate the trade-offs between time compression methods like crashing or fast tracking and the associated risks to quality or cost by using data-driven visual aids and clear, concise language. For instance, presenting a side-by-side comparison of…   Read more»

When deciding between speed and accuracy in cost estimating, project teams should consider the project’s phase, and the level of uncertainty involved. In the early stages, analogous estimating can provide quick, broad estimates to secure initial funding and set expectations….   Read more»

Diversifying the alternative vendors for a medical device increases supply chain management complexity which in turn increases oversight costs. If the number of alternative vendors is too small, it also increases a company’s risk of supply chain disruptions. Careful alleviation…   Read more»

Balancing resource allocation with team building and training is quite a difficulty some companies specializing in medical devices face, especially when there is an existing financial constraint. These companies usually focus their spending on the more crucial areas of R&D,…   Read more»

Quality Management is not simply a legal box to check; it is integral to the thoughtful design and development of a medical device. It protects patients by ensuring that products are safe, effective, and consistently align with the design and…   Read more»

Design review meetings play a big role in keeping projects on track, especially in the medical device space where documentation and compliance are so important. Even though I haven’t been directly involved in one yet, I’ve learned that solid preparation…   Read more»

You make a great point about how important those early estimates are when it comes to using SV and CV effectively. I haven’t used these metrics myself yet, but it makes sense that if the original plan is off, like…   Read more»

I agree with the previous posts that sometimes project delays and exceeding the budget is not always expected or at the fault of any team member. Rather, I would prefer delays and going over the budget over poor quality and…   Read more»

When it comes to project management, communication skills are a must. This helps the project manager facilitate collaboration, prevent conflicts, define goals & expectations, and allows for decision-making in the project to occur. Communication within a project is what allows…   Read more»

I haven’t had any hands-on experience with EVM yet, but from what I’ve learned, it’s a valuable project management approach. One of EVM’s biggest strengths is how it combines scope, cost, and schedule into one system, making it easier to…   Read more»

Lessons learned can also be used to include things discovered during experimentation that can be improved or modified to achieve better or different results. These can lead way to interesting ideas that can be a whole project to study itself….   Read more»

These cases highlight the importance of keeping up-to-date with newer regulations. As more research is done, certain things are found to be harmful or dangerous. The FDA is always updating their policies. Additionally, many small changes to a device after…   Read more»

As you mentioned, EVM is a good tool for identifying if a project is behind schedule by using EV and PV. One additional benefit of EVM is its ability to detect scope creep before it happens. Projects that have requirements…   Read more»

I think this is a great point. For bigger projects that have a larger impact or cover something new (new line of medical devices for the company or international product), it is very important to document risks and lessons learned…   Read more»

Budgets can be high with animal experiments. This has to do with how time and labor intensive the studies are, resources needed for animal care, long-term nature of the studies (if applicable), material and equipment costs, and compliance with regulations….   Read more»