It is difficult to state that only one person can do a certain job. One person can certainly have more experience and knowledge, but is not the only one capable. This person going on maternity leave can hold training sessions…   Read more»

Absolutely, I believe in a project environment, it is essential to be informed of what each and every team member is doing and what they should be doing to allow smooth cooperation and progress. When the team members are aware…   Read more»

If a member leaves midway through a project, the first step is to reassess and briefly redistribute their responsibilities to capable colleagues. Also, to prevent disruptions, I would have the exiting person thoroughly document their procedures and, if possible, be involved in a brief transition. Meanwhile, holding a short team meeting to r…[Read more]

It is an excellent idea to go over each member’s role before beginning work. This “precious time” that might be seem that it is taken away from time to work is indeed “precious”. What is the purpose of having more…   Read more»

Effective project management implementation relies on the equilibrium of scope, time, and cost, which needs strategic planning and ongoing supervision to balance these factors. I think scope management is not just about setting goals, but also about managing expectations and…   Read more»

The first step would definitely be to conduct a thorough risk analysis, considering things like the scope, resources, deadlines, and potential impacts on quality. Cost benefit analysis specifically can really help determine what may offer the best balance between saving…   Read more»

Team development is a controversial topic because it is questionable whether or not employees are required to interact outside of work hours. While it is true that team members can bond and develop friendships, or get to know each other…   Read more»

I feel the biggest factor in deciding a number of vendors is a projects risk tolerance. In the case of medical devices, such as in the minisim, the tolerance is very low. There is very little room for errors and…   Read more»

I definitely believe that an overemphasis on regulatory considerations can limit quality management. An overemphasis can often encourage a “just enough” mindset where the regulations are met, but not exceeded. It is important to remember that regulations are not a…   Read more»

Maximizing quality management in project management for medical devices is crucial to ensure patient safety and regulatory compliance. It begins with implementing a robust Quality Management System (QMS), such as ISO 13485, to standardize processes and documentation. Clear design controls…   Read more»

The Critical Path Method (CPM) and Program Evaluation and Review Technique (PERT) are essential tools for managing complex projects like medical device development. CPM focuses on identifying the longest sequence of dependent tasks to determine the minimum project duration. It…   Read more»

When deciding the number of alternative vendors in project management for medical devices, several critical factors must be considered. First, regulatory compliance is essential—vendors must meet FDA or international standards like ISO 13485. Second, the complexity of the device can…   Read more»

One factor to take into consideration would be the risk associated with losing your only supplier. If you opt to more suppliers, you reduce the risk associated with procurement, but increase the risk of effectiveness complaints. Therefore, having fewer suppliers…   Read more»

Adding on to what was said, an effective way to manage time compression while mitigating risk if employing a scenario-based method that can evaluate the trade-offs faced when pressed for time. A project manager can approach the stakeholders or executives…   Read more»

It’s never truly safe to use any method that causes an increase to risk or cost. After completing a risk analysis, duration compression should only be used if there’s no safer option. In the case of an emergency authorization from…   Read more»

In order to prevent scope creep from happening, the scope process should begin as soon as possible. During initiation, all information of project history should be compiled when determining what the product can or can’t do. The Work Breakdown Structure…   Read more»

Scope management can get complicated fast, especially when project goals shift or new requests come in from leadership. One approach that helps handle this is how Agile frameworks deal with scope. Instead of trying to lock everything down from the…   Read more»

Many of the tools mentioned, like FMEA, RCA, and scenario-based simulations, are essential for safety-critical projects, especially regarding systems-level risk management. But what often gets overlooked, particularly for technical employees, is how the human side of performance and communication plays…   Read more»

The risks and trade-offs of duration compression in medical device projects are complex. Both crashing and fast tracking can offer time savings, but the potential impact on cost, quality, and compliance makes it something that must be handled carefully. Integrating more…   Read more»

Compressed schedules are often encountered in the development of medical devices, particularly when the team is working under a prominent market opportunity, is facing pressure from investors, or has an urgent clinical need. Although having reduced timelines may bring a…   Read more»