I don’t have industry experience yet, but from what I’ve learned, figuring out the critical path seems super important for keeping projects on track. It makes sense that not all tasks are equally urgent, and if teams don’t recognize that,…   Read more»

Keeping all the project elements coordinated across the 10 knowledge areas comes down to strong Integration Management, which keeps everything running smoothly. A solid project plan helps align the scope, schedule, budget, quality, resources, and risks while keeping communication clear…   Read more»

Scope management goes hand in hand with time and cost management since all three work together to keep a project on track. The project scope lays out what needs to be done, which directly affects the schedule and budget. A…   Read more»

I think your ranking makes a lot of sense, especially with SOPs being the easiest to change and anything after the design control phase being more complicated. SOPs are mostly procedural, so updating them is usually pretty straightforward since they…   Read more»

The most common risk in a project really depends on the industry and scope, but schedule risk tends to show up the most. Delays can happen for all sorts of reasons—resource shortages, technical challenges, or scope creep—and when deadlines slip,…   Read more»

Scope management goes hand in hand with time and cost management to keep projects on track. A clear scope helps with scheduling by breaking work into manageable tasks using a Work Breakdown Structure (WBS), making it easier to stick to…   Read more»

I totally agree—regular design reviews are key to catching issues early and avoiding costly delays. One way to make them more effective without slowing things down is by using real-time collaboration tools and simulation software. Digital twins and predictive modeling,…   Read more»

In this week’s simulation, we were given a failed design verification test and tasked with redesigning the test to find out why it failed and how to fix the test. In the scenario given, there was a single factor that…   Read more»

Having an in-house regulatory team is really important, especially for companies with a lot of complex combination products. They know the company’s processes inside and out and can handle the mix of device and drug/biologic regulations more easily. That said,…   Read more»

Although I don’t have direct experience in managing medical device projects, I can imagine it’s quite a complex process. The combination of strict regulatory requirements, technological innovation, and the need to balance cost, time, and quality seems like a significant…   Read more»

The FDA approves medical devices through two main pathways: PMA for high-risk Class III devices, requiring extensive clinical testing, and 510(k) for moderate-risk Class II devices, which must show similarity to an existing product. PMA is rigorous, costly, and time-consuming,…   Read more»

Although I don’t have direct experience working as a Project Manager, these are some things I have learned through my courses. Conflicts over opinions or work styles can definitely be tricky, but good communication and proactive problem-solving make a huge…   Read more»

Although I don’t have direct experience managing medical device projects, my background in chemical engineering and biomedical engineering studies have given me insight into the challenges of balancing time, cost, and scope. From what I’ve learned, scope is often the…   Read more»

When it comes to agreements, one of the most important things is making sure everyone knows what’s expected from the start. For example, in consulting contracts, being super clear about what needs to be done and by when is key….   Read more»

Having a solid plan in place for emergencies is definitely a smart move. If something happened to me, I’d want a clear roadmap for how things should be handled—like managing deals and legal stuff—so the business keeps running smoothly. I’d…   Read more»

To strike a good balance between protecting sensitive information and being transparent when working with consultants, companies need a thoughtful approach. NDAs should be specific and focus on truly confidential details, avoiding overly broad terms that could get in the…   Read more»

In manufacturing, risk management is all about catching potential issues early to keep things running smoothly and safely. While avoiding risks is a big focus, there are also other strategies like reducing risks and accepting them if necessary. One way…   Read more»

A key but often overlooked part of risk management in medical devices is human factors engineering (HFE). While frameworks like ISO 14971 help address device risks, HFE focuses on how users interact with devices to avoid mistakes that could harm…   Read more»

When developing medical devices, figuring out what level of risk is acceptable comes down to balancing patient safety, technology, and costs. It involves doing a risk-benefit analysis, applying the ALARP principle (reducing risk as much as reasonably possible), and using…   Read more»