In my opinion, it’s important to evaluate hazards and hazardous situations separately because they focus on different aspects of risk. Hazards are the potential sources of harm, like exposed electrical components or harmful chemicals, while hazardous situations occur when someone…   Read more»

Based on the lecture, risk management is not confined to a single phase but spans multiple areas, including product design, manufacturing, and post-market processes. As discussed, avoidance is often the most preferred strategy, particularly in manufacturing, where designing out risks…   Read more»

Risk management is clearly a critical part of the planning phase for medical devices. It ensures that risks are identified, analyzed, and mitigated early, preventing costly mistakes and ensuring patient safety. Without it, companies risk device failures, lawsuits, and regulatory…   Read more»

I think these four columns give a solid starting point, but adding a few more could definitely enhance the matrix. A ‘Timeline’ or ‘Deadlines’ column, for example, could help keep track of when each design phase is expected to be…   Read more»

My capstone project focused on using machine learning to detect defects in roll bearings. We trained models on a variety of datasets to identify early signs of bearing wear and tear. One challenge we faced was balancing model complexity with…   Read more»

Totally agree on how industry deadlines can limit the number of inputs! From my own experience in school projects, we had to prioritize essential features to keep on schedule. In a real industry setting, I imagine it’s even more pressing,…   Read more»

It’s so true that getting the sale is just the start. The real win is keeping customers coming back, and that’s where long-term connections are key. Businesses need to make people feel valued, not just sold to. Personalized communication makes…   Read more»

I think medical device companies can make a huge difference by being upfront and honest in their marketing, not just trying to sell a product. For doctors, it’s all about the evidence—showing real data on safety, effectiveness, and how the…   Read more»

I find it fascinating how researchers try to keep the placebo effect from skewing the results. One of the main methods is blinding. In single-blind trials, participants don’t know if they’re getting the actual treatment or a placebo, and in…   Read more»

Clinical trials are so controlled that they sometimes fail to show how a treatment works in real-world settings. Things like a person’s lifestyle, environmental influences, or even how consistent they are with their meds can have a huge impact. Plus,…   Read more»

Switching between the two can be possible, but it might depend on the skills you’ve developed. Moving from QC to QA might be trickier since QA requires a deeper understanding of systems and regulations, whereas moving from QA to QC…   Read more»

For Class III medical devices, which come with higher risks and stricter regulations, QA has a huge role in making sure safety standards are met early on. During the design and development stages, QA can help by doing thorough risk…   Read more»

During audits of a Quality Management System (QMS), common issues that pop up include incomplete documentation, non-conformities with procedures, and missing or outdated training records. Companies often face challenges with risk management or ineffective corrective actions as well. To avoid…   Read more»

In my opinion, communication is one of the biggest factors—keeping everyone on the same page helps avoid costly mistakes. Regular check-ins with your team can catch potential issues early on, saving time and money. 

For me, I think working in the industry side of EEG companies would be a better fit because it aligns with my research and interests. My work focuses on EEG technology, and I love the idea of taking the research…   Read more»

Apart from internships, I’d say focus on building skills that are directly relevant to the industry you’re interested in. Things like project management, teamwork, and understanding how to apply your research in a practical, real-world context are super important. Also,…   Read more»

in my opinion, yeah, harmonizing should definitely be a priority, because the sooner you get everything aligned, the less likely you’ll run into delays or compliance issues later on. But it’s also tricky, especially when regulations are constantly being updated…   Read more»

It’s frustrating for companies, especially smaller ones, because the cost and time involved in getting through the FDA’s process can be super high. I think there’s room for improvement in finding that middle ground—maybe by making the approval process a…   Read more»

It’s totally understandable to be concerned about how minor errors can impact a company, especially when it comes to FDA audits. From what I know, even minor errors like incorrect labeling or paperwork issues might not seem like a big…   Read more»

Industry and academic research have different regulations mainly due to their end goals. Industry follows strict guidelines like FDA’s GLP since their products need to be market-ready and safe for patients, requiring detailed documentation and compliance. Academic research, though, is…   Read more»