I agree that organizational structure is foundational to culture, setting the rules for authority and work environment. The correlation between struct...

I think the discussion perfectly highlights why separating management from leadership is crucial, especially in a regulated field like medical devices...

That is an excellent distinction to make, as the daily reality for a Project Manager varies wildly between these structures. From my perspective, a Ma...

In past projects, I’ve used brainstorming and the Failure Mode and Effects Analysis (FMEA) method the most. Brainstorming is great for quickly generat...

At my previous internship, I learned how easily hazards can turn into serious situations if not managed properly. For example, imagine working at a co...

I definitely believe risk management is an essential part of the planning phase. It’s not a waste of time or money; it’s actually a smart investment t...

I think the four columns in the Design Matrix, inputs, specifications, validation, and verification, provide a strong foundation, but they might not b...

I think our current design control systems have definitely come a long way since the Therac-25 incident, but I’m not sure they’re strong enough to com...

I agree that product development is an evolutionary process that requires careful control and documentation to maintain quality. From my perspective, ...

Design control plays a huge role in developing safe and effective medical devices, but problems can definitely arise when it isn’t followed properly. ...

I agree that catching issues before verification officially starts is the best case, because once the verification protocol and reports are underway, ...

I was thinking about this too! From what Dr. Simon explained, design verification is all about making sure our design outputs match the design inputs,...

I really like your choice of wanting to be a Clinical Investigator. Investigators have a key responsibility in clinical research; they not only enroll...

I see what you mean; it might seem like a single-blind study should be enough. However, according to this week's notes, bias can occur not only from t...

I agree that clinical studies are essential despite their risks. According to the Week 5 slides, clinical research is the only way to determine how a ...