I agree that organizational structure is foundational to culture, setting the rules for authority and work environment. The correlation between structure and culture creates a critical feedback loop f...

I think the discussion perfectly highlights why separating management from leadership is crucial, especially in a regulated field like medical devices. Personally, I believe the best team outcomes ari...

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

In past projects, I’ve used brainstorming and the Failure Mode and Effects Analysis (FMEA) method the most. Brainstorming is great for quickly generating ideas and identifying possible risks from diff...

At my previous internship, I learned how easily hazards can turn into serious situations if not managed properly. For example, imagine working at a company called MedTech Labs that develops diagnostic...

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 that can prevent much bigger losses later on. By id...

I think the four columns in the Design Matrix, inputs, specifications, validation, and verification, provide a strong foundation, but they might not be enough to capture the full scope of the design p...

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 completely prevent a modern “Therac moment,” especial...

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 critical role in ensuring t...

Design control plays a huge role in developing safe and effective medical devices, but problems can definitely arise when it isn’t followed properly. If design inputs aren’t well-defined or don’t clea...

I agree that catching issues before verification officially starts is the best case, because once the verification protocol and reports are underway, going back to revise the DID or DSD can slow every...

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, and design validation checks that those inputs tr...

I really like your choice of wanting to be a Clinical Investigator. Investigators have a key responsibility in clinical research; they not only enroll and treat subjects but also make sure informed co...

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 the patient but also from the investigator. In a do...

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 medical product, device, or drug truly works in hu...