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 ...

I fully agree that biotech and medical device companies are extremely strategic, using a targeted approach to advertising based on demographics and ne...

Based on the scenario of an engineer transitioning to a commercial role, I would choose to go into Upstream Marketing after my engineering role. My re...

I agree that the strategic use of color is one of the most fascinating aspects of Branding in marketing. When I look at companies, I notice they are m...

If I had the chance to build my own business, I would start by identifying a problem I’m passionate about solving and then create a plan around that. ...

I think both improving patient care delivery and innovating with new technology are equally important for physicians who want to start their own pract...