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 for project success: the structure dictates the flow of resources and decision-making…   Read more»

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 arise from a powerful synergy where the two are integrated, not separated….   Read more»

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 challenging for a PM simply because it often creates a dynamic…   Read more»

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 different perspectives, but I find FMEA to be the most beneficial…   Read more»

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 equipment. During testing, a technician accidentally spills a sample…   Read more»

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 identifying potential risks early, teams…   Read more»

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 process. I would recommend adding columns for risk…   Read more»

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,” especially with the rise of AI-driven devices. Standards like…   Read more»

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 that any modifications made to a device are intentional and traceable….   Read more»

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 clearly connect to user needs, the product might end up…   Read more»

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 everything down. But I personally don’t think companies…   Read more»

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 truly support the user’s needs. I do think…   Read more»

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 consent is obtained and that adverse events (AEs)…   Read more»

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 double-blind study, both the…   Read more»

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 humans, since not all results from…   Read more»

The FDA’s dual mission to ensure product safety while also “helping to speed innovations” creates a necessary but challenging balance. While the agency’s rigorous review process can seem slow, it is rooted in historical public health disasters, such as a…   Read more»

I agree that the responsibility for medical product recalls is a shared one, and your points about Vioxx and the Philips CPAP machines are great examples of how things can go wrong after approval. I think it’s crucial to see…   Read more»

FDA approval is not a guarantee of absolute safety, but rather an assurance that a product’s scientifically-proven benefits for its intended use outweigh its known risks. The extensive list of side effects in drug commercials is a direct result of…   Read more»

Quality Assurance (QA) and Quality Control (QC) are fundamentally different, leading to distinct career paths and training. QA is preventive and process-oriented, focusing on creating and managing the overall system to ensure quality is built in from the start 1;…   Read more»

You’ve perfectly captured the essential difference between the two roles. While both QA and QC are absolutely critical, I believe the biggest impact on patient safety comes from prioritizing resources in Quality Assurance (QA). The slides define QA as “Preventive…   Read more»