As the project manager for a Class III bio-absorbable vascular stent, I would see the animal study results as critical data rather than a setback, and I would pause the original strategy to reassess whether dissolving faster truly aligns with…   Read more»

As the project manager for a Class I bio-absorbable vascular stent, I would see the animal study results as critical data rather than a setback, and I would pause the original strategy to reassess whether dissolving faster truly aligns with…   Read more»

I think the most important responsibility of the FDA is ensuring the safety of drugs and medical products before they reach the public. This is important because people rely on medications and medical devices to improve or protect their health,…   Read more»

I think both small and large teams have their pros and cons. Personally, I prefer working in a small team because it’s easier to communicate, stay organized, and make decisions without too much back-and-forth. I also find that working with…   Read more»

I agree that internal and external factors can really shorten or extend a product’s life cycle, especially in tech-driven fields like medical devices. In addition to verification and validation, I think tools like risk management (such as hazard analysis), post-market…   Read more»

@ms2768 I think your perspective is really interesting, especially since you’ve experienced both fully in-person work during the pandemic and now a hybrid setup. I agree with you that in-person meetings often feel more productive because people are less likely…   Read more»

I would prefer to work under a project manager who communicates mainly in person because face-to-face interaction makes expectations clearer and helps prevent misunderstandings. Being able to read body language and tone also helps build trust and makes feedback feel…   Read more»

I prefer working in a small team because it’s easier to communicate, stay organized, and make decisions without things getting slowed down. Everyone’s role is usually clearer, and it’s harder for people to get lost or disengaged. That said, I…   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»