Great point! You’re correct that QA and QC are frequently confused, yet they serve distinct roles. In the long term, I believe QA makes the greatest benefit for patient safety since sound processes avoid issues before they occur. QC is…   Read more»

The FDA’s mission statement reflects a twin responsibility: to ensure the safety and efficacy of pharmaceuticals and devices while simultaneously encouraging innovation that promotes public health. On the one hand, its stringent regulatory structure keeps dangerous or ineffective items from…   Read more»

The De Novo 510(k) pathway is a regulatory procedure created by the FDA for innovative medical devices that are low to moderate risk but lack a lawfully marketed predicate. Instead of being automatically classed as high-risk Class III items necessitating…   Read more»

Clinical trials are an important part of the medical device clearance process, but their aim and standards are very different from those for medicines. Randomized controlled trials for medications are often required to establish safety, effectiveness, and dose in large…   Read more»

I believe that the integrity of the data determines the difference between a feasible study and a bad study. It is common in industry to confront time and financial constraints. Still, if cutting corners results in incorrect data or conclusions…   Read more»

That’s an intriguing point, and one that I’ve considered as well. One of the reasons why animal research receives more unfavorable attention than animal eating is due to its goal. Most people regard eating animals as a personal decision or…   Read more»

I believe that both sorts of research—industrial and academic—play important roles in progressing society, but I personally prefer research that serves the current generation. It’s immensely motivating to know that your work has the potential to impact people’s lives right…   Read more»

I absolutely agree that project planning is one of the most critical stages of the project lifecycle. A well-structured strategy gives clarity, establishes expectations, and makes the subsequent phases much more manageable. I also get your idea about striking the…   Read more»

I absolutely get what you’re saying—organization and leadership have a significant impact on project outcomes. A chaotic project manager can cause a domino effect in which deadlines are missed, budgets are surpassed, and team morale suffers. Even if everyone on…   Read more»

I feel that missing a milestone should not be deemed a failure; it all relies on the circumstances and logic behind it. While milestones are established to keep teams on track and evaluate progress, they are ultimately tools rather than…   Read more»

Your point of view is quite similar to mine. Academia is excellent for developing a solid theoretical and research foundation, but I agree that it has limitations in terms of hands-on product development and understanding the business side of things….   Read more»

I believe you make a key point: while innovation and regulation appear to be opposing forces, they must work together. Prototyping swiftly may drive innovation, but ignoring compliance early on typically results in costly redesigns later. For small teams, it…   Read more»

One thing I’ve found about getting a Biomedical Engineering degree is that it truly seems like “a little of everything.” We study electrical engineering, mechanical systems, physiology, coding, and certain regulatory and commercial topics. While this might make it difficult…   Read more»