I believe the friction you identify is quite common—quality teams prioritize compliance and safety, whereas production and R&D prioritize speed an...

QA and QC do overlap because they both focus on product quality, but the skill sets and career pathways can be quite distinct. QA is primarily about s...

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 b...

The FDA's mission statement reflects a twin responsibility: to ensure the safety and efficacy of pharmaceuticals and devices while simultaneously enco...

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 lawful...

Clinical trials are an important part of the medical device clearance process, but their aim and standards are very different from those for medicines...

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...

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 anim...

I believe that both sorts of research—industrial and academic—play important roles in progressing society, but I personally prefer research that serve...

I absolutely agree that project planning is one of the most critical stages of the project lifecycle. A well-structured strategy gives clarity, establ...

I absolutely get what you're saying—organization and leadership have a significant impact on project outcomes. A chaotic project manager can cause a d...

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 establish...

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...

I believe you make a key point: while innovation and regulation appear to be opposing forces, they must work together. Prototyping swiftly may drive i...

One thing I've found about getting a Biomedical Engineering degree is that it truly seems like "a little of everything." We study electrical engineeri...