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...

Corporate teams often have structured roles and hierarchies that make them more productive by keeping goals clear and responsibilities organized, as s...

To keep QA efficient with new technologies like AI, we should enhance foundational principles rather than replace them. By applying adaptive framework...

You've perfectly captured the essential difference between the two roles. While both QA and QC are absolutely critical, I believe the biggest impact o...

Quality Assurance (QA) and Quality Control (QC) are fundamentally different, leading to distinct career paths and training. QA is preventive and pr...

FDA approval is not a guarantee of absolute safety, but rather an assurance that a product's scientifically-proven benefits for its intended use outwe...

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 examp...

The FDA's dual mission to ensure product safety while also "helping to speed innovations" creates a necessary but challenging balance. While the agenc...

I think the deciding factor between a viable study and a poor one really comes down to study design. From the slides, one of the biggest pitfalls ment...

@nick-carrillo That’s a great example, and I think it really shows the balance between simulation and physical testing. I’ve had similar experiences ...

Managing multiple projects at once can get messy, so prioritizing really comes down to planning and being realistic. The slides emphasize tools like W...

I don’t think missing a milestone automatically means failure. From the slides, milestones are just checkpoints to measure progress and keep the proje...

I agree with you that pre-clinical research is really the backbone of medical device development; it’s where you catch problems early before anyone ge...

I think you really nailed the issue of being on the same wavelength for managers and engineers. The Challenger example shows us how bad communication ...