In past projects, I’ve primarily used Failure Mode and Effects Analysis (FMEA) because it provides a structured and quantitative way to assess potenti...

I agree with your explanation — distinguishing between hazards and hazardous situations is essential because it helps clarify when and how a potential...

I agree with your stance that risk avoidance tends to be the most favored approach in manufacturing, particularly because it directly supports safety,...

You’re absolutely right — design control provides structure and accountability throughout the medical device development process, but when it’s implem...

That’s a great point — keeping “living documents” like the DDP continuously updated is essential, but it can easily become overwhelming if not managed...

Yes, typically when an error is discovered in formal design documents like a DID (Design Input Document) or DSD (Design Specification Document), a cha...

That’s a really thoughtful point — and one that a lot of people in medical device design struggle with. Design controls can definitely feel like barri...

That’s a great question—and one that every real-world engineering team faces. In practice, it’s all about finding a balance between user-centered desi...

That’s a great question — it’s true that design verification and validation (V&V) can seem redundant at times, especially when tests or documentat...

I agree that Good Clinical Practice (GCP) is essential for maintaining ethical standards and protecting patients, but I also see how it can sometimes ...

You raise a really good point — it does seem at first that a single-blind study, where only the patient doesn’t know what they’re receiving, should be...

The placebo effect is a fascinating and challenging aspect of clinical research because it highlights how powerful the mind-body connection can be. Wh...

If I were to transition from an engineering role, I would likely choose marketing over sales, particularly in an upstream capacity. Marketing allows f...

Storytelling is a powerful marketing strategy because it helps brands connect with customers on an emotional level and stand out in competitive market...

I fully agree that securing a sale represents only a portion of the overall challenge; sustaining long-term relationships with customers is what truly...