In past projects, I’ve primarily used Failure Mode and Effects Analysis (FMEA) because it provides a structured and quantitative way to assess potential risks. By breaking down each step of a process ...

I agree with your explanation — distinguishing between hazards and hazardous situations is essential because it helps clarify when and how a potential danger actually becomes a risk. A hazard on its o...

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

You’re absolutely right — design control provides structure and accountability throughout the medical device development process, but when it’s implemented poorly or insufficiently, several issues can...

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

Yes, typically when an error is discovered in formal design documents like a DID (Design Input Document) or DSD (Design Specification Document), a change request is issued. This is part of the documen...

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 barriers when you’re trying to move quickly or experime...

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 design and business feasibility. Engineers should abso...

That’s a great question — it’s true that design verification and validation (V&V) can seem redundant at times, especially when tests or documentation overlap. However, they serve distinct purposes...

I agree that Good Clinical Practice (GCP) is essential for maintaining ethical standards and protecting patients, but I also see how it can sometimes feel overly focused on documentation rather than t...

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 enough. However, the reason double-blind studies ...

The placebo effect is a fascinating and challenging aspect of clinical research because it highlights how powerful the mind-body connection can be. When patients receiving a sham or inactive treatment...

If I were to transition from an engineering role, I would likely choose marketing over sales, particularly in an upstream capacity. Marketing allows for a more strategic approach, where I could use my...

Storytelling is a powerful marketing strategy because it helps brands connect with customers on an emotional level and stand out in competitive markets. When done effectively, it allows companies to e...

I fully agree that securing a sale represents only a portion of the overall challenge; sustaining long-term relationships with customers is what truly defines a company’s success in competitive market...