If I were the owner of a company, I would absolutely see value in having a documented contingency plan for legal and operational decisions in case I b...

Balancing legal protection with collaboration is one of the biggest challenges when drafting agreements in the medical device industry. NDAs, confiden...

In the medical device industry, written contracts are the standard because they protect all parties, clarify responsibilities, and support compliance ...

As healthcare systems continue shifting toward value-based care, medical device companies need to adapt their operations, product strategies, and supp...

From a project manager’s perspective, both matrix and project-based organizations offer advantages—but they also come with very different types of cha...

A Gantt chart and a network diagram are both useful tools for visualizing a project timeline, but they serve slightly different purposes within the de...

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...