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 became temporarily unavailable. In the medical devi...

Balancing legal protection with collaboration is one of the biggest challenges when drafting agreements in the medical device industry. NDAs, confidentiality agreements, and consulting contracts are m...

In the medical device industry, written contracts are the standard because they protect all parties, clarify responsibilities, and support compliance with FDA and ISO requirements. Still, verbal agree...

As healthcare systems continue shifting toward value-based care, medical device companies need to adapt their operations, product strategies, and support services to align with outcomes rather than ju...

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

A Gantt chart and a network diagram are both useful tools for visualizing a project timeline, but they serve slightly different purposes within the design development plan. A Gantt chart is task-orien...

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...