In general, there is a clear line between neglect and making mistakes. At times, people might change or alter a process and forget to note it down. Although this is also not the correct way of doing things, especially when…   Read more»

At times, things like regulations may seem like barriers. But in reality, they aid in making a more robust device and reduce the chances of adverse effects (lower risk). At times, some regulations may seem too much and may cause…   Read more»

Since they are two distinct aspects of the product development process, it is important that both are still completed. Although they do overlap, sometimes more significantly than in other cases, it is important to perform both because they both still…   Read more»

I liked the point regarding maintaining consistent QC and QA in transferring design control. I also agree that there is great importance in maintaining traceability and documentation. Something that no one else has mentioned, however, is how the intent of…   Read more»

When transferring design controls to a contract manufacturer, it is critical to maintain traceability and design intent throughout the production process. Even if contract manufacturers have strong QC & QA systems, there can still be gaps if communication/documentation is not…   Read more»

One issue that would arise is the failure of meeting its intended purpose. Without proper design controls, a product would most likely never make it to its end stages with proper functionality. Product recalls, risks, and general non-compliance would occur…   Read more»

From what I have seen, most feedback can be influential and positive in terms of making a device or product better. Feedback can be in any form, and for the most part it is not a bad thing (if you…   Read more»

An interesting perspective is how emerging development models (e.g., human-factors-driven design) are reshaping the distinction between verification and validation. In traditional systems, V&V has been more linear to align with regulatory expectations. However, in new iterative development cycles, teams now…   Read more»

I think this is a great question to consider since it is something that most of us, as engineers will eventually face. What is more important, user needs or the business limitations/needs. I think, in a consumer-seller relationship, the seller…   Read more»

Another perspective to consider is how regulatory and ethical obligations can affect the balance between user needs and business constraints. In other industries, such as consumer technology, compromises between the two may result simply in less convenient user experience. However,…   Read more»

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 experiment with new ideas. Having to document…   Read more»

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 absolutely advocate for the ideal design that best meets user needs, because that’s…   Read more»

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 that complement each other. Verification ensures the device meets its design…   Read more»