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 or component function, FMEA helps identify possible failure…   Read more»

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 own may not always lead to harm unless…   Read more»

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 manufacturing, risk management is deeply integrated into process design and quality control…   Read more»

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 arise. One major problem is traceability gaps. If design inputs, outputs, or verification activities…   Read more»

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 controlled versioning and scheduled updates rather than real-time edits…   Read more»

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 document control and quality management process to ensure…   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»

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 the people participating in the studies. The guidelines are…   Read more»

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 are preferred is to remove investigator bias…   Read more»

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 (placebo) report improvements similar to those receiving the actual drug,…   Read more»

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 technical background to better understand the product,…   Read more»

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 express their values and create meaningful connections that build long-term…   Read more»

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 markets. Organizations can implement customer retention strategies by emphasizing consistent engagement,…   Read more»

I would want to be the owner of a Limited Liability Company (LLC) because it provides an excellent blend of legal protection, operational freedom, and simplified taxation. One of the most major benefits of an LLC is the limited liability…   Read more»

You raise an excellent point, which many technically qualified people encounter while pursuing entrepreneurship. I believe that engineers and scientists may start successful firms without an MBA, especially if they are prepared to devote the necessary time to learning important…   Read more»

You make an important argument regarding the tradeoffs between public accountability and private freedom. I think that becoming private allows a firm like EA to focus on long-term creative objectives without the continual burden of quarterly profitability reports. This might…   Read more»

I believe the friction you identify is quite common—quality teams prioritize compliance and safety, whereas production and R&D prioritize speed and innovation. Document control might be improved by determining how to be both rigorous and efficient. For example, switching from…   Read more»

QA and QC do overlap because they both focus on product quality, but the skill sets and career pathways can be quite distinct. QA is primarily about systems and processes—it ensures that the proper procedures are in place and that…   Read more»