I agree that avoidance is often the way that is preferred in manufacturing because preventing a risk before it happens is the most reliable way to protect both workers and product quality. When avoida...

To put a plan into action, I would focus on using tools and methods that help me stay organized about potential problems. I would start with a detailed risk register so I can track each risk, who its ...

This post brings up an important point about whether the use of FMEA has become too rigid for the reality of modern devices. FMEA is a useful starting tool but it usually fails to capture the unpredic...

Rebuilding a design history file for a legacy combination product can be hard especially when the original documentation isn't finished or does not exist. Since a lot of these products were made befor...

A contract manufacturer plays a important role in process validation by giving documented evidence that the manufacturing equipment, processes, and controls are capable of consistently producing produ...

Even though verification and validation may seem similar, they do serve different purposes. Verification is focused on confirming that the design meets the technical and regulatory requirements. Valid...

The best way to translate a qualitative user need into a testable and quantitive design input is by breaking it down into measurable criteria. To maintain traceability, teams can utilize a design trac...

I think that multiple design reviews should be held throughout the development process. Each stage of design can reveal different issues that might not be able to seen later. Having several reviews he...

I think design controls can actually support innovation when they are utilized in the correct way. Although ISO 13485 and FDA 21 CFR 820 seem rigid, they help teams think through safety, user needs, a...

Clinical studies are crucial in advancing medicine because they give the evidence necessary to determine whether new drugs and medical devices are effective and safe. One advantage is that they lead t...

The placebo effect can complicate clinical trials because it makes it harder to tell whether improvements in patients are because of the actual drug or the belief in the treatment. The psychological r...

I think participants in pharmaceutical trials should receive compensation in some situations if it is ethical. The compensation should be based on the type of risk and time that the trial is. I think ...

Participation in marketing is when brands invite customers to help shape their products. Crumbl cookies for example use changing their cookies once a week as marketing to their customers. When custome...

Personally, as a biomedical engineer, I would choose marketing after an engineering role. I think I would be able to use my background to understand customer needs and product design. Engineers are tr...

I do agree that color is one of the most crucial tools that is used in branding because they appeal to consumers. For example coca-cola uses red because its bold. Every color displays a different mood...