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 before modern design controls, the best method is…   Read more»

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 products that meet specifications. A contract manufacturer is expected to give detailed process documentation,…   Read more»

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. Validation makes sure that the product meets the user’s needs and performs efficiently…   Read more»

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 traceability matrix thank connects each user need to…   Read more»

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 helps ensure that the risks are identified early…   Read more»

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, and risks before going too far…   Read more»

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 to discoveries that can saves lives which helps patients…   Read more»

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 response can hide the effectiveness of a medication,…   Read more»

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 there should be a screening process…   Read more»

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 customers feel like their voices matter they are more likely…   Read more»

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 trained to solve problems which is why I…   Read more»

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 and companies/brands do rely…   Read more»

I think these business courses are very beneficial for engineers that want to work in the industry. I took classes like these and they helped me learn a lot and I think they are very important. While technical knowledge is…   Read more»

I think the type of company can play a role in deciding whether to accept a job, but it wouldn’t be the only factor. Some companies will offer more stability and opportunities because they can be larger, while smaller companies…   Read more»

This is an interesting topic and it is important to discuss. I do think further education can be beneficial but I do not think it is necessary in all situations. Further education is important when the thing you are doing…   Read more»

I think technology is always evolving and it is doing so rapidly so I do believe that QA should adapt to the rapidly changing technology. Tools like AI can be beneficial in making processes go faster and improve outcomes. I…   Read more»

I think that both quality assurance and quality control are crucial for patient safety. QA is important because it focuses on preventing issues before they happen. Through training, QA establishes clear processes and minimizes the chances of problems making it…   Read more»

I think the most efficient way for quality teams to collaborate with R&D teams would be for both teams to communicate with each other consistently. I think quality teams should be involved in the early development process so they can…   Read more»

This is a good question that is difficult to answer. I do not think that FDA approval means a drug or device is risk free. There have been many drugs that have been approved and put out on market but…   Read more»

A product that was recently recalled is Zantac. This is a heartburn drug and it was recalled in 2019 because of a cancer causing chemical called NDMA. This became clear after testing when it was in market. I do not…   Read more»