I think that even though companies know the risks that come with not following the rules, problems still happen within the companies themselves. This can come from poor management, pressure to meet deadlines, cutting costs, or steps not being double…   Read more»

I agree that the user fee system raises real concerns about bias. Even though the fees are set by Congress and paid whether or not a drug is approved, relying on industry for so much funding can still create pressure…   Read more»

During FDA inspections, the consequences depend on how serious the problem is. Serious issues can lead to warning letters, recalls, delayed approval of new products, or even fines and legal action. For smaller issues, it depends on what the problem…   Read more»

During FDA inspections, the consequences depend on how serious the problem is. Serious issues can lead to warning letters, recalls, delayed approval of new products, or even fines and legal action. For smaller issues, it depends on what the problem…   Read more»

Precision and accuracy play an important role in medical devices. The small mistakes can be life threatening when it comes to medical devices. Accuracy is how close the device gets to the right value and precision is if it gives…   Read more»

Precision and accuracy play an important role in medical devices. The small mistakes can be life threatening when it comes to medical devices. Accuracy is how close the device gets to the right value and precision is if it gives…   Read more»

When it comes to taking risks, it’s about a 50/50 chance of success. Companies can stick to the materials they know are safe, which keeps the business running, just not as fast as it could go if they took more…   Read more»

Medical devices must be biocompatible before any further steps. To test the biocompatibility, it must undergo in vivo and in vitro experiments. One technique is a cytotoxicity test, which is in vitro. The purpose of this is to test how…   Read more»

Before clinical trials, it is important for companies to test the device. I think the way they should do these tests depends on what it is they are testing and which one would be more efficient. For example, replicating an…   Read more»

When planning a project, no one should just dive in and figure things out as they go, but spending an excessive amount of time planning every detail is not the answer either. It is about finding the right balance. Starting…   Read more»

This is a great question. I would say setting a project plan depends on preference and how well it works for the person executing it. There may be two amazing but different plans, and one might simply work better for…   Read more»

Personally, working with teammates can be a great thing, yet also tough. Having a group that works together and communicates efficiently can make the team stronger and lead to more progress. On the other hand, having teammates who rely on…   Read more»

I certainly agree that Biomedical Engineering is a mix of different types of engineering, such as electrical, chemical, and mechanical, as well as biology. However, I do not believe that knowing a little bit of everything prevents someone from eventually…   Read more»

As technology continues to develop quickly, I can see how AI is changing biomedical companies, as well as specific roles within them. For example, medical companies are using AI-powered robots to assist surgeons in the operating room. I do not…   Read more»

There are many medical devices that can always be improved in some way to make healthcare better for patients. One medical device I would improve is the glucose monitor for diabetic patients. Currently, there are two ways to test the…   Read more»