Yeah, I agree. At some point of the project when it is going through lots of troubleshooting, the quality team may seem like they are too nosy. However, it is for the ultimate benefit, the benefit of the end user,…   Read more»

I think all departments already have the impression that the quality department will be strict with the rules and regulations, as it is their job. One way to keep a healthy office environment would be to, from the very beginning…   Read more»

I think that would be helpful in the sense of saving time in QA. Maybe AI can be trained with both positive and faulty data. That way, when it sees any similar data, it will not take much time to…   Read more»

I agree that the FDA’s response should depend on the risk, not just the number of mistakes found. If an audit finds a few isolated paperwork errors that do not affect the device or patients, the company should still correct…   Read more»

@james-olson I also had a similar impression as yours and thought that it was mostly quality assurance. After this week’s lecture I feel like it would be difficult to name one particular department, as all are interconnected, and I would…   Read more»

I think there should be a balance between rules and risks. What I mean to say is, a simple device should not have to go through the same level of review as a device implanted in the body. Regulators could…   Read more»

I used to work with hydrogels during my undergrad, where I incorporated antimicrobial peptides to promote wound healing in infectious wounds. While working, I felt like hydrogel is a very versatile kind of biomaterial device that can incorporate things in…   Read more»

I would say both have some pros and cons. In academia, you get to delve into a particular field of interest, whereas in industry you need to do tasks in different kinds of projects. Even though it feels like industry…   Read more»

Most of the researchers are now interested in lab-on-a-chip devices, which can minimize animal trials to some extent. Again, researchers are now trying more in vitro and ex vivo experiments so that they need to do very final in vivo…   Read more»

As a project manager, I would prefer delaying rather than taking a risk at the patient level. In case of developing a medical device, the end goal of a product is always the benefit of the user/patients. Therefore, compromising quality…   Read more»

Planning is most crucial to reach the execution phase. However, I agree with a flexible mindset in this. Because, even with a very smart plan, as technology is always evolving, you might consider things differently and think a change in…   Read more»

I work on a project with multiple managers. I feel like it has both sides of experience. It is sometimes more efficient, as I get insights from both experts. However, sometimes there are conflicting sets of opinions between them, and…   Read more»