From what I’ve read, one of the most common issues during QMS audits is weak traceability, especially when companies can’t clearly connect design changes or complaints back to something they documented. Studies point out frequent findings in supplier management, such…   Read more»

Quality assurance can also make sure Class III devices meet safety standards by focusing on strong documentation and traceability during design and development. Every change and decision should be recorded so that risks can be tracked and then addressed. I…   Read more»

I think the biggest challenge right now is keeping quality control up to speed with how quickly medical device technology is advancing. Devices aren’t simply hardware anymore, they have AI, software updates, and connectivity, which makes risk management and validation…   Read more»

I’ve also been interested in regulatory affairs since this class started, especially because Professor Simon keeps mentioning how it’s a growing field with a lot of job opportunities. What I keep wondering, though, is whether there is any creative aspect…   Read more»

I like how you framed this because it made me think of how it really is all about balance. I agree that engineers don’t need to be regulatory experts, but they need to know the “rules of the game”, the…   Read more»

I think the FDA has a difficult position of wanting to encourage innovation while also making sure the devices are not going to cause harm and are productive. One challenge I think is about how long the approval process can…   Read more»

Biocompatibility throughout a device’s whole lifecycle is tough since the body will always react to foreign materials in some way. Even metals like titanium or ceramics can still cause issues over time. That’s why manufacturers look beyond just the base…   Read more»

One thing I think is interesting when comparing academia and industry is the pace and priorities. In academia, it feels like the goal is more about discovery and publishing. You need to be patient and persistence and be able to…   Read more»

I think everyone raised really good points about cost, time, variability in biological responses, and different supplier issues could all be hurdles in device development. Something I would like to add that was discussed in the lecture videos is that…   Read more»

Something I’ve noticed in my own group projects is how the environment has an impact on whether people actually share concerns or just keep them to themselves. Even if the manager isn’t the more technical person in the room, the…   Read more»

I like all the points that have been made so far, it does feel like academia follows a much more relaxed and less structed project management path than the industry does. This is definitely the case because the industry involved…   Read more»

I agree with what has already been said and discussed here so far, communication and active listening are vital parts of handling disagreements on a project team. Since we learned about the importance of project planning and how beneficial it…   Read more»

I also wonder the same thing if internship and co-op experience gives you a step ahead when it comes to looking for a job. I feel like it’s very situationally based because I know of some people who had great…   Read more»

As an undergrad student with no industry experience, my perspective is based off of what I have heard from others. I remember being in a seminar where the professor brought in a past student who is currently working in the…   Read more»

@knm7 As an undergrad student pursing a master’s degree in biomedical engineering with the hope of working in the industry, I really appreciate this post. From a student perspective, I feel like taking courses stresses the deadline aspect of projects…   Read more»