These are good points about post-market surveillance and the UDI system. I agree that regulatory compliance doesn’t stop at FDA approval- it’s an ongoing responsibility. The UDI system, in particular, is a crucial tool for improving traceability and responding quickly…   Read more»

I couldn’t fully follow along with the most recent comment on this thread because it was pretty lengthy without any paragraph breaks. As for the other comments, these all raise valid points about potential bias in the FDA’s review process,…   Read more»

These are great points about the FDA’s challenge of balancing safety with innovation, especially when it comes to combination products. The blurred lines between devices, drugs, and biologics definitely complicate regulatory pathways and can slow down the approval process. This…   Read more»

These are some good points raised about the complexity of material characterization and variability in biological responses. I agree, the challenges around biocompatibility testing, especially with complex materials or components from third-party suppliers, can be significant. I think the need…   Read more»

These are all great points, and I would also add that the role of regulatory consultants becomes even more critical as device complexity increases. For example, with the rise of combination products- like drug-device hybrids or devices that incorporate software…   Read more»

I agree with the points made earlier about the high costs being influenced by the materials, expertise, and precision required for dental implants. As mentioned, R&D plays a huge role too—especially since the field is still advancing. A lot of…   Read more»

Balancing scope and innovation is definitely challenging, especially in medical device development where timelines and regulations are strict. I think that it is key to distinguish between necessary innovation that improves safety or compliance and the ‘nice-to-have’ changes that could…   Read more»

Variance does give us insight into whether a project is ahead or behind schedule, but it can also serve as a signal for deeper issues. For instance, consistent variances in the early stages could suggest problems with initial estimates and…   Read more»

I agree that while a PM in biomed engineering doesn’t need deep technical knowledge, having a solid grasp of the basics is crucial. One thing I’d add is that in fields like biomed engineering, projects often involve a lot of…   Read more»

Grades and GPA do matter to an extent– if you are applying to graduate school, you need to have the grades to be accepted into a program. That academic experience is also a requirement for some jobs. I do think…   Read more»

I think that you definitely want to have some sort of experience to put on your resume– especially if you’re applying to the big companies. I wouldn’t say that internship/co-cop experience is required though. You could certainly get sufficient experience…   Read more»