I agree that the complex and rigorous regulatory process of medical device development is difficult for companies to navigate. This is where regulatory consultants can play a crucial role in navigating the intricate requirements for FDA approval and other compliance…   Read more»

As many mentioned, it’s clear that there are significant differences between academia and industry research, particularly in terms of how they use their skills in each field. However, I also think the skills themselves are similar. For further/higher education, in…   Read more»

In fields like biomedical engineering, while deep technical expertise may not be mandatory, having foundational knowledge is crucial for understanding the complexities of projects and managing teams effectively.For a PM in biomedical engineering, the basics should include a working knowledge…   Read more»

I agree with many of the points made about the role of project managers and their need for strong communication and social skills. In my view, effective project management hinges on a few key abilities: listening, clear communication, and leadership….   Read more»

In the medical device industry, beginning certain aspects of execution during the initiation phase can be crucial, particularly for preliminary testing and development. In the medical device industry, the initiation phase often involves assessing feasibility and defining initial project scopes….   Read more»

I agree with the perspective that there is no “golden ratio” for the balance between practical and academic courses, as it truly depends on each student’s career goals. For instance, a student pursuing research may benefit more from a higher…   Read more»

While the question asks for an example of a corporation not complying with FDA regulations, I feel it’s important to highlight a broader issue—how the FDA has historically been reactive in its regulatory role, often evolving in response to public…   Read more»