The FDA’s approval of Abilify MyCite in 2017 marked a significant step in digital pill technology, combining a traditional antipsychotic medication with an ingestible sensor to track adherence. While ...

During the lecture, my question was raised regarding the FDA’s role in evaluating medical devices. My understanding is that the FDA prioritizes safety over effectiveness—they do not conduct independen...

This topic raises an important question about the flexibility of medical device classification, particularly in ambiguous cases. In reality, the classification process inherently involves many grey ar...

It is highly beneficial for both the project team as a whole and individuals in non-PM roles, such as engineers or scientists, to have a solid understanding of project management principles. For the t...

The decision to adapt a new technology in an ongoing project requires careful consideration from the project manager. Before implementing any new approach or model, priority should be given to quality...

The responses above effectively highlight the fundamental differences between drugs and medical devices, particularly emphasizing that drugs typically involve a chemical reaction. However, I would lik...