@sn64 Hi sn64! I agree with you- keeping abreast of regulatory trends is an evolving and complex endeavor. A noteworthy aspect to reflect on is the growing importance of AI and machine learning in regulatory intelligence. My company that I…   Read more»

Missing a milestone is seen often as a setback, but it can also serve as an important indicator that the project timeline did not accurately reflect the work that was listed for a given project. I have noticed in my…   Read more»

@devdesai Hi there! You made a great point about how it is important to incorporate slack into a project’s timeline. Slack helps account for expected delays like vacation and unexpected issues that might arise. Having extra time as a buffer…   Read more»

Hi everyone! My name is Tiffany Magno, and I am pursuing both my BS and MS in BME at NJIT. A fun fact about me is I am also in the military!  Tiffany Magno | LinkedIn I look forward to…   Read more»

@sn64 Hi sn64! I recently learned about a tool used at work to facilitate analysis regarding regulatory classification. The company one of my professors work for uses an AI-powered regulatory decision matrix for this process. The tool streamlines analysis by…   Read more»

@amm7 I agree that finding the right balance between tight and loos specification is very important however I would also like to note that beyond functionality is the impact on long term performance and regulatory compliance. What do I mean…   Read more»

@archishak Hi there! While project management skills can be beneficial in many fields, I would actually argue against your post that a deep understanding of project management is not always necessary to contribute effectively to a project’s success. Many professionals…   Read more»

@anthony Hi Anthony! That is a very valid concern. The endorsement of Abilify MyCite highlights an important disparity between regulatory adherence and real-world clinical usefulness. Although the FDA’s responsibility is to confirm safety and adequate effectiveness, it does not always…   Read more»

@bryan-xavier Hi Bryan! I certainly agree. Utilizing a traceability matrix is a fantastic method to keep organization in the Design History File (DHF), I found it quite useful when organizing one for a previous semester project. It guarantees a systematic…   Read more»

@mjc22 Hi there! I agree with you that filing for FDA approval of a misclassified device can cause major hinderances to the entire process. I can recount a personal experience with this. While I was interning in a small startup…   Read more»

@sn64 Hey sn64! Although empathy and comprehension are essential characteristics for a project manager, I would also like to make note that altering goals or reallocating tasks shouldn’t be the initial strategy in such scenarios. The main duty of a…   Read more»

@benjaminrofail Hi Ben! You make a good point about how conflicts can either strengthen or weaken a team, depending on how they are handled. I agree that overcoming disagreements through clear communication and discussion fosters camaraderie. I can personally attest…   Read more»

I find that collaborating in teams of varying sizes presents distinct benefits and challenges. During my time in the military, I noticed that small teams typically offer efficient communication and quicker decision-making, yet might lack a range of expertise, while…   Read more»

When presented with new technology during a project, a project manager should carefully evaluate their possible effects by considering their compatibility with project objectives. This evaluation includes performing a detailed cost-benefit analysis, taking into account aspects such as increased efficiency,…   Read more»

During the lecture, we explored different organizational structures, and I think the leadership style—whether it be hands-off or micro-managing—significantly impacts a project’s success. Based off my previous work experience, I personally favor collaborating with a leader who takes a hands-off…   Read more»

@ms3548 This is a thoughtful question! I think that Agile approaches are very efficient in handling changing project objectives since they prioritize flexibility and teamwork. By dividing the project into smaller, time-limited sprints, Agile enables teams to reevaluate priorities and…   Read more»

Hi Roberto, I agree with you that these situations can feel awkward especially when the intent is simply to show professional gratitude. One way to address this awkwardness might be to have clear communication up front. I would have had…   Read more»

@cef3 You make a valid point however, I would argue that even legal action seems unlikely, having a contract is still strongly beneficial. A contract ensures that all parties are on the same page regarding stated terms, reducing any misinterpretations…   Read more»

@cef3 You make a good point! An NDA is surely an important piece in the early stages of development especially when engaging with collaborators to collect necessary data. Without an NDA, it is true that there is significant risk that…   Read more»