Maintaining the critical path is just as important as it sounds, it is absolutely critical to the success of the project. I was the dedicated “Project Manager” for my BME capstone team during my time as an undergrad. Although the…   Read more»

@sn64 Hey! The first step would be to establish a framework, defining a clear tiered approach to classify the changes. Then I would ensure that there is a clear documentation and tracking system in place to ensure proper documentation and…   Read more»

I believe the most present risk in the majority of projects would have to be a schedule risk. This is because of the immense number of factors that can all affect the schedule of the project at any given moment….   Read more»

Hello! My name is Sean Caswell and I am doing my master’s in BME at NJIT! I look forward to connecting with you all!
Here is my LinkedIn -> Sean Caswell | LinkedIn

One important nuance I have always noticed is that it has never been “Nature or Nurture” but rather “Nature vs Nurture.” It is not black or white, it is more comparable to grayscale. I think of it as a large…   Read more»

I personally believe that testing in extremes is important. For example, say the labels were only tested for what was deemed “practical application” and tests were never conducted on bottles wet for the time period. The labels pass without issue…   Read more»

Fortunately, my group did not seem to run into any issues. However, we did run into a similar situation where everyone seemed to have a slightly different background. I believe it helped us as well. Our group was able to…   Read more»

A Design History File (DHF) is essential for regulatory compliance, but a massive part of good project management as well. Any issues with regulatory boards will have drastic implications for the company in question. One of the best ways I…   Read more»

I believe the best way to handle Design Change Requests is to plan for them in the first place. Obviously no one wants to plan for something to go wrong, but good project management will always plan for setbacks and…   Read more»

I think this common practice clearly limits the potential for innovation in the medical field. The most obvious reasons to me are rooted in financial capacity and resources. Innovation and new devices and treatments are essential to the medical field…   Read more»

Understanding the differences between these pathways is essential to Project Management since they drastically effect the timelines and requirements for projects that fall under them. Typically, a PMA will take the longest and it is required for any Class III…   Read more»

Balancing the values between stakeholders and customers is what I would call being stuck between a rock and a hard place. In a perfect world, all values would align in perfect harmony. However, as anyone can assume this is almost…   Read more»

I believe there are three keys to effective communication: speed, detail, and situational awareness.  Firstly, effective communication must happen as soon as possible. As soon as a need for communication is identified, I strongly believe an attempt at said communication…   Read more»

You’ve certainly nailed the importance of Project Managment! To answer your proposed question, my experience definitely leads me to believe that rules and regulations are by far the biggest hurdle in any medical industry, including when it comes to medical…   Read more»