One way I think it is best to organize a meeting is to get straight to the point. I have been a part of meetings with introductions to people or topics, Q&As, or unrelated company updates at the beginnings of…   Read more»

Managing change fatigue can absolutely be tricky, especially in the medical device field with so many regulatory bodies and guidelines that can force very suddenly. Too many of these changes can lead to change fatigue, but with such strict laws…   Read more»

I am surprised to see that no one is focusing on developing technical skills and familiarization with industry-specific standards and regulatory boards. Personal development is about much more than personality and traits, but development within the actual area of work…   Read more»

Unfortunately, without regulatory compliance there is no innovation. I do not necessarily agree that there is a balancing of innovation and regular compliance. Regulatory compliance is far more important than innovation, as with any violations a project or company can…   Read more»

I personally feel as in person meetings are essential to success. Emails simply cannot get important information across. We live in an age where many young people barely check their email, and when they do they skim it as it…   Read more»

One of the best ways to manage your inbox is built directly into every major email provider and/or manager. I have not seen many people use this function personally, but you can create customizable folders and filters using “rules.” For…   Read more»

I believe it is more important to consider money during the planning phase. I say this because without money, there is no project and deadlines don’t matter. You can be given 2 years to replace a broken fridge, but if…   Read more»

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»