The first step would definitely be to conduct a thorough risk analysis, considering things like the scope, resources, deadlines, and potential impacts on quality. Cost benefit analysis specifically can really help determine what may offer the best balance between saving…   Read more»

I feel the biggest factor in deciding a number of vendors is a projects risk tolerance. In the case of medical devices, such as in the minisim, the tolerance is very low. There is very little room for errors and…   Read more»

I definitely believe that an overemphasis on regulatory considerations can limit quality management. An overemphasis can often encourage a “just enough” mindset where the regulations are met, but not exceeded. It is important to remember that regulations are not a…   Read more»

I can definitely relate to having my definition of a stakeholder changed. What changed for me the most was that a stakeholder technically does not even have to be a person. I always thought of a stakeholder as a single…   Read more»

I personally believe that the planning phase is the most important phase of project management. I believe so because poor planning can doom a project from the start. Without thorough planning, a project will run into too many walls and…   Read more»

In my experience, the best ways to document and share “lessons learned” or other important announcements is through a tool like Microsoft Sharepoint. Sharepoint is a very useful tool that many organizations use to store useful documentation and have it…   Read more»

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»