@sn64 I completely agree with your points! eClinical platforms and eConsent are growing and modernizing clinical trials. Real-time risk-based monitoring (RBM) could be a real game-changer for identifying issues early and improving overall study quality. I also like how you…   Read more»

Throughout this semester in BME 682, we explored various subjects related to industry stages, project creation, and adhering to deadlines. These topics definitely significantly assisted me in considering my future direction. To answer your question, if I had a choice,…   Read more»

This is an awesome question. I feel that one of my biggest motivators is competition as well. The drive to continuously improve was fostered during my time in the military. I found that some parts of that were carried into…   Read more»

If I’m leading a team in my medical device company, I’m maintaining a positive atmosphere and ensuring the objective is clear. To begin with, I would ensure that everyone understands their contributions truly count and give credit where it is…   Read more»

I believe that while job satisfaction is often glorified as the key to retaining your employees and promoting productivity, it is quite idealistic. In my experience, compensation frequently outweighs satisfaction, especially in high pressure fields. You can love your job…   Read more»

I believe that clinical trial teams can find a good balance between following the protocol and keeping patients safe by treating their given protocol as a flexible guide rather than a strict rulebook. I know this is not a conventional…   Read more»

@eowinomsm-edu Hi there. I agree with you! What’s intriguing is that the budget not only indicates the financial condition of a project; it also actively influences the project’s character. In other words, it functions as a framework behind the framework….   Read more»

In my opinion, although both communication and technical abilities hold value, superior communication skills are more crucial for project managers. It was discussed in class that the main responsibility of a project manager is to organize teams, synchronize stakeholders, oversee…   Read more»

In my experience in industry, missing deadlines can mean the difference between a successful and failing project. Yes, I believe there should be some kind of consequence for going over project deadlines or budgets. More specifically, it should be a…   Read more»

@benjaminrofail Hi Ben! You’ve made a good point— change fatigue is indeed a reality, particularly in regulated settings such as medical device development, where alterations in documentation and design are frequently unavoidable. I experienced this myself firsthand when I was…   Read more»

@ms3548 In my experience, working in the medical device industry, one of the biggest challenges was ensuring that data from labs outside our immediate workplace aligned with our internal expectations. This is especially true during verification and biocompatibility testing. We…   Read more»

@sa2847 I agree with you! On top of this, project managers can also manage their inboxes more efficiently by setting specific times during the day to respond to emails. I personally enjoy utilizing filters and folders to organize my messages….   Read more»

From a medical device intern’s perspective, I believe that hiring from within the company is often the better choice, especially for roles that require deep understanding of internal processes. Many tasks, even for the same role at different institutions, have…   Read more»

In my opinion, preventing change fatigue while maintaining a strong change control process in medical device development can be done by teams implementing a prioritization system that categorizes changes by the risk and impact. In my experience in medical device…   Read more»

@ms3548 Although collaborations can offer advantages, they are not always the most efficient or economical method. Working in industry has taught me that collaborations such as the one between BoneFix and FactoSet bring about intricacies that may actually hinder decision-making…   Read more»

@cs22 I fully agree with you—jeopardizing the integrity of experimental data can lead to much graver outcomes than merely delaying a project. I noticed that if inadequate experimentation results in unnoticed design defects, the problem might not emerge until significantly…   Read more»

@sa2847 In root cause analysis (RCA), defining the issue, setting timeframes, and identifying locations are crucial, but I believe that this method is sometimes overly strict and fails to encompass the full depth of an effective RCA. In my experience…   Read more»

@kellyepcarter I see where you’re coming from, and I have to disagree with the original definition of success. An important thing to note is that even though the project may check all the boxes in terms of budget, timeline, and…   Read more»

@jo277 Hi there, that is a really excellent observation. I noticed in my industry internship that managing change in validated processes can be highly intricate, especially when trying to balance efficiency and compliance. Implementing an effectiveness assessment is essential to…   Read more»