@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»

@arianaburch I agree with you! Well said. Allocating time not only properly enables comprehensive development, it also guarantees that the product adheres to quality benchmarks. In my experience with industry, although obtaining investments may be really important, a thoroughly developed…   Read more»

I believe the question depends on what you mean by “valid.” There is no doubt that the Google PMP certification (Google Project Management Professional Certificate) serves as a strong entry-level qualification. This is especially true for individuals who are new…   Read more»

@mirna-cheikhali I understand the argument that schedule risk is common, but I would actually argue that financial risk is truly the primary concern in many industries. Delays are certainly an issue, yet in many situations, they can be handled. Teams…   Read more»

@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»