You’ve got a good point about how corporate teams and research labs differ! In a corporate setting, having clear roles and hierarchies can really help with getting things done since everyone knows their responsibilities. But it can also stifle creativity…   Read more»

An extra business course could really help engineering students, especially those looking to get into project management, product development, or even starting their own businesses. While NJIT’s engineering management course covers the basics, having a deeper understanding of things like…   Read more»

Regulatory agencies like the FDA and EMA act more like government service organizations than typical businesses. Their main job is to make sure medical products are safe and effective, and they fund this work through a mix of government budgets…   Read more»

For Quality Assurance, two big things that come to mind are regulatory compliance and training. Sticking to regulations like ISO 13485 and FDA guidelines is a must in our industry. Using tools like document control software and compliance management systems…   Read more»

I don’t have much firsthand experience with root cause analysis (RCA), but I understand its importance in quality management, especially in the medical device industry where safety is a top priority. RCA is about analyzing to find the actual cause…   Read more»

Switching from one system to another, whether it’s going digital or moving between ERP/QMS platforms, comes with a lot of challenges, especially for teams like QA, QC, document control, and training. Data migration is a big deal because if something…   Read more»

You made some really good points about the significance of using hydrogels in pre-clinical research! Another big plus is that hydrogels can be easily modified to release drugs in a controlled manner, making them ideal for studying how treatments can…   Read more»

You make a great point about the importance of choosing the right animal models in pre-clinical research, especially in neurology. This is because the brain and nervous system are so complex that it’s crucial to look for a specific species…   Read more»

Based on what we learned from the week 1 lecture, having a good plan and communication are key to avoiding stress. Breaking the project into smaller tasks and setting realistic deadlines could help avoid any last-minute issues. In addition, staying…   Read more»

In medical device development, project managers must find a balance between sticking to the project plan and making room for new ideas. One way to handle this is by carefully reviewing incoming innovations and see how they might affect aspects…   Read more»