This is funny to me because I've discussed this exact topic where I work. Someone joked to me that in the summary emails following a meeting, they would include a very brief 2 sentence recap for one o...

Team dynamics play a crucial role in the success of project execution. We can see that in the mini sim we were assigned this week. One team member who was the liason of all business management favored...

I agree with the statements the prvious posts mentioned. I think that patient-reported outcome measures (PROMs) are a great way to identify any issues in a medical device after it's released. However,...

This week, we had our second simulation assignment. It focused on creating a viable injectable bone growth factor syringe. BoneFix, an orthopedic company, was looking to expand its biologics division ...

Emails are a much more formal mode of communication. I typically use it when sendging out formal requests, meeting minutes, or need to contact multiple people. I also use it when I am contacting peopl...

I definitely agree. Having a good grasp on business and strategy can also allow project managers to know which areas to prioritize. For example, if they know a competitor medical device company will a...

This is a really great topic, and I do think that the answer to which types of risks are more predominant and the most impactful depend on the industry. I think that finanical risk and reosurce risks ...

Another very useful tool is the Work Breakdown Structure. It essentially helps define the project scope better and breaks it down into the larger functions and their tasks. This can help with making s...

I agree with the posts above. Indentifying the critical path will aid in a seamless execution of the project. Another tool I find to be helpful is a prioritization matrix. It will allow the stakeholde...

Gantt charts are a great tool especially for sticking to the project timeline in a visual manner. However, sometimes these charts do not offer flexibility in terms of deadlines. There are many ways Ga...

Some other things to keep in mind are ensuring that you are up-to-date with all the regulations and standards/qualifications that must be met. The FDA is constantly updating so it is important to be i...

Hi everyone! My name is Priyanshi Luhar and I'm a student at NJIT in the BS/MS program studying biomedical engineering. I'm also currently doing a co-op at Ethicon in GTO/engineering. Looking forward ...

I agree with the points above. Changing the DSD is a more difficult process compared to the test veriffication plan. However, my decision on whether or not it would be appropriate to change the DSD wo...

My group performed similarly. We took a more collaborative approach. We first did a root cause analysis and identified the areas of error that could have contributed to the testing failure. From that,...

You bring up a really good point that I think is highly debated in this high stakes industry. Medical device developers will try to increase the scope and range the devices are usable to maximize usab...