I agree with the previous posts that sometimes project delays and exceeding the budget is not always expected or at the fault of any team member. Rather, I would prefer delays and going over the budget over poor quality and…   Read more»

These cases highlight the importance of keeping up-to-date with newer regulations. As more research is done, certain things are found to be harmful or dangerous. The FDA is always updating their policies. Additionally, many small changes to a device after…   Read more»

I think this is a great point. For bigger projects that have a larger impact or cover something new (new line of medical devices for the company or international product), it is very important to document risks and lessons learned…   Read more»

Usually projects that start off will consider similar projects that were executed beforehand and learn about what worked well and what didn’t. Otherwise something that could be implemented is a dashboard of projects that were completed with supporting documents and…   Read more»

I think that regular meetings should be set (either weekly or biweekly) where regular updates are discussed amongst a team. However, in the case mentioned above, there was a crucial piece of information that was found outside of the regular…   Read more»

To add onto the previous posts, I agree with sending out an agenda prior to the meetings. It gives attendees an idea of what topics will be covered and if any preparation is required.A meeting format that I’ve seen work…   Read more»

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 of the project…   Read more»

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 time schedules and…   Read more»

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 is a more reactive approach and I…   Read more»

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 people for the first time as…   Read more»

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 also be laucnhing a similar product, they…   Read more»

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 are not as…   Read more»

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 sure that no task is overlooked. Forgetting…   Read more»

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 stakeholders and project managers to break…   Read more»

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 Gantt charts can be improved. For example,…   Read more»

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 informed of any changes that would…   Read more»

Hi everyone! My name is Priyanshi Luhar and I’m a student at NJIT in the BS/MS program studying biomedical engineering. Looking forward to connecting with everyone. I’ve included my linked in below:https://www.linkedin.com/in/priyanshiluhar/

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 would depend on if it…   Read more»

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, we listed ideas on which methods we…   Read more»