I agree with everyone else. It is important to not rush the project process. Each and every step needs the proper amount of time to ensure proper documentation is covered, quality is ensured after appropriate testing, and other key factors….   Read more»

I think it is important to maintain proper communication and be transparent of the current issues. A project managemer should approach leadership with a plan on how the team will mitigate the challenge. A plan shows that the team is…   Read more»

Some things to consider when choosing a vendor are quality, timeliness, compliance to regulatory standards, communication, prioritization for patient safety, cost, and more. A vendor needs to understand exactly what the company is requesting and be able to deliver on…   Read more»

I think this is a great point of discussion. I find myself asking this a lot. I think both roles require a different skillset. Engineers/scientists require more technical knowledge and working with different softwares. Project managers require more poeple skills,…   Read more»

This is a tough question to answer. To provide encouragement on professional growth, a goal is necessary. So without any scope of a promotion or development, it would be difficult to stay motivated. Moving up in a company is more…   Read more»

Something I’ve seen managers do a lot is have regular 1:1s with people and then recurring team meetings where people can bring up any concerns that they have. Something important is for the managers to create a welcoming environment where…   Read more»

This mini-sim showed great importance of procurement management and risk management. I think it is better to have a backup plan and vendors so in case something goes wronge, you are prepared. I see in many cases where a supplier…   Read more»

I think it is fair for companies to encourage their suppliers to comply with more ethical standards. For example, using more ethically sourced materials. However, if the suppliers disagree, companies should have other suppliers in mind that they can use….   Read more»

In my opinion, I think the 3 knowledge areas that are most important are quality management, risk management, and integration management. Quality management is a very critical area and procurement doesn’t matter if they aren’t of high quality. Quality regulations…   Read more»

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»