Hi everyone. My name is Kelsi, and I am a BME PhD student at Rutgers. I would love to connect with you all on LinkedIn:
http://www.linkedin.com/in/kelsi-petrillo
Thanks!

A very useful tool for managing scheduling in project management and medical device development is the Gantt Chart. Gantt charts can be used to visualize the timeline of a project. They give valuable information about which tasks must be finished…   Read more»

As previously mentioned above, there are many negative consequences of having a poorly designed project proposal: misused resources, shareholder disappointment, projects delays, etc. I have never been apart of a project with this challenge, although I have some ideas of…   Read more»

I have worked with Gantt charts previously on medical device projects and believe they have more benefits than limitations. In my experience, one of the biggest cons of Gantt charts is that they can be tedious/ time consuming, especially early…   Read more»

DSDs include the key features of the device and outline in which conditions a device can not fail. Therefore, changing the DSD would almost certainly have implications of requiring changes within the verification testing as well. As mentioned in the…   Read more»

As has already been discussed, I agree that it’s important to test a variety of conditions. This way, you can mimic more common/ “real world” settings and also test the limits of the product. With that being said, in the context…   Read more»

As mentioned, matrix structures can lead to power struggles/ conflicting priorities, however, there are many ways an organization can mitigate conflicts without compromising efficiency and compliance.  1. Create clear roles and guidelines for all projects. “Power struggles” will most likely…   Read more»

I completely agree with the information you have included here about efficiently managing design change requests. I would expect that design changes are quite common in medical device development, so it is critical for companies to consider how they will…   Read more»

An important consideration when deciding to use in house or external consultants is the longevity and size of the company. If the company has prior experience with similar devices, developing in house consulting will probably be more efficient since they…   Read more»

In my experience, time is the most difficult aspect of a project to control. I had a personal experience with this when I was working on designing a medical catheter, which was designed to burst at a certain pressure to…   Read more»

As mentioned throughout this thread, it is critical to consider regulatory restraints early in the design process to have effective project management. However, I believe there may also be some advantages in waiting until later in the process, even though that…   Read more»

I don’t believe anyone is born ready to be a leader without actively working towards that goal. As many people have mentioned in this thread, there is a lot of practice and experiences that must occur first to shape a…   Read more»

I would like to expand on an idea that has been briefly mentioned in this thread, which is the idea that “toxic workplace culture” may be a largely subjective term. One example of this that I often see debated is remote…   Read more»

One of the commonly mentioned strategies in this thread is to meet with all involved parties and work together to find a solution that will appease everyone. While I believe that’s a great idea, my own experiences have taught me that…   Read more»