In my opinion, communicating via email is much better than Teams in a project management context. In my own work, there are some projects I have been involved in for years now. Often, communications c...

Designing a good verification protocol is a key aspect of project development. An effective verification protocol will ensure that the project scope is fulfilled and stakeholder expectations are met. ...

As briefly previously mentioned here, one big obstacle that can occur during the project initiation phase is lack of regulatory understanding. Medical devices are subjected to strict regulatory consid...

I have worked on a project before that faced some major scheduling complications. In my case, we noticed very late in the project that a manufacturing device we had used early in the project had been ...

I totally agree with the points you made in your post. It is crucial to develop both an effective and realistic schedule. As you briefly mentioned, a great way to do this is by using Gantt charts. Whi...

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: 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 ...

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...

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 b...

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 ...

This week in class, we had our first project simulation. The goal of the simulation was to determine how to modify a testing protocol to identify what was causing a failure in the label adhesive. One ...

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 tha...

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....

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 ...

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...