Gantt charts are useful tools to help you keep track of what tasks are on schedule, behind schedule, or ahead of schedule as well as providing an estimate of how long tasks should take. Medical device...

This week we discussed various strategies to help with plan execution. These broadly include general management and product skills, work authorization systems, status review meetings, project manageme...

To prevent scope creep, eliminating vague statements when outlining the scope of the project, establishing an agreement with the customer about how changes can be implemented, and ensuring clear commu...

I second what yg385 said. Team members should be aware of the time and energy requirements of a project and plan accordingly. In the case of major life events that would shift their ability to complet...

Hello! Nice to meet you all. I'm a senior undergrad in the biomedical engineering BS/MS program (biomaterials concentration) at NJIT.

For my capstone project, many of the delays we ran into were communication-based. We needed to order chemicals, but since we had an external sponsor (and therefore external payment), we had to go thro...

I don't know if there's a good reason to keep the PM out of the loop financially. Everything in a company relates to finances. "Time is money," and when it comes to the development of a medical device...

When creating a medical device, key expectations are to be met that are held by the FDA, shareholders, and customers. Especially for Class II or Class III devices, the FDA regulatory pathways can take...

I think what is useful about the FDA regulatory aspects of medical devices is that once your device class and required documents/steps are determined, there is a relatively clear pathway that your tea...

If members of your team are working on multiple projects, it may be useful to speak to the other PMs to get a sense of the project timeline to ensure that the project has people available to work on i...

As Dev said, there should be multiple design review meetings and controls such that there is no need to return to a completed phase. If a PM and their team are thorough, and the proper design document...

I think that certifications without the degree to back them up don't really mean anything in an industry setting, whereas someone with a degree (say a Bachelor's in Biomedical Engineering) would likel...

I agree with Krish that the PM's role combines task management with the objective of completing the DHF and compliance assurance. While the PM shouldn't be the only one focused on compliance, when try...

I agree with Ehab that changing the DSD may not be necessary in this case due to the nature of its stipulations not including that the water bath had to be 37C. Additionally, if the DSD is changed any...

In the first simulation that we were given this week, we met with an issue where a part of a product failed verification testing, and we had to propose ideas to rectify that. In a real-world situation...