Echoing several responses above, the PM has many important responsibilities. However, I believe that these responsibilities would not be as challenging as communicating effectively amongst all departm...

This type of scenario was part of the mini-sim this week in which we were asked to deal with delays in timeline which happened due to incorrect task duration. Creation of WBS and task duration is a cr...

One of approaches to take would be to look “easy” fixes first (e.g. improve packaging configuration first, then propose modifications to the device, then propose modifications to the combination produ...

Risk/ Benefit Ratio is an assessment of the risks against their benefit. Ideally the benefit has to outweigh risks in order for the company to accept the risk. Typically, risk analysis has a qualitati...

A successful project will include risk management as part of planning phase. As stated by the professor, "if you fail to plan, plan to fail". Risk management will help the company anticipate issues/ p...

It seems the company has a lot to worry about and updating the Gantt Chart may be the last of their worries. The balloon pops immediately instead of lasting for days could be a catastrophic issue and ...

I think another great example of process group within medical device are product complaints and change control that fall under monitoring and controlling process group. This continuous monitoring prov...

As mentioned in today’s lecture, often companies disregard project management with design controls thinking they are one and the same. This leaves gaps that can implicate the success of the project. T...

The marketing team typically identifies the need based on market evaluation for a new product to be developed and often provides design inputs mostly from VOC (voice of customer). However from my expe...

Selection of the members of the project team is extremely important in several ways. Obviously you desire the project team to be composed of people a high level technical knowledge/ skills from all fu...

Based on the PMBOK, there are five phases of project management. Phase 1; Project Initiation - This is the start of the project, and the goal of this phase is to define the project at a broad level. T...

In my opinion, it is very important that projects are properly prioritized and that every member of the team understands the details around priority that the project holds. Ultimately, successfully p...

In agreement with some of what was described in previous posts, if the manufacturer is not the one claiming that the TJA total joint arthroplasty can be used while performing high intensity or extreme...

I believe no matter how flawless a medical device design and manufacturing process is, there is still potential for users to be harmed (e.g. use error). That said, the manufacturer is responsible for ...

Verification and validation are distinct, but related activities that combined demonstrate through objective evidence that the medical device meets the design requirements defined and the medical devi...