One technique that is truly effective is the work authorization system because it acts as a checkpoint or transition between the planning and action stages. A team may have reliable communication and ...

Project management information systems can be argued to be the most essential strategy since they are the central point where aspects such as planning, execution, communication, and accountability all...

Along with avoiding lack of communication and understanding the project requirements from the start, I would like to add that another challenge can occur in the development of a design phase. There ca...

In industry, a PM can rely on types of structured experimental strategies instead of trial and error. The simulation provided the opportunity to set out experimental designs to test our parameters. In...

It is also essential to consider a different perspective when it comes to coming back to the previous phase in a project. Overall, it is much less about the quantity of deviation of a project and more...

An interesting perspective that can be overlooked is how individuals who never interact with the project can still be a stakeholder since they are integral to being affected as a general byproduct of ...

As mentioned, estimation failures can be detrimental in the planning phase of a medical device since they can disrupt budgets and timelines but also the confidence of stakeholders. Compared to general...

A PM has the responsibility to balance FDA expectations, shareholder pressures, and consumer needs. The way they may tackle these objectives is by prioritizing regulatory compliance and patient safety...

An essential difference when it comes to constructing a WBS for medical devices is that it should be built around regulatory readiness as an ongoing process instead of a final step. In a general engin...

I agree, a certification can be complementary to a degree, especially for a PM. However, I would argue that it is also a representation of how much resilience a PM can have through the changes and fas...

I agree with Krish, a DHF is evidence that the developed device meets regulatory requirements. I would like to add a different perspective as well. It is also worthwhile to question if a DHF is actual...

As others have mentioned, a methodology for design review can be crucial when assessing changes from a completed project. A perspective that can also be considered is the importance of decision struct...

Another impact to organizational structure that can be considered, it how accountability and making decisions can speed up a project, especially when there are technical risks and challenges that aris...

A new concept that can be discussed is design controls and regulatory documentation and traceability when animal data affects the product's timeline. In a Class III medical device like the bio-absorba...

In development lifecycle of a medical device, one aspect that hasn't been discussed is how the development life cycle affects verification and validation. As mentioned, development lifecycles can be p...