From another perspective, project management tools are not only about having a planning aid, but they also work as a tool to support decision making through a system that shapes how a team can think about a project. As mentioned…   Read more»

Another perspective can be that the impact of changes to a project is not only about documenting and communicating the associated effects. The process also involves presenting the change as a choice with alternatives rather than a single solution to…   Read more»

It is also significant to take the perspective on how an overreliance on EVM metrics can also develop a false sense of control for everyone, especially in a highly complex project where progress can be nonlinear. EV, PV, and AC…   Read more»

In one situation I encountered, my team was working towards a hard regulatory deadline for FDA submission. Initially, as in most engineering projects, there was a built-in buffer time that made the timeline feel manageable. However, right at four weeks…   Read more»

The added advantage of a Gantt chart is that they are indispensable in the medical device industry since they not only map timelines but also make regulatory expectations visible compared to other project management tools. Medical devices are commonly developed…   Read more»

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 meetings; however, if a task is executed without…   Read more»

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 fit together. A PM has to be diligent at leading, delegating,…   Read more»

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 can be an instance where engineers can add…   Read more»

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 my experience, it is crucial for teams usually…   Read more»

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 about if the…   Read 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 the project. For instance, when it comes…   Read more»

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 engineering projects, medical devices have to meet strict verification,…   Read more»

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 above all while managing cost, risk planning, timelines, and communication. The…   Read more»

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 engineering project, compliance and testing usually…   Read more»

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 fast developing technologies that…   Read more»

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 actually the PM’s major deliverable…   Read more»

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 structures. This structure can relate to distinguishing between a…   Read more»

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 arise. In some instances, there can be weak functional decisions where…   Read more»

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-absorbable stent, since the dissolution rate can be directly caused…   Read more»

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 predictive however, there can be unpredictable setbacks that can lead to…   Read more»