For non-PMs, the understanding of project management concepts strengthens one’s risk ownership, even without formal authorization. In engineering roles, small decisions such as selecting certain materials or sizes, adjusting tolerances, or delaying tests can create downstream risks that aren’t immediately…   Read more»

System-level accountability is essential, and it covers aspects that involve a larger group of individuals who are underperforming along with individuals. At times, underperformance is less about the individual and more about how success is measured or supported in the…   Read more»

The decision is usually driven by the overall risk and the long-term cost instead of the unit price. Although it may seem reasonable to spend time investigating and finding a solution to a defect with a low-cost supplier, the effort…   Read more»

Agreed, blaming a specific person isn’t productive; instead, looking for a direct solution or remediation is most suitable. In many cases, elements such as site selection and early-stage predictions can keep problems from arising. In clinical trials, underperformance can be…   Read more»

Companies usually rely on the informal leverage systems when legal protection is not effective. Even though there aren’t any explicit quality clauses, vendors are usually part of a larger network where reputation, contracts, and long-term partnerships are a priority. Companies…   Read more»

COVID-19 is a special case where vaccines were able to achieve that “fast, good, cheap,” result compared to how it works traditionally. One difference is that instead of resolving all uncertainty before the approval, there was risk that was acknowledged,…   Read more»

A way PMs can make an informed decision between utilizing crashing and fast-tracking is by questioning which decision is more reversible if something goes wrong. For example, since crashing means adding resources or supplemental support, then it can be scaled…   Read more»

Similar to Sami, in my time working as an intern at a medical device company, I was onboarded into a team at a later stage of a project, before FDA submission. One part that I believe is overlooked is when…   Read more»

One way a PM is able to navigate an unknown budget is by integrating changes that are centered on structured prioritization, phased decision-making and proactive escalation instead of waiting for a full budget before executing. If new regulatory requirements or…   Read more»

One of the most difficult parts when it comes to working on a team project is maintaining team alignment as the project evolves. This also includes all stages of product development, from planning to production. As other commenters have stated,…   Read more»

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»