I do not think quality control is intentionally avoided in small projects, but rather it is scaled differently based on available resources and the level of risk involved. Small projects do not have the resources for dedicated quality teams or…   Read more»

Initially, Project Managers should evaluate both the critical path and whether the time reductions in the overall project schedule will be impacted by the reductions before determining if they will crash or fast track an activity. In general, when crashing…   Read more»

My view is that creating effective teams can be accomplished without spending a fortune; there are many low-cost options available that can make an impact if done correctly and meaningfully. Project managers should focus on providing development opportunities for team…   Read more»

Selection of whether to hire within or externally for a project manager may rely on each individual project’s uniqueness; however, there can be many advantages to hiring internally. These advantages include: familiarity with the company’s processes, culture, and expectations—leading to…   Read more»

In my opinion, giving a product its license before verifying it is unethical because it will directly impact the safety of patients in biomedical manufacturing. Regardless of any marketing or stakeholder pressure, speeding or skipping over the verification testing puts…   Read more»

I have found when project delays are due to events outside of a team’s control, reassessing the project plan is the most effective way to determine the actual critical path of the project. When there are major milestones being delayed…   Read more»

General management and communication skills are vital for effective execution of plans because the methods used to complete the plan (such as work permission systems, status meetings and project management systems) are all reliant upon how well the project manager…   Read more»

It is essential for a project manager to manage expectations among the investors (shareholders), the FDA, and the customers (patients), and this requires that they prioritize compliance with regulatory requirements and the safety of patients. The requirements of the FDA…   Read more»

In the event that a defect spike occurs during the validation phase, I think that the first thing that should be done is to formally document the defect either through deviation or non-conformance instead of continuing normally. Continuing to validate…   Read more»

Although each phase is critical, the most important phase in the project process for longitudinal success is the planning phase, as it is when the project proposal, scope, and requirements are established. Such items are crucial as they set the…   Read more»

The first step to effectively balancing expectations from all involved bodies (e.g., FDA, shareholders, and consumers) is for the PM to recognize that all these groups value different outcomes. Regulatory organizations are focused on safety/compliance, shareholders focus on ROIs, and…   Read more»

The phrase “everything is about risk” in risk management refers to the habit of organizations to contextualize decisions, meetings, and discussions around identifying/evaluating potential risk. Such a mindset is critical in the medical device industry, however, it can be excessive…   Read more»

@mmd55 You definitely bring up an interesting point about the relative importance of resources vs. management oversight in a project’s early stages. While having funding or other resources is definitely and obviously required to initiate many projects, effective management makes…   Read more»

A way companies can reduce the cost of returning to earlier development phases is through strengthening early-stage planning and risk identification. This can be facilitated by thorough design reviews, failure mode and effects analysis (FMEA), and early prototyping. As teams…   Read more»

A WBS definitely facilitates better project planning via facilitating the organization of a complex project into smaller and more clearly defined tasks that can be more easily managed and tracked. By deconstruing the total scope of work into a hierarchy…   Read more»

One aspect of EVM that has yet to be discussed is its value in forecasting, not just monitoring. EVM can certainly convey whether a project is ahead or behind, but it can do more than that. EVM enables PMs to…   Read more»

Another way to consider the distinction is to focus on what event is being protected. In FS dependencies, you are protecting the start of the successor task, since these tasks cannot begin until the predecessor task is complete. Thus, these…   Read more»

An additional way to mitigate financial pushback in front-end R&D could be to rework the product architecture before assuming the business case is fixed. Rather than presenting a high-COGS device as the only option, teams should explore modular design, platform…   Read more»

In medical device development, the PM’s responsibilities definitely expand beyond traditional management, but I would not say they shift completely away from it. Instead, I think compliance assurance is embedded in task management itself, as the DHF is not just…   Read more»

For a project to return to a previously “completed” phase in the PDCA cycle, a PM needs strong skills in risk assessment, change management, and stakeholder communication. This is an extremely expensive and frustrating process, financially and politically. In such…   Read more»