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»

As you had said, Jacob, I think the longitudinal ROI in Project Management for degrees and certifications serves different, yet complementary functions. I certainly agree that PMP/Six Sigma gives you the immediate credibility and a standardized framework that employers recognize….   Read more»

Your example certainly highlights how verification failures often shed light on component selection and manufacturability issues rather than about the test itself. This certainly illustrates how the first time designs are truly tested against real-world constraints happens during verification. Thus,…   Read more»

An effective way to avoid such a situation would be to do integrate “version control checks” into the design change request process. For example, by mandating requesters to directly reference the document version/revision number prior to submitting a change request…   Read more»

Effective project managers can skillfully align business needs and customer satisfaction by rectifying organizational strategy and customer value. Typically, business needs and customer satisfaction are viewed separately. Business needs are focused on cost, efficiency, compliance, and fiscal growth, whereas customer…   Read more»

I think predictive development life cycles work most aptly in highly regulated industries, such as medical devices, when requirements and regulatory pathways are explicitly defined early. Their structure is one of their key strengths, including the incorporation of phase gates,…   Read more»

Design reviews and design change requests are most integral during the Check and Act phases. During the Check phase, verification activities are performed, enabling teams to assess whether outputs truly meet design inputs, user needs, and regulatory requirements, or only…   Read more»

When design controls and project management are segmented, gaps may be created that could affect verification, validation, and design reviews. If schedules prioritize speed over requirements, verification activities could deviate from original design inputs. Validation can be affected if user…   Read more»

The relationship between the project and the product life cycle is that the project life cycle is embedded within the product life cycle. The product life cycle encompasses the entire process from conception through development to market introduction and, eventually,…   Read more»

I have not formally worked in industry either, but I do have some knowledge of PERT and CPM in the medical devices industry, gained through conversations and internships. I certainly agree that PERT and CPM are rarely mentioned directly by…   Read more»

First, I certainly agree that a PM’s role goes past market release to monitoring outcomes and project value. For post-market management, the PM’s main role would be to shift to oversight and, more specifically, to translate feedback on complaints/CAPAs/regulatory updates…   Read more»

The most effective medical device PM would be a cross between a specialist and a generalist. Due to the cross-functional nature of MDD projects, a PM’s true value may come more from understanding the regulatory backbone of biology, engineering, and…   Read more»

I certainly agree that most interpersonal conflict may arise from misalignment rather than dispositional differences. Misalignment may stem from expectations or from the styles of communication employed. Thus, PMs should first try to understand the root cause of the conflict rather…   Read more»

Project management is certainly a very demanding role, uniquely situated at the crossroads of biomedicine, regulation, and team coordination. Given its current state, I don’t think there’s really an either-or in the debate of “technical skills vs. interpersonal skills.” A…   Read more»

I agree that medical device companies must prioritize patient outcomes and cost-effectiveness to run their corporations and practice efficient, value-based healthcare. The responses thus far have covered data analytics and partnerships with healthcare providers, which are needed to demonstrate measurable…   Read more»