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»

I definitely agree that the choice of matrix structure should depend on the project, rather than being a one-size-fits-all situation. Reading the responses, I see that a strong matrix is preferred in highly regulated projects as it would enable faster…   Read more»

I think the way you outlined that the balance of power between project managers and functional heads as the critical factor of whether matrix organizations works or does not is quite strong. Furthermore, I actually thought your examples highlight something…   Read more»

The key to determining whether a risk is truly worthwhile lies in evaluating how integral that risk is to the product’s intended use. However, it is crucial to strike a balance between ethical responsibility and technological progress. For example, in…   Read more»

I think everyone made really strong points about environmental conditions, user error, and maintenance being major risk factors for AEDs. I would like to introduce the additional risk of patient-specific failure in electro-pad adhesion. For example, excessive body hair, sweat,…   Read more»

I really appreciate how many of you emphasized that the success of risk management ultimately depends not just on structure, but on how all participants are invited to engage. Personally, I believe that the combination of preparation, rotating facilitators, and…   Read more»

An important dimension to consider is how risk-based approaches guide companies in retrospectively building a DHF for legacy products. Legacy devices already have a level of technical documentation, however, the focus has been more on demonstrating current safety and effectiveness…   Read more»