I think predictive development life cycles work most aptly in highly regulated industries, such as medical devices, when requirements and regulatory p...

Design reviews and design change requests are most integral during the Check and Act phases. During the Check phase, verification activities are perfo...

When design controls and project management are segmented, gaps may be created that could affect verification, validation, and design reviews. If sche...

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 ...

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 conversati...

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...

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'...

I certainly agree that most interpersonal conflict may arise from misalignment rather than dispositional differences. Misalignment may stem from expec...

Project management is certainly a very demanding role, uniquely situated at the crossroads of biomedicine, regulation, and team coordination. Given it...

I agree that medical device companies must prioritize patient outcomes and cost-effectiveness to run their corporations and practice efficient, value-...

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 resp...

I think the way you outlined that the balance of power between project managers and functional heads as the critical factor of whether matrix organiza...

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 c...

I think everyone made really strong points about environmental conditions, user error, and maintenance being major risk factors for AEDs. I would like...

I really appreciate how many of you emphasized that the success of risk management ultimately depends not just on structure, but on how all participan...