As discussed, arbitration, mediation, and jurisdiction clauses certainly influence consulting relationships, even before any conflict arises. However,...

Ring fencing is both a stabilizing strategy for company acquisition and a formidable source of frustration for employees. Fiscally, it makes sense for...

I certainly agree that documentation, from consulting agreements to time logs/deliverables, is critical as a clear, auditable trail connecting payment...

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...

An important dimension to consider is how risk-based approaches guide companies in retrospectively building a DHF for legacy products. Legacy devices ...

The Therac-25 disaster serves as a poignant reminder of the vital importance of design controls and verifications in medical device development. I rea...

I wanted to add that the way design controls are perceived also goes a long way. A lot of tension is generated, I think, when design controls are view...

When transferring design controls to a contract manufacturer, it is critical to maintain traceability and design intent throughout the production proc...

An interesting perspective is how emerging development models (e.g., human-factors-driven design) are reshaping the distinction between verification a...

Another perspective to consider is how regulatory and ethical obligations can affect the balance between user needs and business constraints. In other...