As discussed, arbitration, mediation, and jurisdiction clauses certainly influence consulting relationships, even before any conflict arises. However, one area that particularly deserves emphasis is p...

Ring fencing is both a stabilizing strategy for company acquisition and a formidable source of frustration for employees. Fiscally, it makes sense for purchasers to seek protection for their investmen...

I certainly agree that documentation, from consulting agreements to time logs/deliverables, is critical as a clear, auditable trail connecting payments to legal services rather than product influence....

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 cove...

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 ...

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. Furthermo...

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 respons...

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-speci...

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 th...

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, h...

The Therac-25 disaster serves as a poignant reminder of the vital importance of design controls and verifications in medical device development. I realize that modern frameworks (e.g., IEC 62304 and I...

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 viewed simply as a regulatory burden rather than a way...

When transferring design controls to a contract manufacturer, it is critical to maintain traceability and design intent throughout the production process. Even if contract manufacturers have strong QC...

An interesting perspective is how emerging development models (e.g., human-factors-driven design) are reshaping the distinction between verification and validation. In traditional systems, V&V has...

Another perspective to consider is how regulatory and ethical obligations can affect the balance between user needs and business constraints. In other industries, such as consumer technology, compromi...