ABSTRACT:

FDA-mandated design controls for medical devices provide a structured, systematic engineering paradigm that supports human-centered systems engineering. Engineering design controls are nothing more than the fundamental elements of classical systems engineering. The human focus is enabled through the iterative reidentification of stakeholders, reassessment of their NWDs, and reconciliation of their evolving/conflicting NWDs. The implementation of design controls and embedded risk management must begin prior to commercial development to reap the full benefit of the approach; partial approaches dilute or negate the effectiveness and efficiency of this nearly century-old systems engineering paradigm. Properly employing engineering design controls is a strategic business decision. The central value of this proposition is the reduction of economic, technical, and operational risks for both producers and consumers; regulatory compliance is a secondary benefit. Misuse or abuse of design controls only undermines long-term profitability and increases the risks to the consumer.