Cognitive Engineering – The Tools, Mindset, and Strategy for an Integrated Development Standard
Internet technology facilitates connectedness but often fails to foster collaboration. Advanced modeling techniques can provide insight for development discussions, but in many cases, these tools infrequently result in integrated knowledge for real time decision making. Cognitive engineering (CE) fuses human expertise and creativity with technology and provides the strategy for maximizing human, company and product potential. CE is based on a classic model of strategic decision-making – the OODA loop (observe, orient, decide, act). The power of the OODA loop exists in its conversion of information to knowledge, and the communication of that knowledge, in real time, to a global team at key milestones when flexibility still exists to rationally adjust or change course. The successful implementation of CE has three critical components: aggressive data management and assembly processes; innovative data analysis, modeling and simulation strategies; and capability to engage globally dispersed teams in the use of knowledge. CE requires individuals to function at a demanding and creative level. However, the use of generated knowledge often challenges pre-conceived notions of the desirable dosing and development strategy and the collective bias that may exist as to whether a target product profile is being met. Failure to generate, critically evaluate, and utilize knowledge at critical milestones can result in lost opportunities.
American Society for Clinical Pharmacology and Therapeutics (ASCPT); Atlanta, Georgia; March 2002
By Thaddeus H. Grasela