Using questions in development

The question-based approach is designed to make the central issue in medical intervention development projects explicit rather than implicit. This central issue can be described concisely as “Have all the relevant questions been asked and answered adequately?” If so, a regulatory authority can confidently give market authorization. During the development period, managers can monitor the progress of the study by the questions that are answered and the length of the remaining list. Obviously, it remains important to answer these questions as rapidly and as cheaply as possible, but the tools for doing so should be in place in any sensible company.