Managing product requirements for medical IT products

In this paper we shall describe our experiences over several years in improving the product requirements management process in an industrial environment where information technology products are made for use in hospitals and clinics. Central to our approach is that we have introduced an improved product requirements management process and supporting tools on a step-by-step basis. This policy of "evolution rather than revolution" is necessary to build stakeholder confidence in the new approaches and not to hinder on-going product development. During this time, we have transformed the process from being one of managing documents filled with requirements to a more efficient process where the requirements are managed in a database and are published into documents for release projects. The availability of better quality product requirements at the start of a release project has contributed significantly to improved project leadtime estimation for the feasibility phase-potentially improving the time to market and human resource usage.