Chicken and the Egg: Developing Input Requirements for First of a Kind Medical Systems | Tor Alden

Tor Alden will focus on the research and discovery challenges required for adoption of first of a kind complex medical systems that need to follow regulated documentation controls for FDA. There is a need for increased collaboration in the design of complex systems in the medical and lifescience device development. The ability to capture user needs and balance them with technical requirements runs concurrently with the development of the requirement documents. All too often there is a question of what comes first. How companies navigate through the front end of next generation devices is critical in establishing a well-written requirement document. Additionally, a wide variety of information from contextual inquiry needs to be transferred to various disciplines. In some cases, trade offs are required based on initial technical and use requirements. In most cases, the design team must transition the research under design control to capturing workflows, process and user needs to multiple disciplines, including industrial design, user experience, user interface and engineering.  The information acquired must feed into URS, PRD and SRS documents. There is a “chicken and egg” approach that requires immersion into the technology as well as new unmet needs and opportunities.