Many medical device innovations begin with a strong idea, an early prototype, or a clear clinical need, but when is a concept truly ready for formal development and eventual design transfer?

This presentation explores the critical early-stage activities that help prepare medical devices for successful development. Topics include establishing lightweight quality system foundations, defining user needs, assessing technical feasibility, initiating risk management, and creating a practical development plan.

Drawing on real-world experience working with startups, innovators and medical device companies, the talk will provide practical guidance on building the right foundations before entering formal design control, helping attendees reduce risk, avoid costly rework, and improve their chances of development success.