Ideation
At the ideation phase of a medical device, innovators define the clinical need and begin shaping a regulatory and development strategy to guide the path forward.
Regulatory Strategy and Regulatory Assessment
At the Ideation phase of the medical device lifecycle, innovators and entrepreneurs should begin shaping a regulatory strategy and conducting a preliminary regulatory assessment. Developing a well-informed and forward-thinking strategy is essential for establishing a realistic go-to-market timeline and development budget. Early regulatory planning not only guides technical decisions but also helps de-risk the program in the eyes of potential investors, strengthening your position during fundraising efforts.
Quality Management System Strategy
Medical device companies should also start planning their quality management system strategy. Every innovator and entrepreneur want their medical device to not only get to market as quickly as possible, but they want it to stay there. A compliant quality management system is necessary to ensure that happens. The quality management system regulations provide a framework, and it’s important to apply this framework appropriately to your organization and your product(s) to ensure that compliance is not achieved at the expense of being burdensome. A quality management system strategy will tell you what you need and when. You do not need a full quality system at the outset. It’s important to phase-in your quality system as development progresses so that resources are allocated appropriately during the project. QMS elements we would recommend at this stage to facilitate success at the next phase are Document Control, Employee Training, and Procedures for Purchase.