Ideation
In the ideation phase of a diagnostic test, defining the intended use, target population, and clinical context is essential to guide development strategy and regulatory pathway selection.
Regulatory Strategy and Regulatory Assessment
At the Ideation phase of the IVD lifecycle, innovators and entrepreneurs should start to plan for a regulatory strategy and regulatory assessment of their test. Having an accurate and creative regulatory strategy for your final prototype design will be critical to establishing a 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
Diagnostic device companies should also start planning their quality management system strategy. Every innovator and entrepreneur want their IVD 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.
Laboratories need to start planning for CLIA, CAP and other accreditations, as well as New York State and other state requirements. Whether you are standing up a laboratory from scratch or moving in to a partly built or fully built laboratory, there are numerous facility commissioning, equipment qualifications, and personnel trainings which need to be performed in addition to the development activities for the assay itself. The assay needs to be scored accurately so that the requirements can be right-sized to the complexity of the test. Operations, quality, regulatory and clinical professionals must be in lock-step during this time to prevent undue delays and costly mistakes.