There was a time when diagnostics used basic chemistry to produce “yes” or “no” results. Today’s IVDs use complex technologies and sophisticated computer models to produce risk scores, predictions and prognostic evaluations as well as critical diagnostic calls.
Product development requires design discipline and rigorous development methodology. To emerge from development with an assay that meets the right intended use, you’ll want a robust process for establishing design requirements and ensuring that they are met.
Reducing Time and Cost to Market
Design control is much more than just a checkbox item for regulators. It is a key way to demonstrate strong value to investors, partners, customers and payers. When design control is approached thoughtfully, it is one of the key processes an early-stage company can embrace to give them a leg up on their customers.
Well-crafted design control imposes a powerful focusing effect on product development efforts. This focusing effect not only improves product quality, but also reduces time and costs to market by eliminating expensive late-stage gaps.
Design control is not required at the early stages of product feasibility, but there aren’t many good reasons to wait. You will need it eventually and if it’s integrated from the beginning of the development process, it can yield real value instead of simply being an additional expense. However, if design control wasn't part of the original design environment for a product, a process of retrospective design control may be applied if regulatory goals are identified late in the development process.