Medical Device Design and Development Cycle Process Map
Where does the cost of change really creep in during medical device development? Design iterations obviously become costlier, the later they happen. However, what isn’t always appreciated is that the cost is not just confined to the redesign work required, this may be relatively minor, compared with the cost of gathering additional preclinical data and clinical evidence, to demonstrate the safety and performance of the new design.
Our process map traces the journey from initial concept through to first Technical Documentation submission. Risk analysis, standards assessment, and design traceability run continuously. If you get these right early on, your design will be more stable, testing more predictable, and the final Clinical Evaluation / Investigation costs will be a fraction of those that result from multiple, late redesigns.
The point is not to avoid design iterations, these are virtually inevitable and are a good thing when they lead to device improvements. It is to make the important changes while the device is still a prototype, before you have generated preclinical and clinical evidence (at some expense), against a design that then has to change in response to the data obtained.
