Bringing a new medical device to market is a marathon of market analysis, design, verification, and regulatory hurdles. AI is now slipping into these steps to remove bottlenecks and accelerate the entire process.
In the Define & Measure phase, NLP tools sift through literature and clinical data in minutes, providing insights that used to take weeks. AI-based patent searches uncover emerging materials and mechanisms.
During Analysis and Planning, regulatory intelligence tools map requirements to product features, while ML-based project management predicts delays. Generative design tools can produce dozens of viable options for engineers to evaluate.
In Design & Development, digital modeling and generative CAD help explore design variations. AI suggests test conditions and failure modes, saving time on physical testing.
For Verification & Validation, digital twins model reliability behavior, reducing the need for repetitive physical testing. AI also supports usability testing by predicting human-factor risks.
Finally, in Regulatory Approval, GenAI tools help draft documentation like DHFs and CERs, potentially reducing effort by 20-30%.
AI is not replacing engineers but clearing friction points, making every phase of development clearer, faster, and more predictable.