Generative AI in MedTech: Five Predictions for the Next Five Years
Medical device manufacturers have moved beyond asking whether generative models can draft text. The more consequential question is how these models will operate within design control, clinical evidence generation, regulatory affairs, quality systems, and post-market surveillance without weakening accountability. Over the next three to five years, the winners will not be the companies with the most pilots. They will be the manufacturers that connect artificial intelligence to governed product data, validated workflows, and named decision owners while preserving the traceability expected under ISO 13485, ISO 14971, 21 CFR Part 820, and regional market-authorization regimes. The emerging discipline of Generative AI in MedTech therefore needs to be understood as a lifecycle capability rather than a standalone writing assistant. Its value will come from reducing the friction between user needs, design outputs, verification evidence, clinical conclusions, submission content, manufacturing r...