A | SINGLE-USE TECHNOLOGY HAS ENABLED FLEXIBLE MANUFACTURING SCALES, and pre-fab modular labs and cleanrooms have improved facility remodel/ build speed. The role of continued process verification (CPV) to identify and control sources of variation drives improved process robustness. The FDA’s Pre-Certification Pilot Program should streamline software as a medical device (SaMD) approval. A structured innovation framework with early, frequent, and fully integrated support from internal functions such as development, manufacturing, and quality (and from the regulators) is critical for enabling faster and cheaper solutions that are suitably robust for the critical products we supply.
CHARLENE BANARD is former head of quality, technical operations at Shire. Sam Kitchell, former head of engineering at Shire, assisted with this answer.