AI-Driven Product Life Cycle Management in Combination Products
EducationalTHE NEXT FRONTIER IN COMBINATION PRODUCTS
2026-05-28 | 10:20 AM - 10:35 AM | TPD Room
Abstract
In regulated healthcare environments, Artificial Intelligence (AI) creates value when it strengthens human expertise; AI supports, and humans decide. Responsibility, regulatory judgement, and strategic decisions remain human. What AI brings is speed, structure, and the ability to process complex and fragmented datasets at scale. When positioned as an augmentation tool, AI enhances consistency and enables teams to focus on risk-based decision-making rather than manual data handling.
For pharmaceutical stakeholders working with primary packaging, secondary packaging, and drug–device combination products, this structured approach extends across the product development lifecycle. From design optimisation and usability insights through to manufacturing reliability and real-world evidence, AI enables earlier risk identification and more informed decisions leading to increased speed of development and lifecycle optimisation.
Within the Quality Management System, teams manage growing volumes of documentation, post-market data, and audit expectations. AI can, for example, improve the efficiency of these processes by accelerating document impact assessments, strengthening traceability, supporting structured complaint analysis, and enhancing audit readiness. When AI solutions are implemented within a defined regulatory and normative governance framework, with clear intended use, validation strategy, and continuous oversight, it reinforces compliance while improving efficiency.
Connected ecosystems further illustrate how big data analysed using AI can generate measurable clinical, operational, and economic value, while preserving human oversight and regulatory integrity.
When strategically governed and properly validated, AI transforms complexity into clarity and supports sustainable growth across the entire product lifecycle.
