White Paper
The State of Materiovigilance: Capability Gaps, Technology Momentum, and Outsourcing Readiness.
How pharma, biotech, and MedTech organizations are adapting to growing device safety complexity, regulatory pressure, and the need to scale through technology and partnerships.
Feb 26, 2026
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Materiovigilance is entering a period of rapid change as pharmaceutical and biotechnology companies increasingly bring drug–device combination products, companion diagnostics, software, and digitally enabled delivery technologies to market. This research report focuses on how pharma and biotech organizations are adapting to the expanded scope of device-related postmarket safety oversight, drawing on findings from IQVIA’s 2025 Materiovigilance and Technology Adoption Survey conducted by Citeline.

The results show that many pharma and biotech organizations, particularly those new to managing device and combination product safety, remain early in their materiovigilance maturity and are working to close gaps in expertise, processes, and technology while navigating rising global regulatory complexity. The report highlights how outsourcing and technology adoption are becoming central strategies for pharma and biotech companies seeking to scale combination product portfolios with confidence, efficiency, and regulatory consistency. It examines where capability gaps persist, why regulatory pressure is now nearly universal for organizations operating across drug and device frameworks, and how external partnerships and AI enabled solutions are shaping the future of combination product materiovigilance.

Download the full research report to understand the trends influencing materiovigilance today and what they mean for pharma and biotech organizations responsible for safeguarding patients across increasingly complex, integrated product portfolios.

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