As medical devices become more connected and complex, materiovigilance is evolving to ensure patient safety. This process monitors and evaluates safety issues related to medical devices on the market, identifying concerns like malfunctions, usability, and software problems.
The Growing Importance of Materiovigilance
Unlike pharmacovigilance, which focuses on treatments, materiovigilance examines how users interact with devices in real-world settings. With the rise of connected devices and digital tools in healthcare, materiovigilance is becoming central to post-market safety oversight.
Dr. Padmalakshmi Jnaneshwar, Director of Safety Operations at IQVIA, leads teams supporting both medical device pharmacovigilance and drug safety. She highlights the challenges organizations face in building the capabilities needed for this expanded mandate.
The Execution Gap in Safety Operations
The life sciences industry struggles to turn digital ambition into results. According to Deloitte, only 22% of leaders have successfully scaled AI, and just 9% report significant returns. This execution gap affects teams relying on manual processes and fragmented data.
Materiovigilance teams must create processes separate from pharmacovigilance, focusing on physical devices. They require expertise in device design, performance, handling, and software updates, while also considering user behavior. These processes establish guidelines for intake, classification, and investigation of safety events.
For patients relying on medical devices, the impact of these processes is significant. A delayed or incomplete investigation into a device malfunction could lead to prolonged health risks, eroding trust in both the device and the healthcare system. Conversely, a well-structured materiovigilance system can quickly identify and address issues, ensuring devices remain safe and effective for long-term use.
Fragmented data complicates materiovigilance. Safety signals come from various sources, including call centers, manufacturing records, and healthcare providers. A unified data strategy, with common definitions and consistent coding practices, is essential for effective trend analysis.
While materiovigilance teams operate independently, collaboration with pharmacovigilance remains necessary, especially for combination products like insulin delivery systems. Integrated workflows help process events quickly and prevent information siloing.
AI and automation can significantly enhance materiovigilance by identifying duplicate cases, routing complaints, and detecting trends. However, their effectiveness depends on clean data and defined governance. Human expertise is essential for context, usability assessments, and validating conclusions.
Building a Robust Materiovigilance Framework
To establish effective materiovigilance, organizations must develop processes tailored to physical devices, distinct from pharmacovigilance.
AI’s Role in Enhancing Materiovigilance
Artificial intelligence is a valuable asset for the pharmaceutical industry, particularly in materiovigilance. It ensures consistency by classifying information according to established rules and workflows.
Data Unification and Collaboration
Fragmented data from various sources complicates materiovigilance. This approach helps teams understand data origins, classification, and access during investigations.
