Materiovigilance is the process of monitoring, evaluating and reporting on safety issues related to medical devices available to the market. This continuous monitoring helps organizations and regulatory agencies identify patient safety concerns regarding potential malfunctions, usability or even software issues. Unlike pharmacovigilance, which focuses on the safety of treatments and therapeutics, materiovigilance examines user interaction with devices in real-world settings. As connected devices, diagnostics and digital tools continue to merge with therapies, materiovigilance is becoming the discipline central to post-market safety oversight.
Building a Separate Operating Model
The challenge is that many organizations are still building the capabilities needed to support this expanded mandate. While pharmaceutical and biotechnology companies have deep experience in pharmacovigilance, device vigilance requires different workflows, expertise and evidence. A product issue may appear straightforward at first, but the underlying cause can sit within the device design, the software, the user interaction or the conditions in which the product was used. Without a clear operating model, teams risk reporting delays, incomplete investigations and compliance exposure.
The life sciences industry has already seen how difficult it can be to turn digital ambition into measurable results. According to Deloitte, only 22% of life sciences leaders say they have successfully scaled AI, and just 9% report significant returns. While teams understand the need for faster, more full safety screening, this execution gap impacts teams that rely on manual processes and fragmented data. To close this gap, materiovigilance teams must create their own processes separate from pharmacovigilance and focused on physical devices.
Dr. Padmalakshmi Jnaneshwar is Director, Safety Operations, in Lifecycle Safety at IQVIA where she leads safety operations, regulatory reporting and project management teams supporting medical device pharmacovigilance, drug safety for clinical trials and post-marketing products. Beyond biological or chemical interactions, materiovigilance teams must have deep expertise in every detail of a device, from design and performance to handling and software updates, while also accounting for user behavior. These new processes must establish guidelines for how teams intake complaints across channels and how these events are classified.
Standardization and Governance
Another critical factor in the development of materiovigilance is governance. Governance allows teams to coordinate with additional safety teams while ensuring clear ownership across safety, regulatory affairs, quality, clinical, manufacturing and technology functions. Without governance, teams may be unsure of what they are responsible for handling and critical information can fall through the cracks, leading to missed deadlines. Strong governance standards shift teams from a reactive, case-by-case approach to a proactive stance that enables coordinated decision-making across the entire product lifecycle.
Creating a unified data strategy does not require every system to be identical. What materiovigilance teams need to catch and analyze these signals is a set of common definitions, consistent coding practices and clear pathways for information to move between functions. With these baselines established, teams should have a clearer understanding of where relevant data originates, how it is classified and who can access it when an investigation begins. Fragmented data hinders the development of trend analysis because teams do not have full data sets.
While materiovigilance teams create new processes independent of their pharmacovigilance counterparts, some level of collaboration is still expected. Combination products, such as insulin delivery systems, often create safety questions that bridge the two operating models. Patients may submit complaints about adverse events related to their medication or comment on the quality of the device. In this situation, both materiovigilance and pharmacovigilance teams can leverage an integrated workflow that helps them process events quickly and mitigate the risk that information is siloed by one team or the other.
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When treated as a strategic capability, materiovigilance will be best positioned to deliver safe, reliable therapies to patients worldwide. Materiovigilance will mature when organizations bridge the gap between pharmacovigilance and device vigilance without losing specialized expertise. Strong standardization practices and disciplined technology adoption will also support that progress. With these foundations, materiovigilance can evolve from a reactive compliance function into a proactive driver of patient protection.
The Role of AI and Automation
One of the greatest assets to the pharmaceutical industry is the adoption of artificial intelligence. However, to truly unlock AI’s potential, materiovigilance teams must identify and apply it to clearly defined operational challenges. AI can prove its value by identifying duplicate cases or information, routing complaints to the correct teams or identifying trends that human team members may have missed. AI supports consistency by helping teams classify information against established rules and workflows.
Even as AI, automation and other digital tools make their impact on materiovigilance, human expertise remains essential. Human oversight adds the context that automated tools often miss. For example, materiovigilance teams may need to assess device usability or software performance. While AI and automation can quickly assess vast amounts of data and provide insights, human expertise is still the gold standard when it comes to reviewing outputs, validating conclusions and documenting the reasoning behind safety decisions.
The most effective use cases for AI will focus on quantifiable operational improvements. Teams should evaluate AI first in areas such as signal detection, compliance documentation and case completeness. Instead of being another digital tool that adds complexity to already strained workflows, AI provides materiovigilance teams with the capability to improve safety operations. Organizations should prioritize technology that is compliance-ready, audit-defensible and globally scalable. The most valuable systems are not necessarily the most advanced; they are the ones that support clear workflows, consistent classification, traceability and reporting across regions.
Regulators will continue to expect sound judgment, but they will also expect organizations to demonstrate how decisions were made and why they can be trusted. AI and automation can strengthen materiovigilance operations, but only when they are built on a controlled foundation that includes audit trails, role-based decision-making, version management and explainable outputs.
As therapies and treatments become more digitally connected, so will the importance of materiovigilance. Organizations that invest now in integrated data, device-specific expertise and practical automation will be able to detect and respond to events faster. Without these investments, organizations will remain reactive and struggle to match both patient and regulatory expectations. Materiovigilance is more than case processing; it helps organizations build a safety function that uses real-world product experiences to continuously learn.
