2025年材料警戒状况：能力差距、技术动力与外包准备

The State Of Materiovigilance2025: Capability Gaps,Technology Momentum,And Outsourcing Readiness MEREDITH LANDRY, MANAGING EDITOR OF CUSTOM CONTENT, CITELINE|FEBRUARY 2026 The State Of Materiovigilance 2025:Capability Gaps, Technology Momentum,And Outsourcing Readiness Materiovigilance is entering one of the mosttransformative periods in its history. With theconvergence of drug and device innovation, globalregulatory reform, and rapid digital adoption, post-market safety surveillance now extends well beyondtraditional medical devices. Jnaneshwar, director of safety operations, lifecyclesafety at IQVIA, materiovigilance is no longer simplyabout investigating mechanical malfunctions. It isincreasingly about safeguarding patient experienceacross digitally-enabled, full-lifecycle therapies. “Materiovigilance is evolving at a rapid pace dueto the complexity of new devices, global regulatorypressure, and the shift toward patient-centric care andtransparency,” she says. “Newer device modalities,connected technologies, and software-basedinterventions require continuous surveillance, dynamicrisk assessment, and new skill sets that many pharmaand biotech companies are still building internally.” Drug-device combination therapies, companiondiagnostics, software as a medical device (SaMD),artificial intelligence, and connected digital platformshave dramatically expanded the scope of vigilanceresponsibilities. As products become more complex,so do the risks that emerge once they reach real-worlduse—shifting materiovigilance from a narrow technicaldiscipline into a core strategic function within modernhealthcare. This report explores the results of the 2025 survey andreveals the areas where organizations remain behind,the operational hurdles they face, and the capabilitiesthey will need to keep pace with global expectations. This rapid expansion has left many organizationsstrengthening their capabilities while activelynavigating new compliance burdens. IQVIA’s 2025Materiovigilance and Technology Adoption Surveyshows that70% of organizations have 10 years orless of experience in materiovigilance, reflectingthe relative youth of the discipline across the industry.Compounding this challenge,approximatelytwo-thirds (70%) of respondents representpharmaceutical or biotech organizations, confirmingthat materiovigilance is no longer just a concern for theMedTech industry. METHODS The data informing this report comes from the 2025Materiovigilance and Technology Adoption Surveyconducted by Citeline on behalf of IQVIA betweenSeptember 30 and October 8, 2025. A total of 827respondents participated. Of these, 102 met theinclusion criteria of director-level seniority or higherand direct involvement in materiovigilance, regulatoryaffairs, device safety oversight, call center leadership,or safety technology management. This represents a major shift in how safety isapproached. According to Dr. Padmalakshmi RESULTS leadership of device safety functions. As previouslynoted,approximately two-thirds (70%) ofrespondents represent pharmaceutical or biotechorganizations, signaling the widespread introductionof delivery systems, diagnostics, and digital tools intotherapeutic pipelines. 1. Pharma And Biotech Are Now Central ToMateriovigilance OversightThe most significant shift detailed in this survey is the steep rise in pharmaceutical and biotechnology These companies must now comply not only withwell-established pharmacovigilance protocols, butalso with specialized device vigilance frameworks thatdiffer significantly in reporting structure, root-causeinvestigations, and lifecycle monitoring requirements. regulatory and patient-impact consequences.“Pharma and biotech companies stepping intomateriovigilance face a steep learning curve becausedevice vigilance differs fundamentally from drug safetymonitoring,” Dr. Jnaneshwar says. The shift in accountability is occurring faster than skillsets are evolving, according to Dr. Jnaneshwar. 2. Outsourcing Is A Core Operating ModelRising operational complexity is driving a powerful shift toward external support. The report found that amongthe84% of organizations that outsource some or allof their materiovigilance activities, 45% outsourcetheir call center operations, underscoring the viewthat internal capacity alone is insufficient to managecurrent obligations. “Pharma and biotech companies are used tomonitoring biological or chemical interactions,” shesays. “But with devices, adverse events often stemfrom mechanical failures, usability challenges, orsoftware issues. Understanding whether an incidentwas caused by the device, by a user handling mistake,or by an environmental factor requires deviceengineering knowledge and human-factors expertisethat pharma teams may not yet possess.” In addition to call center operations, surveyedorganizations report that they commonly outsourceSaMD vigilance, technology/database management,data analysis, incident reporting, regulatorysubmissions (In