Drug-device combination products are reshaping treatment delivery by improving convenience, supporting adherence, and enhancing the patient experience. As adoption accelerates, safety oversight is becoming more complex. For pharma and biotech companies, device-related safety is no longer a niche responsibility. It is now a core part of lifecycle safety and regulatory strategy.

Recent materiovigilance survey findings discussed in an IQVIA and Citeline webinar highlight a clear trend. Organizations are expanding into combination device safety faster than many internal teams can build the specialized processes, systems, and expertise required to support it. As a result, leaders are rethinking how they approach materiovigilance, from operating models and governance to technology and outsourcing.

Why combination device safety is becoming a bigger priority

Combination products sit at the intersection of pharmacovigilance and device vigilance. This creates a broader safety remit for companies already managing complex post-market obligations across products, markets, and regulatory frameworks.

The challenge is not just understanding the regulations. It is building the operational capability to classify events accurately, manage complaints consistently, meet reporting timelines, and maintain inspection readiness. As more pharma and biotech organizations take on these responsibilities, many are still developing the specialized capabilities needed for device-specific safety oversight.

Where internal capabilities are under pressure

For organizations managing materiovigilance internally, device safety introduces challenges that differ from traditional pharmacovigilance workflows. Teams often require deeper expertise in areas such as complaint handling, device deficiencies, software-related risks, human factors, and root cause analysis.

Without these capabilities, recurring issues may be misinterpreted, escalation may slow, and compliance risk can increase. Regulatory expectations are also rising, with increasing complexity tied to data privacy, reporting requirements, software oversight, and combination product regulations.

A key operational challenge is event classification. Safety teams must determine whether an issue relates to the drug, the device, software behavior, or user interaction. This level of complexity requires more than standard processes. It requires a connected and mature operating model.

Why materiovigilance outsourcing remains a strategic lever

For many organizations, outsourcing is not simply a short-term solution. It provides immediate access to specialized expertise, validated systems, and local regulatory knowledge while internal capabilities continue to evolve.

Outsourcing is especially common in areas such as call center operations, software vigilance, technology platform management, and data analysis. More importantly, organizations are shifting how they view their partners. The focus is moving from transactional support to strategic collaboration that strengthens compliance and extends internal capabilities.

Technology will matter more, but only with the right foundation

Looking ahead, technology is expected to play a much larger role in materiovigilance. AI-driven automation is emerging as a top priority, alongside regulatory harmonization, real-world data integration, and stronger CRO partnerships.

However, technology alone will not resolve fragmented safety operations. To deliver value, automation must be built on a strong foundation that includes standardized taxonomies, consistent coding, validated workflows, and integrated data across complaint handling, vigilance, and risk management.

When implemented effectively, automation can support key activities such as case classification, triage, routing, duplicate detection, and timeline tracking. These capabilities can improve efficiency and consistency, but only when supported by strong governance and validation frameworks.

The next challenge is ownership and governance

As materiovigilance becomes more central, clear ownership is essential. When responsibilities are spread across teams without defined accountability, delays can occur. Missed timelines, slow escalation, and inconsistent decision-making are often symptoms of governance gaps.

Effective operating models bring together specialized expertise, enabling technology, and clear accountability. Organizations do not need every team member to be a device expert. However, they do need sufficient internal understanding to interpret issues accurately, connect signals across functions, and maintain control of safety strategy.

What this means for safety leaders now

For companies developing or commercializing combination products, materiovigilance is quickly becoming a strategic requirement. It is directly tied to compliance, operational performance, and regulatory confidence.

Organizations that act now to strengthen operating models, establish clear ownership, and build the right mix of internal and external capabilities will be better equipped to scale safely and meet evolving regulatory expectations.

Ready to go deeper?

The full report explores these findings in greater detail, including where organizations face the most operational pressure, which functions are most commonly outsourced, and how leaders are approaching AI, governance, and regulatory readiness.

Download the full materiovigilance research report to explore what these insights mean for your materiovigilance strategy.