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New Survey Highlights Concerns Over Regulatory Data Quality in Medtech

A recent survey conducted by Veeva Systems sheds light on the challenges faced by professionals in the medtech industry regarding the quality of their regulatory data. As innovation in medical technology continues to advance, understanding the integral role of reliable data in regulatory compliance has never been more crucial.

Key Findings from the Survey

The 2025 Veeva Medtech Regulatory Affairs Benchmark report revealed that 50% of respondents expressed doubts about the completeness of their underlying data required for global product registrations. This lack of confidence is alarming and points to an industry-wide issue that could impact the timely approval of new medical devices.

Heavy Administrative Burden
Many regulatory affairs teams are still relying on manual data reconciliation processes to ensure compliance, which significantly increases their administrative workload. This reliance makes it difficult for them to keep up with the pace of innovation, as they struggle with cumbersome data management practices.

The survey found that preparing submissions for regulatory approvals is time-consuming. Specifically, 80% of respondents indicated that it takes a month or more to prepare a submission for a 510(k) application, with 24% stating it took six months or longer. When considering the Medical Device Regulation (MDR) submissions, organizations can spend up to two years per submission. Such lengthy timelines hinder the ability of medtech firms to bring their products to market swiftly, ultimately affecting patient availability.

Need for Faster Time to Market

Currently, only 5% of those surveyed utilize a fully automated process for monitoring time to market, a critical metric for the effective planning of resources. The majority, approximately 67%, continue to depend on partial or entirely manual methods, which complicates the generation of accurate and timely performance insights.

Identified Gaps in Regulatory Operations

The survey also highlighted key gaps in regulatory operations, with respondents noting:

• - Heavy administrative burden (61%)
• - Siloed processes (49%)
• - Digital tool proficiency (35%)
• - Educational shortcomings (24%)

These issues complicate product registrations and delay the necessary speed for getting medical devices to market.

Embracing Technology to Improve Compliance

The good news is that the medtech sector is beginning to embrace technology to streamline processes. 56% of organizations plan to implement regulatory information management (RIM) systems, while 52% are looking to develop integrations between their existing systems. Additionally, nearly half of the respondents are considering solutions such as automated submission tracking and reporting tools to foster better data accessibility and reliability.

Seth Goldenberg, president of Veeva MedTech, stated, “The report illustrates key areas to evolve regulatory affairs to a strategic enabler of business objectives through connected, automated processes for increased data reliability and speed.” This sentiment underscores the necessity for the medtech industry to improve its operational efficiency to remain compliant in an ever-evolving regulatory landscape.

Conclusion

As the survey illustrates, there is a pressing need for regulatory teams within the medtech industry to address the operational gaps currently hindering their effectiveness. By adopting more advanced technological solutions, these teams can foster agility while ensuring compliance and, ultimately, reduce the time it takes for innovative medical devices to reach patients.

To delve deeper into these insights, the full benchmark report is available through Veeva MedTech.