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Survey Results Highlight Gaps in Medtech Regulatory Data Trust

A recent report from Veeva Systems, titled the 2025 Veeva Medtech Regulatory Affairs Benchmark, has revealed a troubling trend among professionals in the Medtech industry. The survey indicates that 50% of respondents lack confidence in the completeness of the regulatory data available for global product registrations. This mistrust may have significant implications for compliance and operational efficiency within medical technology companies.

One of the foremost challenges identified is the reliance on manual data reconciliation processes. These outdated methods increase the administrative burden on compliance teams, making it more challenging to meet regulatory requirements promptly. In a field where data integrity and quality are paramount, it is concerning that only 17% of participants rated the quality of their regulatory data as 'very good,' with the majority classifying it as average or worse.

Time-Consuming Submission Processes

The report sheds light on the sheer amount of time required for regulatory submissions. The preparation of a 510(k) application, for instance, takes one month or longer for 80% of the respondents, with 24% stating it requires over six months. This contrasts sharply with industry expectations, where companies may spend up to two years on each MDR submission. Thus, Medtech companies that can shorten these timelines are bound to benefit from quicker market access, leading to substantial savings in both costs and resources.

Prioritizing Time-to-Market Metrics

Interestingly, only 5% of the surveyed organizations utilize a fully automated method to monitor time-to-market—a critical metric for efficient resource allocation. Approximately 67% still depend largely or entirely on manual processes, complicating the acquisition of accurate and timely insights into performance. This results in missed opportunities and delayed product launches, which can hurt competitive advantage.

Identifying Areas for Improvement

The survey points toward several areas for potential enhancement in regulatory operations. 61% of respondents reported significant administrative burdens, while 49% highlighted isolated processes, 35% noted the lack of proficiency with digital tools, and 24% cited educational gaps—all factors that can impede product registration and delay market introduction.

Leveraging Technology for Regulatory Success

In light of these findings, many companies aim to leverage technology strategically to improve both efficiency and regulatory compliance. Notably, 56% plan to adopt a Regulatory Information Management (RIM) system, while 52% express interest in developing integrations between existing systems to streamline data access. Additionally, 48% indicated they would implement automated tools for tracking submissions and generating reports, seeking unified and accessible data.

According to Seth Goldenberg, President of Veeva MedTech, “The report underscores how regulatory affairs can evolve into a strategic enabler of business goals through connected, automated processes that enhance data reliability and speed. As teams are expected to achieve more with the same resources, it becomes critical to close operational gaps to foster agility while ensuring compliance with changing regulations.”

Conclusion

The findings from the 2025 Medtech Regulatory Affairs Benchmark, which surveyed a diverse group of 130 regulation experts, provide valuable insights into the primary challenges faced by compliance teams today. Addressing these issues may facilitate smoother pathways to market, ultimately improving the efficacy and speed of product launches in the Medtech sector. To gain deeper insights, interested readers can access the full benchmark report via Veeva's platform.

For more information on how Veeva MedTech supports medical technology and diagnostics firms in streamlining product development and marketing cycles, visit veeva.com/medtech/. Veeva is cloud software leader dedicated to innovation, product quality, and customer success, serving over 1000 clients including prominent biopharmaceutical corporations and emergent biotech firms.

This article reflects the need for med-tech firms to adapt rapidly to an evolving regulatory landscape while enhancing trust in their data quality for successful market endeavors.