Survey Highlights Medtech Sector's Concerns Over Regulatory Data Quality and Streamlining Challenges

Medtech Sector Faces Challenges in Regulatory Data Quality

A recent survey from Veeva Systems has unveiled significant concerns within the medtech sector regarding the quality of regulatory data. According to the 2025 Veeva Medtech Regulatory Affairs Benchmark report, nearly half of the surveyed professionals express a lack of confidence in the completeness of the data that underpins their global product registrations. This finding underscores the pressing need for improved processes in regulatory affairs, as companies continue to grapple with inefficiencies rooted in manual data management.

Key Findings from the Survey

As many as 50% of the survey respondents reported that they do not fully trust the accuracy of their regulatory data. This lack of confidence is troubling given the critical role that data quality plays in the successful navigation of complex regulatory environments. Organizations are currently investing substantial administrative resources to manually reconcile their data, resulting in heavier workloads for regulatory affairs teams and elongating the product development lifecycle.

The report emphasizes that the existing challenges in the medtech sector inadvertently slow product market entry, a problem exacerbated by lengthy submission preparation times. For instance, 80% of respondents indicated that it takes over a month to compile all necessary data and obtain internal approval for a 510(k) submission, with 24% reporting timelines that exceed six months. These delays not only hinder timely market access but also impose significant costs on resources allocated to the submission process.

Need for Automation and Improved Metrics

The survey also highlighted a crucial gap in how organizations measure their 'time to market.' Surprisingly, only 5% of respondents utilize a fully automated technique to track this vital metric, which is instrumental for effective resource allocation. Most (67%) continue to depend on manual processes, hampering their ability to generate timely and accurate insights into their regulatory performance.

Identified challenges such as a heavy administrative burden (61%), siloed operations (49%), proficiency with digital tools (35%), and lack of adequate education (24%) indicate that many organizations have not yet optimized their regulatory affairs function. These operational gaps pose real obstacles to efficient product registrations and could significantly delay time to market.

Moving Toward Technological Solutions

However, there is a silver lining. The report reveals a growing trend among medtech companies to embrace technology as a means to enhance regulatory compliance and operational efficiency. A robust 56% of respondents are contemplating the adoption of regulatory information management (RIM) systems, which can streamline data management and reporting processes. Additionally, around 52% are planning to create integrations between legacy systems, while 48% aim to implement automated tools for tracking submissions, showcasing a clear movement towards improved data accessibility and management solutions.

As Seth Goldenberg, president of Veeva MedTech, pointed out, the findings call for a strategic evolution in regulatory affairs aimed at transforming it into a driver of business success rather than a mere compliance element. By adopting connected and automated processes, organizations can enhance data reliability while accelerating response time to the constantly changing regulatory landscape.

Conclusion

The 2025 Medtech Regulatory Affairs Benchmark effectively shines a light on the crucial challenges facing regulatory teams today, marking the necessity for strategic advancements in technology and processes within the sector. As the report indicates, not only is it critical to foster agility within regulatory operations, but equally essential to maintain stringent compliance standards amidst evolving regulations. For the full benchmark report, visit Veeva’s website.

About Veeva MedTech and Veeva Systems

Veeva MedTech specializes in aiding medical device and diagnostics firms streamline product development and commercialization for quicker patient access. As a leader in cloud software solutions for the life sciences industry, Veeva is dedicated to innovation for exceeding customer outcomes.