Veeva Systems Report Highlights Regulatory Data Trust Issues in Medtech

Veeva Systems Report Unveils Data Trust Challenges in Medtech

A recent report released by Veeva Systems, titled the 2025 Veeva Medtech Regulatory Affairs Benchmark, exposes a worrying trend among professionals in the medical technology sector. Approximately 50% of surveyed individuals expressed doubts about the completeness of their underlying data used for global product registrations. This lack of confidence is primarily attributed to the reliance on manual processes for data alignment, significantly burdening regulatory affairs teams with administrative tasks.

As the medtech industry embraces new technologies that aim to streamline and automate regulatory processes, the quality of data becomes increasingly vital for fostering innovation. Alarmingly, only 17% of organizations feel their regulatory data quality is excellent, while others rate it as average or worse. This gap in confidence raises critical questions about the overall effectiveness of data management within the industry, especially as it prepares for more widespread implementation of artificial intelligence (AI).

Challenges in the Regulatory Process

The Veeva MedTech report delves into the current state of regulatory operations, highlighting several substantial hurdles:

1. Lengthy Submission Timelines: The survey revealed that 80% of respondents take at least one month or longer to prepare a 510(k) submission, with 24% of them stating that this process can extend beyond six months. Some organizations spend up to two years for each market authorization request. By reducing these submission timelines, medtech companies can bring their products to market faster and save significantly on costs and resources.

2. Marketplace Time Tracking: A mere 5% of participants reported using a fully automated process to monitor time-to-market, a critical metric for effective resource planning. Meanwhile, about 67% still rely on manual processes, yielding inaccurate and delayed information on performance metrics and progress.

3. Administrative Burden: Survey respondents identified various shortcomings in their regulatory affairs, including heavy administrative workloads (61%), siloed processes (49%), lack of digital tools mastery (35%), and training gaps (24%). These challenges collectively hinder regulatory product registrations and stretch out timelines unnecessarily.

Technology as a Solution

Despite these challenges, the report highlights a growing trend among organizations taking strategic decisions to enhance regulatory efficiency and compliance. Remarkably, 56% of surveyed entities plan to adopt regulatory information management systems. Nearly half are working towards developing integrations between existing systems (52%) or implementing automated submission tracking and reporting tools (48%) to achieve unified and accessible data.

Seth Goldenberg, President of Veeva MedTech, stated, "The report highlights key areas where regulatory affairs can evolve into a strategic enabler for business objectives through connected and automated processes, enhancing the reliability and speed of data." As teams are pushed to achieve more with the same resources, it is paramount to address operational gaps to support agility while maintaining compliance in an ever-evolving regulatory landscape.

Survey Insights and Future Steps

The 2025 Medtech Regulatory Affairs Benchmark surveyed a diverse group of 130 regulatory professionals, exploring the most pressing challenges currently faced by regulatory teams. For those interested in diving deeper, a complete assessment report is available now.

In conclusion, Veeva MedTech plays a crucial role in streamlining the full cycle of product development and commercialization for businesses in the medical device and diagnostics industries, ultimately delivering care to patients more swiftly and efficiently. Their offerings advance clinical, regulatory, quality, commercial, and medical operations, fostering innovation in healthcare. For further details, visit veeva.com/medtech.

About Veeva Systems

Founded as a leading global provider of cloud software for the life sciences industry, Veeva is committed to delivering innovative and high-quality products that help major biopharmaceuticals and emerging biotech companies succeed. Veeva is dedicated to balancing the interests of its stakeholders, including customers, employees, shareholders, and the industries it serves.