Veeva Systems Highlights MedTech Compliance Challenges and Opportunities for Regulatory Innovation
- Veeva Systems' report reveals 50% of regulatory professionals lack confidence in data completeness for global product registrations.
- Only 5% of organizations use fully automated methods for tracking market entry timelines, contributing to operational inefficiencies.
- Veeva MedTech's Seth Goldenberg stresses the need for connected processes to improve data reliability and compliance in the industry.
Veeva Systems Unveils Insights on MedTech Regulatory Compliance Challenges
Veeva Systems' recently released 2025 MedTech Regulatory Affairs Benchmark report sheds light on the pressing difficulties faced by medtech organizations in maintaining regulatory compliance and ensuring data integrity. The findings underscore a troubling trend: 50% of surveyed regulatory professionals express a lack of confidence in the completeness of their data necessary for global product registrations. This issue is particularly alarming as the integrity of regulatory data is crucial for effective artificial intelligence (AI) implementation in the industry. The report highlights that only 17% of respondents regard their regulatory data quality as excellent, revealing a significant gap that could hinder innovation and compliance in the fast-paced medtech environment.
The report also details inefficiencies in the submission process, with 80% of respondents indicating that it takes a month or longer to prepare 510(k) submissions. Notably, 24% reported timelines exceeding six months, and the situation worsens for Medical Device Regulation (MDR) submissions, which can extend up to two years. These protracted timelines not only escalate costs but also impede timely market entry, an increasingly critical factor for resource planning in the sector. Alarmingly, only 5% of organizations utilize fully automated methods to track time to market, while two-thirds still depend on manual processes, which contribute to operational inefficiencies.
Despite these challenges, there is a silver lining, as the report indicates a growing willingness among organizations to invest in technological solutions. Approximately 56% of respondents plan to adopt Regulatory Information Management (RIM) systems, and nearly half are looking to implement automated submission tracking tools. Seth Goldenberg, president of Veeva MedTech, emphasizes the necessity for connected and automated processes to enhance data reliability and speed. He notes that addressing the operational gaps identified in the survey—such as heavy administrative burdens, siloed processes, and insufficient digital tool proficiency—is essential for fostering agility and compliance in an ever-evolving regulatory landscape.
In addition to the insights on operational gaps, the report highlights the optimism within the industry regarding the adoption of advanced technologies. The commitment to improving regulatory processes through digital transformation reflects a broader trend in the medtech sector, where organizations are recognizing the critical role of data integrity and efficiency in meeting regulatory demands. As the industry navigates these challenges, the emphasis on automation and connected systems may pave the way for a more agile and compliant future.
