Survey Reveals Medical Technology Companies Doubt Regulatory Data Quality
In the fast-evolving landscape of the medical technology sector, data integrity is paramount, yet a recent survey has revealed a troubling trend. According to the 2025 Veeva Medtech Regulatory Affairs Benchmark, a significant portion of medical technology companies exhibit a lack of confidence in the quality of their regulatory data. Specifically, 50% of surveyed professionals do not fully trust the integrity of their underlying data used for global product registrations.
This lack of trust is further compounded by the cumbersome manual processes many organizations still rely on to ensure compliance with regulations. As a result, the administrative burden on regulatory affairs teams has increased, hindering their efficiency. Current technological advancements hold the potential to streamline regulatory processes through optimization and automation, but high-quality data remains crucial for innovation within the medical technology field.
The findings indicate that while 17% of respondents rate their regulatory data quality as excellent, the majority categorize it as average or poor, underscoring an opportunity for improvement. The report sheds light on the current state of regulatory operations, noting several key challenges:
1. Extended Timelines for Submission Preparation: The survey highlights that preparing a 510(k) submission takes a month or longer for 80% of respondents, with 24% stating that the process exceeds six months. Given that organizations can spend up to two years on each Medical Device Regulation (MDR) application, companies capable of reducing submission timelines could bring their products to market more swiftly, saving substantial costs and resources.
2. Focus on Time-to-Market Metrics: Alarmingly, only 5% of respondents utilize a fully automated process to track time-to-market—an essential metric for effective resource planning. Approximately two-thirds (67%) still depend partly or entirely on manual processes, complicating their ability to generate timely and accurate performance insights.
3. Operational Improvements Needed: Survey participants identified excessive administrative burden (61%), isolated processes (49%), a lack of digital tool mastery (35%), and educational deficiencies (24%) as major regulatory shortcomings that may impede product registration and delay time-to-market.
4. Technology's Role in Regulatory Affairs: In response to these challenges, a growing number of organizations are making strategic decisions to enhance efficiency and regulatory compliance. Notably, 56% of respondents plan to implement a Regulatory Information Management (RIM) system. Additionally, nearly half are exploring integrations between existing systems (52%) or looking to establish automated tools for submission tracking and reporting (48%) to achieve unified and accessible data.
Seth Goldenberg, President of Veeva MedTech, stated, "The report illustrates critical areas for regulatory affairs to transform into a strategic facilitator of business objectives through connected and automated processes that enhance data reliability and speed." As teams face mounting pressures to do more with limited resources, addressing operational deficiencies will be essential for ensuring agility while maintaining compliance in the dynamic regulatory environment.
The 2025 Medtech Regulatory Affairs Benchmark surveyed a diverse group of 130 regulatory professionals from the medical technology industry to explore the pressing challenges they face today. For those seeking comprehensive insights, the full benchmark report is accessible here.
Veeva MedTech is dedicated to assisting medical device and diagnostic companies in optimizing the development and commercialization of their products, ensuring swift and efficient access for patients. Their suite of applications supports clinical, regulatory, quality, commercial, and medical operations.
Veeva is a global leader in cloud-based software for the life sciences industry. With a commitment to innovation, product excellence, and customer success, Veeva serves over 1,000 clients, ranging from the world’s largest biopharmaceutical companies to emerging biotech firms. As a Public Benefit Corporation, Veeva aims to balance the interests of all stakeholders, including clients, employees, shareholders, and industries served. More information can be found at veeva.com/eu.
Forward-Looking Statements: This communication includes forward-looking statements regarding Veeva's products and services, expectations on results or benefits from their usage. Actual results may differ significantly from those presented herein, and they are under no obligation to update such statements. Various risks could adversely impact results, detailed in their SEC Form 10-Q for the period ending April 30, 2025, available for review.
Contact:
Deivis Mercado
Veeva Systems
Email
This lack of trust is further compounded by the cumbersome manual processes many organizations still rely on to ensure compliance with regulations. As a result, the administrative burden on regulatory affairs teams has increased, hindering their efficiency. Current technological advancements hold the potential to streamline regulatory processes through optimization and automation, but high-quality data remains crucial for innovation within the medical technology field.
The findings indicate that while 17% of respondents rate their regulatory data quality as excellent, the majority categorize it as average or poor, underscoring an opportunity for improvement. The report sheds light on the current state of regulatory operations, noting several key challenges:
1. Extended Timelines for Submission Preparation: The survey highlights that preparing a 510(k) submission takes a month or longer for 80% of respondents, with 24% stating that the process exceeds six months. Given that organizations can spend up to two years on each Medical Device Regulation (MDR) application, companies capable of reducing submission timelines could bring their products to market more swiftly, saving substantial costs and resources.
2. Focus on Time-to-Market Metrics: Alarmingly, only 5% of respondents utilize a fully automated process to track time-to-market—an essential metric for effective resource planning. Approximately two-thirds (67%) still depend partly or entirely on manual processes, complicating their ability to generate timely and accurate performance insights.
3. Operational Improvements Needed: Survey participants identified excessive administrative burden (61%), isolated processes (49%), a lack of digital tool mastery (35%), and educational deficiencies (24%) as major regulatory shortcomings that may impede product registration and delay time-to-market.
4. Technology's Role in Regulatory Affairs: In response to these challenges, a growing number of organizations are making strategic decisions to enhance efficiency and regulatory compliance. Notably, 56% of respondents plan to implement a Regulatory Information Management (RIM) system. Additionally, nearly half are exploring integrations between existing systems (52%) or looking to establish automated tools for submission tracking and reporting (48%) to achieve unified and accessible data.
Seth Goldenberg, President of Veeva MedTech, stated, "The report illustrates critical areas for regulatory affairs to transform into a strategic facilitator of business objectives through connected and automated processes that enhance data reliability and speed." As teams face mounting pressures to do more with limited resources, addressing operational deficiencies will be essential for ensuring agility while maintaining compliance in the dynamic regulatory environment.
The 2025 Medtech Regulatory Affairs Benchmark surveyed a diverse group of 130 regulatory professionals from the medical technology industry to explore the pressing challenges they face today. For those seeking comprehensive insights, the full benchmark report is accessible here.
About Veeva MedTech
Veeva MedTech is dedicated to assisting medical device and diagnostic companies in optimizing the development and commercialization of their products, ensuring swift and efficient access for patients. Their suite of applications supports clinical, regulatory, quality, commercial, and medical operations.
About Veeva Systems
Veeva is a global leader in cloud-based software for the life sciences industry. With a commitment to innovation, product excellence, and customer success, Veeva serves over 1,000 clients, ranging from the world’s largest biopharmaceutical companies to emerging biotech firms. As a Public Benefit Corporation, Veeva aims to balance the interests of all stakeholders, including clients, employees, shareholders, and industries served. More information can be found at veeva.com/eu.
Forward-Looking Statements: This communication includes forward-looking statements regarding Veeva's products and services, expectations on results or benefits from their usage. Actual results may differ significantly from those presented herein, and they are under no obligation to update such statements. Various risks could adversely impact results, detailed in their SEC Form 10-Q for the period ending April 30, 2025, available for review.
Contact:
Deivis Mercado
Veeva Systems
Topics Health）
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