Survey Finds Medtechs Lack Confidence in Regulatory Data Quality
Veeva Systems (NYSE:VEEV) released its 2025 Medtech Regulatory Affairs Benchmark report, revealing significant challenges in regulatory data quality and processes. The study found that 50% of respondents lack full confidence in their global product registration data, while only 17% rate their regulatory data quality as excellent.
Key findings show that 80% of respondents take a month or longer to prepare 510(k) submissions, with 24% requiring over six months. Only 5% use fully automated time-to-market monitoring, while 67% rely on manual processes. Major operational challenges include administrative burden (61%), siloed processes (49%), and digital tool proficiency (35%).
To address these challenges, 56% of organizations plan to adopt regulatory information management systems, while 52% aim to develop system integrations.
Veeva Systems (NYSE:VEEV) ha pubblicato il suo rapporto 2025 sul Benchmark delle Affari Regolatori nel settore Medtech, evidenziando importanti difficoltà nella qualità e nei processi dei dati regolatori. Lo studio ha rilevato che il 50% dei partecipanti non ha piena fiducia nei dati di registrazione globale dei prodotti, mentre solo il 17% valuta la qualità dei dati regolatori come eccellente.
I risultati principali mostrano che il 80% dei partecipanti impiega un mese o più per preparare le sottomissioni 510(k), con un 24% che necessita di oltre sei mesi. Solo il 5% utilizza un monitoraggio completamente automatizzato del time-to-market, mentre il 67% si affida a processi manuali. Le principali sfide operative includono l'onere amministrativo (61%), i processi isolati (49%) e la competenza negli strumenti digitali (35%).
Per affrontare queste difficoltà, il 56% delle organizzazioni prevede di adottare sistemi di gestione delle informazioni regolatorie, mentre il 52% mira a sviluppare integrazioni di sistema.
Veeva Systems (NYSE:VEEV) publicó su informe de referencia 2025 sobre Asuntos Regulatorios en Medtech, revelando importantes desafíos en la calidad y los procesos de datos regulatorios. El estudio encontró que el 50% de los encuestados no tiene plena confianza en sus datos globales de registro de productos, mientras que solo el 17% califica la calidad de sus datos regulatorios como excelente.
Los hallazgos clave muestran que el 80% de los encuestados tarda un mes o más en preparar las presentaciones 510(k), con un 24% que requiere más de seis meses. Solo el 5% utiliza un monitoreo totalmente automatizado del tiempo al mercado, mientras que el 67% depende de procesos manuales. Los principales desafíos operativos incluyen la carga administrativa (61%), procesos aislados (49%) y la competencia en herramientas digitales (35%).
Para abordar estos desafíos, el 56% de las organizaciones planea adoptar sistemas de gestión de información regulatoria, mientras que el 52% busca desarrollar integraciones de sistemas.
Veeva Systems (NYSE:VEEV)는 2025년 메드텍 규제 업무 벤치마크 보고서를 발표하며 규제 데이터 품질과 프로세스에서 상당한 어려움을 드러냈습니다. 조사에 따르면 응답자의 50%가 글로벌 제품 등록 데이터에 대해 완전한 신뢰를 갖지 못하고 있으며, 단지 17%만이 규제 데이터 품질을 우수하다고 평가했습니다.
주요 결과는 응답자의 80%가 510(k) 제출 준비에 한 달 이상 걸리며, 24%는 6개월 이상 소요된다고 나타났습니다. 완전 자동화된 시장 출시 시간 모니터링을 사용하는 비율은 5%에 불과하며, 67%는 수동 프로세스에 의존합니다. 주요 운영 문제로는 행정 부담(61%), 분리된 프로세스(49%), 디지털 도구 숙련도(35%)가 꼽혔습니다.
이러한 문제를 해결하기 위해 56%의 조직이 규제 정보 관리 시스템 도입을 계획하고 있으며, 52%는 시스템 통합 개발을 목표로 하고 있습니다.
Veeva Systems (NYSE:VEEV) a publié son rapport de référence 2025 sur les Affaires Réglementaires en Medtech, révélant des défis importants concernant la qualité des données réglementaires et les processus associés. L'étude a révélé que 50 % des répondants n'ont pas une confiance totale dans leurs données d'enregistrement produit à l'échelle mondiale, tandis que seulement 17 % évaluent la qualité de leurs données réglementaires comme excellente.
Les résultats clés montrent que 80 % des répondants mettent un mois ou plus pour préparer les soumissions 510(k), avec 24 % nécessitant plus de six mois. Seuls 5 % utilisent une surveillance entièrement automatisée du time-to-market, tandis que 67 % dépendent de processus manuels. Les principaux défis opérationnels incluent la charge administrative (61 %), les processus cloisonnés (49 %) et la maîtrise des outils numériques (35 %).
Pour relever ces défis, 56 % des organisations prévoient d'adopter des systèmes de gestion de l'information réglementaire, tandis que 52 % visent à développer des intégrations système.
Veeva Systems (NYSE:VEEV) veröffentlichte seinen Benchmark-Bericht 2025 für Medtech Regulatory Affairs und zeigte dabei erhebliche Herausforderungen bei der Qualität und den Prozessen regulatorischer Daten auf. Die Studie ergab, dass 50 % der Befragten kein vollständiges Vertrauen in ihre globalen Produktregistrierungsdaten haben, während nur 17 % die Qualität ihrer regulatorischen Daten als ausgezeichnet bewerten.
Wesentliche Erkenntnisse zeigen, dass 80 % der Befragten einen Monat oder länger benötigen, um 510(k)-Einreichungen vorzubereiten, wobei 24 % mehr als sechs Monate brauchen. Nur 5 % nutzen eine vollständig automatisierte Überwachung der Markteinführungszeit, während 67 % auf manuelle Prozesse angewiesen sind. Zu den wichtigsten operativen Herausforderungen zählen administrative Belastungen (61 %), isolierte Prozesse (49 %) und digitale Tool-Kompetenz (35 %).
Um diese Herausforderungen anzugehen, planen 56 % der Organisationen die Einführung von Systemen zur Verwaltung regulatorischer Informationen, während 52 % die Entwicklung von Systemintegrationen anstreben.
- 56% of organizations planning to adopt regulatory information management (RIM) systems
- 52% of respondents looking to develop integrations between existing systems
- 48% planning to implement automated submission tracking and reporting tools
- 50% of respondents lack full confidence in their global product registration data
- Only 17% rate their regulatory data quality as excellent
- 80% of respondents take a month or longer for 510(k) submission preparation
- 67% still rely on manual processes for time to market monitoring
- 61% report heavy administrative burden in regulatory affairs
Veeva MedTech report reveals opportunity to move beyond manual processes for speed and compliance
With the rise of new technology to streamline and automate regulatory processes, high data quality is paramount for medtech innovation. When considering effective AI implementation, only
The report from Veeva MedTech examines the current state of regulatory operations, including:
- Lengthy timelines for submission preparation. From data gathering to internal approval, preparing a submission for a 510(k) takes a month or longer for
80% of respondents, with24% indicating that it takes more than six months. With organizations spending up to two years on each MDR submission, medtechs that reduce submission timelines can get products to market faster with considerable cost and resource savings. - Prioritizing time to market measurement. Only
5% of those surveyed use a fully automated process to monitor time to market, a key metric for effective resource planning. About two-thirds (67% ) partially or entirely rely on manual processes, making it difficult to generate accurate and timely performance insights. - Room for regulatory operational improvement. Respondents identified heavy administrative burden (
61% ), siloed processes (49% ), digital tool proficiency (35% ), and educational shortcomings (24% ) as the largest gaps in regulatory affairs, all of which may hinder product registrations and slow time to market. - Technology advancing regulatory affairs. More organizations are making strategic decisions to improve efficiency and compliance, with
56% planning to adopt a regulatory information management (RIM) system. Nearly half of respondents are looking to develop integrations between existing systems (52% ) or implement automated submission tracking and reporting tools (48% ) to gain unified, accessible data.
"The report illustrates key areas to evolve regulatory affairs to a strategic enabler of business objectives through connected, automated processes for increased data reliability and speed," says Seth Goldenberg, president, Veeva MedTech. "As teams are asked to do more with the same resources, addressing operational gaps to foster agility while maintaining compliance in the evolving regulatory landscape will be critical."
The 2025 Medtech Regulatory Affairs Benchmark surveyed a diverse group of 130 regulatory professionals, exploring the most critical challenges facing regulatory teams today. To learn more, read the full benchmark report here.
About Veeva MedTech
Veeva MedTech helps medical device and diagnostics companies streamline the complete product development and commercialization lifecycles to deliver products to patients with greater speed and efficiency. Veeva MedTech's offering includes applications that advance clinical, regulatory, quality, commercial, and medical operations. For more information, visit veeva.com/medtech/.
About Veeva Systems
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world's largest biopharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com.
Veeva Forward-Looking Statements
This release contains forward-looking statements regarding Veeva's products and services and the expected results or benefits from use of our products and services. These statements are based on our current expectations. Actual results could differ materially from those provided in this release and we have no obligation to update such statements. There are numerous risks that have the potential to negatively impact our results, including the risks and uncertainties disclosed in our filing on Form 10-Q for the period ended April 30, 2025, which you can find here (a summary of risks which may impact our business can be found on pages 32 and 33), and in our subsequent SEC filings, which you can access at sec.gov.
Contact:
Deivis Mercado
Veeva Systems
deivis.mercado@veeva.com
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SOURCE Veeva Systems
FAQ
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