Digital Transformation Weighs Heavy in Medtech Regulatory Performance

Medtech regulatory teams are understaffed compared to their workload, according to a new report released by Rimsys.

The firm's 2023 Regulatory Performance Report tracks trends in regulatory priorities, processes, and performance within medtech companies. Based on a survey of 200 regulatory professionals and executives across North America and Europe, the report explores how regulatory affairs teams are staffed, their workload, average times to complete regulatory projects, where they experience compliance issues, and the growing trend of accelerating digital transformation within the industry.
 
“The need for this report was driven by conversations with several of our customers,” Rimsys CEO/Founder James Gianoutsos said. “Regulatory leaders don’t have clear benchmarks to measure the performance of their teams. They’re looking at digital transformation initiatives to improve the efficiency and effectiveness of their teams and want to understand what’s possible, what really good execution looks like.”
 
Key findings include:

• Regulatory teams are lightly staffed compared to their workload.
• A quarter of large medtech companies have 15 or fewer regulatory employees. These small teams complete over 100 renewals or license updates each year. Only 13% of companies make resourcing decisions based on anticipated workload, leaving any gaps to be filled with external consultants. Today, 90% of companies rely on consultants to complete regulatory projects.
• Process failures are common.
• Regulatory leaders self-assess the performance of their teams highly. A majority believe they outperform other regulatory affairs teams in similar companies in both project planning and execution. Yet more than 60% reported a major non-compliance issue in that past year, and 24% had to withdraw products from a country or region due to non-compliance.
• Digital transformation makes a measurable impact on productivity.
• Companies are investing in process improvement, both by increasing staffing and growing technology budgets. They are moving away from generic productivity tools to more specialized solutions designed for regulatory processes. Companies that have implemented regulatory information management and regulatory intelligence systems report very high productivity gains and they complete regulatory projects more quickly.

“A major trend we are tracking this year is focused on medtech’s engagement with regulatory bodies against a backdrop of new requirements for advanced technologies such as AI, and evolving legislation such as the MDR and IVDR transition in Europe. This has forced organizations to re-evaluate old processes and adopt new tools,” said Marck Aghnatios, medtech expert at PA Consulting. "The impact of this change will be largely absorbed by the regulatory affairs function, which is accurately reflected Rimsys’ study findings. The industry imperative for medtech leaders will be to digitize their business functions, starting with regulatory.”
 
Rimsys worked with a third-party market research firm to field and administer the survey in July 2022. Survey respondents included 200 regulatory professionals at medtech (medical device, in-vitro diagnostic, and software as a medical device) companies headquartered in the United States, Canada, and the European Union. Companies were evenly sampled across all sizes, from $10 million to more than $1 billion in revenue.
 
Rimsys is improving global health by accelerating delivery and increasing availability of life-changing medical technologies. Rimsys Regulatory Information Management (RIM) software digitizes and automates regulatory activities, helping medtech regulatory affairs teams to plan more effectively, execute more quickly, and confidently ensure global regulatory compliance. Rimsys centralizes all regulatory information, automates submission processes, and provides detailed visibility into product registrations, expirations, relevant standards, and global regulations. Traditional approaches to regulatory affairs can’t keep pace with the growing complexity of the global landscape, and overburdened teams face increasing compliance risks. Rimsys is designed around medtech regulations and workflows and supports a full breadth of regulatory activities including registrations, submissions, UDI, essential principles, standards management, and regulatory intelligence in a single, integrated platform.