Medtechs plan to centralize regulatory information management in modernization push: survey

This article first appeared in Medtech Dive.

Dive Brief:

• Medtech companies plan to change how they manage regulatory documents over the next two years, a Veeva MedTech survey of people at almost 100 organizations found.
• Most respondents expect the industry to prioritize creating a single source of truth, processes for reusing content and centralized regulatory information management systems.
• The forecasts, which are in line with the changes that happened last year, come as the medtech industry works to adapt to changes such as the new European Union regulations on devices and diagnostics.

Dive Insight:

The survey suggests the old ways remain the norm at many medtech companies. Seventy percent of the respondents manage regulatory content on local laptops, file shares or regional document management systems, and 41% review, approve and publish regulatory submissions individually, via email.

Most, 83%, of respondents use partial integrations, siloed solutions or manual processes to capture their post-market changes. Veeva, a provider of software designed to supplant such approaches, argues that those predominant methods raise the risk of missing product updates. Similarly, the software provider sees the lack of Unique Device Identification governance structures slowing data registration.

There are signs that the industry is moving toward the systems offered by Veeva and competitors such as IQVIA and Rimsys. Last year, the proportion of medtech executives surveyed who reported their firms collect global registration data in a single system climbed six percentage points to 14%, and the percentage of respondents with an integrated file share across regions rose eight percentage points to 31%.

Seth Goldenberg, vice president at Veeva MedTech, sees the trend as evidence that the industry is adapting its practices in response to changes including the Medical Devices Regulation and the In Vitro Diagnostic Regulations in the EU.

“With new regulations and increasing supply chain complexity, medtech companies are evaluating paths to more seamless processes so high-quality data can be shared across teams. This research shows the medtech industry is making progress by advancing regulatory operations for better global visibility, data accuracy and compliance,” Goldenberg said.

The survey suggests the changes will continue over the next 24 months. Over that period, 62% of the respondents expect the industry to modernize its approach to having a single source of truth for regulatory information. Other areas in which respondents said they expected to modernize their systems included global content reuse across submissions, regions and business units (57%), and global and centralized regulatory information management systems (51%).