Element Materials Technology Introduces AI-Powered Platform for Medtech Development

Element Materials Technology (Element) has launched Element RegNav (RegNav), its first artificial intelligence (AI)-powered regulatory intelligence platform for medical devices. Initially intended to support U.S. Food and Drug Administration (FDA) regulatory pathways, RegNav will help bring medical innovations to market safely and more reliably for those in need, the company claims.

“The end goal for RegNav is simple: to help our customers bring life-enhancing devices to market safely and more efficiently,” Element CEO Jo Wetz said. “Speaking to our existing medical device customers we realize there is a real opportunity to alleviate confusion around medical device regulation and standards, and further enhance our role as a trusted partner in their compliance and certification journey.”

RegNav’s proprietary software combines AI with expert guidance to support medical device manufacturers in identifying the regulations, standards, requirements, and testing needed to support the FDA submission process. Currently, bringing a medical device to market is a lengthy procedure with manufacturers facing a complex regulatory environment.

According to insights from BTIG, a global financial services firm, the average 510(k) premarket submission clearance takes approximately 162 days, nearly twice the FDA goal of 90 days. Delays in clearance are commonly caused by the need for multiple submission turnarounds when missing or additional information is required. In turn, manufacturers are experiencing vast losses of time and money.

To address these issues, RegNav has been co-developed with a specialized team of leading regulatory experts, engineers, and data scientists. The expert pool is comprised of ex-notified body regulatory professionals who have sought to ensure that the framework of RegNav is comprehensive and accurate.

RegNav is designed for companies both with and without existing regulatory support, offering two key services:

• RegNav Premium: Most suitable for companies with devices pre- or post-design freeze who are seeking to ensure that they are well-prepared ahead of submission. RegNav Premium provides a comprehensive and reliable compliance plan for a medical device in under two weeks. The compliance plan outlines the FDA pathway, regulations, FDA product codes, and standards that apply to a device and provides a summary of the testing requirements within each applicable standard.
• RegNav Verify: Most suitable for companies with an existing plan who want confidence that it is comprehensive before submission. RegNav Verify offers a double-checked and expert-backed review of the standards applicable to a medical device and identifies any gaps ahead of submission.

“There is an incredible synergy between our new RegNav offering and existing services. Once we identify a regulatory pathway, we can also support customers in the testing and certification process, acting as a true partner for market access,” Element Chief Commercial Officer Renae Leary stated. “RegNav strips away the complexity to give customers a clear path to compliance.”

RegNav currently supports Class I, II, and III medical devices seeking clearance/approval under FDA CFR. Element hopes to expand RegNav to other jurisdictions, including EU Medical Device Reporting (MDR) and In Vitro Diagnostic Regulation (IVDR). 

The Element Materials Technology Group is a global provider of testing, inspection, and certification services for a diverse range of products, materials, and technologies in advanced industrial supply chains. Headquartered in London, Element’s roughly 9,000 scientists, engineers, and technologists, work across a global network of more than 270 laboratories, support customers from early R&D, through complex regulatory approvals, and into production ensuring their products are safe and sustainable and achieve market access. In 2021, Element set out its new environmental commitments, adopting science-based targets and committing to net zero emissions across its global business by 2035.