Launching the Post-Market Surveillance Solution (MDR and IVDR)

Intended to ensure the safety and efficacy of all medical devices and diagnostics sold in the EU, the European Medical Device Regulation EU 2017/745 (EU MDR) and the In Vitro Diagnostic Medical Device Regulation EU 2017/746 (IVDR) now require Device and IVD manufacturers to meet new compliance and oversight requirements that require, among others, a PMS system. The PMS system must actively and systematically gather, record and analyze relevant data on the quality, performance and safety of a device throughout its entire lifetime.

“It’s practically impossible to keep up with the volume and velocity of scientific, analytical and performance data and meet the new obligations of Risk Management, Performance Evaluation and Post-Market Surveillance,” said Dr. Feng. “Until recently, device and diagnostics manufacturers have been able to make do with a patchwork of tools and systems, and a largely manual and error-prone regulatory compliance process. MDR and IVDR have changed all that. Put simply, that status quo approach is suddenly obsolete.”

Huma.AI’s PMS solution is a faster, more precise and scalable approach that leverages the latest ML and NLP technologies. According to Dr. Feng, the solution has been validated by customers to shorten the time spent on literature searches from weeks to minutes with a 10x increase in accuracy. Most importantly, the platform connects multiple data sources meeting regulatory requirements to help ensure compliance.

Rapid Growth and Expansion

Launched in 2018, Huma.AI’s annual revenues tripled during 2021 even in the midst of the pandemic. The company currently has 10 global pharma, large medical device and diagnostics companies as customers and continues to add more as awareness grows across the industry. Existing use cases range from medical affairs and clinical development to real-world evidence and post-market surveillance. Its unique, human-centered AI technology allows rapid development of new use cases and expansion into adjacent sub-verticals.

Dr. Feng explained that Huma.AI’s transformative machine learning (ML) and natural language processing (NLP) platform make interrogation of healthcare data “as easy as using Google.” She noted the platform is especially advantageous for exploring the 80 percent of data that are unstructured. “In an industry that still relies on manual curation, the Huma.AI platform enables users to extract key insights across millions of documents or billions of rows of unorganized texts more accurately in minutes rather than months,” said Dr. Feng.

“We are excited to partner with the Huma.AI team as they expand their innovative platform enabling pharmaceutical and life science industry leaders to gain critical actionable insights that were previously difficult and time-consuming to obtain from large and siloed data repositories,” said Andy Schwab, partner at Excelerate Health Ventures.

"MDR and IVDR are top of mind for the entire medical device and IVD industry, and we are very excited that Huma.AI's artificial intelligence breakthroughs provide a fast, accurate and scalable solution to alleviate the challenges of post market surveillance requirements," said John Crumpler, General Partner at Hatteras Venture Partners. "We believe Huma.AI's team has the potential to transform how the life science industry uses data insights to accelerate product cycles and save lives.”

About Huma.AI

Co-founded by Lana Feng Ph.D. and Greg Kostello, Huma.AI is a leading healthcare AI company offering a no-code/low-code knowledge automation platform that turns life science domain experts into their own data scientists. The name Huma means human plus machine where humans always come first. Its transformative, human-centric AI platform has garnered tremendous industry recognition, and Huma.AI currently works with 10 large pharmaceutical and medical device and IVD companies across the globe. Learn more at https://huma.ai.