Featured1/18/18

FDA compliance made easy: Welcome, Enzyme!

Written by Bill Evans

Managing Director

Regulatory compliance has its own language: QMS, MDR, 510(k), NDA, CAPA… And for innovators in healthcare, FDA compliance can be a daunting, pricey bowl of alphabet soup. Even small med device, drug, or digital health companies can shell out hundreds of thousands of dollars annually in consulting fees on labor-intensive, slow, paper-based processes—with larger companies spending millions. These companies are tackling some of healthcare’s biggest problems, and we believe regulatory compliance workflow shouldn’t be an expensive bottleneck. That’s why we’re thrilled to announce our latest investment in Enzyme, a company building software to help large and small enterprises alike streamline workflow, making regulatory compliance a seamless part of the development process.

Digital health companies, in particular, have at times steered clear of developing new innovations that would fall under the purview of the FDA because of the associated cost and financial risk. Though the agency’s recent moves to streamline its oversight of digital health innovation have the potential to ease this burden, FDA compliance remains table stakes for life science companies and for many digital health business models. It’s no longer a matter of if a company should become compliant, but how—something many founders struggle with. Enzyme co-founders Jared Seehafer and Jacob Graham each bring to the table over a decade of regulatory and quality systems experience in the biopharma and medical device industries. Using their intimate knowledge of the hurdles companies face on the path to regulatory compliance, they built Enzyme to help companies navigate FDA waters and, in the process, transform legacy compliance “overhead” into a modern, renewable information resource.

The Enzyme platform provides an easy-to-use interface for development teams to enter their information, enabling it to generate internal reports for quality and regulatory oversight and final documentation for regulators. Enzyme replaces cumbersome documents and spreadsheets—often numbering in the tens of thousands—with a modern, straightforward information management system. This means companies can instead focus on reducing the time it takes to bring a product to market—thereby driving real clinical value to patients.

Enzyme graduated from Y Combinator’s 25th batch of companies in the summer of 2017. Since launching in late 2017, their product is now in use at 10 medical device and diagnostic companies—including PathAI and Biomeme—working on a myriad of problems in healthcare. We at Rock Health are proud to join Refactor Capital, Data Collective, and Soma Capital in Enzyme’s latest $1.85M round. Jared, Jacob, and the team at Enzyme bring the expertise and ease fervently sought by healthcare trailblazers—and we know their solution will continue to deliver tremendous fundamental value to the ecosystem. Welcome to the Rock Health family, Enzyme!

Want to join a dynamic group automating FDA compliance and approval? Enzyme is hiring!

Check out a few of their open positions, including VP of Engineering, Senior Software Engineer, Senior Quality Systems Engineer, and Regulatory Affairs Director.

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