New top story on Hacker News: Launch HN: Enzyme (YC S17) – Automating FDA Compliance and Approval

Launch HN: Enzyme (YC S17) – Automating FDA Compliance and Approval
5 by seehafer | 1 comments on Hacker News.
Hey HN! I’m Jared, the cofounder & CEO of Enzyme ( https://www.enzyme.com ). We’re building software that helps life science companies with FDA approval and compliance. Think of something like TurboTax but for companies that are regulated by FDA. Our product reduces both the time and cost of taking a drug or medical device to market. People often talk about how software is eating the world, but that process has taken longer for heavily regulated industries in part because of their complexity. However, there are now subject matter experts who grew up using and writing software and who have also spent enough time in their industries to be able to write useful software for them. This problem is very personal for my cofounder and me. We’ve both spent 11 years in the med device/biopharma industry and have personally felt the pain of how inefficient this is, having seen products we put our heart and soul into take months (sometimes years) longer than they should to reach patients and change lives. We’re taking a labor-intensive, paper-based business process and replacing it with software that allows existing teams to perform much of the needed compliance work themselves, reducing the need to engage consultants or full-time compliance officers. Staying compliant is unfortunately very costly: small companies spend $100K+/yr on consulting fees, while larger companies spend $100M+/yr on FTEs and $10M+/yr on software packages that perform only a small part of the compliance workflow! We’re focused on medical device/diagnostic/digital health companies for now, so if you’re a founder in this space we’d love to talk. We can answer questions about regulatory/compliance strategy — in the US, EU, and other geographies — along with other aspects of medical product development (such as design controls, verification & validation strategies, risk management, user experience, etc). There’s some additional info on our TechCrunch launch announcement, here: http://ift.tt/2EUgfHO… Thanks for reading and we welcome your feedback!