5 ms·
Launch HN: Enzyme (YC S17) – Automating FDA Compliance and Approval
Hey HN! I’m Jared, the cofounder & CEO of Enzyme (https://www.enzyme.com 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: https://techcrunch.com/2018/01/18/enzyme-io-wants-to-make-fda-compliance-easier-for-startups/ https://techcrunch.com/2018/01/18/enzyme-io-wants-to-make-fd...
Thanks for reading and we welcome your feedback!
- Glibaudio 9y agoHere is the announcement from Rock Health: https://rockhealth.com/fda-compliance-made-easy-welcome-enzyme/ https://rockhealth.com/fda-compliance-made-easy-welcome-enzy...
- Glibaudio 9y agoAnd from Refactor Capital: https://medium.com/refactor/enzyme-58bb068c40b4 https://medium.com/refactor/enzyme-58bb068c40b4
- sxates 9y agoCongrats on the launch, Jared - best of luck!
- deleted 9y ago[deleted]
- seehafer 9y agoHi all, happy to answer questions!
- notlob 9y agoWill this be self-hosted? Also, why FDA first instead of CE?
- enzymejacob 9y agoMost of our early customers have 510(k) products, which are typically less burdensome to commercialize in the US vs obtaining CE marking.
- enzymejacob 9y agoEnzyme is hosted in a 'private cloud' for each customer to ensure compliance and data isolation.
- untilHellbanned 9y agoCurious to know how you conveyed this as a venture scale company? There is a YC incorporation company that didn’t scale (not meant to be a dig), so curious about what’s different.
- seehafer 9y agoThere are a couple of things that are distinct about us contra an incorporation company: 1) Compliance is an ongoing activity regardless of how many new products you release. Think something like HIPAA, but more pervasive. So there’s an ongoing need that is ordinarily fulfilled by people - everything from a consultant for a garage startup to 1,000s of FTEs for a Fortune 500 company. This creates an ongoing, sticky customer relationship for anyone who can deliver significant value. 2) Our product and approach is valuable to more than just startups and enterprise life science companies routinely spend $10M+/yr on software systems.
- kumarski 9y agoFDA approvals are increasing. FDA has policy dynamicism which creates a moat. Many foreign countries co-opt the FDA process as their own. That's how performant our FDA happens to be, despite criticisms from a lot of people in web tech.
- Thriptic 9y agoAre you building only a QMS or also an automated system to handle registration and listing, CAPA, labeling, submissions, etc? Class 1 all the way to class 3? Alternative submission pathways? If you are dealing with digital health products, what are your thoughts on the pre-cert pilot that is occurring right now? How significantly do you believe the changes will impact your process and infrastructure given minimal data about FDA timelines?
- enzymejacob 9y agoOur QMS is an all-inclusive electronic QMS, or eQMS. All quality sub-systems including Document Control, Design Control, Risk Management, Complaint Handling, CAPA, etc. will be integrated.
- seehafer 9y agoTo your other questions: Registration and listing: harder to automate because information systems on FDA’s side aren’t quite there yet. For GUDID, yes CAPA, labeling, submissions: yes Alternative submission pathways: what do you mean by this precisely? Pre-cert: I think the premise is correct, in that the current quality system regulations aren’t well suited to modern SW development practice. But the devil will be in the details. Regardless it won’t affect us significantly because whatever gets released will have to have a phase-in for existing process that we’ll be able to adapt to.
- Thriptic 9y ago> Alternative submission pathways: what do you mean by this precisely De novos, abbreviated 510(k)s, lesser used pathways. > Pre-cert: I think the premise is correct, in that the current quality system regulations aren’t well suited to modern SW development practice. But the devil will be in the details. Regardless it won’t affect us significantly because whatever gets released will have to have a phase-in for existing process that we’ll be able to adapt to. My general concern being in digital health is implementation timeline. 1 year timeline is different than 2 year timeline is different than 5 year etc. In my eyes it's really a question of how long FDA will be expecting traditional submissions while they roll out a model geared more around approval of companies vs products.
- javiramos 9y agoWow! Getting that enzyme.com domain must have been very pricey.
- seehafer 9y agoTook quite a bit of negotiating to get to a figure we could afford ;)
- dawhizkid 9y agoI've been researching building the Dollar Shave Club for condoms...I know there has been some recent FDA guidance on relaxing rules around size - would a new condom produced by an OEM be a good candidate for Enzyme?
- seehafer 9y agoYes. This type of innovation — where you can demonstrate evolution on an existing product class — is very much in our wheelhouse. And, yeah, FDA recently increased the range of condom sizes they would accept, thus enabling the kind of thing you’re proposing.
- devicesecq 9y agoDo you have any plans to work with or refer to a preferred set of qualified device security professionals? AFAIU, medical devices tend to require a lot of fuzzing and secured upgrades. The Update Framework requires multiply-signed releases.
- devicesecq 9y agoBarnaby Jack would probably respect having his story told as an anecdote about the real costs of medical device security. https://en.wikipedia.org/wiki/Barnaby_Jack https://en.wikipedia.org/wiki/Barnaby_Jack ... FDA > Digital Health > Cyber security: https://www.fda.gov/MedicalDevices/DigitalHealth/ucm373213.htm https://www.fda.gov/MedicalDevices/DigitalHealth/ucm373213.h... """ Information for Healthcare Organizations about FDA's "Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software" """ https://www.fda.gov/RegulatoryInformation/Guidances/ucm070634.htm https://www.fda.gov/RegulatoryInformation/Guidances/ucm07063...
- kumarski 9y agoThis is no small deal. Thank you for your work in this space. It is exceedingly hard to find people w/ a decade's worth of biotech experience looking to move into viable software for the space. Rooting you on from the sidelines mate!