A beginning
I chose medical technology as a career after watching a two ounce pacemaker seemingly cure¹ Parkinson’s disease. The debilitating tremors and muscle rigidity that characterize the disease were simply - gone. In an instant.
It was (and remains) one of the most amazing things I’ve ever seen. The process is called deep brain stimulation. Neurosurgeons implant a wire in the basal ganglia of the brain, and that wire is connected to an implanted pacemaker. The results look unreal the first time you view them, I encourage you to watch if you’ve never seen the impact of this technology.
A few years and a graduate degree later, I was ready to take on the world, working as one of the first employees at a startup spun out of my university. And then I saw that the process of making drugs and medical devices often means spending as much time on paperwork as on medical innovation. Countless hours making sure that this engineering change request is properly signed, or that document is drawn up according to the right procedure, or taking another meaningless 2 hour training just to check off a box on some administrator’s desk. Then after the years of hard work and long hours comes the waiting. And worse than the waiting is the uncertainty of what will happen when you submit your product documentation to the FDA to gain approval to sell it.
My experience is not uncommon. And, since I started my career it’s been shocking to me that this crucial business process — perhaps the most crucial business process — underlying a $1.5 trillion industry does not have specialized software to address it.
Today we’re announcing the first financing of Enzyme, a company I co-founded to change the way the life science industry deals with regulation. (Think of us as something like “TurboTax for companies that are FDA-regulated”.) Our aim is to turn regulatory compliance from an amorphous risk into a definable, boundable series of steps. Our means is a web-based software platform that integrates disparate data sources, guides users through validated workflows, and generates reports that are consumable by regulatory authorities.
We want to free founders to start companies knowing how/when/what they need to stay compliant. To give investors certainty when investing in regulated life science, knowing they can predictably model how regulation will impact time-to-market. To enable regulatory professionals to focus on strategy and relationship building with their counterparties, not document drafting.
We believe, unlike some of our colleagues here in Silicon Valley, that the FDA and other life science regulators are a necessary part of the life science industry. Indeed, paraphrasing Voltaire, if the FDA did not exist it would be necessary to invent it. The reason is one of scale. There are tens-of-thousands of medical products, and it would take several lifetimes for a single physician to understand them all (let alone a patient). There is a need in our ecosystem for some entity to evaluate products and render impartial judgments on safety and efficacy².
In our experience, most regulators are earnest professionals. They spend each day dedicated to their mission of protecting public health. But there are clear ways in which interactions between regulatory agencies and industry can be improved and streamlined.
We are excited to see a new FDA Commissioner focused on innovating the agency, particularly in the realm of software and digital health products, which are currently some of the most difficult to conform into existing regulatory frameworks. The standard wisdom when I started my career was that companies would launch products overseas first because the regulations abroad were more transparent. I’m hopeful that this will soon be viewed as an anachronism.
My cofounder Jake Graham and I are pleased to have assembled a fantastic team of investors operating at the intersection of software and healthcare: YCombinator, Refactor Capital, Rock Health, Soma Capital, Data Collective, and a handful of angels with deep experience in enterprise software and healthcare. We are heads-down now focused on building out our team and technology so we can reach more customers (and millions of our customers’ patients). If the idea of building software that accelerates the time-to-market of medical products is intriguing to you, we’d love to talk. We’re hiring in software, software quality, and regulatory roles.
Jared Seehafer
CEO & Cofounder
¹ It’s not a “cure” of course, merely an alleviation of certain symptoms. But it sure looks as magical as a cure the first time you see it.
² There’s certainly an alternate world one could conceive in which the functions that FDA performs were done by some private organization; an Underwriters Laboratories for medicine, for instance. That said, there would still be a need for some entity to set a standard and make judgments about product safety and efficacy.
