$14M to Build the Future of Medical Software
New, innovative software continues to disrupt and transform society as we know it, including solving big problems, squeezing out new efficiencies and creating a better quality of life.
Healthcare is now ripe for similar disruption. While cloud platforms and the usage of AI/ML will revolutionize health care, they also complicate an already complex regulatory process. Traditional software methods based on moving fast and “breaking things” aren’t appropriate for software-based medical devices because software errors can result in patient harm or even death.
Unfortunately, I've seen this again and again across the industry. Most companies aren’t able to take advantage of modern development tools, off-the-shelf code, and open-source libraries to release software rapidly at scale—an inherent need for AI. Companies simply lack the tools and processes, and thus, many improvements and life-saving innovations never make it to market.
Why Regulation Matters
Not surprisingly, most safety-critical industries are already regulated. Our healthcare, construction of buildings, transportation, and even the electrical grid all require compliance with regulations designed to keep us safe and ensure critical systems perform reliably. In healthcare, regulatory compliance is all about ensuring high-quality patient care. Some point to this regulation and say that this is a prime reason why software and AI in medicine lag behind its use in unregulated industries. In reality, the problem is not with the regulation but lies with the way medical companies are trying to meet regulatory requirements.
While it’s hard to believe, the infrastructure and quality systems deployed within most medical device companies were designed for hardware systems from the 1990s and never anticipated today’s technologies or product complexity. Not surprisingly, talented developers today don’t want to use these antiquated tools. They fear getting stuck in a vicious cycle of paperwork and bureaucracy when all they want to do is build great products.
Manufacturers ranging from start-ups to global billion-dollar enterprises all struggle with balancing the costs and resources associated with regulatory compliance while trying to bring new products to market. Many potential innovators just avoid opportunities altogether because they’re concerned about getting hamstrung from the outset. A refrain I’ve heard often in my career is “the juice isn’t worth the squeeze.”
To maintain market share and profitability and address the broader goal of bringing good quality care to all patients, MedTech companies can’t afford NOT to invest in a more streamlined process.
Several years ago, I was fortunate enough to assemble a talented, like-minded group of software developers, former regulators, and AI experts to tackle this problem. We found it untenable that software innovation was so underutilized in healthcare when it’s a driving force in the world today. We all want the best people and the best technologies coming together to improve our healthcare so we asked a simple question: What if we could empower regulated software teams to innovate and release high-quality software at the same speed as those in unregulated industries?
With this objective in mind, we built Ketryx around several core beliefs:
- Regulations are processes…computers are great at following processes. A huge part of the regulatory burden is adhering to processes, a skill at which computers excel.
- Machines track things easily that humans can’t. Computers track relationships regardless of complexity or type (i.e. numbers, text, or other data).
- Manage the risk, not the paperwork. In contrast with machines, humans are strong at thinking. By empowering teams to spend their time evaluating, and mitigating risks, rather than managing documents and wrangling outdated IT processes, better patient outcomes will follow.
- Reduce the complexity, and innovation will follow. By reducing the regulatory burdens to enter the market and level the playing field for newer companies, more innovators will be able to bring new products to market faster and potentially address making high-quality healthcare more accessible for more patients.
And so, Ketryx was born – powered by passion, personal investments and seed money from similarly inspired investors. We started with a simple three part strategy.
- Create a proven solution that would help teams to quickly launch validated solutions. We set out to build a system on which we could build and release medical-grade validated software using modern DevOps and CI/CD practices. (And, yes, we eat our own dog food, using Ketryx in-house to release and improve our own software).
- Deliver an enterprise-grade solution that enables medical software teams to create a defensible system that automatically outputs reports and audit trails in language that FDA regulators understand and accept. FDA regulations are the most safety-critical and stringent in the world, setting a high bar for us right out of the gate.
- Make Ketryx available for ALL safety-critical industries. Because all quality and regulatory standards come from the same basic principles, we believe that we can deliver the same value we’re providing in the healthcare industry to automotive, aerospace, energy industries, and beyond.
Our New Funding
We’re now squarely in Stage 2 of our strategy, having proven we could build a repeatable product that serves enterprise companies. With today’s addition of $14 million in funding, we’ll be able to scale our operations across the company so we can continue extending our platform to enterprise medical device and SaMD manufacturers across the globe who would benefit from Ketryx.
We couldn’t be more excited to work with Lightspeed Venture Partners’ Guru Chahal, who joins our board as part of our latest funding round. Guru’s background as a product expert, founder, and SaaS expert will be critical to taking us to the next level. Guru’s hallmark is to invest in early-stage technologies that tackle big problems with a unique mix of simplicity, elegance and scale. We share the belief (see Guru's blog post here) that good software is a pillar of societal change for the better and look forward to mastering the complex dance of regulation and innovation together.
With our incredible team, investors and early customers, we’re working to redefine the norms and expectations for managing MedTech and other regulated software and to improve outcomes for patients around the world.
We invite you to follow us as we transform how companies approach safety-critical software to increase innovation and improve outcomes. And, if you’re interested in joining us on this journey, please check out our career opportunities. We’ll be hiring for dozens of positions across the company in 2024.