From Vision to Validation: The Story Behind Ketryx's Journey to Transforming MedTech Software

When people think about medical devices, they often imagine physical hardware that administers insulin or keeps their hearts beating at a regular pace. But, as with many things in the 21st century, today’s medical devices are also powered by complex, powerful, and highly regulated software. 

Historically, it has been challenging to keep the medical device software development process moving efficiently while maintaining stringent quality standards for compliance (and ultimately for patient safety). 

Like many developers and engineers, I found the highly manual work of compliance frustrating and wanted to find a more efficient way to work within the constraints of the medical device industry. I was fortunate to cross paths with like-minded innovators who wanted to help me build tools that could eliminate human error and even self-correct along the development journey to drive innovation. 

The power of medical device technology  

Medical technology has the power to transform lives. Growing up with a mother who was the first person to both have a cochlear implant and implant the device in others, I saw firsthand the life-changing impact of biomedical technology. This technology gives people who were once deaf the ability to hear and gives people with life-threatening illnesses like diabetes the chance to live a normal life. My mom often remarks how grateful she is to have been born in a time when hearing loss can be greatly improved with a tiny machine powered by invisible software. 

Her experience inspired not only her career but my own. I developed a deep interest in technology, medicine, and innovation early on, ultimately earning a dual MS/MBA from MIT. I began my career as a theoretical physicist and software developer, initially working on fusion reactors at Princeton Plasma Physics Lab under Dr. Nathaniel Fisch, who pioneered modern fusion. I then was hired by Stephen Wolfram, founder of Wolfram Research, creators of the world's largest AI knowledge engine. I later went on to become the head of AI and Machine Learning at Amgen, the largest biotech company in the world, where I had the opportunity to help solve big, complex problems that directly affect millions of patients’ lives. 

At Wolfram, I met Jan Pöschko, the software visionary responsible for shaping Wolfram Cloud and managing the team that worked on the product. Jan is a world-renowned developer who has spent two decades of his life building developer tools and reliable infrastructure to create high-quality software. We became close friends and found our unique blend of technical expertise and business acumen helped us quickly take projects from idea to execution. 

Jan and I bonded over our shared love of innovation as a catalyst for improving people’s lives. So, one night as we were having dinner in Kendall Square, the global hub of biomedical innovation, we decided to build a new way for people to create regulated software. Our premise for Ketryx was simple: to help developers in highly regulated industries release safe, high-quality software at the same speed as unregulated industries. 

A common nemesis: The slow pace of regulated software development  

As engineers who cut our teeth in the fast-paced world of 21st-century SaaS and AI, Jan and I have often felt frustrated by the sluggish pace of software innovation in regulated industries. Why can’t developers move faster to build life-saving technologies? In most cases, it’s because they are hindered by outdated tools and cumbersome manual approvals typical in compliance workflows. 

Of course, quality assurance and compliance with regulatory requirements are non-negotiable. Tech mantras like “move fast and break things” don’t work for medical device software. We can’t risk patient harm for the sake of speed; however, we also risk patient harm when we completely sacrifice speed. 

I felt this frustration when I first started working in the medical field. I understood the importance of regulations in protecting people but didn’t think that compliance and agility should be mutually exclusive. The current status quo in the world of medical devices is such that manufacturers bring products to market very slowly, which delays the positive impact new technologies can have on patients’ lives. It even prevents some new companies from entering the market at all. 

Regulated means valuable. Society only regulates things that truly matter and can impact people’s lives. 

Inspired by our experiences at some of the world’s most innovative companies, Jan and I knew there had to be a way to allow developers to embrace modern DevOps best practices while still ensuring quality and compliance across the board. We wanted teams to be able to easily satisfy important regulatory requirements as a result of the work they already do.  

Giving every developer speed and quality superpowers 

As I’ve worked on high-reliability systems throughout my career, I’ve often been tasked with reading and implementing long, complicated regulatory documents. As an engineer and proponent of automation and AI, I started to wonder: Why do I have to manually document evidence and follow all of these complex rules when a computer could ingest this information and provide automated guardrails to help me?  

As seasoned technologists, Jan and I were keen to solve this tooling problem. We knew that many companies are so mired in documentation and QMS procedures that they can’t take advantage of modern development best practices to release software rapidly and at scale. They needed a way to bridge the gap — especially with the new reality of systems powered by AI/ML.

Jan and I assembled a world-class team to help create a solution. We recruited John Koontz, former VP of Engineering and CIO at Wolfram Research, and Paul Jones, regulatory expert and former head of the FDA's Software Engineering Lab. Together, our team set out to build something that would speed up development and eliminate human error, self-correcting along the development journey to push the limits of innovation safely. 

We developed a set of shared design principles:

• Allow developers to use their preferred tools and processes to build regulated software. 
• Automatically enforce processes so developers don’t have to manually implement regulations or SOPs. 
• Ensure that necessary documentation is generated automatically from the work being done. 
• Provide a connected system that gives real-time visibility across the entire lifecycle. 
• Keep risk management and cybersecurity at the center of everything teams do. 

The result of this work was Ketryx, a connected lifecycle management platform that empowers developers and quality professionals to reduce the complexity, time, and cost of building regulated software and hardware products. Today, I’m proud to say that Ketryx answers the question, “What if regulated software teams could release high-quality software at the same speed as unregulated industries?” by automatically generating FDA-compliant documentation and enforcing QMS procedures inside preferred developer tools like Jira and GitHub.

As one Ketryx customer put it:

“Ketryx has allowed us to channel our hardware and software engineers’ existing set of development, testing, and documentation practices directly into the generation of compliant documentation with minimal additional burden. This has allowed us to remain agile while delivering high-quality products.” – Alexander Chan, VP of Analytics and Machine Learning at Beacon Biosignals 

The future of Ketryx 

I’m very optimistic about a world where medical innovation is not at odds with regulation. The best companies embrace regulations — as these rules are vital for keeping people safe — while adopting 21st-century tools that allow them to automate key compliance activities and bring products to market faster. 

That’s exactly what Ketryx does: We help regulated companies build FDA-compliant software, fast, using preferred DevTools. Our company’s growth directly impacts patient lives, as the platform helps teams spend less time juggling manual work and more time building life-saving products. In fact, we have a tangible goal: We want Ketryx to help 100 million patients access superior medical care over the next five to seven years. I can’t wait to see where this journey and growing team go next. 

‍Visit the About Ketryx page to learn more about our company’s mission, vision, and leadership.