4.4.23-Health-Ketryx

EREZ KAMINSKI: OK, hello, everybody. Nice to be here today, on a wonderful Tuesday at MIT. My name is Erez Kaminski. I'm the founder and CEO of Ketryx, a company that helps regulated industries develop fast and stay compliant. We are a team of software developers, health care industry professionals, and regulators, from bodies like the FDA, that came together to build a connected life cycle management platforms that helps a team create highly validated software and products across the tools they want to use at a much faster pace, at a much lower cost, and with significantly less quality risk and compliance risk

I'm also an alum of MIT. I have an MBA and a master's of electrical engineering and computer science. We're kind of an MIT startup, funded by various venture entities within MIT, including the E14 fund.

The problem we're trying to solve is that building regulated software, also known as validated software or validated systems overall, is extremely complex, expensive, and slow. Almost 50% of all FDA audits end with a citation or a finding. And part of this is the challenge that building large complex systems of the variety that are built by people in this room is just getting harder and harder, and the tools that are used within regulated industries, like the medical device industry, pharmaceutical, aerospace, automotive, were never really built for the size and complexity in which teams work today.

There's a lot of different challenges to build regulated software and regulated products. I've listed a few of them here. And I think that the worst one is the fact that change management is so complex in organizations. Most software companies release software on a daily basis, sometimes even an hourly basis, while medical companies, as an example of the regulated industry, tend to release software kind of on a yearly basis, so a factor of about 300. That's a big, big difference. We even hear of companies that the difference is about 1,000. They release software every year or two.

We can see that this issue is affecting society at large. Massive recalls right now for Tesla, other automotive providers, 737 MAX incidents and things of this nature because it's just really, really hard to build this type of software and, in general, build validated systems.

The way we see the industry today, and it's not just the medical industry, it's also the aerospace industry, the automotive industry, any kind of regulated industry that needs to provide proof that their products are safe and reliable for consumers and patients. They live in a disconnected life cycle management space, where they use multiple tools maybe 10, 20, 30 different systems. They connect them through human power. There's a lot of manual work being done in companies, transferring information between systems, manually ensuring processes are followed, manually generating evidence documents, and that's not really working. Companies self-report overheads of 40% to 90%, as compared to developing the same system in an unregulated space.

With Ketryx, what we do is we allow you to continue to use the systems you already have with the processes you already use, and we preconfigure different systems. And this is just a small list of the systems we connect to. We can enforce that your processes are followed across all these systems, using guardrails and different types of process control and that the work you're doing inside these different source systems is generating evidence for compliance. So you do less work, and your teams know what to do. And on top of that, they are able to leverage the most modern software and product development tools.

Just as a small case study product that I've worked on, products that we work on with customers, we mostly serve large public medical companies today with a lot of interest from the Department of Defense and other kind of regulated industries. You can think of a combination product, a very simple one, something that like an infusion pump that sits at home. Maybe today, it has a patient app, some kind of sensor, some kind of cloud-based inference engine.

This is a really complicated system of systems to validate, to release multiple things simultaneously. And companies are not really instrumented to do this type of work from an IT perspective. It used to be that systems had tens of design controls. Now they have thousands, just larger teams and more complexity.

We help in a variety of ways with our approach called computerized quality assurance, where we connect all the systems. We enforce the different SOPs, and we ingrain risk inside all the processes you're already doing.

We'd love to talk to teams in your company, whether they're building medical devices, GXP systems, or other validated industries, like energy, automotive, and defense. That's my email right there. I'm kind of the chief designer and would love to sit and talk to anyone. We have a booth in the room, next door, in the back left corner. Or if you're facing in on the right, it says Ketryx, with a big motorcycle on it. Because part of what we do is to help people move fast and stay compliant. Thank you so much.