RD-11.15-16.2022-Ketryx

EREZ KAMINSKI: Hey, everybody. I know it's a little bit of a tough time right now, right? Because it's right before lunch, and I'm like one before last. So it's not always good to be that person. But I'm happy to be here. My name is Erez. I'm the CEO and founder of Ketryx. I'm not talking to everybody in the crowd, unfortunately, because we serve safety-critical industries.

So I think there's some people here from our industries but not everybody. So if you work on medical devices and are trying to be compliant with ISO 62304 or 13485, if you work on automotive and you care about automotive spice, if you work in aerospace and you're trying to make software compliant with DC-178B or C, you would be really, really interested in what we're doing.

Prior to Ketryx, I was the head of AI for the world's largest biotechnology company, Amgen, where I led there AI work in the combination product division. For those of us not in medical devices, combination product means when you have a medical device that also has a drug in it. So the system has much more complexity than just a mechanical, electrical, or even chemical system, especially if you have biologics, right?

Just think, what does that mean? They do a clinical trial with so much complexity. Out of that work, I came to MIT for a small stint and then started a company focused on enabling the type of safety-critical innovation we believe the 21st century will be based on. So if folks here are building safety-critical stuff, you want to talk to us.

So our first industry that we focus on the most is medical device and, in general, medical software and biopharmaceutical or regular pharmaceutical industries, "GMP software" sometimes it's called. And what we're trying to solve is the fact that it's really, really hard to make this type of software. Well, it's really hard because it's not just a game or an app, right? These types of applications are life-threatening, life-saving. And so there's a lot of regulation around their design and validation, for those who have ever heard that term.

The second issue is that all software development tools today that are mainstream in use were never developed to build safety-critical system, right? Software tools were built to move fast and break things. That's also a real big issue for engineers trying to use those tools in highly risk-based environments.

And this third thing is that, as systems continue to grow and we move away from small embedded devices with hundreds or thousands of lines of code to modern connected devices that have millions and tens of millions of lines of code, that complexity can't really be dealt with with existing processes. And that results in extremely expensive change management and change control procedures who, if anyone here works in the safety-critical industry, I'm sure they can share some time to lament over it in my booth, here on the left.

So what do we do in reality? What we do is we have built an ecosystem that allows people to use the most modern software development tools to build safety-critical application. And the work itself could be used as evidence for pre-market approval or compliance with regional safety-critical regulators, like the FDA, right? So it's a way to take all the knowledge that exists in modern software engineering, AI, cloud, and so on, use those tools in a slightly different way that's more aligned with quality management system regulations globally.

The challenge with this is that it's end-to-end and it has to be quite massive in its scale. The way Ketryx is built is to take all these tools, modify them slightly so developers still feel comfortable with them. So you can still leverage the way you've been building software today and use those methods to build software for tomorrow. We reduce substantially the amount of time it takes to release software. We ourselves build everything validated. And we're able to release software between four to six weeks, which, for class III system, would be kind of unheard of, that anyone releases that fast. So we're pretty excited about that. And here's a few of the platforms we integrate with.

I wanted to take one moment to talk about a use case. It's one of my favorite use cases. One of our first clients is a multinational fortune 500 medical device manufacturer that is building a pretty complicated class III system. And for those of us know, class III means it can injure or kill a patient. So it's quite delicate. And this system, if you really look at it from a systems engineering approach, it's quite similar to most systems, right? It just has a few different components. It has a sensor, so there's some input from the real world that goes into some cloud-based engine.

And then that could kind of inform the patient, ask for their feedback, or produce some output in a combination product, again like an infusion pump. Now, many people don't know, but about 50 people a day die in the US from an infusion pump software errors. And we're trying to prevent that in these type of systems. What I'm trying to show here is that it's quite generic, right? You can build any system you could ever imagine and validate it through us. And if you want to hear more about that, we have a booth here on the left, kind of second booth on the left.

The last thing I want to say is, what am I asking here for? Why am I here? So we are looking for champions. We are looking for champions in the medical device, biopharmaceutical, and other regulated industry, like energy, automotive, and aerospace, to come and help us drive innovation through their organization.

So if you have one project around software that you want to see maybe you can take 50% off the cost of it and the amount of time it takes to build it, we will work for you and show you that value through a collaboration. Would love to hear from you. Again, my email is right there, Erez@ketryx.com. It sounds a little unbelievable because I'm sure you all have heard the story before. But this time, it works. And if you want to check it out, I can show that to you. So thank you.