Medical device development company Ketryx raise $14M

Steven Loeb · December 5, 2023 · Short URL:

Ketryx helps medtech companies build safer, faster FDA-compliant software

The typical release cycle for software updates these days is weekly, daily, or sometimes even hourly; however, most medtech companies only release software every year or two, making  updates more expensive and risky. That results in the companies not taking on a project that they would take if it was cheaper and more predictable, which is ultimately bad for the patient. 

This is what Erez Kaminski saw while serving as head of AI for the medical device division of Amgen, and it's what led him to found Ketryx, a provider of connected application lifecycle management software for the life sciences industry.

"The capability of utilizing AI and other kinds of complex software for automation is inherently tied to your capability to release software often because you want to teach the AI more and more about data you get; you don't want to retrain the guy once a year, once every other year," he said.

Seeing all those things together, it is very hard to make medical device software, it is very difficult to make software overall that has AI and connected systems and requires fast release time."

Now the company will have the opportunity to build out its platform thanks to a $14 million Series A funding round the company announced on Tuesday. The new funding round was led by Lightspeed Venture Partners, with the rest of the round taken by existing investors, including MIT E14 Fund and Ubiquity Ventures, bringing the company's total funding raised to date to $18 million.

Ketryx uses automation to improve quality, moving humans away from more monotonous tasks that can be assured through a computer, such as quality assurance, so they can spend more of their time focusing on tasks that require complex, critical thinking aspect, such as risk management.

In addition to helping its customers iterate faster and focus on critical work, Ketryx also helps them maintain safety and to comply with regulations, tasks that have historically been done manually.

The way the company does that is by connecting to different IT systems, allowing developers to use those systems to develop medical products while the company manages their procedures, making sure they're executing them correctly. That means automating it to improve their quality assurance while also automatically generating all the compliance documentation a regulator would expect to have from the systems they work in. So, instead of needing to redocument everything they just already did after a product development cycle, and doubling up on the work, Ketryx automatically allows them to generate that documentation from the work they're already doing. 

"Today, people do the work, and then they document the work. We're saying, ‘What if doing the work could lead to documenting it as the FDA regulation is originally intended to be?’" explained Kaminski.

The company currently works with what Kaminski calls, "some of the top medtech companies in the world," including Oui Therapeutics, Talkiatry, Galen Robotics, and Beacon Biosignals, and it has been able to accelerate teams' work in certain processes for them in their development cycle, going from taking weeks to taking just a few hours, or even less. In some cases, the company has able to accelerate their customer's software development by up to 50%. 

"We can already say that using our software reduces the cost and time it takes to develop medical software. As a result, patients have access to newer features that they wanted to have that can save them time of day," said Kaminski, while noting that it also leads to higher quality, since it's not a machine making judgements, rather than a human. 

"It's much more objective than a human judging if that result is achieved or not, so products produced under us are of higher quality; we have not had a product that had any considerable quality issues or recall yet. And it's clear for some of our customers that they've been able to deliver features faster to patients, and if you're building a medical device, every feature is something that helps the patient, you're not developing stuff in order to develop it. It needs to be tied to a use case in a patient," he said. 

The new funds will be used to accelerate product development and commercial expansion; that includes enabling more advanced artificial intelligence and machine learning utilization in medical products, to help companies with the artificial intelligence Predetermined Change Control Plan released by the FDA this year, allowing companies to re-update and change their machine learning and AI models in their devices without approval from the agency.

"Doing that is not really practical because of the way they do it in these companies, with a bunch of people doing it manually, so they lose the benefit of being able to release so fast," ," Kaminski explained.

"We're going to incorporate a lot of features that make it possible for large, at scale medical device companies to deploy artificial intelligence in a way that's safe and reliable and patients all over the world can trust, that's going to be a huge focal point for us."

The company will also continue its work into cloud development and cybersecurity, while also integrating with more and more ecosystems of tools, allowing it to serve a much larger variety of customers, as well as many more customers within the same companies it works with right now. 

Ultimately, Kaminski sees Ketryx as the bedrock that will enable the development of AI technologies in a safe and reliable way, but also in a more affordable way, thus creating more innovation.

"Think of Ketryx as a way to use automation to improve quality, and utilize risk management in a much more sophisticated way to improve outcomes, both from the manufacturer of the product and for the patient. As a result, that will reduce the cost of development, making it easier to develop, creating a lot of innovation," he said.

"A few years from now, most software medicine will be built on Ketryx and it would be the way that we've reduced the cost of doing it overall."

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