Several significant software-related recalls have occurred across the medical device industry this year.
Last month, the US Food and Drug Administration (FDA) issued a Class I recall for Medtronic’s NIM Vital Nerve Monitoring System due to the risk of false negative responses.
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In June, another Medtronic software used in brain surgeries was recalled for displaying misleading text. In May, Tandem Diabetes’ t:connect app experienced a software glitch that caused repeated crashes, leading to excessive battery drain and shutdowns of their insulin pumps.
“The complexity of medical devices and software has increased significantly over the past few decades, leading to challenges in development and compliance,” said Ketryx’s CEO Erez Kaminski, in an interview with Medical Device Network.
Kaminski explained that companies in the industry are still using outdated tools and processes, spending most of their time on documentation rather than actual product development.
Ketryx has developed a lifecycle management solution that integrates with the existing tools used by companies, allowing them to accelerate their product delivery and reduce the complexity of their lifecycle. It can automate several parts of the cycle, including control processes, documentation, and testing.
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By GlobalDataKaminski said that Ketryx connects to the various tools and systems that companies are already using to manage their product life cycle, rather than requiring them to migrate to a new centralised system: “What if we create a system that allows you to use any kind of tool you want to use to manage that same lifecycle,” he said.
“We’ve embedded a lot of AI (artificial intelligence) on top of everything. You can talk to it [the system], you can communicate with it. Where’s the state of the project? Can you generate tests for these requirements? Can you generate documents? All kinds of stuff like that.”
The Massachusetts-headquartered company has helped companies such as HeartFlow and Beacon Bio Signals achieve improvements in their development timelines and documentation processes.
UK-based HeartFlow is the developer of an interactive Plaque Analysis platform, which is designed to enhance clinical decision-making in assessing patient risk in suspected coronary artery disease (CAD). Kaminski said that before using Ketryx, HeartFlow had to manage over 100,000 items as part of its product life cycle. After implementing Ketryx, HeartFlow was able to reduce the number of managed items from over 100,000 down to 10,000 – a 90% reduction in complexity.
“There’s only one way the story of humanity goes forward, which is all of us are going to rely on technology for a lot of things. The way people build most technology today is not sufficient, in my mind, to trust with their lives,” concluded Kaminski.
In December 2023, Ketryx secured $14m in a Series A funding round led by Lightspeed Venture Partners, with participation from existing investors such as MIT’s E14 Fund and Ubiquity Ventures.
