Ketryx Tackles Software Safety in Medical Devices Amid Growing Recalls
This article originally appeared in Medical Device Network on September 2, 2024.
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.
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Kaminski explained that companies in the industry are still using outdated tools and processes, spending most of their time on documentation rather than actual product development.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.
Kaminski 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.
