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Indianapolis-based Greenlight Guru has been chosen to assist with the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) Tech program to boost the development of technologies used for COVID-19 testing. The company is using its quality management software platform to help participants speed up the process toward commercialization. Director of Global Partnerships Connor Remaley says being selected for the program is an affirmation of the company’s efforts.
Remaley tells Inside INdiana Business the software will help participants complete the requirements of the U.S. Food and Drug Administration in terms of design, risk, and testing.
“Of course, you can imagine the risk that goes into the development of medical devices; I mean, we’re talking affecting humans’ lives in a big way,” said Remaley. “So, what our software does is actually create efficiencies, reduce risk, and also instill some automation in companies actually developing the documentation to prove safety and efficacy in the device that they’re looking to bring to market.”
The software creates a file that includes every step a company has taken to ensure a device is safe that can then be sent to the FDA for evaluation when determining whether a device can be made. Remaley says having the process automated can improve the speed-to-market by a least a few months.
“Returning safely to normalcy depends on our ability to streamline and speed up the COVID-19 testing process,” Michael Wolfson, program manager for RADx Tech, said in a news release. “The use of Greenlight Guru’s [medical device QMS] platform allows our participants to focus on innovation instead of constantly worrying about compliance, efficiency and other concerns often associated with legacy quality management processes.”
Remaley says Greenlight Guru hopes to take the experience from the RADx Tech program to further its growth.
“We strive every day to ensure we’re improving that quality of life and I think this gives us a better platform and credibility in the industry to work with emerging med tech companies to deliver devices to market,” he said. “Long-term, I think it opens up a lot more opportunity globally within leveraging software to support quality systems. I think this is one big step in showing that is endorsed – not required, but endorsed – to move to an electronic fashion. There are better ways to accomplish quality management, more quality products and actually bettering patients’ lives.”
The $1 billion RADx Tech program is led by the NIH’s National Institute of Biomedical Imaging and Bioengineering. The institute says the technologies developed through the program are put through a three-phase selection process to determine the best candidates for at-home or point-of-care COVID-19 tests.
You can learn more about the program by clicking here.
Remaley says the software will help participants complete the requirements of the U.S. Food and Drug Administration in terms of design, risk, and testing.