INDIANAPOLIS - An Indianapolis-based tech company is expanding its touring industry networking event on a global scale. Greenlight Guru, which provides a quality management software platform for medical devices companies, says its True Quality Roadshow will make a stop in Ireland this year, in addition to seven cities in the U.S. The company says the event, now in its second year, gathers medical device experts and industry stakeholders to help them navigate regulatory changes in the industry.

In an interview with Inside INdiana Business, Greenlight Guru Chief Executive Officer David DeRam said this year's roadshow will feature discussions on a report recently released by the firm.

"That industry report was a Greenlight Guru report that was put out for all industry professionals that showed a lot of the trends that are happening in the industry, a lot of the regulatory change (and) a lot of the readiness," said DeRam. "We saw that 81% of medical device companies are not using tools specifically designed for the medical device industry. Seventy-one percent of people reported that data collected by their company's quality system is not accessible in real time. So just getting an understanding of where the industry is as a whole helps companies understand where they fall on that continuum."

The State of Medical Device Product Development & Quality Management Report 2020 report was released in November. It also says 75% of medical professionals reported they would not be prepared for an unannounced audit by the U.S. Food and Drug Administration or other Notified Body.

The True Quality Roadshow launched last year and had more than 400 medical device professionals in seven U.S. cities. The 2020 roadshow will begin next month and continue through July in cities, including:

  • San Jose, Calif. – February 6
  • Houston, Texas – February 26
  • New York City, N.Y. – March
  • Boston, Mass. – April
  • Dublin, Ireland – April 20
  • Minneapolis, Minn. – May 21
  • San Francisco, Calif. – June
  • Chicago, Ill. – July 16

DeRam says he is already looking for further expansion of the roadshow beyond 2020.

"There's just tremendous amount of interest (from) companies that want to partner with us, want to be a part of that roadshow, want to have a voice in the medical device community, so just evaluating the people that will be a part of this journey with us is a big part of it and just continuing to expand the footprint and the good that we can do by helping to communicate best practices in the industry."

In 2017, Greenlight Guru announced its move to The Union 525 in downtown Indianapolis with plans to add 120 jobs by 2020. The company launched a new version of its electronic Quality Management System platform in 2018 with plans to create more than a dozen additional jobs. 

You can read more about the platform in an article featured in our Life Sciences INdiana e-newsletter in August 2018 by clicking here.