"Medical device companies must document Design Controls, yet most struggle with this. Greenlight Guru makes this so much easier for us." - Allan Katz, CEO & President
Long Island Technology Group is the brainchild of long-time medical device veteran and serial entrepreneur, Allan Katz.
LITG is a company that provides medical device design and product development services, as well as contract manufacturing. Their team is a unique blend of seasoned serial entrepreneurs, experienced manufacturing resources, and a hungry engineering team.
When the Greenlight Guru team got started, we knew we wanted to recruit a group of early adopters that have, “been there, done that” to provide feedback to our team to make our product great.
Allan Katz and LITG was an obvious choice. The value that Greenlight Guru could provide LITG was obvious to Allan too; it took him less than 10 minutes to say “yes.”
Why? Allan has built many companies in his career. And each time, he has known how challenging and difficult it can be to establish and maintain a QMS and document Design Controls and Risk Management. He understood the Greenlight Guru vision.
Out of the gate, Greenlight Guru worked closely with the engineering team at LITG. Most of the engineers are new to industry and medical devices. LITG had a handful of product development projects in the works. The first objective was to get the team going with Design Controls.
I remember a comment from Evan Jones, one of the engineers, after capturing user needs, design inputs, and conducting a couple design reviews. He said that he didn’t understand what all the fuss is about this Design Controls stuff. Seems pretty straightforward and easy.
I wanted to punch him in the arm and hug him at the same time.
Evan has never had to deal with Design Controls outside of Greenlight Guru. He hasn’t felt the pain of a complicated, overly burdensome approach which so many medical device companies implement.
Instead, Evan and the LITG engineering team have benefited by using the easy to use, simple solution Greenlight Guru offers.
“We went through 30-40 different documents all in 15-20 minutes total in terms of actually looking at them. They were all in one place. It was all very simple. And we could see where they linked to the rest of the project.” - Evan Jones, Product Development Engineer
At the time LITG started working with Greenlight Guru, the company was ISO 13485 certified. However, their certification did not include clause 7.3 for Design & Development. Adding this clause to their ISO certification was a target. And Greenlight Guru would be a key piece to making this happen.
During the next ISO surveillance audit, LITG requested a scope expansion to include design and development to their ISO 13485 certification. Evan logged into Greenlight Guru and displayed the design controls traceability matrix for a product development project on a screen in the conference room. The auditor asked a few questions, which were all easily addressed using Greenlight Guru. Less than 15 minutes later, the auditor had observed enough evidence to grant the scope expansion.
Afterwards, I had a chance to chat with the ISO auditor. He told me that once the traceability matrix from Greenlight Guru was displayed, he knew right away that Design Controls were captured and linked. It was very obvious to him.
“We launched 2 products in January. And we had the audit for those products coming up within 3 months of the launch so we had to have all our ducks in a row by then and actually by the time the audit came around we used greenlight pretty much exclusively for all the design controls in terms of that audit and we went from being audited 4 times a year down to 2 times a year.” - Evan Jones, Product Development Engineer
LITG continues to bring new devices to market, and Greenlight Guru continues to be an asset to helping this company grow.