Medline President of Quality and Regulatory Affairs Lara Simmons offers insight into innovation and quality as the company grows.
When Lara Simmons joined Medline Industries in 1991, she began by performing packaging validations.
At the time, Medline was bringing in $250 million in sales per year, and the company’s quality assurance team had only about nine members.
In 2021, the Northfield, Illinois–based company reported more than $20 billion in annual revenue — making it the fifth largest medical device company in the world, according to Medical Design & Outsourcing‘s most recent Big 100 report. There are now around 1,800 people in Medline’s quality organization worldwide.
“You don’t get that kind of growth if you don’t have rock solid quality,” Simmons said in an interview with MDO. “You can win customers on price and promises. But, you lose them on bad quality and bad service.”
Simmons is one of the longest-serving women in medtech. She’s currently president of quality and regulatory affairs at Medline and has been leading that division since 2008. The company evolved with the R&D team, testing laboratories and EHS under Simmons.
Medline reported double-digit growth in all but one of the last 50 years, Simmons said. The company has grown to the point where it has boots on the ground in different countries to onboard new suppliers, verify production processes and environmental controls and look at ethical sourcing.
“We literally can have somebody on an airplane or train to wherever in a day to go check something out if there’s a need to do that. That really helped us navigate the pandemic,” she said. “When I look back at it, it’s amazing to think that I used to know every single product manager by name. We have hundreds of product managers, and it’s just not possible nowadays. It’s incredible.”
Dealing with recalls
“Recalls — they’re unavoidable,” Simmons said. “Things happen, and the blessing we have is that our customers all know that.”
She said that Medline’s approximately 2,000 sales representatives in the U.S. can quickly communicate significant recalls to customers.
A more significant step, she said, is Medline’s automation of its paper-based recall process over the past year or so. The company tried having third parties handle recall notifications but was unhappy to lose the personal connection, Simmons said, so it tried automation.
The system sends notices to customers. Then, it takes them to a portal where they can respond to the recall and generate all return information and everything else they need. The main challenge is getting customers to provide a monitored, central email box for these communications, with response rates representing a bump in the road, Simmons said.
“They get so many recalls,” Simmons said. “They get bombarded with so many communications because we are a large distributor of other folks’ medical products as well. We notify them of the recall. The OEM notifies them of the recall. If they have multiple locations, they might get 10 or 12 notices in one day, all about the same recall, and they might have to respond to more than one recall notice. It’s frustrating for them. And for us, it’s getting to that response rate that the FDA requires to get us to close it out. That’s one of the biggest hurdles for recalls.”
Managing through tightening regulations
Simmons said she’s done 40 to 45 FDA 510(k) submissions. She recalls submitting her first antimicrobial device for 510(k) clearance years ago. At the time, all the FDA required was a simple zone of inhibition test, while requirements today are “magnitudes higher,” she said.
“It’s not a bad thing,” said Simmons. “It just makes it far more complex. But, if you manage those expectations with the product divisions in your team, it’s very navigable.”
She expects regulations will become increasingly stringent but said Medline is prepared. The company’s product mix of disposables, reusables and reprocessed single-use devices offers familiarity with those particular markets and processes. In addition, Medline has opportunities to serve on certain committees for developing new standards.
The level of information required is “amazing” to Simmons, who said old submissions came in at just five pages long. The tightened regulations also apply to international bodies and data requirements.
“It’s frustrating from a bureaucracy standpoint and a cost standpoint,” Simmons said. “But for patients, it’s the right thing to do, and that’s what Medline is all about: customers and patients and focusing on what’s right for them.”
How Medline handles regulatory and quality processes
At Medline, the process for a new product usually starts with a division presenting the product to Simmons and her team. Then, her team determines the appropriate pathway for regulatory review, sets a meeting with the FDA, prepares a pre-submission and makes sure the company understands the FDA”s expectations and the likely timeline.
“That’s something really different for Medline, because when we started in the industry, we started with textiles. We were providing butcher’s aprons to the marketplace and stockyards in Chicago way back when the original founder started Medline,” Simmons said. “Textiles has always been a strong backbone. With textiles, there’s not a lot of heavy regulation or a lot of standards, so it was easy when I started at Medline to launch a new product.”
But as the company grew and innovated new products, regulatory timelines stretched from months to years while its medical devices became more complex and required more testing.
“It’s about managing those expectations and really making sure you understand what the agency expects as much as possible upfront, and then working with them to navigate any kind of additional requirements that come up throughout the process,” she said.
With quality assurance, regulatory affairs and more eventually feeding one pipeline to Simmons, nothing must fall off-kilter. In some ways, she said it creates an easier development environment.
“If regulatory says no and quality disagrees, they all end up in my office, and it’s like, alright, let’s figure this out,” said Simmons. “If this is something that we really think is the right thing for the market, and the right thing for the patients, then there is a pathway. We just have to find it.”
Relationships ensure quality
“Good quality people make a good quality organization, which makes good quality products,” Simmons said, sharing her favorite quote and what she sees as representative of how Medline maintains quality.
She said she’s always sought to hire people who are smarter than her (“fortunately not that hard to do,” she jokes) and looks for inquisitive, creative problem solvers who take the initiative with what she calls “that spark.”
“It’s about giving them the tools that they need and getting out of their way,” said Simmons. “Since we’re a very data-driven company, it’s easy to monitor results. We can tell right away when there’s a hiccup or a problem. And the organization, as big as we are, still really retains that family atmosphere. … There are such strong relationships, which is so critical in managing an organization.”