medline Archives - Medical Design Sourcing

FDA issues warning letter to Medline over plastic syringes from China

The FDA followed up on a 2023 warning letter over unauthorized plastic syringes by issuing a warning letter to Medline.

In November, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated with several Chinese syringe manufacturers.

On March 18, 2024, the FDA issued warning letters that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. to three companies: Jiangsu Shenli Medical Production, Medline Industries and Sol-Millenium Medical.

Medline — the fourth-largest medical device company in the world, according to our 2023 Big 100 list — markets and distributes plastic syringes made in China within the U.S.

Get the…

Medline doubles size of Oregon medical device reprocessing plant

The ReNewal medical device reprocessing plant in Redmond, Oregon [Image courtesy of Medline]

Medline announced today that it expanded a facility for its ReNewal medical device reprocessing program.

Northfield, Illinois-based Medline — the fourth largest medical device company in the world, according to Medical Design & Outsourcing’s 2023 Big 100 — said it expanded the Redmond, Oregon, plant by nearly 52,000 square feet.

The expansion doubled the facility’s size and capacity to reprocess medical devices that Medline says would otherwise end up in a landfill.

The Medline ReNewal program has reprocessed nearly 15 million devices since 2014. The reprocessing helped to divert more than 10 million pounds of waste from landfills. In 2022 alone, the company reprocessed 2.3 million medical devices, equating to reducing approximately 1.1 million pounds of waste.

Medline ReNewal Presid…

Medline is having a leadership transition at the top

Medline’s incoming CEO Jim Boyle (left) and incoming President and COO Jim Pigott (right).

Medline announced today that it is promoting from within to fill CEO and president positions opening up at the privately-held medtech giant.

Jim Boyle is taking over the corner office at Medline, effective Oct. 1. Boyle has been at Medline since 1996 and has served as EVP since 2018, managing the company’s customer base of over 5,000 healthcare providers. Meanwhile, Jim Pigott will become president and COO. Pigott joined the company in 1992 and, most recently, was EVP, in charge of strategy and execution of Medline’s 27 product divisions and their 20 manufacturing sites and 14,000 employees.

After more than 26 years of leadership, Charlie Mills (CEO), Andy Mills (president) and Jim Abrams (COO) will retire from their current roles. They’ll continue to play important roles in the company, however, with Charlie Mills as board chair and Andy Mills and Abram…

These 10 medical device companies have the most revenue per employee

[Image from Unsplash]One way to measure medical device companies’ efficiency is to calculate revenue per employee.

While compiling corporate data for MassDevice and Medical Design & Outsourcing‘s recent Medtech Big 100 report on the largest medical device companies, we took the companies reporting headcounts. Then, we divided the revenue by the number of workers.

When it comes to revenue per employee among medtech companies, three dynamic and growing companies top the list: Hologic, Medline Industries and Intuitive.

Below are the top 10 medical device companies regarding revenue per employee. (And read the full Big 100 report here.)

Company Rev/Employee Hologic* $886,976 Medline Industries $673,333 Intuitive $583,080 Henry Schein $574,121 Owens & Minor $565,625 Carl Zeiss Meditec $563,700 Masimo $563,251 Abiomed $515,104 Insulet $477,739 Accuray $477,677

* Note: Hologic doesn’t report its Q4 earning…

How Medline maintains quality while innovating and growing

Lara Simmons is Medline’s president of quality and regulatory affairs. [Image courtesy of Medline]

Medline President of Quality and Regulatory Affairs Lara Simmons offers insight into innovation and quality as the company grows.

When Lara Simmons joined Medline 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. And there are now around 1,800 people in Medline’s quality organization around the world.

“You don’t get that kind of growth if you don’t have rock solid quality,” Simmons said in an interview with Medical Design & Outsourcing. “You can win customers on price and promises. But, you lose them on ba…

Medline invests $500M to bring medical supply inventory to $4B

Medline said it purchased another $500 million worth of medical supply inventory, bringing its total on-hand inventory over $4 billion.

Northfield, Illinois-based Medline — which manufactures and distributes healthcare products — said it purchased the products at the end of June and called the investment another step to fight global supply chain challenges.

“Our inventory management strategy has always been designed with one goal in mind — ensure that the right products are available at the right time to meet the demands of our customers and the patients in their care,” Medline Group Division President Jim Pigott said in a news release this week. “This latest investment reflects our ongoing pledge to provide reliable, superior service to healthcare systems across the continuum of care.”

Medline is the fifth-largest medical technology industry company in the world with more than $20 billion in annual revenue and 30,000 employees, according to Medi…

Medline to distribute Visby handheld STI test to healthcare orgs

Medline announced it is supplying Visby Medical Sexual Health Click handheld PCR test to healthcare organizations.

The point-of-care device for sexually transmitted infections (STIs) is an all-in-one unit that is FDA cleared to provide a diagnosis in under 30 minutes. The company will provide the tests to urgent care centers, student health centers, women’s health facilities and community health centers.

Visby’s PCR test allows clinicians to discuss results and prescribe personalized treatment during patient visits to eliminate the need for presumptive treatment.

“Our partnership with Visby demonstrates our commitment to bringing leading-edge medical innovations to the point of care that revolutionize patient care,” said Doug Sharpe, VP of Lab Capital at Medline. “Winning several awards for design innovation and excellence, the Visby device is the first PCR test of its kind and gives clinicians a tool to help improve patient outcomes.”

Medline to open new distribution center in Illinois

Medline announced that it will officially open a new 1.4 million-square-foot Illinois distribution center next week.

The Grayslake, Illinois, distribution center is estimated to be the largest medical-grade distribution center in the U.S., according to a Medline spokesperson, and will service facilities throughout the Midwest.

Medline’s facility is Leadership in Energy and Environmental Design-certified, reflecting best construction practices designed to reduce energy and water use, lower operating costs and improve air quality. The ribbon-cutting ceremony featuring company executives and local dignitaries will be held on July 20.

The facility represents a $125 million investment in Grayslake, a village in the Chicago metropolitan area, that will create 350 new jobs and a total of 700 jobs once the facility is operating at full capacity. The payroll for the facility is estimated to be $35 million and will require $2.5 million in maintenance and sup…

Medline Unite launches hind foot and ankle trauma implants

Medline Unite Foot & Ankle today launched its Calcaneal Fracture plating system and IM fibula implant in the U.S.

The launch of the products gives surgeons a comprehensive titanium foot and ankle trauma system that addresses nearly all fractures requiring ORIF with plate and screw fixation.

“Obtaining FDA clearance and launching these new implant systems comes on the heels of several other recent, successful launches, including the Unite Jones Fracture Screw system, Unite Distal Tibia Plating system, and Syndex with Constrictor Technology Knotless Syndesmosis implant system,” said Scott Goldstein, director of marketing at Medline Unite Foot & Ankle. “Since Medline Unite was first established in 2013, we have consistently and intentionally developed systems that offer the latest in implant design and technology, along with unique, bespoke instrumentation, and design rationale continuity across all systems. The result is a complete offering of implants th…

GripAble picks MedLine for exclusive U.S. hand therapy product distribution

The GripAble device connects to a tablet app for in-person or remote therapy. [Photo courtesy of GripAble]Medline has inked an exclusive U.S. distribution agreement with GripAble, the developer of a two-in-one hand and arm function assessment and training device.

The GripAble Pro was designed to help therapists serve more patients more efficiently in neurological rehabilitation, pediatrics, hand therapy and other applications.

The device connects to a tablet app and tracks grip and release, wrist flexion and extension, pronation and supination, radial and ulnar deviation, overall strength, repetitions and training time. GripAble said its technology platform lets therapists work with patients in person or remotely, and offers better outcomes with interactive activities for motivating patients, real-time biofeedback and rehab progress tracking.

Get the full story at our sister site, Medical Design & Outsourcing.

GripAble picks MedLine for exclusive U.S. hand therapy product distribution

The GripAble device connects to a tablet app for in-person or remote therapy. [Photo courtesy of GripAble]

Medline has inked an exclusive U.S. distribution agreement with GripAble, the developer of a two-in-one hand and arm function assessment and training device.

The GripAble Pro was designed to help therapists serve more patients more efficiently in neurological rehabilitation, pediatrics, hand therapy and other applications.

The device connects to a tablet app and tracks grip and release, wrist flexion and extension, pronation and supination, radial and ulnar deviation, overall strength, repetitions and training time. GripAble said its technology platform lets therapists work with patients in person or remotely, and offers better outcomes with interactive activities for motivating patients, real-time biofeedback and rehab progress tracking.

London-based GripAble said its product is used at more…

Medline Industries revenue up nearly 15% in 2021

Medline Industries’ sales grew nearly 15% to $20.1 billion last year as the medtech manufacturer and distributor added more than 230 additional healthcare providers to its prime vendor partnerships.

The new relationships, announced today, were worth nearly $2 billion in annual, incremental sales of medical supplies and services spanning the care continuum. The new health provider partnerships included Northwestern Medicine in Illinois, Rochester Regional Health in New York, Kelsey-Seybold Clinic in Texas, Windsor Lane Health Care in Ohio, Ochsner Health in Louisiana, and Golden LivingCenters in Indiana.

“Throughout 2021, the Medline team remained laser-focused on supporting our customers through another challenging year and strengthening the resiliency of the healthcare supply chain,” said Doug Golwas, EVP of acute care sales for Medline.

“Heading into 2022, that commitment remains as we continue to partner with our customers and together identify …