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…

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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…

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What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers again lead the Medtech Big 100 list of largest medical device companies.

However, there is so much more to Medical Design & Outsourcing and MassDevice‘s 2023 edition of the Medtech Big 100 report. We pulled thousands of data points to provide information on annual revenue, R&D spending, headcount, CEOs and key leaders, headquarters locations and descriptions of each of the 100 largest medical device companies.

Senior Editor Danielle Kirsh’s analysis shows that even as the largest medtech companies engaged in layoffs over the past year, they also made a bet on innovation to boost future growth: R&D spending increased nearly 13% to $26.4 billion. (Read the full story on MDO.)

In addition, the full Medtech Big 100 list includes already completed medtech company spinoffs such as Embecta , GE HealthCare and ZimVie.

Read the full Medtech Big 100 report to find out …

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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…

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Medtech jobs: The world’s largest medical device companies are hiring

Medical device companies are trying to fill thousand of medtech jobs. [Photo by ijeab – stock.adobe.com]

The world’s largest medical device companies are still hiring for medtech jobs despite layoffs in tech and other industries.

Medtech developers — and medtech jobs — are resilient, with the industry’s COVID-19 pandemic performance only bolstering its recession-proof reputation.

That’s not to say there haven’t been job cuts in medtech, led by thousands of layoffs at Philips as it struggles with a massive recall of deadly respiratory devices. But most medical device manufacturers are still hiring, and in some cases they can’t attract enough candidates to fill every vacancy in a tight labor market.

Stryker, for example, grew to approximately 51,000 employees as of the end of 2022, increasing its headcount by nearly 11 percent last year. Boston Scientific reported nearl…

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Medline Industries signs $140M distribution deal with Bryan Health

Medline Industries today announced it entered a multi-year prime vendor partnership with Nebraska-based Bryan Health to deliver medical supplies.

Through the $140 million deal, Medline Industries will exclusively provide an extensive portfolio of essential medical supplies and solutions to Bryan Health’s acute care medical centers.

“Medline’s proactive approach facilitated a smooth implementation and the customer support has been incredibly responsive,” Bryan Health Director of Supply Chain Heather Seeba said in a news release. “We look forward to partnering with the Medline experts to optimize our operational processes and improve our supply consistency.”

Dedicated Medline resources will work with Bryan Health to address specific caregiver needs and operational efficiencies to support the system’s efforts in providing quality healthcare in the region. Bryan Health will also be able to easily monitor key metrics …

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October 2022 Issue: Women in Medtech

Rachel Ellingson is driving Zimmer Biomet toward new tech

What Laura Mauri learned from a ‘firestorm’ in her first months at Medtronic

How Medline maintains quality while innovating and growing

How a wrist-worn device treats essential tremor

Diversity in medtech: 2022 markedly the best for women in medtech

Diverse executive teams bring more innovation to medtech Diversifying the executive suite is more than just a push for representation — it helps bring more diverse ideas to the table to innovate for more than half of the global population.

The leadership gap in the medical device industry closes slightly every year, but women still account for less than a quarter of executive roles, according to our annual analysis in this Women in Medtech edition of Medical Design & Outsourcing.

Women hold just 23% of executive roles at the top 100 medical device companies, up 2 percentage points since 2021. After Accuray and Ambu appointed f…

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The 10 largest medtech employers — and what their employees really think

Employees of the 10 largest medtech employers are happy to be a part of a company that is having a positive impact on patient populations.

That was one major takeaway as MassDevice compiled some current and former employee reviews posted on Glassdoor.

Medtronic, Philips and Johnson & Johnson MedTech top the list of largest medtech employers. The 10 companies we looked at were the largest employers in Medical Design & Outsourcing‘s newest Big 100 report on the largest medical device companies.

Company Employees Medtronic 95,000 Philips 78,189 Johnson & Johnson MedTech 75,000

As with most companies, there are some qualms with corporate bureaucracy and reorganizations creating frustration for employees.

Employment in the medtech industry is on the rise, according to a recent analysis of our Medtech Big 100 data. There were 1,268,924 employees among the 100 largest companies that report human capital in their annual repor…

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What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers top the Big 100 list of largest medical device companies by revenue.

The 2022 edition of MassDevice and Medical Design & Outsourcing‘s Big 100 report also holds surprises.  Big conglomerates are spinning out medtech businesses as stand-alone companies, and that means changes to the list of 100 largest medical device companies.

Colfax, for example, engaged in business moves that turned DJO’s parent into Enovis, a large, stand-alone orthopedic device company that is No. 56 in 2022’s Big 100. ZimVie, formerly Zimmer Biomet’s spine and dental business, is 69th. And after decades under larger corporate umbrellas, Cordis debuts at No. 76 on the list.

We collected thousands of data points to size up the industry’s publicly traded companies and privately held firms. The Big 100 includes annual revenue, R&D spending, employee counts, key leaders, headquarters locatio…

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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…

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Henry Schein hires former Medline veteran to drive ‘One Distribution’ push

Dirk Benson is chief commercial officer of Henry Schein’s North American Distribution Group. [Photo courtesy of Henry Schein]Henry Schein (Nasdaq:HSIC) today named Dirk Benson as VP and chief commercial officer of the medical device manufacturer and distributor’s North America Distribution Group (NADG).

Melville, New York-based Henry Schein is the world’s largest provider of health care supplies and services for office-based dental and medical practitioners, and NADG is the company’s largest business group.

The role of chief commercial officer is new at NADG. In it, Benson will drive Henry Schein’s “One Distribution” initiative, which the company called a “critical element” of its 2022-2024 Bold+1 strategic plan.

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

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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 …

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