B. Braun : Top Global Medical Device Companies in 2021 | Medical Product Outsourcing

Rank: #12 (Last year: #13)
$9.12 Billion
Prior Fiscal: $8.39 billion
Percentage Change: +8.7%
No. of Employees: 64,317
Global Headquarters: Melsungen, Germany

Anna Maria Braun, LL.M., CEO
Dr. Meinrad Lugan, Member of the Board, Hospital Care Division, Out Patient Market Division
Dr. Joachim Schultz, Member of the Board, B. Braun Aesculap Division
Markus Strotmann, Member of the Board B. Braun Avitum Division
Jean-Claude Dubacher, Chairman and CEO, B. Braun Medical Inc.
Bruce Heugel, Sr. VP and CFO, B. Braun Medical Inc.
Juergen Schloesser, Sr. VP and COO, B. Braun Medical Inc.

Caroll H. Naubauer had led Bethlehem, Pa.-based B. Braun’s North American operations as CEO for almost two and a half decades. Neubauer announced his retirement last June, and left the company on Aug. 31.

Since leading the company, B. Braun of America’s revenue rose from $247 million to over $2 billion. He began his tenure at B. Braun in 1988 as a legal assistant to the company’s management board. Three years later he was named general counsel for B. Braun Group, and took the helm as CEO in 1996. Jean-Claude Dubacher began succeeding Neubauer on June 1 of last year, while Neubauer continued in various management roles through August. Dubacher became chairman and CEO of B. Braun Medical on Jan. 1, 2021.

“We thank Caroll Neubauer for more than three decades of truly remarkable achievements for our company, for his close collaboration with our partners in the healthcare industry, and for his tireless work for the benefit of patients and healthcare providers,” Prof. Ludwig Georg Braun, chairman of the Supervisory Board of B. Braun SE, told the press. “Unforgotten will remain as well his persistent, determined and successful efforts to achieve the repeal of the U.S. Medical Device Tax.”

B. Braun settled patient infringement litigation against Mallinckrodt Hospital Products Inc., its affiliates, and New Pharmatop L.P. in October. The lawsuit was brought on in response to the firm’s new drug application to market its acetaminophen injection product. Under the settlement terms, B. Braun earned a non-exclusive license to launch a competing IV acetaminophen product in the U.S. with dosage amounts of 1,000 mg/100mL and 500 mg/50 mL.

B. Braun had some issues concerning fraud and unauthorized product distribution in late 2020. In October the firm warned against attempted fraud when selling the company’s disposable gloves. The company reported new cases of people abusing supply shortages associated with the pandemic by using fake B. Braun business documents for distribution of Vasco Guard disposable gloves. Customers and business partners from Italy, Australia, and the Netherlands had been increasingly contacting the firm to verify authenticity of offers, products offered. And business documents.

Last April, the firm earned FDA emergency use authorization (EUA) for its Perfusor, Infusomat, and Outlook infusion pumps to deliver continuous nebulized medications into a nebulizer to treat COVID-19 patients. They were also authorized to decrease healthcare workers’ exposure to COVID-19 patients during the pandemic. The EUA also authorized ground medical transport use of Infusomat.

In December, the company was made aware of a recall from the company Janus Trade Group of eight Introscan safety catheter product codes not authorized for U.S. sale. B. Braun claims the recalled products were distributed in the U.S. without their knowledge, and urged that the recall didn’t indicate clinical performance concerns for the products. B. Braun pursued action against Janus to cease and desist distribution.

Because B. Braun is a manufacturer of critical care and other hospital products, the pandemic did not impede the company’s growth due to the steady need for those products. Its $9.12 billion in revenue gained last year represented an 8.7 percent rise from the year prior. Its Aesculap surgical division was the only one that fell from the previous year—dropping 11.4 percent to 1.7 billion euros—due to the reduced volume of elective surgeries.

The Hospital Care division posted gains to 3.5 percent to reach 3.5 billion euros. The Out-Patient Market business swelled 5.8 percent with 971 million euros in proceeds. Finally, the Avitum franchise rose a slight 1 percent, coming to rest at 1.2 billion euros.

Last August, B. Braun won FDA clearance for its SpaceStation MRI to let Space infusion pumps continuously deliver medications to patients in the MRI suite. SpaceStation MRI shields Space infusion pumps against 1.5 and 3 T magnetic fields to protect the scanner and remove imaging interference. Each station holds up to four pumps and proprietary TeslaSpy software monitors magnetic field strength to allow proper MRI placement and positioning.

Also in August, the company gained FDA clearance for Onvision ultrasound guidance for real-time needle trip tracking. It combines the B. Braun and Philips Xperius ultrasound system with the Stimuplex Onvision needle to accurately position the needle tip for peripheral nerve blocks. It was the latest advance in Philips and B. Braun’s multi-year alliance for innovation in ultrasound-guided regional anesthesia. The tip tracking technology indicates needle tip position in relation to the ultrasound viewing plane to an accuracy of 3 mm, according to the company. A micro-sensor on the needle indicates real-time needle tip location.

Last April the company recalled one lot of 2g Ceftazidime for Injection USP and Dextrose for Injection USP (50 ml)—a cephalosporin antibacterial—in Duplex Container to the hospital/user level. During stability testing, the batch was found to exceed specification limits for high molecular weight polymers (HMWP) at the 19-month stability interval. Elevated HMWP levels have been shown to cause kidney damage and liver issues in animal studies.

In December, B. Braun gained a new pediatric indication for Cefalozin for Injection and Dextrose Injection (1g and 2g) in Duplex to treat infections and for perioperative prophylaxis in ages 10 to 17.