Baxter Lays Off Nearly 100 after Regulatory HiccupBaxter Lays Off Nearly 100 after Regulatory Hiccup

According to local reports, Baxter is laying off almost 100 employees at its plant in Medina, NY. According to a report from the area, the cost-cutting measure came as the company attempts to regain FDA favor for its highly-scrutinized Sigma Spectrum pump.

Following the layoffs, Baxter will have approximately 370 employees at its New York facility. Baxter first acquired the production facility from Sigma International in 2012 as part of a $90 million buyout.

With the acquisition, the company gained access to the Sigma Spectrum infusion pump. While the device was able to pad Baxter's revenue in the short term, the device caused the company issues this year. In April, FDA regulators sent Baxter a warning letter, stating that it had modified the pump without proper approval.

Following the warning letter, Baxter halted distribution of the pump until it wins favor with FDA regulators. Since this pump was manufactured in the company's Medina facility, that facility now has an excessive number of employees.

For now, Baxter doesn't know when the Sigma Spectrum will regain entry into the United States.

In 2009, Baxter purchased a two-fifths stake in Sigma. This stake gave Baxter the right to pick up the rest of the company, which it followed through on in 2012. Before the merger, Medina was the home of Sigma's headquarters.

In any event, 2013 has been a year of significant layoffs for the medical device industry. An informal poll hosted on Qmed found that nearly one third of medical device professionals were concerned about their job security. More than 10% reported having been laid off.