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A look at what’s behind today's Minnesota business headlines.

FDA watching for med-tech shortages in wake of Puerto Rico power grid failure

The U.S. Food and Drug Administration is monitoring about 50 kinds of medical devices manufactured in Puerto Rico to make sure that the ongoing failure of the island’s power grid following recent hurricanes doesn’t trigger shortages of much-needed health supplies.

In particular, the FDA is working closely with about 10 companies to prevent shortages of products across the U.S., with a specific focus on “blood-related” medical devices. Some of the 10 companies are the sole suppliers of their devices, though the FDA didn’t identify the companies or products.

“Puerto Rico’s device industry is facing the same basic — but significant — challenges as most manufacturing sectors in Puerto Rico: a lack of power; connectivity; transportation; and clean water,” FDA Commissioner Dr. Scott Gottlieb said in a statement Friday

“Most, if not all, of these medical device manufacturers continue to run on generator power, and as a result, have been unable to return to pre-hurricane production levels.”

Gottlieb addressed similar impacts to the pharmaceutical and biotech industries in Puerto Rico in an Oct. 6 statement.

Puerto Rico was still addressing impacts from Hurricane Irma when Hurricane Maria made a direct hit on the island on Sept. 20, knocking out the power grid and shutting down critical hospitals and roads. A month later, more than 80 percent of the territory is still without power

The U.S. territory is home to more than 18,000 people who work at upward of 50 different medical device plants around the island, including manufacturing sites owned by companies with major presences in the Twin Cities like Abbott Laboratories, Boston Scientific and Medtronic.

Their plants sustained varying levels of damage. Medtronic, which has four major production facilities that make products for each of its four product divisions on the island, recently reopened its plants at partial capacity using generator power. But the company has said the storm is expected to decrease sales by as much as $250 million during the quarter, and there’s no firm timeline for when the factories will return to pre-storm production levels.

Medtronic CEO Omar Ishrak visited the island on Oct. 13, meeting with employees and posing for photos like one at the child care center at Medtronic’s Juncos facility that was posted on Twitter.

“Visited MDT Puerto Rico facilities Friday. Inspired by employees’ dedication & commitment. Great to see operations ramping up at all sites,” Ishrak wrote on Twitter on Oct. 15.

 

Joe Carlson • 612-673-4779

Pepin Manufacturing expands with $2.4 million project in Wabasha, Mn.

Lake City-based Pepin Manufacturing has broken ground on a $2.4 million factory expansion project in Wabasha that will help it keep up with growing demand for its contract manufacturing services, company officials recently announced. 

Construction of the new 18,000 square foot facility will be finished next year.

It will include10,000 square feet of new manufacturing space, a 6,000 square foot warehouse, and space for offices. The company purchased additional land next door to the site that can accommodate future growth, officials said.

As part of the total project, Pepin is investing $1.1 million in the new buildings and $1.2 million in a new high-tech SYSCO rotary press that features high-speed CO2 die cutting.

It also purchased a $127,000 piece of automated packaging equipment that will make protective foil or poly pouches for pharmaceutical or other medical products. That equipment will have the ability to instantly bar code packages in compliance with FDA guidelines.

The  additions are expected to help Pepin keep up with growing demand and attract new customers who need production help.

 “We are thrilled to break ground on our new sister facility and be a part of the Wabasha community,” said Pepin CEO Jeff Solberg in a statement.  “For many of our customers, risk mitigation is critical. By having two manufacturing facilities, Pepin can mitigate risk for our customers due to unforeseen natural disasters. This provides huge value to our customers and their investors.”