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Invacare: Ready to earn back your business

Invacare: Ready to earn back your business Limitations on making and selling products comes to end after nearly five years

ELYRIA, Ohio ­- Invacare looks forward to re-introducing providers to a “different company” now that it has the green light to resume full operations at its corporate headquarters and Taylor Street facilities.

The U.S. Food and Drug Administration notified Invacare in a letter dated July 24 that the company has satisfied requirements under a consent decree that has limited its ability to make and sell products from the facilities for nearly five years, since December 2012.

“When I came on board in 2015, I came with a clean slate, and we didn't waste that opportunity at all,” said Matthew Monaghan, chairman, president and CEO. “We've looked at everything we could change.”

For much of that time, Invacare made improvements to its quality system as part of lifting the consent decree in lockstep with a broader effort to transform the company into a more specialized, clinically focused company.

The results of those efforts include a more unified approach to its product portfolio and sales structure, something that was sorely needed after, according to lore, 51 acquisitions over 30 years, Monaghan says.

“Now the engagement points with Invacare are more cohesive,” he said. “You see all the benefits.”

Invacare plans a big comeback in the complex rehab market in the third quarter when it launches its TDX SP2 Power Wheelchair with LiNX Technology, which has a controller with the look and feel of a smart device.

“We have to give people good reason to embrace us immediately,” Monaghan said. “Part of that is, we are a clinically relevant technology company.”

While under the decree, Invacare could still sell complex power wheelchairs, but clinicians had to submit documentation that their chairs were medically necessary for a particular condition and couldn't be addressed by another manufacturer's product. Thankfully, some did, Monaghan said.

“It allowed us enough opportunity to be in all the places we needed to be across the U.S. during this time,” he said, “and because the forms required that the clinician attest that our product did something specific, it helped to reinforce our brand and products.”

Invacare must still undergo five years of audits. Its auditor will inspect the facilities every six months for the first year and once every 12 months for the four years thereafter, a temporary reminder of all the company has been through and all it has overcome.

“It was a heart attack,” Monaghan said of being under the consent decree. “It was a problem, but it made us take seriously strategic change.”

For now, though, the bulk of the consent decree is behind Invacare. And nothing pleased Monaghan more than to stand in the bed of a pick-up truck owned by Dean Childers, who heads up the company's North American operations, in the parking lot at 8:30 a.m. on Tuesday, July 25, and announce by megaphone to hundreds of employees that they were fully back in business.

“We're really proud of this achievement,” he said, “and thankful to providers and customers for trusting us and giving us the room to do this, and giving us permission to earn back their business.”


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