Drum Line Heralds New Day for Invacare
DME manufacturer enters August no longer under the injunction of its FDA consent decree, ending nearly five years of heavily restricted production and sales.
- By Laurie Watanabe
- Jul 31, 2017
Invacare Corp. has emerged from the injunctive phase of a U.S. Food & Drug Administration consent decree that started more than four years ago.
While the manufacturer will still be subject to regular third-party audits for the next five years to confirm sustainable compliance, Invacare can sell products freely from its Taylor Street facility. Also the verification of medical necessity requirement for equipment is over.
The news was made to a July 25 gathering of employees on the front lawn of the company’s Elyria, Ohio headquarters. The announcement, accompanied by a drum line fanfare, elicited an emotional response from Invacare employees.
Matt Monaghan, Invacare’s chairman, CEO and president remarked, “It’s been so much hard work; we deserved a little drum line.”
“It’s Not a Paperwork Exercise”
For employees who weathered the consent decree that began in December 2012, as well as those like Monaghan who joined Invacare while the consent decree was in place, the announcement was a long time coming.
While the consent decree sharply restricted Invacare’s production and sales – and, for a while, its product development – Monaghan made clear that the manufacturer used the time to also think about how it wanted to operate going forward.
In an interview with Mobility Management on the afternoon of the announcement, Monaghan said, “When I came here in 2015, the company took the opportunity of the consent decree to think about a different strategy, and I certainly came with a different perspective of what to do. The founder before me did a wonderful thing to bring as many [products] as possible to this industry. But I see this as an interesting opportunity, and that was to do more with the technologies we have in our portfolio for the benefit of end-user clients and providers and clinicians and non-professional caretakers, the family members who do so much.
“We did a few things in parallel. We certainly had a vision for solving the consent decree: Let’s get all the right people dealing with that, and let’s make sure the culture pervades the whole company. It’s not a paperwork exercise, it’s a culture exercise. Then in parallel: We have to get back to being great. That consent decree can’t be an excuse for everything.”
More Meaningful Products & Greater Efficiencies
Monaghan enthusiastically pointed to the launch this week of Invacare’s TDX SP2 power wheelchair, “which has even a better ride. For people with great and not so great trunk control, you can do a lot. For people who want to climb unbelievable obstacles to make the outside world very amenable to their abilities, it does even more.”
He also mentioned the reintroduction of high-performance Küschall ultralightweight manual wheelchairs to the United States, and the fact that Invacare wheelchairs can now be sold without the previously required verification of medical necessity.
But Monaghan also talked about the significance of quality over quantity, and of making the entire technology acquisition process more efficient for all stakeholders.
“One big theme that has emerged in the last two years is moving away from ‘More products for our customers is better’ to ‘More meaningful products for everyone is better,’” he said. “I view the provider as incredibly important, I think underappreciated in our industry. Because, with the clinicians, [providers] are out there doing their best to match millions of possible combinations of parts to very specific clinical needs of a person. There’s always a person at the end of this, and I want to focus on that person at the end and help our providers have the easiest way to make those products available.
“And then I pull back and say, “how do I make the clinicians’ time most productive?’ It’s a balance of a compassion for the end user and the frustration over the practical issues of paperwork and bureaucracy that are really getting in the way of doing more with the time [clinicians] have.”
Monaghan said that talking to wheelchair users makes him to want to create products that could make their lives simpler and more efficient.
“I interface with clients who tell me very interesting stories: ‘I was on my way to a job interview, and the battery died.’ Well, why did the battery die? Could we have predicted that better so they could have gotten to that job interview? Or instead of just red, yellow, green LEDs on the battery indicator, which don’t really tell you too much, what they really want to know is ‘Can I get to the grocery store and back without the battery going dead?’ We can do that now.”
On the supplier end, Monaghan said, “We’re creating a business segment around complex rehab, and that includes integrating our sales force. We used to call on complex rehab technology (CRT) customers with an Alber sales rep, a Küschall sales rep, an Invacare sales rep, a Motion Concepts sales rep, a Freedom Designs sales rep. We didn’t make it as easy as possible to do business, and that’s all being integrated. So now, my vision, which is a current reality, is a provider meets one Invacare representative, and they get the benefit of all that, from PinDot with its marketing-leading response times, to Alber and power add-ons that are really remarkable.”
A Clinical Focus
Monaghan said Invacare has invested in placing larger numbers of demo units in clinical settings, and with the injunctive portion of the consent decree lifted, those units can be taken home for client trials or can remain in clinics for longer periods.
“That makes evaluations a little easier,” he noted. “Over the last year, we’ve spent a great deal of time and effort recruiting people with strong clinical backgrounds because we want to be great partners to our providers. And because of all the differences that our products make, I want to make sure there are people in clinical settings that can help ATPs be successful.”
Asked if he had a message for an industry that has also been waiting for the big consent decree announcement, Monaghan said, “Thank you for your trust in us through this period of time. We want to be your best ally and supporter in successfully helping as many people in the world be as independent as possible. At the end of every day, that’s what motivates us.
“We do have a great purpose that’s absolutely aligned with clinicians and ATPs and end users and their families. We have got to do more than just make really great products. We’ve got to reflect our nuanced understanding of what these families are going through. They have a lot of other things to do, and we can certainly help them even more than we have.”