Posted on Mon, Apr. 21, 2003
Lexington-area inventors making
wheelchairs safer and easier to use


HERALD-LEADER STAFF WRITER

For Irene Mason, Keith Tanksley is a guardian angel with a tool belt.

Eight times in 12 months, the 82-year-old Wilmore woman was pitched out of her wheelchair -- most often onto the cold linoleum of her bathroom floor.

Paralyzed on her left side by two strokes, she can't lock the left wheel on her manual wheelchair.

When the wheel isn't locked, the chair often lurches when she transfers in and out of it.

"If the chair moves -- forget it, I'm gone," Mason said. "It scared the heck out of me."

Tanksley knew how hard it was for his friend. "She'd call me from the floor, sometimes," he said.

After a fall in July 2001, Mason asked Tanksley if he could find something to help her easily lock the left wheel with her right hand.

"I know that he's handy -- and he's willing," Mason said. "That's half the battle."

Tanksley thought he'd simply order and install the device.

There was one problem: Nothing like it existed in the medical equipment marketplace.

Mason's request ultimately was an inspiration. It prompted Tanksley, 38, to invent the appliance that solved the dilemma. He and a partner formed a Lexington company to take the product to market -- and their company has recently partnered with one of the nation's largest medical supply companies, which will distribute it nationwide.

Tanksley, a contractor by trade, first met Mason about three years ago, when he installed a wheelchair ramp and grab bars in her home. A friendship grew, partly inspired by the biblical passage James 1:27, which defines the purest religion as caring for orphans and widows in trouble. The son of a career Marine officer, Tanksley has been a devout Christian since childhood.

Tanksley, who lives in Nicholasville, visits Mason several times a week, often driving her to medical appointments, snowblowing or changing light bulbs. His young sons adopted Mason as a great-grandmother, and she proudly displays the crayoned document they made.

Independence

Initially, Tanksley thought finding a one-handed wheel lock would be a snap -- simpler than changing her door hinges to widen the passage for her chair. The usual solution, he learned, is to add an extended handle, to make the locking lever easier to reach with the opposite hand.

He found that disappointing. He pictured both locks activated with a single lever.

Local wheelchair vendors told him that such devices had been attempted, unsuccessfully.

That challenge inspired Tanksley. He soon fashioned a wheel lock that connected with a solid bar under the seat. It wasn't until Mason tried to go to lunch with a friend that the typical flaw in such systems came to light: The chair wouldn't fold.

Tanksley and his contracting partner, Stone Donaldson of Lexington, were soon ruminating, seated on five-gallon plastic buckets in their workshop, examining wheelchair brakes and brainstorming a solution.

They tried 50 evolutions before they hit upon the final product: a lightweight flexible cable system. The weight is crucial for a folding wheelchair; it weighs only about three ounces more than a typical braking system. Five patents have so far been filed on the system and some of its components.

The final product was installed permanently on Mason's wheelchair. She's used it ever since.

"I tell people that I'm his test dummy," Mason said with a chuckle. "He's been my guardian angel. It gives me a great deal of independence, which I wouldn't normally have."

Nothing like it

Tanksley and Donaldson soon realized that if Mason needed this device, so would thousands of others.

In the nearly two years since Mason first asked for help, Tanksley and Donaldson have founded a Lexington company, Lawrence-Nelson LLC, to manufacture and market their invention, called the Flex premium wheelchair immobilizing system. Each invested more than $15,000 to get the company off the ground. The company's name includes the first name of their fathers -- Lawrence Tanksley and Nelson Donaldson.

Their first Flex hit the market this month. So far, about 700 have been made and more than 100 have been distributed. The main components are manufactured at Lexington's EastLex Machine Corp. and assembled at the Lawrence-Nelson headquarters on South Broadway Park -- a building that once housed the Eddie Brooks Baseball Academy.

The University of Kentucky Center for Robotics and Manufacturing Systems helped with further testing and development; in September, researchers there found that the system could be continuously locked and unlocked more than 100,000 times without defect.

Most sales have been in 13 states in the South and Midwest, where Flex's marketing efforts have been focused. The company has held more than 60 informational sessions at hospitals and rehab centers.

Ramping up

Tanksley and Donaldson recently formalized a strategic partnership with Medline, one of the nation's largest medical equipment companies.

"Any time people come out with a new product that's pretty nifty, so many people say, 'That's so simple! Why didn't we think of that?'" said John O'Daniel, Medline's vice president for government sales. "It's a compliment to the person who finally does it."

Medline carries more than 100,000 products, has a sales force of 650 and logs sales of $1.5 billion each year. Medline expects to focus on marketing the Flex to Veterans Affairs facilities, one of the nation's largest buyers of wheelchairs; the Flex is expected to be added to Medline's VA contract in early May.

O'Daniel said they don't know how big the Flex will be, but its potential is major.

"You would certainly have 5 to 10 percent of wheelchair users who would have a real need for this," he said. "So you are talking about thousands of people."

Michelle Graybeal, physical therapy practice coordinator for Cardinal Hill Rehabilitation Hospital, thinks the braking system has a bright future.

"It could make a big difference," she said. Cardinal Hill tested several early Flex prototypes. Graybeal said the hospital is likely to install the device on some of its in-house fleet. For caregivers, it offers the benefit of reducing by half the number of times an attendant must bend over to lock the wheels.

"It interested me right away, because there was nothing out there like it," said Conrad Bowman, president of Choice Medical Resources in Houston, which has installed two of the Flex systems. "You see a lot of products, and very few of them have the horsepower and thought behind it to hold up in the marketplace," said Bowman, who has been in medical equipment sales and marketing for 40 years.

"I was sort of amazed that it was a hometown product," said Ken Green, the rehabilitation equipment manager for Lexington's National Seating & Mobility. "It's safer, so there is a lot of potential, but I worry about the cost."

The Flex systems cost $649 retail, which includes installation -- but few people would pay for it themselves. Most durable medical equipment is paid for by Medicare, Medicaid or insurance. The VA, for instance, will pay the wholesale price, which is significantly lower.

Flex's future in the marketplace depends largely on whether Medicare, Medicaid and private insurance will consider it a medical necessity and pay for it. That answer will vary by patient.

In early February, the device cleared a major hurdle -- getting a Medicare billing code that covers miscellaneous wheelchair accessories. The devices can now be billed to Medicare, but reimbursement will still be decided on a case- by-case basis depending on the patient's medical necessity.

Bowman said he thinks it's fairly priced. "They put a lot of quality into it," he said.

The Flex also may have changed the competitive landscape, Bowman said.

In September, about five months after Flex was launched, Sunrise Medical, one of the nation's largest medical equipment companies, began offering its Quickie 2 wheelchair with optional unilateral wheel locks for an additional $200. Bowman said the Flex remains unique because it can be installed on any manual wheelchair.

'Sheer audacity and nerve'

Tanksley and Donaldson have more than 10 other ideas for new or modified medical equipment that have grown out of their research on the Flex in rehabilitation settings.

"We'd like to be that little niche think-tank company," Tanksley said. "We'd like to be doing what we're doing for a long time."

Tanksley and Donaldson had no idea about the intricacies of the medical equipment field -- they've had to quickly learn the ropes on Medicare and Medicaid, engineering, quality assurance, physical therapy and patent law.

"It's a tortuous process, bringing out a new product," Bowman said. "It's a long haul."

He said that it takes "sheer audacity and nerve."

Tanksley and Donaldson said they were such newcomers, they didn't know when to be intimidated. Dealing with the 146-page solicitation necessary to try for a Veterans Affairs contract was one wake-up call. "We had no preconceived notions, nor the education to worry about it," Tanksley said.

Tanksley and Donaldson are also negotiating with a major wheelchair manufacturer, which may produce the Flex.

"We believe it should be the default wheelchair brake" -- the brake installed on all wheelchairs, Tanksley said. "Why would anyone flip two levers if they can flip one? Luckily, we had the freedom to sit on a bucket and look at wheelchair brakes."


Find out more

The Lexington-made Flex wheelchair immobilizing system will retail for about $649, including installation. It can be billed through Medicare, but reimbursement depends on whether it is deemed a medical necessity for each patient. To find out more, see the Flex Web site at www.lawrence-nelson.com. Contact the company by e-mail at lawrence-nelson@insightbb.com or call (859) 252-0335.

Keith Tanksley, co-inventor of the Flex single-lever wheelchair lock


Herald-Leader news researcher Linda Niemi contributed to this report.