By Deborah Conn

It’s not surprising that so many orthotists and prosthetists are inventors. The profession demands creative problem-solving. Patients are different, devices need tinkering, and improving on the status quo is just part of the job.

But some practitioners take that inventiveness a step further, moving it out of their own practices and into the marketplace. Some form companies to manufacture and market their inventions to fellow practitioners across the country and, in several cases, around the world.

The Almanac interviewed four of these entrepreneurs and found a common thread: in every case, the practitioner identified a need during his work, set about finding a way to address it and, eventually, shared that solution with his colleagues.

The Table
For Pedro Llanes, CPO, owner of Prosthetic Laboratories, Inc., in Miami, the idea for his invention, “The Table,” germinated nearly 30 years ago when he was a technician with Hanger. The facility was short on space, and technicians crowded together, moving from bench to bench for each task.

“My idea came about in a Chinese restaurant,” Llanes says. “I was seated at a big table with a lazy Susan in the middle. There were five or ten different dishes on the lazy Susan, and you could rotate the items and serve yourself. I realized I could make a small table like that for O&P, with different work stations, that would rotate 360 degrees.”

After Llanes opened his own practice in 1982, he drew a design for the table and took it to a welder in a machine shop to create a prototype. “I set up a four-station table that could do laminating and vacuum forming,” he explains. “I used it for four years. After I saw that it worked, I knew it was time to get it patented.”

Llanes hired a lawyer and applied for a patent, but the process ate up money and time. “I finally gave up on the patent,” he says, “and just put the table out on the market.” He established the Orthotic and Prosthetic Equipment Corp. in 1992, had a sample table made, and took in three orders at his first show, the 1992 AOPA National Assembly in Washington, D.C.

The business grew, and Llanes’ customers started making suggestions. “I kept perfecting the equipment,” he says. “Then one thing led to another, and I started making all of the equipment as well as the table.” His expanded product line includes such items as floor model and portable routers, vacuum systems, vertical jigs, and a vacuum press.

Today, Llanes offers several sizes of The Table, with two to 12 working stations that rotate 360 degrees. Each station can be used in the vertical position for lamination and fabrication of thermoplastic sockets, in the horizontal position to modify molds and for thermoplastic fabrication, and at intermediate angles for other applications. An automatic vacuum system turns on and off by itself.

Contracting out the manufacture of his tables became problematic. “After a few years of struggling with contractors and subcontractors, I finally found someone who could meet my demands for quality, craftsmanship and precision,” says Llanes. “I hired him and opened a machine shop about three years ago. Now we do everything in-house.”

Llanes markets his product at trade shows and through distributors, advertises in trade publications, and donates tables to schools and universities to spread awareness. He has sold The Table throughout North America and in Guatemala, Spain, Germany, France, Turkey, China, and the Philippines.

He is optimistic about the continued growth of his business. “People are becoming aware of the product,” he says. “Practitioners are designing models by computer, but they’re still being fabricated on low-tech wooden benches. It’s time to be more efficient and technologically advanced.”

OrthoInnovations: The Mackie Hinge
One good idea launched a whole new company: OrthoInnovations, in Rochester, Minn., which now manufactures and markets a range of orthotic devices and products.

The idea came from technician Kevin McLaughlin at Prosthetic Laboratories of Rochester. In 1996, McLaughlin took an existing mechanical hinge (which had been used in completely different applications, such as car seats) and applied it to a contracture elbow brace.

The company launched the Mackie Elbow, dubbed in honor of McLaughlin’s nickname, at the 2002 AOPA National Assembly. McLaughlin followed up with magazine ads, direct mail, and personal presentations. Prosthetic Laboratories also came up with a simpler way of making the brace, obtaining finished parts at a steep discount and remanufacturing them.

Richard Miller, CO, director of education and marketing for OrthoInnovations, explains the benefits: “It’s a hinge that has infinite adjustability. It’s strong, nonslip, and very simple to use. With this device, the patient can engage the brace to stretch the contracture gradually, in very small increments. Patients can determine what they can tolerate.”

In 2003, Prosthetic Laboratories spun off OrthoInnovations as a sister company, with a larger holding company over both. The two businesses occupy the same physical space and moved into larger quarters three years ago. OrthoInnovations has eight full-time employees.

While the Mackie Elbow was the impetus behind the creation of OrthoInnovations, the company markets other innovative devices as well, such as the Low-Rider hip abduction orthosis, which Miller developed in 1984. Additional products include a Mackie Hinge knee brace, an elbow hyperflexion sling/brace, a trans-femoral post-operative dressing, and the B-E-T casting frame.

Miller believes one of the most effective ways to market OrthoInnovations’ products is to speak directly to orthotists and prosthetists about proven clinical results.

“One of my responsibilities is to talk about the clinical application of our orthoses,” explains Miller. “For example, Gillette Children’s Hospital is using them in pediatric applications, and their orthotic residents did a study of the outcomes.”

Miller was selected to give the Howard R. Thranhardt lecture at the upcoming AOPA National Assembly in September. He will also present the results of a joint study with the Mayo Clinic, “Update on a Five-Year, 1,000-Patient Study of Post-Operative Hip Abduction Orthoses Treatment Outcomes.”

Miller is looking forward to expanding into additional markets throughout the United States and overseas. “We spent the first two years focusing on the U.S. market,” he says. “Last year, we started to pursue the European market. We’ve gone through the process of having most of our products CE marked for overseas sales.”

The CE mark stands for “European conformity” and means that a product complies with European health, safety and environmental protection legislation.

“The process of moving into the European market is complicated,” says Miller. “Something like facility accreditation times three. We have to have a permanent presence in Europe, language translations, compliance with export regulations. It’s one thing to build a device and fit it on a patient,” he notes. “But when you start manufacturing, you’ve got to pay attention to many layers of regulation.”

Surestep™
While many practitioners devise new products to help their patients, Bernie Veldman, CO, owner of Midwest Orthotic and Technology Center in South Bend, Ind., had a more personal interest.

Veldman noticed that his son, Kevin, was extremely hypermobile through his lower limbs and wanted to do something about it. “There are many children like Kevin,” says Veldman, who was then working for Toenges Prosthetics and Orthotics in Fort Wayne, Ind.

“As I worked with physical therapists and physicians in the community, I began to better understand what was happening with children who have low muscle tone. I started using different types of materials and trim lines to find something that would support and stabilize Kevin’s feet without immobilizing them in rigid braces.”

The result was the SureStep™ dynamic stabilizing system, a device that allows the foot to remain dynamic throughout the gait cycle and intrinsic muscles to continue to develop.

“When you use a traditional orthosis, rigid plastic immobilizes the foot,” explains Veldman. “But the foot needs dynamic movement throughout the gait cycle in order for the proper muscle strategies and motor plans to develop.

“The SureStep supramalleolar orthosis (SMO) is made of thinner, more flexible plastic. It employs the concept of compression to maintain stability of the foot, instead of the more traditional concept of wedging the foot into one static position. As a result, the intrinsic musculature can continue to develop, resulting in less dependency on bracing, and a much more natural development of balance reactions.”

When Veldman saw that his new brace worked well for Kevin, he began using it with patients. “When we would see a child with low tone, we would fit them with traditional bracing and also give them a pair of SureSteps at no charge,” Veldman says.

“Very soon, the physical therapists and doctors no longer wanted the traditional bracing, and only wanted the SureSteps. That was when we knew it was time to do something bigger with it.”

In 1999 Veldman purchased his South Bend practice, which was a small satellite office of Toenges P&O, thanks to the generosity of the owner, Fred (“Buck”) Toenges.

Initially, Veldman marketed his device to orthotists, setting up presentations in their offices. “We didn’t see much response, and I realized that it was the physical therapists who would make it happen,” he says.

Veldman launched a campaign to market his invention to pediatric physical therapists around the country through their local orthotists. Marketing to the physical therapy community has been the key to the success of Veldman’s device.

“This is exactly what the physical therapy community is looking for: alignment and function all rolled into one,” he says. But while his campaigns target physical therapists (the primary referral sources for pediatric orthotists), he only sells SureStep to orthotists.

“A few of the physical therapists and many podiatrists are put off by that policy,” he says, “but we don’t make exceptions. It’s a matter of principle, and also one of the best moves we have ever made.

“Our decision is about supporting the field that has been very good to me personally and to my company. I wish more manufacturers out there would take the same stand. I believe that it would bring about a positive change in the field.”

Veldman purchased Midwest Orthotic & Technology Center in January 2000, and the Surestep is integrated into the company’s operations and new patient care facility. When he bought the facility, it had three employees, including himself. Today, largely thanks to his products, Veldman employs closer to 40 people.

In addition to the SureStep SMO, he has developed a SureStep spinal orthosis, a SureStep Advanced AFO, and a SureStep De-Rotation strap.

Veldman’s marketing efforts continue to take a personal approach as he and a physical therapist on his staff present SureStep around the country and support ongoing research on the products.

He plans an expansion of the marketing department in the next year. “We have a great deal of ground left to cover,” he says. “And wherever we focus our marketing efforts, we will continue to grow. I am confident that as long as we continue to support the O&P field, it will continue to support us and our efforts.”

KISS Suspension System
The problem Lee Mantelmacher, CPO, set out to solve is one that has plagued prosthetists for years. “Prosthetists need a system that enhances linkage between the prosthesis and the body, especially when there’s volume loss in the residual limb,” he explained.

One major issue has been to control the rotation of the limb within the socket. Another problem is “pistoning,” where the limb moves up and down in the socket.

To prevent unwanted rotation of the prosthesis and ensure that it moves when the residual limb moves, prosthetists have devised a wide range of devices: socks with friction pads, pelvic bands and a shuttle-lock system in which a roll-on liner attaches to the socket with a distal pin.

The problem with these methods, according to Mantelmacher, is they are overly restrictive or extremely uncomfortable, especially for geriatric patients whose skin and bones are more delicate. “I first came up with the idea for a new kind of system in 2002, while I was working in the lab,” Mantelmacher says.

“The Keep It Simple (KISS) Suspension System uses a roll-on locking liner, but no pin or ratchet. Instead, we designed an innovative pulley action system to anchor the limb in the socket both proximally and distally. It controls pistoning and rotation so well, clinicians can use much less aggressive socket design and patients are far more comfortable. We have patients from age 3 to 90 using the system,” he says. “And it works well for new amputees as well as those with more mature residual limbs.”

Like his fellow inventors, Mantelmacher used his patient care practice, Maryland Orthotics and Prosthetics Co. Inc., in Baltimore, as a proving ground for his new device. “It worked so well in-house we contacted an attorney and applied for a patent in 2002. We received the patent in September 2004,” he says.

Mantelmacher created a new company, KISS Technologies LLC, to handle marketing and sales. His son, Adam, who holds degrees in marketing and logistics, came on board to design the company’s Web site and create demonstration videos. KISS Technology set up a booth at the AOPA National Assembly and relies on advertising and word of mouth to spread awareness.

“We’re hoping for global acceptance,” says Mantelmacher. “Orders are increasing every day. And so is our interest in developing new products.”

Deborah Conn is a freelance writer based in Falls Church, Va.