Looking Ahead: The Future of O&P Manufacturing

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By Brady Delander

Major manufacturers celebrate milestones by looking to the future.

Over the last couple of years, O&P manufacturing companies have celebrated some major milestones. Last year, Otto Bock HealthCare, Minneapolis, Minnesota, celebrated the 50th anniversary of its U.S. incorporation; Becker Orthopedic, Troy, Michigan, celebrated its 75th anniversary; Ohio Willow Wood, Mt. Sterling, Ohio, surpassed 100 years in business; and this year, The Fillauer Companies Inc., Chattanooga, Tennessee, will celebrate its 95th anniversary. While all of these companies have recognized their milestones with a healthy dose of nostalgic reflection, they are also using the occasion as a springboard into the future.

When The O&P EDGE asked O&P manufacturers what the next 50 years might hold for them, most agreed that consumers' needs and desires will be paramount. Mobility, comfort, and security are the roots of this business. Beyond that, however, the predictions get a little more interesting.

"We are all going to be robots," deadpans Tabi King, director of marketing for Ossur Americas, Aliso Viejo, California. While that might sound like a joke, other predictions carry an eerily similar tune.

King
King

Newman
Newman

Stark
Stark

Colvin
Colvin

Ruhl
Ruhl

"I will offer one prediction for the next 50 years," says Phil Newman, director of marketing for Touch Bionics, Livingston, Scotland. "People will make a lifestyle choice to adopt prosthetic technology. People will 'super-humanize' themselves."

Though nobody claims to own a crystal ball, a number of industry insiders offered The O&P EDGE a glimpse at what might develop over the next several decades. Gerald Stark, BSME, CP, FAAOP, director of product development and education for Fillauer Companies, says that predicting what the future holds is difficult, at best. He stresses that first, "you have to examine past processes that contributed to the quantum leaps in modern development."

'Breakthrough' Times

One of the more significant periods of "breakthrough" prosthetic technology advancement occurred shortly after World War II. The desire to assist injured war veterans, as is often the case during breakthrough times, was producing impressive results. Researchers at the University of California, Berkeley, created the first suction socket for transfemoral prostheses. Around the same time, Samuel Alderson, inventor of the crash-test dummy, helped to develop the first motor-powered prosthetic arm as part of his work with IBM. The practicality of the first creation was quickly recognized; the second was ahead of its time. Plastics were emerging as a lighter, stronger, more adaptable alternative to wooden devices, and the first myoelectric hand was on the horizon.

It is doubtful that even the researchers involved in these developments could have predicted the amazing capabilities of the devices and technologies on the market today, not to mention emerging technologies.

Comfort, Control, Function, and Speed

The needs and desires of the end-user drive all of today's manufacturers, and what users want in an orthotic or prosthetic system has evolved rapidly over the past 20 years as advanced prosthetic and orthotic systems have enabled users to achieve higher levels of function. To meet the end-user's goals, manufacturers are integrating new materials, electronic technologies, improved socket interfaces, and visual design concepts. They are also examing and testing new ways for users to control devices that will, ideally, offer unparalleled stability and security. Jim Colvin, director of engineering at Ohio Willow Wood, says, "The sheer number and variety of products that are available have made big improvements for amputees. The desire is always for a prosthesis that is more comfortable and more functional."

"Looking at what amputees were dealing with 50 years ago, the real change definitely has been security and stability as well as the ability to take increased impact levels," King adds.

Materials such as carbon fiber also have changed the O&P landscape, making lighter and stronger designs possible. But even carbon fiber could become obsolete sometime over the next several decades, King surmises. Researchers at the University of California, Santa Barbara (UCSB), have looked to the animal world-namely giant squids and their beaks-for ideas. The beak changes density gradually from the hard tip to a softer, more flexible base where it attaches to the muscle around the squid's mouth. That could open the door for a socket interface that doesn't press or rub against the soft tissue of the user. (Editor's note: For more information on this research, see the EDGE Direct article "Squid Beaks for a Better Prosthetic Fit?" )

As is the case with computer hardware, the goal for prosthetic and orthotic manufacturers is to make smaller, lighter, stronger, and faster products. "The progression will be heavier will go to faster, and faster will go to stylish-something that looks cool, like an iPod," Newman says.

Newman adds that coverings should not be underestimated in the design process. Some users want a lifelike look, while others prefer a rugged, robotic style.

Closer to Real

The research of today will become the products of tomorrow, and expectations continue to climb each year as new advancements move beyond the laboratory and into clinical trials. One of the most widely anticipated advancements is targeted muscle reinnervation (TMR), a surgical technique that has shown exciting potential in early testing and which was pioneered by Todd Kuiken, MD, PhD, at the Research Institute of Chicago (RIC), Illinois. Advanced prosthetic arms are also being developed by two teams in association with the Defense Advanced Research Projects Agency (DARPA) Revolutionizing Prosthetics program: DEKA Research and Development, Manchester, New Hampshire, and the Johns Hopkins University Applied Physics Laboratory, Laurel, Maryland, in coordination with the Research Institute of Chicago, Illinois, and other research institutions. The "Luke Arm," developed by Dean Kamen and his team of researchers at DEKA, is expected to go into clinical trials in 2009. (Editor's note: For more information on TMR and its potential applications for both DARPA arm projects, see the EDGE article "Targeted Muscle Reinnervation: The Future Is Now" ; for more information on the DARPA Revolutionizing Prosthetics Program, see DARPA Revolutionizes Prosthetics: How and Why? from 2007 )

Other research is drawing attention as well. Hugh Herr, PhD, a professor at the Massachusetts Institute of Technology (MIT), Cambridge, and principal investigator of MIT's Biomechatronics Group, developed an active ankle-foot orthosis, among other recent achievements, that has the potential to provide more mobility to patients with foot drop. Neuroprosthetic research-part of a larger trend that aims to integrate body, mind, and machine into so-called "bio-hybrid" limbs-is seeing advancement on many fronts. "Some breakthroughs may blur the distinction between biological and non-biological," says Roy Aaron, MD, director of the VA Center for Restorative and Regenerative Medicine.

Regardless of whether or not these devices and technologies make it to the marketplace, the underlying research involved in their development will have an impact on prosthetic and orthotic advancement for years to come. "There will be continued improvement with materials, designs, control systems, and the development of devices that are smarter," Colvin says. "We are seeing more functional upper-extremity prostheses with more capabilities and controls, and that technology is starting to be transferred into the lower-extremity area."

The advances won't be limited to limbs. "In addition to external prostheses, other aspects being looked at for the near future are internal," Newman says.

As for the super-humans Newman predicts, the U.S. military and DARPA are leading the charge. Exoskeletons would give soldiers amplified speed and strength, and these same systems offer mobility to almost everyone, even lifting paraplegics out of wheelchairs.

In addition to the closely guarded developments within their own R&D departments, manufacturers are keeping a close eye on all of these areas of emerging research. Though no one in the industry would offer a glimpse at exactly where their R&D dollars are going, they all agreed that practicality for the user is the goal. If the past 50 years are a guide, today's manufacturers are prepared to move into the future. "It's an exciting time, and our view of the future is very bright, says Brad Ruhl, vice president of sales for Otto Bock U.S. "The challenges are there. How do we climb the ladder to provide better outcomes for patients?"

Old-fashioned Customer Service Not Forgotten in O&P's Future

Customer relations have always been a priority for those in the orthotics and prosthetics business, but the waves of exciting technology in the industry can pull attention away from that goal. In today's marketplace, with increased competition, an uncertain economy, and savvy consumers, the consumer must come first for manufacturers.

"As the complexity of the technology increases, we have to make sure that practitioners are trained so that they know how to provide that technology," says Brad Ruhl, vice president of sales for Otto Bock U.S., Minneapolis, Minnesota. "The market needs proven and reliable technology that delivers powerful benefits to patients, but it needs to be delivered in a framework with a high level of patient satisfaction."

As is the rule in any competitive market, unhappy customers won't have too far to go if their needs aren't met. "Our business skills must continue to grow," says Gerald Stark, BSME, CP, FAAOP, director of product development and education for Fillauer Companies, Chattanooga, Tennessee. "The competition is out there with hungry eyes. The profession should band together to respond by marketing, improving, and transforming itself."

Custom orthotics and certainly prosthetics are not off-the-shelf products, but speed of service is a sometimes-overlooked aspect of O&P. "When you buy a car or a sofa, these things are immediate. You buy them and take them home. It can take six weeks or more to get a prosthesis," says Phil Newman, director of marketing at Touch Bionics, Livingston, Scotland. "We don't want people...walking around without limbs, when the possibilities for immediate connection are out there."

Newman speaks to the benefits of a more competitive marketplace, where new and even complex products are made more readily available. "The O&P sector is fairly established, and it moves at its own pace. The end-user community lives in a slightly different world," Newman says.

In addition, no product will make it to market without rigorous testing, and today's users are pushing products to the limit by running marathons, jumping out of airplanes, and riding bikes down mountains. Says Tabi King, director of marketing for Ossur Americas, Aliso Viejo, California, "At the end of the day, it's all about mobility and being able to do whatever you want."

Brady Delander is a freelance writer based in Denver, Colorado.