Companies worldwide are competing to bring exoskeletons to the general public. The devices will be vetted by the medical community, academia, government and, eventually, by the toughest critic of all ? the marketplace.

There are millions of potential users around the world: those who have suffered spinal cord injuries; stroke victims; patients with multiple sclerosis and cerebral palsy. Even if only 1 percent of the aforementioned ultimately purchases an individualized version, that’s a lot of exoskeletons.

One such entrant into the race is Parker Hannifin of Cleveland, Ohio. With $13 billion annual sales, 58,000 employees, it has the heft to be a major player. And the company is expanding clinical trials of its Indego exoskeleton (name derived from the concept of “going independently”) with a goal of FDA approval and wide usage by 2016, according to Achilleas Dorotheou, head of the human motion and control business unit.

The technology is licensed from developers at Vanderbilt University in Nashville, Tenn. The team behind Indego won a 2013 Breakthrough Innovator Award from Popular Mechanics magazine, and demonstrations are scheduled at several events around the globe starting in May.

Parker is serious and deliberate about gathering “real clinical evidence” to demonstrate that Indego is “not only safe, but effective” in the “functional recovery” of those who need it for mobility, balance and a return to independence.

A strong engineering team, experts in neurorehabilitation and “a strong code of ethics” are just some of the factors Parker brings to the table, according to Dorotheou. The “very exciting technology” translates into specific benefits for patients ? and competitive advantage for the company, he says. These features fall mainly into three categories.

Made of metal, plastic, electronic and computer components, Indego is a modular device that can be easily assembled and disassembled. Indego is light, tipping the scales at 27 pounds, a weight to be further reduced in the version to debut next month. And its slim, sleek profile means users can put it on and take it off while sitting in a wheelchair; the ability to don the exoskeleton by oneself is “huge,” Dorotheou says. And the new version will be even easier than the prototype to put together and to take apart, Dorotheou adds.

Increasing Indego Clinical Trials

The prototype has been tested with some dozen patients at the Shepherd Center in Atlanta, Ga., which will continue as the lead rehabilitation center for clinical trials. However “generation 2,” the commercial version of Indego, is ready for 25 patients at that same institution to try out for three months.

Four more rehabilitation centers, like Shepherd recognized as being in the Top Ten by U.S. News & World Report, will participate, so there will be a total of 40 patients using the latest version for roughly a year. The four coming online with formalized agreements are Rehabilitation Institute of Chicago; Kessler Foundation/Kessler Institute for Rehabilitation in West Orange, N.J.; Rusk Rehabilitation at NYU Langone Medical Center in New York, N.Y.; and Craig Hospital in Denver, Colo.

The commercial version “was conceived from the beginning to be very much a personal device” that a person can use independently.

“We are confident that it will be approved, but it’s not our decision,” says Aidan Gormley, director of corporate communications for Parker. This approval process is estimated to take about a year, with Indego, he hopes, available for purchase by approximately summer or fall 2016.

The projected timelines are as follows, Gormley says:

• April 2014 to July 2014: Use at Shepherd Center
• July 2014 to July/September 2015: clinical trials at all five centers (12 to 14 months)
• July/September 2015 to July/September 2016: reports from clinical trials being considered by the FDA over approximately one year
• July/September 2016: approval by FDA if all goes well

In a medical setting, the Indego now is provided in a set, coming in sizes small, medium and large; and the pieces can be “mixed and matched.” Each set costs $150,000. The final version for personal use is estimated to cost about $75,000, and each one sold will be customized for its user.

That’s hardly chump change, and that’s why Parker is being so careful to ensure that all the data be complete and reliable. There are four distinct categories of players involved in the overall process, and all of them must be satisfied. The obvious ones are the patients and the clinicians. But then there are facility administrators and “the payers,” or the insurance companies, who in most cases would be footing the bill for the robotic device.

Dorotheou says FDA officials have indicated that they’ve seen nothing else quite like the Indego and that Parker hopes to be the first firm to make it through the rigorous FDA process. Thus, Parker will be “helping the industry overall, and we’re fine with that.”

Exoskeleton Market Outlook

The overall picture for the exoskeleton market remains bright ABI Research has projected the overall market for exoskeletons could reach $292 million by the year 2020. Other companies sharply focused on the technology’s medical applications include Cyberdyne (Japan), RBR50 company Ekso Bionics (California), Rex Bionics (New Zealand) and Argo Medical Technologies Inc. (Israel).

Cyberdyne may be a particularly worthy competitor, having just enjoyed the second-best opening performance among Japan IPOs this year. Cyberdyne’s HAL (Hybrid Assistive Limb) exoskeletons are meant to aid patients undergoing physiotherapy recover strength in their arms or legs.

Nathan Harding, co-founder and CEO of Ekso, recently said on Clear Channel Business Talk Radio’s The Traders Network Show that “We’re the leader in this very new field” and that his company publicly committed two years ago to having “a million people up and walking in 10 years.”

Harding noted that Ekso’s alternative public offering went public Jan. 15, 2014, and now the company is hiring “seasoned veterans” in sales and marketing.

Barriers to Entry

Standing just outside the fray is James L. Patton, Ph.D., director of the National Center for Rehabilitation Robotics, who says, “I think there’s a bright future for all of it.” Patton is also head of the Machines Assisting Recovery from Stroke Rehabilitation Engineering Research Center, with the Rehabilitation Institute of Chicago, a bioengineering professor at University of Illinois Chicago and also affiliated with Northwestern.

There are at least three ways to approach the home market, he says. First is the “pull” phenomenon in which consumers provide the impetus. Second is “push” in which research is paramount in demonstrating feasibility. There may even be a third path, which would be to go around the issue of it being a medical device” and undergo a lower level of FDA scrutiny by selling a device not as medical technology but instead as an exercise or mobility device for essentially healthy people

Whereas Harding envisions “Grandma at the mall in her Ekso pants” and eventually even “Iron Man-like suits hanging up at REI next to the backpacks,” Patton cautions that there are “lots of barriers ? it’s not sorted out yet,” and that these are cultural, practical, legal, medical and technical.

For instance, therapists may be tech-averse, fearing that a robotic device could break down during use or otherwise injure a patient. Plus, a typical therapy session is 40 minutes, so time spent putting on and taking off the device could be seen as prohibitive. Legitimate fears exist about safety in a sophisticated machine being used by a patient on his or her own. Also, with the U.S. the lawsuit-prone place that it is, there’s always a specter of litigation

And then there is the medical view. Those who most need an exoskeleton are, by definition, less than healthy, and the longer the immobility the greater the risks due to bone-density loss and blood pressure regulation. “Getting someone standing upright can be dangerous,” Patton says. “We still don’t know what happens to their physiology. We’re still learning. We’re being cautious. We don’t want to do any harm.”

Last but not least are engineering issues. Chief among them, Patton says, is that there will always be a delay between the individual’s intentions and the robot’s ability to notice and follow, so it’s unlikely that a wearable robot will restore its wearer to a truly natural gait. But there will always be a market for exoskeletons in the therapeutic realm; Patton envisions it enabling a therapist to be more productive when working with the patient.

And even Harding concedes that all the feverish corporate efforts only add up to an enormous “tech demo – till somebody shows that they can make a buck.”

For his part, Patton is looking forward to what comes next. “Any device that helps a person is wonderful. And there may be really cool innovations for overcoming some of the problems.”