Ranica Arrowsmith , Associate Editor08.04.14
Part four of film director Michael Bay’s bombastic franchise “Transformers” earned a dismal average of 3.8 stars (out of 10) on the film review aggregator website Rotten Tomatoes this year. That doesn’t stop the movies from raking in the big bucks, though. The first film, released in 2007, was the highest grossing non-sequel film that year worldwide. It grossed a whopping $709.7 million. Fast-forward to the fourth installment, which was released this year. As of press time, the movie had generated $966.4 million worldwide. Despite what the critics think, robots are reliably popular among the common (read: non film-critic) folk. And why wouldn’t they be? They’re machinery with feelings. How cool is that?
It’s no surprise that most of the franchise’s success comes from outside the United States, particularly in East Asia and other areas of the world where English is not the native language. Robots don’t need translation. The impressively big, in-your-face computer generated imagery, for which Michael Bay is known, are enough to attract audiences and keep them coming back for more. The cool factor cannot be denied.
This year, transformers came to life in the United States—well, almost. In June, the U.S. Food and Drug Administration (FDA) approved for the first time an exoskeleton device, a wearable, motorized device made to help people walk. While admittedly users aren’t a match for Optimus Prime quite yet, the device is giving new hope to people suffering from lower-limb paralysis.
A New Industry
The inaugural product on the U.S. market is ReWalk, which helps individuals with lower-limb disabilities such as paraplegia but who still have upper-limb mobility. It provides individuals with user-initiated mobility through the integration of a light wearable brace support, a computer-based control system and motion sensors.
ReWalk was invented by Amit Goffer, Ph.D., himself a quadriplegic since 1998. In 2001, he founded Argo Medical Technologies Ltd., based in Israel, to develop a product that would enable people with spinal cord injuries to walk again. During the past decade, Argo has grown from a small research-and-development startup based in Israel to an international company with offices in the United States and Germany as well as Israel. Argo changed its name to ReWalk Robotics at the time of FDA approval.
ReWalk consists of a fitted, metal brace that supports the legs and part of the upper body; motors that supply movement at the hips, knees, and ankles; a tilt sensor; and a backpack that contains the computer and power supply. Crutches provide the user with additional stability when walking, standing and rising from a chair. Using a wireless remote control worn on the wrist, the user commands ReWalk to stand up, sit down or walk.
The FDA approval of ReWalk also served to set the stage for any other similar devices that will come after it (and there are a few in the waiting room). The approval classified exoskeletons as Class II devices. In order to grant ReWalk approval, the agency reviewed clinical data based on 30 study participants. The clinical tests assessed the participants’ ability to walk various distances, the amount of time needed to walk various distances, performance on different walking surfaces and slight slopes, and performance walking in areas where jostling might occur. Studies also assessed the risk of certain physical effects on the user. Additionally, observational data from 16 patients also were provided to support use of the device on various walking surfaces in the home and community with various levels of assistance from a trained companion. ReWalk is for people with paraplegia due to spinal cord injuries at levels T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra) when accompanied by a specially trained caregiver. It also is for people with spinal cord injuries at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra) where the device is limited to use in rehabilitation institutions. The device is not intended for sports or climbing stairs.
“This was a new breakthrough technology. There was nothing like it,” CEO of ReWalk Robotics, Larry Jasinski, told Orthopedic Design & Technology. “One of the challenges with the FDA was they had to learn this industry, just like everybody else in the world. They didn’t have already have clear guidelines, and a lot of the past four years leading up to approval was a combination of establishing these guidelines and meeting all the requirements of the agency. Because the FDA made the decision to classify the device as Class II, all exoskeletons in the United States will also be Class II. They will have to go through clinical and bench testing and a rigorous level of software validation, which makes it a safer and better product. This depth of the rigor has prepared us well for commercialization.”
“Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “Along with physical therapy, training and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities.”
But what does it mean to own an exoskeleton? For one, if a person is using a motorized device, they need more than just a doctor, physiotherapist or company sales representative they meet once.
Because it is a motorized device, people who use it need to know they can reach service representatives any time they need to, just like car owners can.
Jasinski stressed the importance of good training and service.
“If you buy a car, you want to make sure everything works, and you want to know that if you ever have a problem it will be taken care of,” he said. “A big function for those of us creating this industry is to create a significant training and service network in the areas we’re selling so that any user can have high confidence they can get information on how to use the device and that if they need anything fixed it can be done quickly. In creating a brand new industry, these are some fundamentals we address to make sure our users have a wonderful customer experience so they’ll tell others about it.”
Next in the waiting room is Parker Hannifin Corporation’s Indego. Parker Hannifin is based in Cleveland, Ohio, and is focused on motion-control technology. Indego is its first foray into the human motion-control space.
Earlier this year, Parker Hannifin announced that it formalized clinical trial agreements with five of the top-tier U.S. rehabilitation centers for its Indego exoskeleton device. Like ReWalk, Indego is a wearable lower-limb orthotic that allows paraplegic patients or patients with similar immobilizing conditions to walk and gain some measure of independence—hence the name, which is a portmanteau of “independent” and “go.”
“Indego is a powered exoskeleton, which in essence operates like a legged Segway,” Achilleas Dorotheou, vice president and head of the human motion and control business unit for Parker Hannifin, told ODT. “We like to use that phrase to relate that it mimics natural human movement by using postural cues to provide legged mobility for people with paraplegia and people with other mobility impairments of the lower limbs. The idea is that it helps a paraplegic get up and walk with the aid of just plain crutches.”
The main difference between ReWalk and Indego is how they are operated. While ReWalk has a remote control worn on the wrist, Indego works via “vibratory feedback,” controlled by the subject’s posture, Dorotheou explained. If a subject wishes to stand up from a seated position, all he or she has to do is lean forward. Indego will register posture and vibrate in order to signal that it is ready to help the person stand. If the patient did not mean for that action, he or she just needs to lean back again.
Otherwise, Indego will move mechanically to bring the user into a standing position. To then walk forward, the Indego user leans forward again. To stop, the user leans back. In this way, Parker Hannifin has tried to make its operation as intuitive as possible. The system has a modular design, which means that it can be disassembled into five pieces and stored in a case about the size of an airplane carry-on luggage allowance.
“The subject can take those components and then attach the calf pieces, thigh pieces and back piece around his body,” Dorotheou said. “Between the pieces are ‘quick connects.’ We paid special attention to these over the past year to make them particularly user friendly and forgiving, so that the user can connect ‘blind’—i.e. they don’t even have to look at them to assemble them.”
Dorotheou’s relationship with Indego began in 2012, three years after the system had been conceived at Vanderbilt University. At the time, Dorotheou was the vice president of business development at another Parker Hannifin group, and already had gained experience commercializing medical devices in collaboration with Cleveland Clinic. Parker Hannifin’s chief technology officer asked him to negotiate an agreement with Vanderbilt, and he was able to obtain an exclusive license for commercializing the device globally. He and Parker Hannifin then hired co-inventor of the technology, Ryan Farris, Ph.D., as engineering manager for human motion and control. Farris was still a doctoral student when he brought the exoskeleton to life under the instruction of Michael Goldfarb, Ph.D., the H. Fort Flowers Chair in mechanical engineering and professor of physical medicine and rehabilitation at Vanderbilt. Since 2012, Dorotheou’s team along with several new hires, worked on a second generation of the exoskeleton, making it lighter, more modular, extending its battery life, and all in all getting it ready for the clinical trial stage. Now, the team is ready to hand the system over to the Shepherd Center, a highly regarded Atlanta, Ga.-based spinal cord and traumatic brain injury rehabilitation and research center, for three months of pilot clinical trials.
Following this, the system will move into clinical trials in the United States, for which Parker Hannifin has made clinical trial agreements with four of the top-ranked U.S.-based rehabilitation institutions: Rehabilitation Institute of Chicago, Ill.; Kessler Foundation/Kessler Institute for Rehabilitation in West Orange, N.J.; Rusk Rehabilitation at New York University Langone Medical Center in New York, N.Y., and Craig Hospital in Denver, Colo. These institutions will work in concert with the Shepherd Center, which will continue as Parker's lead rehabilitation center for clinical testing of the device. Each of these institutions currently is ranked in the top 10 U.S. rehabilitation centers by U.S. News & World Report magazine. Additionally, to aid in building a body of evidence required for reimbursement coverage, Indego now is available by request to additional select U.S. rehabilitation clinics to be included in clinical studies.
“Some of Indego’s competing devices use very sophisticated, lightweight aerospace materials in order to make the device light. That really adds to the cost of the device,” Dorotheou said. “The genius of our device, which we recognized from the beginning, is that its light weight is not due to any material, but the mechanical design itself. Therefore it allowed us to use quite standard materials. We have spent a lot of time and money on optimizing the battery so it can basically snap on. The external pieces are made from basic plastic resin, and there are some internal metal components. The original design was 3-D printed, and the current design is formed plastic material.”
The Indego clinical trials in the United States will last between 12 and 14 months to reflect protocols desired by the FDA and payers. Following that, Parker will apply for FDA approval, a process that is projected to take a year. By mid-2016, Parker hopes to have Indego on the U.S. market ready for clinical and personal use. Meanwhile, Parker also is pursuing ISO 13485 and CE mark approval in Europe, and Indego should be on the European market by early 2015.
“We see [Parker] as truly being a leader in the human motion control space not in the sense of not only being the largest company, but by enriching and enabling the field,” Dorotheou said. “Intelligent, powered, connected devices that enhance the quality of life for the mobility impaired. That is the theme for how Parker will approach this new industry."
What’s Next for Exoskeletons?
Like any modern technology, especially those that depend on software to operate, powered exoskeletons will go through many improvements and advancements as the years pass. Jasinski makes the analogy to smart phones. The Apple iPhone has gone through a full seven generations of advancements. Similarly, the ReWalk has already been updated to its 2.0 version, with version 3.0 on the horizon. The difference between the first iteration and the second mainly was modifications to make the system more producible in high volumes, a process that Japanese commercialization partner Yaskawa Electric Corporation helped with.
“We hope to make ReWalk applicable to more injury states in the future,” Jasinski said. “Right now it’s indicated for spinal cord injury, but in the future we’ll look at things like multiple sclerosis, cerebral palsy, stroke, etc. However, we will need clinical data and regulatory approvals, which we do not have yet. We’re also looking at variations on the technology to continue to advance it dramatically. Right now you use it outside of your clothing as one big system—perhaps we could change that by downsizing it, and adding more variation to the way it works and the control.”
ReWalk (as Argo) released its exoskeleton in the United Kingdom in 2012 with the help of East Yorkshire-based mobility solutions provider, Cyclone Technologies. Now, the device is available in the United States and Canada. With Yaskawa’s help, ReWalk will reach Japan, China, Korea and Taiwan, and Jasinski said ReWalk will expand into other Asian nations on its own as well. Next up: South America.
For its part, Parker Hannifin wants to play “where the pack is going, not where it has been,” according to Dorotheou. “Parker will not be investing in passive orthotics and prosthetics. We are interested in technologies that are intelligent, that have sensor-based technology and that are powered, because they better mimic the true biomechanic limb. And we are excited about the potential of connecting these devices and making them alive with rich data collected from all payers, clinicians and the subjects themselves.”
It’s no surprise that most of the franchise’s success comes from outside the United States, particularly in East Asia and other areas of the world where English is not the native language. Robots don’t need translation. The impressively big, in-your-face computer generated imagery, for which Michael Bay is known, are enough to attract audiences and keep them coming back for more. The cool factor cannot be denied.
This year, transformers came to life in the United States—well, almost. In June, the U.S. Food and Drug Administration (FDA) approved for the first time an exoskeleton device, a wearable, motorized device made to help people walk. While admittedly users aren’t a match for Optimus Prime quite yet, the device is giving new hope to people suffering from lower-limb paralysis.
A New Industry
The inaugural product on the U.S. market is ReWalk, which helps individuals with lower-limb disabilities such as paraplegia but who still have upper-limb mobility. It provides individuals with user-initiated mobility through the integration of a light wearable brace support, a computer-based control system and motion sensors.
ReWalk was invented by Amit Goffer, Ph.D., himself a quadriplegic since 1998. In 2001, he founded Argo Medical Technologies Ltd., based in Israel, to develop a product that would enable people with spinal cord injuries to walk again. During the past decade, Argo has grown from a small research-and-development startup based in Israel to an international company with offices in the United States and Germany as well as Israel. Argo changed its name to ReWalk Robotics at the time of FDA approval.
ReWalk consists of a fitted, metal brace that supports the legs and part of the upper body; motors that supply movement at the hips, knees, and ankles; a tilt sensor; and a backpack that contains the computer and power supply. Crutches provide the user with additional stability when walking, standing and rising from a chair. Using a wireless remote control worn on the wrist, the user commands ReWalk to stand up, sit down or walk.
The FDA approval of ReWalk also served to set the stage for any other similar devices that will come after it (and there are a few in the waiting room). The approval classified exoskeletons as Class II devices. In order to grant ReWalk approval, the agency reviewed clinical data based on 30 study participants. The clinical tests assessed the participants’ ability to walk various distances, the amount of time needed to walk various distances, performance on different walking surfaces and slight slopes, and performance walking in areas where jostling might occur. Studies also assessed the risk of certain physical effects on the user. Additionally, observational data from 16 patients also were provided to support use of the device on various walking surfaces in the home and community with various levels of assistance from a trained companion. ReWalk is for people with paraplegia due to spinal cord injuries at levels T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra) when accompanied by a specially trained caregiver. It also is for people with spinal cord injuries at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra) where the device is limited to use in rehabilitation institutions. The device is not intended for sports or climbing stairs.
“This was a new breakthrough technology. There was nothing like it,” CEO of ReWalk Robotics, Larry Jasinski, told Orthopedic Design & Technology. “One of the challenges with the FDA was they had to learn this industry, just like everybody else in the world. They didn’t have already have clear guidelines, and a lot of the past four years leading up to approval was a combination of establishing these guidelines and meeting all the requirements of the agency. Because the FDA made the decision to classify the device as Class II, all exoskeletons in the United States will also be Class II. They will have to go through clinical and bench testing and a rigorous level of software validation, which makes it a safer and better product. This depth of the rigor has prepared us well for commercialization.”
“Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “Along with physical therapy, training and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities.”
But what does it mean to own an exoskeleton? For one, if a person is using a motorized device, they need more than just a doctor, physiotherapist or company sales representative they meet once.
Because it is a motorized device, people who use it need to know they can reach service representatives any time they need to, just like car owners can.
Jasinski stressed the importance of good training and service.
“If you buy a car, you want to make sure everything works, and you want to know that if you ever have a problem it will be taken care of,” he said. “A big function for those of us creating this industry is to create a significant training and service network in the areas we’re selling so that any user can have high confidence they can get information on how to use the device and that if they need anything fixed it can be done quickly. In creating a brand new industry, these are some fundamentals we address to make sure our users have a wonderful customer experience so they’ll tell others about it.”
Next in the waiting room is Parker Hannifin Corporation’s Indego. Parker Hannifin is based in Cleveland, Ohio, and is focused on motion-control technology. Indego is its first foray into the human motion-control space.
Earlier this year, Parker Hannifin announced that it formalized clinical trial agreements with five of the top-tier U.S. rehabilitation centers for its Indego exoskeleton device. Like ReWalk, Indego is a wearable lower-limb orthotic that allows paraplegic patients or patients with similar immobilizing conditions to walk and gain some measure of independence—hence the name, which is a portmanteau of “independent” and “go.”
“Indego is a powered exoskeleton, which in essence operates like a legged Segway,” Achilleas Dorotheou, vice president and head of the human motion and control business unit for Parker Hannifin, told ODT. “We like to use that phrase to relate that it mimics natural human movement by using postural cues to provide legged mobility for people with paraplegia and people with other mobility impairments of the lower limbs. The idea is that it helps a paraplegic get up and walk with the aid of just plain crutches.”
The main difference between ReWalk and Indego is how they are operated. While ReWalk has a remote control worn on the wrist, Indego works via “vibratory feedback,” controlled by the subject’s posture, Dorotheou explained. If a subject wishes to stand up from a seated position, all he or she has to do is lean forward. Indego will register posture and vibrate in order to signal that it is ready to help the person stand. If the patient did not mean for that action, he or she just needs to lean back again.
Otherwise, Indego will move mechanically to bring the user into a standing position. To then walk forward, the Indego user leans forward again. To stop, the user leans back. In this way, Parker Hannifin has tried to make its operation as intuitive as possible. The system has a modular design, which means that it can be disassembled into five pieces and stored in a case about the size of an airplane carry-on luggage allowance.
“The subject can take those components and then attach the calf pieces, thigh pieces and back piece around his body,” Dorotheou said. “Between the pieces are ‘quick connects.’ We paid special attention to these over the past year to make them particularly user friendly and forgiving, so that the user can connect ‘blind’—i.e. they don’t even have to look at them to assemble them.”
Dorotheou’s relationship with Indego began in 2012, three years after the system had been conceived at Vanderbilt University. At the time, Dorotheou was the vice president of business development at another Parker Hannifin group, and already had gained experience commercializing medical devices in collaboration with Cleveland Clinic. Parker Hannifin’s chief technology officer asked him to negotiate an agreement with Vanderbilt, and he was able to obtain an exclusive license for commercializing the device globally. He and Parker Hannifin then hired co-inventor of the technology, Ryan Farris, Ph.D., as engineering manager for human motion and control. Farris was still a doctoral student when he brought the exoskeleton to life under the instruction of Michael Goldfarb, Ph.D., the H. Fort Flowers Chair in mechanical engineering and professor of physical medicine and rehabilitation at Vanderbilt. Since 2012, Dorotheou’s team along with several new hires, worked on a second generation of the exoskeleton, making it lighter, more modular, extending its battery life, and all in all getting it ready for the clinical trial stage. Now, the team is ready to hand the system over to the Shepherd Center, a highly regarded Atlanta, Ga.-based spinal cord and traumatic brain injury rehabilitation and research center, for three months of pilot clinical trials.
Following this, the system will move into clinical trials in the United States, for which Parker Hannifin has made clinical trial agreements with four of the top-ranked U.S.-based rehabilitation institutions: Rehabilitation Institute of Chicago, Ill.; Kessler Foundation/Kessler Institute for Rehabilitation in West Orange, N.J.; Rusk Rehabilitation at New York University Langone Medical Center in New York, N.Y., and Craig Hospital in Denver, Colo. These institutions will work in concert with the Shepherd Center, which will continue as Parker's lead rehabilitation center for clinical testing of the device. Each of these institutions currently is ranked in the top 10 U.S. rehabilitation centers by U.S. News & World Report magazine. Additionally, to aid in building a body of evidence required for reimbursement coverage, Indego now is available by request to additional select U.S. rehabilitation clinics to be included in clinical studies.
“Some of Indego’s competing devices use very sophisticated, lightweight aerospace materials in order to make the device light. That really adds to the cost of the device,” Dorotheou said. “The genius of our device, which we recognized from the beginning, is that its light weight is not due to any material, but the mechanical design itself. Therefore it allowed us to use quite standard materials. We have spent a lot of time and money on optimizing the battery so it can basically snap on. The external pieces are made from basic plastic resin, and there are some internal metal components. The original design was 3-D printed, and the current design is formed plastic material.”
The Indego clinical trials in the United States will last between 12 and 14 months to reflect protocols desired by the FDA and payers. Following that, Parker will apply for FDA approval, a process that is projected to take a year. By mid-2016, Parker hopes to have Indego on the U.S. market ready for clinical and personal use. Meanwhile, Parker also is pursuing ISO 13485 and CE mark approval in Europe, and Indego should be on the European market by early 2015.
“We see [Parker] as truly being a leader in the human motion control space not in the sense of not only being the largest company, but by enriching and enabling the field,” Dorotheou said. “Intelligent, powered, connected devices that enhance the quality of life for the mobility impaired. That is the theme for how Parker will approach this new industry."
What’s Next for Exoskeletons?
Like any modern technology, especially those that depend on software to operate, powered exoskeletons will go through many improvements and advancements as the years pass. Jasinski makes the analogy to smart phones. The Apple iPhone has gone through a full seven generations of advancements. Similarly, the ReWalk has already been updated to its 2.0 version, with version 3.0 on the horizon. The difference between the first iteration and the second mainly was modifications to make the system more producible in high volumes, a process that Japanese commercialization partner Yaskawa Electric Corporation helped with.
“We hope to make ReWalk applicable to more injury states in the future,” Jasinski said. “Right now it’s indicated for spinal cord injury, but in the future we’ll look at things like multiple sclerosis, cerebral palsy, stroke, etc. However, we will need clinical data and regulatory approvals, which we do not have yet. We’re also looking at variations on the technology to continue to advance it dramatically. Right now you use it outside of your clothing as one big system—perhaps we could change that by downsizing it, and adding more variation to the way it works and the control.”
ReWalk (as Argo) released its exoskeleton in the United Kingdom in 2012 with the help of East Yorkshire-based mobility solutions provider, Cyclone Technologies. Now, the device is available in the United States and Canada. With Yaskawa’s help, ReWalk will reach Japan, China, Korea and Taiwan, and Jasinski said ReWalk will expand into other Asian nations on its own as well. Next up: South America.
For its part, Parker Hannifin wants to play “where the pack is going, not where it has been,” according to Dorotheou. “Parker will not be investing in passive orthotics and prosthetics. We are interested in technologies that are intelligent, that have sensor-based technology and that are powered, because they better mimic the true biomechanic limb. And we are excited about the potential of connecting these devices and making them alive with rich data collected from all payers, clinicians and the subjects themselves.”