September 15, 2009      

The market penetration of commercial robotic rehabilitation systems has been minimal, despite the growing social need. Researchers and companies can proactively address the situation.

Robotic rehabilitation systems are those robotics technologies that support the restoration of function following physical trauma, medical intervention, or the advent of disease, with most commercial versions assisting with recovery from neurological disorders such as stroke. The devices use computer-controlled robotics technology to move body parts in a consistent, repeatable manner, providing patients with the physiological and psychological benefits of motion and exercise. In some cases, the repetitive motion provided by robotic rehabilitation technology facilitates the rewiring of neural pathways around damaged areas, restoring partial or full mobility (a phenomenon known as neural plasticity).

Social Need
Robotics can be used to support many types of rehabilitative therapy targeting a large number of physical disabilities. Primary among these are disabilities associated with cerebrovascular accidents (CVA), better known as stroke.

The numbers of individuals affected by stroke and the costs to provide rehabilitative care are staggering. The National Stroke Association estimates that approximately 750,000 people suffer stroke each year in the United States (and more than one million in the European Union). With more than 85% of stroke victims recovering, stroke is the leading cause of long-term morbidity and disability in the U.S. The National Stroke Association notes that today more than 6 million people in the U.S. have survived a stroke, and puts the yearly cost for stroke rehabilitation at $4.5 billion (16% of the total direct medical costs).

It Gets Worse
Since approximately 1900, life expectancies in most of the world have been on the rise and are expected to continue increasing. For example, the World Health Organization (WHO) estimates that between 2009 and 2050 the number of persons over 65 years old will increase 73% in industrialized countries and 207% worldwide. According to WHO, the percentage of the U.S. population over 65 years should almost double from 12.3% to 20.6% (from 40 to 80 million people) by 2050.

Increasing life expectancies will impact the world in several ways, including swelling the number of individuals with disabilities, many of whom can be treated using different therapeutic approaches, including robotic rehabilitation therapy. This is especially true in the case of stroke. The elderly are particularly prone to stroke, with the relative incidence of stroke doubling every decade after age 55.

Automating Manual Tasks
It is well established that the guided, repetitive movements of limbs has the beneficial effect of increasing muscular strength, improving coordination, and “remapping” the brain of patients with neurologic and orthopedic impairments. Specifically, the brain has the ability to regain function through rehabilitative exercises following an injury such as a stroke. Also, it has been demonstrated that increasing the intensity and duration of training sessions amplifies the positive effects of rehabilitation therapy. Traditionally, therapists perform these repetitive tasks by manually manipulating patients’ arms, legs, and other body parts.

The effectiveness of rehabilitation therapy is largely a function of the length of treatment. Rehabilitation therapy, however, is very time consuming and labor intensive, and therefore expensive. Robotic systems excel at carrying out directed, consistent, repetitive motions without tiring, making them extremely well suited for automating manual therapeutic techniques. Compared with manual methods, which are dependent on the availability, physical strength, and endurance of individual therapists, robotic rehabilitative systems increase the accuracy, repeatability, and duration of treatments while freeing therapists to perform other tasks.

Technology and Products
The science of robotic rehabilitation has existed for at least a decade, and in that time the technology has advanced considerably. In many cases, the prices for advanced technology have dropped while functionality has increased. Microelectronics in the form of sensors, motors, and microprocessors, as well as myoelectric control technology, provide just a few examples.

The robotic rehabilitation technology market itself is typically divided between products that support the rehabilitation of upper-body extremities and those focused on lower-body extremities. The former are represented by robotic arm rehabilitation systems such as Hocoma’s Armeo and Kinetic Muscles’ Hand Mentor, while the latter are characterized by robotic body-weight-supported treadmills such as HealthSouth’s AutoAmbulator and Hocoma’s Lokomat. A third class of products, wearable robotic exoskeletons, is under development, but at this time commercial versions are not available.

Numerous clinical studies from throughout the world have clearly demonstrated the advantages of rehabilitation robots for assessing and treating impairments in both the upper and lower extremities. Still, at this time the number of fielded, commercial robotic rehabilitation systems is low.

Editor’s Note: For a more detailed description of robotic rehabilitation/therapeutic systems, see the feature article “Healthcare Robotics—Current Market Trends and Future Opportunities” in the April 2009 issue of Robotics Business Review.

What’s the Problem?
To date, the market penetration of commercial robotic rehabilitation technology has been minimal. This would seem to fly in the face of the dramatic and growing social need for such  technology. The paradox becomes greater when one considers the proven clinical effectiveness of rehabilitation robotics and the existence of powerful, low-cost enabling technology.

Issues related to interoperability and standards have slowed commercial expansion. However, it seems that the primary culprits are a burdensome regulatory approval process as well as a lack of suitable financing and reimbursement models for robotic rehabilitation therapy (Medicare, private payer, fee for service, etc.) as described below:

  • Medicare—Healthcare robotics, with the possible exception of robotic surgical systems, has been met with indifference by the U.S. federal health insurer Medicare. Hospitals are reluctant to use technology that is not covered by this government bellwether until they are given assurances the government will cover some costs.
  • Private Sector Insurers—Medicare’s indifference to robotic rehabilitation provides little reason for insurers to embrace robotic rehabilitation technology and techniques.
  • Regulatory Approval—A burdensome and sluggish regulatory sanctioning process by governmental agencies such as the U.S. Food and Drug Administration (FDA) slow the granting of approvals required to enter commercial production.
  • Reduced Capital Expenditures—Cost-control efforts in healthcare environments are having a restrictive effect on new capital expenditures. The budgets of hospitals and rehabilitation centers were under a great strain even before the U.S. real estate bubble burst in the fall of 2008, taking the world economy down with it. Since that time, budgets for new capital expenditures have been frozen or slashed.

Fostering Commercialization
To summarize, the commercialization of robotic rehabilitation technology has been slowed by a combination of limited funding for capital expenditures, slow regulatory approval, and most important, the lack of working reimbursement models for robotic therapy.

Developing reimbursement models for robotic therapy has become a classic chicken-and-egg situation, with all participants in a perpetual “wait state.” Reimbursement models will not develop until robotic rehabilitation is more widely accepted and available (has proven itself), while commercial products for robotic therapy will remain an unproven niche market until reimbursement models are developed for it.

It is clear that while companies can do little to impact international economics, they are not powerless participants in the market. For example, companies can reduce the cost of products in an effort to increase sales (through standardization and modular development, perhaps) and speed regulatory approval by working through a partner program with a larger commercial or governmental entity. Similarly, researchers and companies can work to hasten the evolution of payment models. Consider the following:

  • Department of Defense—In the United States, sources of funding for basic rehabilitation robotics research include a number of science- and health-related federal agencies such as the National Institutes of Health (NIH) and the National Science Foundation (NSF). Another source for similar funding in the U.S. is the Department of Defense (DoD), as well as daughter agencies such as the Army Medical Research and Material Command (MRMC), the Telemedicine and Advanced Technology Research Center (TATRC), and the Defense Advanced Research Projects Agency (DARPA). Defense budgets, which continue to expand, are increasing their financial support for basic medical research, including, as one would expect, research into rehabilitation. Often agencies will offer support programs for speeding the commercialization of promising technology, including assistance for overcoming regulatory hurdles.
  • Additional Studies—While there are studies that measure the efficacy of commercial robotic rehabilitation solutions using relatively large samples of patients, most studies are more limited in time and scope, with studies rarely exceeding a six-month trial period and often focusing on prototypes in a laboratory environment. What is lacking (and required) for regulatory approval are more robust studies focusing on the long-term health benefits and risks of using commercial-class technology. It is perhaps even more important to develop business analyses that speak to the issues of reimbursement models and productivity improvements (see Business Drivers, below), as well as provide statistically robust evidence that robotic rehabilitation does in fact reduce overall costs for patients, insurers, and healthcare providers.
  • Business Drivers—Aside from addressing social needs and increasing the clinical and biomechanical efficacy of treatments, rehabilitation robotics also provides business advantages to healthcare providers. These benefits, which are quantifiable and are thereby evidentiary, include reducing costs while increasing revenue and productivity:
    • Cost Control/Reduction. Robotic rehabilitation systems allow hospitals and rehabilitation centers to do more with less. For example, rehabilitative procedures can be accomplished with limited supervision by a clinical therapist, decreasing the costs for individual sessions and allowing therapists to support a greater number of patients compared with conventional manual therapy.

    • Marketing Tool. Hospitals are attracting patients and filling beds (increasing revenue) by actively marketing the availability of robots to perform specific procedures. Robotic rehabilitation therapy has the same potential.

    • Increased Productivity. Robotic rehabilitation technology reduces the physical demands and monotony associated with manual therapy, making the tasks more appealing and increasing overall staff productivity.

    • Healthcare Reform—The current debate over healthcare reform in the United States focuses on three desired outcomes: expanding coverage to all citizens, increasing the quality of services, and controlling overall costs. Existing studies provide evidence that robotic rehabilitation systems produce more constant, accurate movements compared with manual methods. Such studies should be increased in number and scope, as well as combined with rigorous multivariate analysis focusing on both short-term and long-term costs savings. This would act to provide evidence that academic and business initiatives related to robotic rehabilitation therapy can be tailored to support key goals of healthcare reform.

Many Roads to Commercialization
The lack of commercial development of robotic rehabilitation technology in the face of staggering social need is intolerable. To wait while commercialization efforts make slow, steady progress is equally unsupportable. In fact, there are a number of ways in which researchers and companies can drive the market, including expanding core research, demonstrating the business benefits of robotic rehabilitation therapy, and supporting the goals of healthcare reform.

The Bottom Line

  • The primary driver for the robotic rehabilitation systems market is the high incidence of stroke and the high cost of stroke rehabilitation.

  • The number of stroke victims and other individuals treatable with robotic rehabilitation therapy is expected to grow rapidly, in step with increasing life expectancies.
  • Robotic rehabilitation systems increase the accuracy, repeatability, and duration of treatments compared with manual methods.
  • In spite of social necessity, continuing technological advancement, and a large volume of research, the number of fielded, commercial robotic rehabilitation systems is low.
  • A lack of suitable financing and reimbursement models has limited commercial expansion of robotic rehabilitation technology.
  • Researchers and companies have many options for proactively addressing the slow pace of robotic rehabilitation technology commercialization.
  • Companies can use the “draft” of healthcare reform and other methods to speed the commercialization of robotic rehabilitation technology.