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 August 1997
Hearings on Assistive Technology
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Statement of Dr. Bruce Webbon
Chief Commercial Technology Office
NASA-Ames Research Center

Before the

Subcommittee on Technology
Committee on Science

U.S. House of Representatives

July 15, 1997

Madam Chair and Members of the Subcornmittee, I am pleased to have the opportunity to discuss NASA technology and its application to assist people with disabilities.

Introduction

A significant and growing percentage of US citizens are afflicted with some form of physical disability. These range from relatively slight disabilities, which still may seriously interfere with their quality of life and work productivity, up to the near total disability caused by conditions such as severe spinal cord injury. In many cases technical solutions may exist which could benefit these citizens but that technology is often not available to them. In spite of the large overall number of citizens with some form of disability, the needs of particular individuals are often very dissimilar and as a result, the market for specialized assistive devices is often very small As a consequence of this fragmented market, large private companies that may have sufficient scientific and engineering resources to develop the needed devices, are often reluctant to do so since the return on investment would be small or even totally non-existent. Small companies that might serve these niche markets often don't have the resources necessary to develop such new products. The end result is that while the necessary technology may exist in many cases, the private sector is often not able to apply it to serve the needs of many disabled citizens. The Federal Laboratories, including agencies such as the National Aeronautics and Space Administration, may be able to help to bridge this technology gap.

The following are some of the specific issues that must be addressed in order for this to happen:

The Federal Government and its laboratories are uniquely qualified to address these issues and make major contributions in the area of medical assistive devices if they are given specific direction to do so as well as the resources to meet the challenge. Their most important resource is the technical expertise of the lab staffs and the facilities and specialized equipment that have often been built up over many years to accomplish the lab's primary mission. These resources are not tied to a company's "bottom line" so that a portion of their efforts can be re-directed if desired. Since they are not in the business of selling commercial products they have no commercial vested interest in any particular design solutions. Therefore, they can potentially be completely objective in selecting the best solution to meet the patient's needs. Most Federal labs also have the capability to design, fabricate, and test prototypes in-house at low cost and many labs already have the required legal review mechanisms in place to deal with the medical and patient liability issues.

Overall NASA Efforts

The National Aeronautics and Space Administration has a long history of applying the aerospace technology that has been developed to accomplish its primary mission to help to solve problems on Earth. Many medical devices that are currently on the market had their origins in NASA technology. The primary NASA headquarters organizations that have directed these field center efforts are the Life Sciences Division of the Office of Life & Microgravity Sciences & Applications and the Commercial Technology Division of the Office of Aeronautics & Space Transportation Technology. The Commercial Technology Division has been given primary responsibility for ensuring that NASA technology is expeditiously transferred to the private sector. Many examples of such technology transfer are reported in publications such as Spin-off Magazine and NASA Tech Briefis.

The Director of the Commercial Technology Division has already assigned staff to participate in the Interagency Committee on Disability Research, Subcommittee on Technology. This committee will produce a "Compendium of Federal Rehabilitation Technology Research." The Commercial Technology Division is also in the process of formulating a program plan that will focus resources on the problems of the disabled with the intent that NASA will become a model for the effective transfer and commercialization of technology to benefit people with disabilities. This program will utilize both Federal and private assets as appropriate in order to accomplish its goals. All NASA centers are involved in this new program just as all centers have made contributions to medical technology in the past. Some recent examples of NASA contributions to medical device technology include:

Specific Examples of Medical Assistive Device Development

I would like to give several specific examples based on my own experience as to how the process of technology transfer for medical assistive devices has worked at NASA's Ames Research Center. These will illustrate how the process has worked in the past and will point out how it might be improved in the fliture.

For many years NASA Ames was responsible for the development of advanced technology for space suits and portable life support systems for human space exploration missions. As a result of this primary mission, a highly skilled technical staff had been assembled along with the unique facilities and equipment they required. This technical area required staff expertise in a wide range of disciplines including various engineering skills as well as physiology and bio-mechanics. Since their role was advanced R&D, the staff had also developed a number of collaborations with both academia and industry. These staff skills were particularly applicable to the development of medical devices and over many years this group responded to requests from private companies, physicians, and individuals to assist in finding solutions to medical device problems. These efforts were enabled by a supportive and tolerant center management and in particular by the active support and participation of the Ames Chief Medical Officer who was responsible for ensuring that all human use and patient liability issues were properly handled.

As a result this group was able to develop prototypes of the following devices, many of which are currently being manufactured by commercial companies, in addition to accomplishing its primary job of providing advanced technology for NASA missions:

Those indicated by an * have resulted in successful commercial products

These development efforts fall into two distinct classes, those that resulted from a planned, programmatic effort and those which occurred by serendipity due to the existence and reputation of the technical group. I will provide examples of both.

Liquid cooling garment systems were first conceived by the British Royal Aircraft Establishment during the 1950's to help aircraft pilots maintain their body temperature while wearing bulky protective suits in a hot aircraft environment. The concept was adopted and flirther developed by NASA during the Apollo program when it was found that astronauts wearing space suits suffered from similar heat stress, Both NASA and Russian astronauts still use refined versions of these cooling suits today.

Ames Research Center staff began research in the late 1960's to better understand the alterations in the human physiology caused by the use of such garments and then to apply that knowledge to the development of improved garments. They soon realized that there were many Earth applications of this technology that could be used in both hot and cold environments as well as for medical applications. The first focused effort was instigated by the U.S Bureau of Mines which asked us to develop a portable cooling system that could be used by mine rescue workers who were required to work very hard in very hot environments following disasters such as a fire in a mine. This effort resulted in the first prototype of the portable cooling systems that are currently produced by a number of companies.

In 1978 a physician at UCLA, who knew that the symptoms of multiple sclerosis patients were greatly exacerbated in a hot environment, approached us to request that we try to use an astronaut type cooling system on some of his patients to determine if artificial cooling would provide any symptomatic relief We took an experimental cooling system to a physical therapy clinic at UCLA and deterinined that it did indeed appear to provide some relief to the patients. A private company then adopted the system design and began to produce commercial Systems for sale to MS patients.

These Systems are still available today but they are not widely used in the MS community primarily because the scientific foundation establishing their effects has not been established and the currently available devices are expensive and simultaneously relatively expensive. In 1994 the NASA Administrator signed a Memorandum of Understanding with the Multiple Sclerosis Association of America and committed us to collaborate with the MS community in order to improve the technology and expand its use.

We recognized immediately that we did not understand the needs of the MS community. Therefore, we began the program by organizing an invited workshop that included members of the MS research and patient care community as well as representatives of the companies that were producing cooling systems for use by MS patients. The purpose of this workshop was to define the specific requirements of the program to which we had been committed by the Administrator. We believe that this is a critical first step in any such program. The needs and requirements must be identified and defined by the actual end users of the technology to be developed.

This program has been extremely successflil. We determined during the workshop that the most critical problems that we could assist the MS community in solving were to collaborate with them in performing careflilly documented scientific experiments to define and quanti~ the effects of cooling on MS patients. This would establish the scientific basis of cooling therapy. In addition the small companies involved would benefit greatly ifNASA undertook the development of several key hardware components that could be used to improve their devices. We have largely accomplished the first goal and the result is a number of scientific papers that validate the efficacy of cooling therapy for MS patients. As a result of these publications the technique is being widely adopted including the establishment of cooling therapy clinics in Veterans Affairs' hospitals and elsewhere. We collaborated with a university to develop the hardware components. This was accomplished by teams of undergraduate students working under a cooperative agreement with NASA so that the cost was very low. The student teams produced several innovative designs that will result in patents in addition to the valuable real world experience they obtained. These component designs will be made available to the manufacturers in the near fixture.

This program, which has been supported by both the Life Sciences Division of the Office of Life & Microgravity Sciences & Applications and the Commercial Technology Division of the Office of Aeronautics & Space Transportation Technology over the last 3 years, was not completed during the planned 3 years. Therefore, we have recently brought in a large corporate partner, the Lockheed Martin Corporation to help to provide the resources necessary to complete the program during FY98. In order to accomplish this a Memorandum of Understanding was negotiated and signed in June of this year between NASA Ames Research Center, Lockheed Martin Corporation, and the Multiple Sclerosis Association of America. Each of the participants has p]edged to contribute both financial and other resources necessary to complete the program We are extremely proud of this program and we believe it can serve as a model of the methodology to be used for similar programs in the fliture.

The development of such applications of liquid cooling technology, including this MS application, was selected by the United States Space Foundation in 1993 to be inducted into the Space Technology Hall of Fame.

The second detailed example, which was also accomplished by the Ames Research Center staff, will illustrate how an informal effort can produce highly significant results if it is nurtured by lab management. This example is the development of what has become known as Medical Anti-Shock Trousers (MAST).

Special suits, which help to protect the pilots of high performance aircraft from passing out during violent maneuvers, have been available for many years. These "anti-g" suits work by applying external pressure to the legs and abdomen to help to maintain blood pressure in the trunk and more importantly in the brain. In the early 1950's such a suit was used to attempt to maintain blood pressure during cranial surgery but the technique was not widely accepted. The US military also investigated the use of such suits during surgery. The Ames staff were actively involved in the development and testing of these suits and were aware of such applications.

In 1969 a surgeon from the Stanford University Hospital placed an emergency call to an Ames space suit physiologist asking for help. Stanford had a female patient who was dying due to uncontrollable internal bleeding following surgery. Several surgical attempts had already been made to stop the bleeding but they were not successifal. The surgeon reasoned that someone at Ames might be able to help and fortunately he was able to reach the right person. A small team of staff members were able to modi~ a pilot's g-suit and assemble a pneumatic controller within a few hours. This system was taken to the hospital and used on the patient. The bleeding stopped within a few hours and the patient recovered. A paper documenting this technique, "Mti-G Suit as a Therapeutic Device" was published in the Journal ofAerospace Medicine, Vol.41, No.8, August 1970.

Over the next several years the Ames staff responded to several similar calls still using borrowed and adapted hardware. In 1975 several Ames engineers collaborated with the Ames medical officer to design and fabricate a suit and controller especially for this purpose. This system was then used a number of addional times and the results were documented in a survey paper reviewing the use of the technique which was published in the Journal of the American Medical Association; Feb 16,1979-Vol 241, No.7. The editorial in that same issue advocated that trauma physicians consider the use of this life saving technique. As a result of this advocacy, a number of companies began to manufacture anti-shock trouser systems.

These systems are now in common use in ambulances and emergency rooms around the world. The development of these anti-shock trousers was selected by the United States Space Foundation in 1996 to be inducted into the Space Technology Hall of Fame. As part of the Space Foundation's due diligence research they determined that these life saving systems have been used more than 2 million times over the last 20 years. This example illustrates what can be accomplished without a formal program by a knowledgeable and dedicated staff provided their management supports and nurtures such efforts.

A final example will illustrate how government staff expertise and resources might be utilized on a volunteer basis to meet the needs of individual citizens with disabilities.

Ames Research Center is currently working with a non-profit organization called the Tetra Society to define and implement the necessary procedures to enable Ames staff to work directly with disabled individuals. The Tetra Society acts as a clearing house to connect disabled

individuals directly with engineers and technicians who can produce specialized devices that will improve their quality of life. For example, the specific disability of paraplegics varies greatly. Many have individual needs for devices allowing them to reach a telephone for example or to carry a back pack on the back of their wheel chair and then be able to move it within reach. These devices can make significant improvements to their quality of life and self-sufficiency but they must often be custom made for each individual. Tetra attempts to match such individuals with the technically skilled people who can fabricate devices to meet their specialized needs.

NASA is a gold mine of such people but they can not be accessed by the disabled community unless a number of legal and liability hurdles are crossed. These include human use issues, Worker's Compensation, and product liability. With the enthusiastic support of center management, the Ames Commercial Technology Office Staff is currently in the process of establishing legal and administrative procedures that will enable technical staff members to volunteer to use both their expertise as well as specialized fabrication and test equipment available at the center to fabricate such devices. We hope that this will become a model for other NASA centers as well as private companies. The Lockheed Martin Corporation has already indicated that they would like to set up a similar volunteer mechanism following our lead.

These specific examples illustrate what may be accomplished even without a formally organized, Agency-wide program. We know that every NASA center has many similar and often unpublicized examples of providing assistance to the disabled community. We believe that far more can be accomplished given a more focused and organized Agency-wide approach.

Summary

Agencies such as NASA have already made significant contributions to the disabled community. Both the Commercial Technology Division of the Office of Aeronautics & Space Transportation Technology and the Life Sciences Division of the Office of Life & Microgravity Sciences & Applications have supported and will continue to support such applications. Because of limited resources available to NASA, only a limited number of such applications may be pursued at any one time. As a technology becomes commercially available and the research to describe its use and scientific merit is published or transferred to the Na' or other user agency, the activity is phased out to release resources for another application.

So-called technology transfer in actuality means the transfer of know-how together with making the technology commercially available. Therefore, the most important NASA asset is the technical strength of its staff This must be preserved above all else to enable such contributions in the fixture.

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