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Innovation and Invention in Medical Devices: Workshop Summary
ground and in space. This collaborative R&D process has been based on the need to utilize a broad range of expertise and experience to meet special requirements, minimize development costs, and exercise the NASA mandate to “provide for the widest practicable…dissemination of information concerning its activities and the results thereof.”
From the earliest years of the United States Space Program, NASA has in many cases taken off-the-shelf commercial biomedical instruments and modified them for use in space. This process mainly involved the use of NASA customized components and packaging designed to survive the rigors of space flight, and special considerations for safety and materials composition. NASA’s special requirements overlapped to a significant extent with military requirements for biomedical devices, including several core needs: portability, operation within intravehicular and extravehicular environments, telecommunication of data, minimally invasive sensors and non-encumbering instrumentation, and low-power, 28VDC and/or battery-powered systems.
NASA has always had especially challenging requirements for medical devices, including operation in variable pressure environments (space capsules and space suits), high radiation environments, and high vibration and shock environments (launch/reentry). Paramount in these considerations for medical devices has been the safety and well being of the astronaut crew and biological subjects. To this end, devices have been designed with the highest medical device standards in mind, and rigorous testing has been performed to validate their performance. In addition, NASA has high reliability requirements for biomedical devices, since on-orbit repair and/or replacement often is not possible. Some of these requirements overlap in part with those of the emergency medical monitoring and transport industry.
More recently, NASA’s Life Sciences Division has established internal Advanced Technology Development (ATD) programs to anticipate needs for medical (and biological) devices and similar technology. Because it can take years to go from initial requirements to having flight-qualified hardware, one aim of the ATD-Biosensors Program has been to collaborate with the future users of biomedical technology and develop and demonstrate modular, prototype systems in anticipation of need. When requirements are more solidly defined, often by multiple users who need similar technology, these prototype systems can be more quickly assembled, tested, and made available for use.
NASA also has established multi-disciplinary teams to plan for integration of advanced technologies into the International Space Station (ISS). The ISS provides a special challenge for development of medical devices, as it is a large, international research laboratory built in space to remain for 10 to 15 years. Over that time period, medical technologies will rapidly evolve, and older technology will need to be infused with new modular systems that take advantage of industry-developed technologies to optimize functional performance at minimum cost. These include sensors and instrumentation, analytical tools, and specialty devices. The emerging medical device industry/academic focus on wireless, tele-