Innovation and Invention in Medical Devices Workshop Summary (2001) / Chapter Skim
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3 The Nature of Medical Innovation
3 The Nature of Medical Innovation
Pages 31-46
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From page 31... ...
Director, Life Sciences Division National Aeronautics and Space Administration Since its inception in 1958, NASA has collaborated with many entities on technology R&D. These collaborations have included the development of medical devices in support of astronaut health and biomedical research, both on the ~ One presenter, Dean Kamen, President of DEKA Research and Development Corporation, played a videotape from a news show that aired on network television.
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From page 32... ...
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 lowpower, 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)
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From page 33... ...
Medical Device Case Studies NASA's transfer of its R&D results to the private sector has been implemented through various methods and mechanisms that provide industry and academia access to spin-off technologies and knowledge, several of which have been applied to commercial biomedical devices. This collaboration is enabled by the provisions of the Space Act Agreement, and is implemented with the assistance of the NASA Commercial Technology Offices (CTOs)
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From page 34... ...
Mechanical heart pumps have three potential problems: destruction of red blood cells, formation of blood clots, and the body's reaction to a more continuous blood flow rather than the normal pulsed flow of blood. A team from NASA Johnson Space Center and NASA Ames Research Center assisted Dr.
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Intensive biomedical monitoring and research was done on the Skylab, the first space station, in 1973, but only relatively simple measurements could be made. Problems with attachment of surface sensors occurred throughout the mission, and needs for wireless biotelemetry data were apparent.
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Hybridized medical devices were increasingly used for human medical support and biomedical research. The first Spacelab, which allowed significant biomedical monitoring, flew in 1983 with several life sciences experiments.
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Several years ago the FDA initiated sweeping changes to the regulatory process that effectively buried device evaluations under the identical regulations imposed for approval of drug entities. This attempt to apply a drug testing method to device testing is a seriously erroneous and inappropriate approach.
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From page 38... ...
Devices, instrumentation, and specialized treatment systems must continually be refined and changed along the process route, which invariable does not lend itself to prospective randomized testing models. In most cases, device evaluations utilizing prospective randomized clinical trials prove not to be the most advantageous method for determining efficacy because prospective randomization, in order to be valid, makes the following assumptions; 1.
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From page 39... ...
As it incubates with a single strand of DNA it will find its complementary structure on the chip and bond. The fluorescent tag allows the DNA to be read using a confocal scanning system made by Hewlett-Packard.
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The reason that inhalable insulin has not been developed to date is the difficulty of getting drugs to reach the deep lung so that they can be absorbed effi
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From page 41... ...
To help drive the drug into the deep lung where it needs to be delivered to enable systemic delivery, researchers developed a unique delivery inhaler. Because drug particles need to be delivered consistently from person to person, researchers could not rely on patients' inspiratory flow rate so they developed an inhaler that operates independently of a patient's inhaling flow rate.
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From page 42... ...
A desirable computation capability being developed is to measure a functional capillary index, or the amount of blood flowing within a tissue along with its hemoglobin concentration. Clinical observations of the microvascular structure have been made by inserting the optical probe into the rectum for the differential diagnosis of Crohn's disease and ulcerative colitis.
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From page 43... ...
legislation were enacted limiting liability for clinical trials, and if there were more industry involvement in the design and implementation of government regulations. GENERAL DISCUSSION OF THE NATIVE OF MEDICAL INNOVATION Discussion of this session's talks began with a question about whether the Cytoscan imaging system had been used in the capillary bed in the nose, where one could gain access to two of the four major arteries that serve the brain.
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Mr. Kamen recounted that 9 years ago when he started building his robot, he did not care what the gyros cost for his proof of concept, so he bought aerospace gyros at $2,000 apiece.
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Dr. Fodor responded that when he first started this pursuing the DNA chip technology he had a lot of thoughts about genetic diagnostics, chips for cystic fibrosis or other diseases, but it turned out that precisely because of the FDA barriers, plus the difficulty of making a profit on those relatively small-market products, he had to make the decision to point the technology toward things that people could just not possibly do otherwise, that is, whole genome scanning, very broad-scale applications.
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From page 46... ...
Fodor took a contrary view, noting that his company had actually found the SBIR programs extremely effective, along with traditional RO1 awards and National Institute of Standards and Technology (NIST) grants in the first few years of the company's existence.
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