Originally published January 1996
Robert S. Seeley
U.S. medical device manufacturers in search of new technologies occasionally need look no further than their own government. Some of these firms can participate in technology transfer, a catchphrase that describes the movement of technologies between the public and private sectors, or between private defense contractors and nondefense companies. The vehicle for transferring these technologies can range from an informal agreement between companies to structured government programs involving Advanced Technology Program grants, cooperative R&D agreements, and other mechanisms.
The idea of transferring technology from government laboratories to private companies took root in the mid- to late 1980s. While the United States was winning the Cold War, some argued, it was losing the battle for world economic leadership to Japan and Europe. Companies in Europe in particular seemed to profit from the active support and involvement of government in their enterprises. To level the playing field, the argument went, the U.S. government should actively seek out ways to move technologies with potential commercial applications out of its national laboratory system and into the hands of the private sector. At the same time, the U.S. military, increasingly in need of high-technology solutions to compensate for budget constraints, could benefit from breakthroughs made by industry.
The most widely traveled route to technology transfer by device companies is the Technology Reinvestment Project (TRP) of the Department of Defense's Advanced Research Projects Agency (ARPA). DOD enters into partnerships with commercial, academic, and nonprofit R&D institutions to take advantage of advances occurring in computers, telecommunications, and microelectronics. The goal is to maintain the U.S. military predominance in the postCold War era, even in the face of shrinking defense outlays.
Of the 99 TRP projects under way, many involve what could be loosely defined as medical device applications, ranging from casualty treatment, battlefield sensors, and command and control, to communications and military mobility. The casualty-treatment projects, for example, aim to help wounded soldiers survive the critical first hour after injury. If a combat zone casualty is not diagnosed and treated during this time, the chances for recovery are poor.
More important to device manufacturers are TRP projects that funnel defense technologies into their hands. The Wilmer Eye Institute of the Johns Hopkins University Medical Center (Baltimore), for example, is developing microelectronic fabrication techniques--such as photolithography and masking and wet-chemical etching--to process ophthalmic surgical knives out of hard ceramic materials such as aluminum oxide and silicon carbide. Typically, these surgical knives have been made of stainless steel that has been ground, lapped, and electropolished; they cost between $9 and $18 apiece and dull after one or two uses. At the other end of the scale, long-lasting diamond knives cost more than $1000 apiece. Other mechanically ground aluminum oxide ceramic knives cost between $100 and $200.
Wafer techniques, however, promise to produce knives with sharpness, durability, and reusability approaching those of diamond, and for a fraction of the price. According to Scott Rader, assistant professor of ophthalmology at the institute, "We found ways of squeezing from 250 to 550 knives on a single wafer. This fabrication process means no more hand sorting or individual grinding and lapping." Johns Hopkins holds the patent on the initial work.
The challenge, says Rader, is that "these hard ceramics are very resistant to chemical etching, making it difficult to form an edge. You could design the process to use expensive excimer laser systems, but your cost per knife wouldn't be competitive." The institute's researchers continue working to perfect the edge control.
Rader contends that technology transfer has made the development possible. "There was never enough funding to try to create a process of commercial or military value," he says, which led him to ARPA. "We have another year on this grant, during which time we will narrow to two promising systems. Over that span, we want to reach the proof-of-concept stage, then look toward commercialization."
Rader adds that the processing technique has military applications as well. "For the military, our techniques can define the edges of ultra-high-temperature materials like aluminum oxide and silicon carbide for window materials to protect cameras and similar devices."
Another TRP project with device applications involves Rio Grande Medical Technologies, Inc. (Albuquerque), the Sandia National Laboratories, and the University of New Mexico School of Medicine. These institutions are developing a patented, rapid, noninvasive arterial blood-gas measurement technique. When a physician attends to a wounded soldier in the field, one of the first tasks is to assess cardiorespiratory condition by measuring arterial gas. This involves drawing blood from the artery, adding reagents to the sample, and measuring it in an assay device. On the battlefield, however, a physician or medic may not have time to draw blood and make the assay.
The technique being developed under the TRP project is based on near-infrared spectroscopy. "You shine near-infrared light through tissue and obtain parameters of blood chemistry for data analysis," says Tom Fortin, vice president for Rio Grande Medical Technologies. The technology originated in the labs of Sandia, which developed it to measure the ages of stockpiled nuclear weapons.
At the end of its $2.9-million, three-year contract with ARPA, the collaborators will have a prototype ready. (A typical TRP project lasts two years, and the goal is to produce a viable technology for defense and commercial applications two to five years after the funding ends.)
The blood-gas measurement technology's current application is for military use, Fortin says, and "we're still several years away from assessing the market for arterial blood-gas monitoring equipment in hospitals and at the point of care. But we know that it is large."
DOD also hopes that a private-sector company, MusculoGraphics, Inc. (Evanston, IL), will be able to develop a high-resolution three-dimensional computer visual model of the human leg. The application would be for military telesurgery; that is, a surgeon in the rear lines would operate on a computerized re-creation of the wounded soldier. Robotic instruments on the front lines would mimic the surgeon's movements via telemetry to perform the surgery.
In civilian hospitals, the limb simulator could permit a surgeon to simulate a surgery before actually performing it in order to identify the best approach. The first application will simulate gunshot wounds.
Beginning in June 1994, the company took data from the National Library of Medicine to create high-resolution models of the leg. "We reconstructed the 2-D physiological slices from the National Library of Medicine data to create this 3-D model," says Arthur Wong, director of marketing and operations for MusculoGraphics. "We're working to make sure that things in the model are accurate and that we understand the responses of the tissues and other structures."
The company intends to simulate surgery by integrating its model with virtual-reality environments created using force-feedback devices and 3-D stereo glasses. (A force-feedback device contains tiny motors and tracking mechanisms that are attached to an individual's hands.) The surgical trainee would manipulate simulated instruments on a 3-D leg model appearing on a screen. "When the virtual surgical instrument bumps into virtual tissue," Wong says, "our software will tell the force-feedback device to apply a force in a direction. The user will get the realistic sensation a surgeon does while cutting."
"The technology we're developing is in the very early stages," Wong adds. "It will be a few years before we see many mainstream applications by companies like us." He says his company's initial focus is on military telemedicine, which is why it received the ARPA funding in 1993. "TRP makes defense technology more affordable," he says.
Some companies are following less structured routes to technology transfer. Bennett X-Ray Technologies (Copiague, NY), for example, has pushed digital imaging to a new limit by incorporating electronic digital imaging technology developed by its next-door neighbor, Grumman Corp.
Bennett developed prototypes of a fullbreast digital imager (filmless x-ray) for clinical trials by using Grumman's infrared imaging technology for airborne and space-based surveillance. Engineers at the two companies collaborated on the project.
"The core technologies--the detector and the electronics, data acquisition, and software manipulation systems--are similar," says Lim Cheung, digital imaging director for Bennett. Cheung came to Bennett from Grumman's R&D department.
Bennett X-Ray's full-breast imager incorporates a digital imaging system that captures the huge pixel area needed for the degree of contrast and spatial resolution that full-breast mammography demands. The radiologist has to see bright spots as small as 100 µm, which indicate cancerous growths. Visualizing them requires a matrix of 4800 * 6400 pixels spread over an 8 * 10-in. area. "It demands even higher resolution than high-definition television. You would need 100 normal television screens to display this whole image," Cheung explains.
He says that alternative scanning technologies--which operate along the lines of a photocopier--must expose a patient for as long as 10 seconds to build an image. The computerized digital imager takes a fraction of the time, and is less prone to mechanical problems.
COMING FULL CIRCLE
Completing the circle of technology transfer back to the defense industry, Cheung says he "wouldn't be surprised if DOD becomes interested" in this advance in digital imaging. Bennett's elaboration of the technology could be reapplied to more accurately spot missile launches, tanks, and the like. This imaging could also find use in teleradiology, which DOD is developing.
Technology transfer represents a new way of doing business for DOD. In theory, it means that the military receives the best commercial technology for its needs, while commercial R&D projects get a boost from government labs. Both the public and private sectors can benefit from technological advances more quickly and at a lower cost than would otherwise be possible.
Robert S. Seeley contributes regularly to MD&DI.
TRP SUPPORT OF TECHNOLOGIES RELEVANT TO MEDICAL DEVICES
Following are some of the key projects related to medical devices that are being supported by the Department of Defense Technology Reinvestment Project.
* An advanced picture archiving and communications system (filmless, digital radiology).
* An amorphous silicon medical imager (electronic replacement for x-ray film using amorphous silicon technology).
* A digital x-ray system for trauma and battlefield applications.
* The microfabrication of ophthalmic surgical knives.
* The national academic medical center information collaborative (access to the databases of one medical facility by others).
* The national information infrastructure--health information network (wide- area information infrastructure to support interoperability among health-care organizations).
* Surgical simulation for limb trauma management.
* Noninvasive arterial blood-gas measurement.
* A trauma-care information management system.