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The bloodiest edge
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May 4, 1998: 1:56 p.m. ET
Surgical microrobots take up residence in the operating room
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SAN FRANCISCO (The Red Herring) - Imagine a robot operating on your brain. Or microrobots dispensing drugs from behind your eyes. Sound like science fiction? Welcome to medicine in the '90s.
Robots can make much more precise movements than humans can; they can also help doctors see what would otherwise be hidden internal areas during surgery. Proponents of robotic surgical systems say robots can reduce medical costs by minimizing the personnel required for surgeries, speeding up procedures, and limiting the need for repeat visits and aftercare. According to Alex Arrow of Wedbush Morgan Securities, the market for surgical robotic systems, software, and devices is crowded with startups.
Obstacles to the widespread use of such devices include high costs, the lengthy Food and Drug Administration approval process, and surgeons who are loath to be replaced, even partially, by machines. But one thing is clear: surgical robots are science fiction no longer.
Hip robots
Paul Merlyn, a senior industry analyst for SRI Consulting, divides surgical robots into three categories: autonomous robots, telemanipulators, and microrobots. Autonomous robots perform fixed functions that involve precise movements and planning, like drilling through a bone. Telemanipulators mimic and refine a surgeon's hand movements, whether the doctor is in the operating room or at a remote location. And microrobots are tiny experimental devices that perform tasks like delivering drugs within the body.
No surgical robotic developer is making money yet, but one of the most persistent companies is Integrated Surgical Systems (RDOC) of Sacramento, California. Integrated makes Robodoc, an autonomous "smart drill" used in hip replacement surgeries. After implanting titanium locator pins in a patient's femur and taking a computerized tomography (CT) bone scan, a surgeon manipulates 3D images of the bone to choose the appropriate prosthesis and where to position it. Robodoc uses the information to determine where to drill the hole.
According to William Bargar, an Integrated cofounder, Robodoc's selling point is its accuracy: the better the fit, the better the chance that the bone will grow around the implant and hold it in place. (Traditional hip replacement surgery affords 20 percent contact between bone and prosthesis; Dr. Bargar says studies indicate that Robodoc ensures virtually total contact.) Patients are therefore less likely to require follow-up operations, or "revisions," which are normally required after 10 to 15 years and cost about $60,000, or almost 50 percent more than the initial surgery.
Robodoc could also reduce the cost of prostheses, which account for almost half the price of hip replacement surgeries. Because surgeons must choose a prosthesis immediately before or during an operation, they require a distributor or middleman to be present with a range of prostheses; the distributor takes a 20 percent cut. But Robodoc can pick the prosthesis well before an operation with 100 percent accuracy, the company claims--22 percent better than its human counterparts. Dr. Bargar speculates that hospitals using Robodoc could save by circumventing middlemen and dealing directly with prosthetics suppliers.
These savings would be offset by Robodoc's cost (about $635,000), but Dr. Bargar says hospitals should be able to use the device for several types of orthopedic operations, including revisions of non-Robodoc hip replacements, tunnel placement for anterior cruciate ligament surgery, and shoulder and knee replacements. He also anticipates nonorthopedic applications in areas as diverse as ophthalmology and neurosurgery.
Still, there is a question mark in Integrated's future. The company has plowed $26 million into the development of Robodoc and just completed the required two-year follow-up study for the FDA, but it is waiting for government approval to offer Robodoc to U.S. hospitals. Although Integrated has delivered 13 systems to countries in Europe, where its technology has been available for two years, the company has yet to prove itself on Wall Street, where its stock has been stagnating. (IBM, codeveloper of Robodoc and a major investor in the company, has the right to purchase up to 27 percent of Integrated's stock.)
Left turn at the right ventricle
If the level of competition is anything to go by, telemanipulation companies developing robotic endoscopic devices have been slightly more successful than their autonomous-robot counterparts. Endoscopy allows surgeons to examine patients internally, using a tiny camera mounted on the tip of an instrument that is inserted into a small incision, or port. The process does less collateral damage than traditional methods, which involve making large incisions or breaking bones. And traditional endoscopy is difficult because surgical assistants often are unable to hold the camera steady for long periods or move the endoscope as fluidly as the surgeon requires.
Several startups have made significant progress in developing robotic devices with which surgeons can peer inside the chest cavity. Computer Motion, based in Goleta, California, outside Santa Barbara, was founded in 1989 to develop robotic systems for the National Aeronautics and Space Administration and the defense industry. In 1994 the company won FDA approval for Aesop, a device that assists surgeons in performing laparoscopy. Using hand and foot controls to manipulate Aesop, surgeons can receive a televised picture of their progress around a patient's abdomen. So far, Computer Motion has sold 300 Aesop machines, which have been used in more than 35,000 operations. Last December Aesop, whose latest iteration includes voice activation technology, was approved by the FDA for use in heart surgeries.
Computer Motion's competitors include Intuitive Surgical Devices, MicroDexterity Systems, and Brock Rogers Surgical. Of these companies, the Mountain Viewbased Intuitive, which employs endoscopic technology developed by SRI International, is the most mature. Although Intuitive does not utilize voice-activated software, the company has argued that its proprietary EndoWrist technology makes its system's controls more lifelike, or responsive, than Aesop's because they are jointed like the human wrist. Founded in 1995, Intuitive closed a third round of $17 million last November and has raised $52.4 million in financing from Sierra Ventures; the Mayfield Fund; Morgan Stanley, Dean Witter, Discover; and individuals. It plans to go public midyear.
Thinking cap
Endoscopic advancements extend to software as well. Vista Medical Technologies (VMTI), based in Carlsbad, California, develops robotic endoscopic software and equipment, including a head-mounted monitor with which surgeons can view the position of their tools within body cavities, 3D anatomical data, and other diagnostic and monitoring information, like ultrasound. Vista is trying to sell systems to hospitals that will allow robotic devices to share such information in real time. In its initial public offering filing last year, Vista called information management a key part of its long-term strategy.
This strategy presents significant hurdles to Vista and others. Although hospitals might be willing to shell out $300,000 to $600,000 for robotic endoscopic equipment, an even more expensive and elaborate robotic information-sharing network may be out of their reach. Vista, which generated slightly more than $4 million in revenues last year, is proposing to ease the cost by charging by the operation. Other companies are following suit, but this approach is far from proven.
Naturally, the cost concerns are particularly acute for the more bleeding-edge approaches. Many laboratories are exploring the viability of microrobots that can travel inside the body. In experiments reminiscent of the 1966 movie Fantastic Voyage, researchers at the California Institute of Technology are developing a colon-inspecting microrobot that measures only 17 by 25 millimeters, and researchers at the Massachusetts Institute of Technology are working on a similar, 4-centimeter-long device.
Merlyn of SRI says that microrobotic surgery won't become a reality for another 20 years. In addition to passing the FDA's inspection, which often takes ten years or more, companies must solve formidable mechanical challenges like micromachining, or how to manufacture the minuscule devices. More important, health care organizations will need to see clear cost benefits before they commit to what will be very expensive technology.
Ultimately, however, these deterrents may be less important than the egos of individual surgeons. Surgeons, of course, play a leading role in the adoption of new surgical technologies. Despite the fact that a robotic device can be programmed to make movements accurate within less than a millimeter, Dr. Bargar concedes that many surgeons who have not worked with robots regard surgery as an art and resent the idea that machines are more accurate than they are. "Most surgeons think they're good with their hands," he gripes.
All of these factors lead Dr. Bargar to estimate that the market for robotic surgical equipment might still be 10 to 15 years away. Russell Hirsch of the Mayfield Fund quibbles with this projection. He says the key to quick adoption lies in designing devices that allow surgeons to do things that traditional tools would never have allowed them to do. Because surgeons can perform hip replacements without Robodoc, he thinks that Robodoc could face a longer adoption curve than other types of devices.
Given the nascent state of the industry, it would be easy to dismiss robotic surgery systems as fantasy, and even Dr. Hirsch admits that many people still think of the robot in terms of the '60s TV show Lost in Space--cute, but lacking any real manual dexterity or utility. But as robots prove their usefulness through FDA trials and in operations in Europe and Japan, the medical community may find that it can't afford to overlook how they can assist in expensive, often invasive surgeries where a 1-millimeter misstep can cost a lawsuit--or a life.
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