In the first article in this series (“High Tech, High Costs,” Vol. 8, No. 4), I argued that new technology is the primary driver of increasing health care costs in the developed world. The second article (“High Tech, High Costs,” Vol. 9, No. 1), reviewed various proposals for health care reform and discussed the impact such proposals would have on developing and deploying new technology. In this article, I want to address the importance of fostering neurosurgical innovation in a health care environment that may become increasingly hostile to technological development.
A Brief History
In the last 25 years, we have witnessed an explosion of technological innovations for diagnosing and treating patients with neurosurgical diseases, including: computed tomographic scanning; magnetic resonance imaging; the operating microscope; digital subtraction angiography; hyperthermia; local delivery of chemotherapeutic agents and gene therapy; stereotactic radiosurgery systems; endoscopic neurosurgery; image guided neurosurgery; thermography; tissue transplantation for degenerative brain disease and stroke; neuroendovascular procedures; intrathecal drug delivery systems; and chymopapain injections for disc herniations; and cerebral perfusion pressure monitoring, to name a few.
Some of these innovations have not been of significant value, but many have unquestionably improved the diagnosis and treatment of neurosurgical patients. Neurosurgeons have become accustomed to a dizzying pace of technological progress, but this is not inevitable. Leaders in government, the health care industry and neurosurgery need to critically think about what has spawned this era of innovation and how we can foster further technological advances in the future.
Factors Influencing Technological Innovation
Many factors influence the pace of technological innovation. These include patient needs and desires, market forces, federal policies on device approval and reimbursement, product liability decisions and the availability of medical and surgical specialists, particularly those at academic medical institutions.
The rapid development of technology in the recent past can be attributed to a uniquely favorable constellation of these factors. Patients expressed a strong desire for access to the newest medical technology. Therefore, institutions and physicians could obtain a competitive economic advantage by offering the latest technological innovations. Federal approval and reimbursement policies for the use of new technology were lenient and product liability concerns were relatively slight. Reimbursement policies favored specialty and procedure-related care. This fostered an environment in which physicians, health care institutions and device manufacturers could all profit by collaborating on the development and deployment of new technology.
Changing Environment
For good or bad many of these factors are changing. Although patients continue to want the latest technology to be employed in their care, they are concerned about the rising costs associated with such care. In any given year, only a small percentage of the population needs health care for acute illness. Even fewer require surgical specialty care. Decision-makers in business, the health care industry and government are, therefore, under considerable pressure to make health care more affordable.
Oversupply and subsequent underutilization of many sophisticated technologies also has made it less economically attractive for institutions to compete by increasing their technological capabilities. Lenient policies on reimbursement have been curtailed and more stringent documentation of benefits is being required for product approval. High profile product liability cases (e.g. silicone breast implants and pedicle screws) have raised concerns about the use of medical devices.
Most important, resources are being diverted from the specialty care of acute disease to primary and preventive care, causing academic medical ceenters to be placed under extreme economic pressure. Every neurosurgeon that I know in the academic community has experienced increased demands for clinical productivity at the expense of research productivity. These changes in the health care environment must eventually result in a change in the pace of technological innovation.
As I indicated in the second article in this series, proposed reforms of the health care system will likely exacerbate these problems. In enacting any reform, we must be careful not to destroy the milieu that has resulted in the dramatic technological advances of the recent past. It is usually not a good idea to kill the goose that lays the golden eggs, even if she does require a lot of feed.
The Process of Technological Innovation
The process of technological innovation is often serendipitous. Technological progress proceeds by small iterative steps with no well-marked course. Some paths lead to dead ends. Some produce unexpected results and open up new avenues of investigation and refinement. It is a dynamic process that is inherently unpredictable and arises from the collaboration of individual investigators, academic medical centers, venture capitalists, small businesses and large corporations.
The development of microneurosurgery is a good example. The vision and dedication of surgical pioneers like R. M. Peardon Donaghy, MD, and M. Gazi Yasargil, MD, were essential. They needed the time and support of the academic community to develop the techniques and equipment responsible for making neurosurgical procedures safer and more effective. Funding from decision-makers in small and large businesses, who thought they could make a profit by producing microsurgical instruments and operating microscopes, was essential. Had the research and development costs been prohibitive or the chances for device approval slim, it is unlikely that the funds needed for investment would have been available.
The introduction of the operating microscope to the neurosurgical community resulted in the ever-increasing refinement in equipment and techniques and a dynamic feedback process between neurosurgeons and manufacturers. Innovative applications of the new technology were developed. All of this occurred without any prospective, randomized study documenting the benefit of microsurgical technique and with little interference from regulatory agencies. Can anyone make a legitimate case that neurosurgical patients would be better served had this development been curtailed? Could the benefit of microneurosurgery have been documented or predicted 40 years ago? I don’t think so.
Determining the Value of Technological Innovations
There are those who believe that by empowering regulatory agencies to rule on the value of technological innovations we will impose order on technological progress. It is my belief that no person or group is wise enough to predict which new technological innovations will be of value. If the process of technological progress outlined above is accurate, evaluating new technology early in its evolution may fail to demonstrate significant benefits that become apparent only after considerable refinement.
For instance, endovascular balloon occlusion of intracranial aneurysms proved to be a procedure of limited value. Nonetheless, endovascular procedures were refined by the introduction of new occlusive devices, improved catheter delivery systems, better angiographic imaging and other innovations. Bureaucratic determination of the value of endovascular treatment early in its evolution might well have resulted in the disapproval of this approach for cerebrovascular disease. Such disapproval would almost certainly have truncated the subsequent refinements that have occurred in this area of neurosurgical care. Similar arguments could be made for many neurosurgical devices and procedures. We need to keep this in mind as we think about how to protect the environment from neurosurgical innovation in the 21st century.
Call to AAction
We, as neurosurgeons, must recognize the crucial role of academic medical centers and medical specialists in developing new technology. The diversion of funds from specialty care to primary and preventive care may give us the biggest bang for the health care buck in the short run, but we will pay the price in the future. Organized neurosurgery, through the Washington Committee and other venues, must make this case forcefully to government agencies and to the public.
We need to critically evaluate our own practices in order to provide the most cost-effective neurosurgical care possible. Neurosurgeons can deliver higher quality and lower cost care by refining our indications for diagnostic studies, surgical intervention and high cost hospital care. Indiscriminate applications of new technologies have resulted in the explosion of medical care costs, and we cannot assume that more technology produces better outcomes. We will be required to document improvements in health care outcomes before device approval and reimbursement for new technology is approved. We, as neurosurgeons, need to face this fact and become more involved in designing and carrying out outcomes studies that take into account the concerns discussed above. Only neurosurgeons understand the intricacies of neurosurgical care, and if we are not involved in technology assessment it will be to our detriment.