An MD&DI September 1997 Column
For the assistant director of SRI International (Arlington, VA), complying with regulatory issues is but a sliver in creating a winning device.
Health care is poised at the brink of profound technological change, motivated by the need to provide improved care to more people at significantly lower cost. In addition, the medical device industry is experiencing a period of uncertainty. Policy shifts and legislative decisions, such as how best to modernize FDA, will definitely influence changes in health care--and add to the uncertainty. Those decisions, however, are not the biggest influence on the health-care system. The marketplace drives health-care reform, not the oversight agencies monitoring device implementation. Technological innovations that improve patient care or reduce costs will find a niche. The challenge for manufacturers is to harness market forces by creating an irresistible product.
Historically, medical innovation was not always accepted immediately, but if a new product was truly useful its acceptance became inevitable. For example, more than 100 years ago physicians were asked to take their hands and ears off the chests of patients and use a new device: the stethoscope. There was, initially, great resistance to this invention. Physicians discovered, however, that they were able to obtain a much more accurate diagnosis using the device while also protecting the patient's modesty. The stethoscope soon became an indispensable tool.
Today, providers say that quality care is the benchmark they use in deciding to adopt a new product. However, cost is ultimately a major factor in the decision. Medical technology companies need to demonstrate the cost savings to be realized by use of their products as well as the products' benefits to patients. The market demands it.
The potential for savings from acceptance of innovative treatment is only now being demonstrated. A recent report compared traditional surgical procedures with minimally invasive laparoscopic surgery. One objective of the study was to understand the true potential for cost savings associated with innovative, technology-intensive procedures. Two laparoscopic surgical techniques were examined, and both resulted in significantly reduced lengths of stay compared with traditional surgery. Additional evaluation of postdischarge survey data indicated reductions in recovery time and time away from work. The study determined that, taking into account case volume and an average cost per bed-day of $200, the innovative procedural techniques could translate into annual savings of millions of dollars.
TELEMEDICINE ROLE EXPANDS
Some of the most exciting innovations that will reshape health-care delivery are in telepresence and the technological revolutions that accompany its implementation. Telepresence refers to a remote telecommunications process of manipulation. It allows researchers on Earth to guide the movements of a tiny explorer craft on the surface of Mars. Someday it may allow a neurosurgeon in Minneapolis to operate on a patient in Boise using sophisticated robotics.
The Health Care Financing Administration is scrutinizing telemedicine to determine whether to allow the associated costs within the current regulatory environment. HCFA's decision will have a significant effect on this multi-billion-dollar industry, as will proposed legislative changes to modernize FDA and bring its review procedures in sync with the rest of the world's regulatory bodies.
It is innovation, though, not policy decisions or legislation, that will determine the impact of telemedicine and other new technologies on health-care delivery. Telemedicine, particularly the remote surgical manipulation it makes possible, has the potential to dramatically alter the medium through which health care is provided. The integration or implementation of telemedicine systems and components is growing throughout the world.
Telemedicine offers the advantages of cost savings, availability of expertise, remote accessibility, and timeliness. A window of opportunity now exists for innovation in telemedicine, made possible largely by a nationwide information infrastructure that is rapidly becoming global. Networking, image compression, systems reliability, and quality user interfaces make some elements of telemedicine a reality today. Telecommunications advances in bandwidth and quality of transmission; dramatic increases in networking that protect security, privacy, and confidentiality; and creative engineering in robotics are having a direct and measurable impact on the future of health care.
The practice of telemedicine is growing, whether through the transmission of diagnostic input to an off-site location for evaluation or through video teleconference consultation. Telemedicine includes medical diagnostics and analytical services. Many advances in the field already support the diagnostic phase, including the ability to read x-rays at a remote medical center or to mentor local physicians as they examine patients. Analytical services such as teleradiology, teledermatology, and telepsychiatry are technologically demanding because of the need to transmit large volumes of data (i.e., imagery). Medical diagnostics are more commonly implemented as consults.
The future benefits of telepresence surgery technology may be immense. Some observers envision highly skilled surgeons at regional medical centers participating in surgeries at remote locales, performing a wide range of minimally invasive procedures with great ease and at a reduced overall cost.
TECHNOLOGY THAT TEACHES
The technology that forms the foundation of telesurgery is also likely to directly benefit the field of microsurgery by overcoming the inherent imperfections of the humans who perform such procedures. Innovations in remote telesurgical manipulation should enhance surgeons' skills by dramatically improving their precision and dexterity.
These same technologies can provide a framework for training that will enable the medical community to further develop its technical skills. Surgeons and physicians of the new millennium will be able to embrace the continued development of this state-of-the-future capability and facilitate its integration into the mainstream of available tools. Innovation will reform health care because providers and surgeons will encourage--even demand--telesurgery's continued development.
Telepresence innovation also has important implications for research. Clinicians at the Department of Veterans Affairs have run into a frustrating situation while studying sleep disorders. When patients with apnea and related disorders are brought into sleep labs for observation and study, their symptoms appear to intensify. More important, the patients in control groups--that is, without sleep disorders--develop symptoms while in the labs, making it all but impossible to differentiate between the two groups. By using a noninvasive, remote monitoring system made possible by telecommunications technology, researchers are able to study patients in their homes and obtain a more realistic evaluation of differences in sleep patterns.
Whether in research or clinical practice, technological innovation will be embraced if it produces a measurable, desirable result. Some observers claim that innovation all too often occurs in a vacuum. Perhaps the focus is on the wrong objective. Innovators must understand the business objectives of the health-care industry as well as they understand legislative and regulatory demands. If they reach this level of understanding, market adoption of technological innovation is more likely to succeed. Whether we're talking about a better mousetrap or a more cost-effective way to treat human illness, the market responds to a better product.
Regulation and legislation will continue to guide the implementation of new medical tools and procedures. But technological innovation that the marketplace finds irresistible will remain the driving force of change in health care.
John B. Parkinson, Jr., is affiliated with SRI International's Advanced Technology Division (Arlington, VA).