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2.1 Technology: A Definition of Terms

Technology is that body of knowledge available to a civilization that is of use in fashioning implements, practicing manual arts and skills, and extracting or collecting materials [1]. It is the science that concerns itself with the application of knowledge to practical purposes. Others have suggested that the characterization of technology be expanded to include those technologies that sustain the way a thing is done or performed, and those technologies that change the way things are accomplished [2]. In this sense, sustaining technologies are those technologies that keep up or improve the status quo but do not disrupt or create chaos in existing situations. New growth is not fostered. On the other hand, disruptive technologies are those technologies that create major new growth in areas they penetrate and disrupt or cause to fail the entrenched technologies. New growth can occur because less skilled persons are enabled to do things previously done only by expensive specialists in centralize (typically inconvenient) locations. The consumer is offered services or products that are cheaper, better, and more convenient than previously provided.

2.2 A Brief History of Medical Technology

Surgical technology and the skills to practice operative intervention were essentially embryonic for the first several thousand years of recorded history. The overwhelming and intense pain associated with surgery limited operative procedures to only those that were simple and rapid. In addition, there was limited knowledge of the role of bacteria in the development of infection. Wound contamination was common, and sepsis frequently resulted in death of the surgical patient.

The discovery of anesthesia and the acceptance of antisepsis stimulated the development of surgical instrumentation during the late 19th century. Growth, nevertheless, was slow, and technological innovation was essentially a sustaining one as clamps, retractors, scalpels, and other devices developed before or during the 19th century were refined, but little changed. Creative surgical innovators focused on ways to extirpate or correct disease processes, and new, innovative operative procedures were developed. However, the technology utilized to perform these operations remained unchanged. And remained so for almost a century. In a similar vein, costs for surgical instruments (technology) remained stable and relatively predictable.

During the latter part of the 20th and the beginning of the 21st century, however, surgery became a technology-driven profession. There was a disruption of the status quo. The development of new technologies (energy sources, mechanical devices, imaging, etc.) ultimately led to a radical change in how surgery was practiced. Spectacular medical achievements were due to advances in technology that in many instances was disruptive of the status quo. These technological advances enabled physicians to diagnose and treat disease more accurately than before. Computerized tomography (CT), magnetic resonance imaging (MRI), and diagnostic radioisotope studies revolutionized the field of radiology. Portable, affordable ultrasound units gave the gynecologist an office-based tool to accurately and conveniently diagnose female genital tract disease. Minimally invasive surgery (a stunning example of the combination of several disruptive technologies) combined solid-state cameras, high-resolution video monitors, and laparoscopes to completely change the way physicians exposed and managed surgical disease. No longer was a large traumatic surgical incision required to visualize intracavitary organs.

Present-day technologies have allowed clinicians to gather more information and refine differential diagnosis prior to operative intervention. CT scans and diagnostic laparoscopies in many instances have replaced the need for exploratory laparotomy. The result has been a decrease in patient risk and morbidity. New technologies have not only enhanced quality of life, but also in many instances, extended it.

2.3 The Economic Burden of Health Care

Men and women throughout the world and particularly in developed Western countries have come to expect, indeed to demand, high-technology health care. The advances in technology and medical devices, however, have come at a very high price and have generated wrenching ethical and social debates. National health expenditure in the United States, for example, increased from $41.0 billion, or 5.7% of the gross domestic product (GDP) in 1965, to $1,299.5 billion in 2000, or 13.2% of the GDP. National health care expenditure on a per capita basis increased from $205 in 1965 to $4,672 in 2000 [3]. Health care spending continued to rise in the United States, reaching $1.4 trillion in 2001. This was an 8.7% increase from the year 2000. Health care spending increased three times faster than did growth of the US economy. In the year 2000, health care spending was $4,672 per person, which increased to $5,035 per person in 2001 [4].

The number of medical schools in the United States increased from 86 in 1960 to 126 in 1994, and the number of medical students increased from 30,288 in 1960 to 66,629 in 1994. There were 5,407 hospitals in the United States in 1960, with 639,000 beds, and 5,321 hospitals, with 923,000 beds in 1992. Only a modest increase of hospital beds, but on the other hand, the number of freestanding ambulatory surgical centers increased from 459 in 1985 (783,864 procedures performed) to 1,862 in 1993 (3,197,956 procedures performed) [5]. The US population in 1960 was 179,323,175 people, and by the year 2001 increased to 284,796,887. Most could afford health care. As reported by the US Census Bureau in 2001, the number of persons with health insurance was 240.9 million; the number of uninsured persons was 41.2 million [6].

The increase in health care demand and supply has not been confined to the United States. All major developed countries have experienced a similar increase. For example, health care expenditures in the United Kingdom increased as a percentage of gross domestic product from 4.5% in 1970 to 7.1% in 1992. Viewed another way, this translated to health care spending per capita increase in the United Kingdom from $146 in 1970 to $1,213 in 1993. Similarly, health care spending as a percentage of gross national product in France increased from 5.8% in 1970 to 9.4% in 1992. On a per capita basis, French health care spending increased from $192 in 1970 to $1,835 in 1993. Countries in the Far East have not been exempt from this trend and in Japan, the percentage of expenditures on health care as related to gross domestic product increased from 4.4% in 1970 to 6.9% in 1992. Put another way, health care spending per capita in Japan increased from $126 in 1970 to $1,495 in 1993 [5].

The demand for health care has been fueled in part by readily available worldwide communication. Nearly universal access to mass communication, radio, television, and the Internet has educated consumers and has helped create a demand for cutting-edge care. A consensus appears to be developing that people of the world are beginning to expect certain rights of their governments including respect of person, dignity, and access to health care. Because of this public demand for health care, a major issue undergoing debate in various countries has been whether a society or a nation should restrain advances in expensive health care technology or attempt to fulfill the universal human desire for good health regardless of cost. Many believe that no one should be denied access to health care because of cost, but few deny the overwhelming importance of prudent economic management in the delivery of health care.

Costs for health care have unrelentingly spiraled upward, and there appears to be no end to the increasing financial burden on individuals, societies, and states. Demand has outstripped supply. As a benchmark, it is worth noting that the average US general surgeon performed 398 procedures per year from 1995 to 1997. Of these cases, 102 (26%) were abdominal procedures, 63 (16%) were for alimentary tract procedures, 55 (14%) were for breast operations, 51 (13%) were for endoscopic procedures, 48 (12%) cases involved soft-tissue operations, 39 (12%) cases were vascular procedures, trauma accounted for 6 (2%) cases, 4 (1%) cases were for endocrine disease, and 3 (1%) were for head and neck. Of the 398 procedures, 44 (11%) cases were for minimally invasive laparoscopic operations [7]. This is an average yearly workload for a general surgeon in the United States, and may be taken as a baseline for what a general surgeon can accomplish in a developed Western country that has a high demand for health care.

2.4 A Technological Solution to Health Care Cost

In many poorer countries, the ability (financial remuneration, personal growth, safety, quality of life issues, academic satisfaction, etc.) to supply and deliver health care is very limited or nonexistent. The solution to the dilemma of providing health care in an environment of limited resources has been obscure, but with the use of disruptive technologies, the solution may be obtainable.

Over the last 50 years, technology has revolutionized health care, and it will likely continue to do so in the future. Technology, however, comes in many guises. It is in the application of technology and, in particular, those technologies of a more simple, convenient form, that may hold the key to reducing costs and allow medical care to be more widely available.

The experience of industry with sustaining and disruptive technologies provide clues and perhaps suggest an answer to the dilemma of providing health care in this technologically driven age. Christensen et al. have suggested that sustaining innovation (technology) is the improvement an industry creates as it introduces new and more advanced products to serve the more sophisticated customers at the high end of a market [2]. Disruptive innovations (technology) are cheaper, simpler, more convenient products or services that start by meeting the needs of less demanding customers. For example, the invention of the printing press (disruptive technology) put a large number of human copiers of books out of business. The lay public was less demanding of book producers than were the clerics and academics of the day. Texts did not need to be hand printed or illuminated in gold to provide their message. The inexpensive, portable camera developed by George Eastman a century ago disrupted the art world by virtually eliminating the need for expensive portrait artists. The invention of electrophotography by Chester Carlson in 1938 (later called xerography) revolutionized the world of printing and decreased reliance on printing professionals.

In each instance, technology, particularly cheaper, simpler, and more convenient technology, disrupted the status quo, diffused throughout society, and brought great benefit to that society. Each particular technology enabled a larger population of less skilled persons to do more of a task, in a more convenient setting, and in a less expensive manner, which previously had required more highly skilled specialists. This caused an upmarket migration of service that has proven to be an essential driver of economic progress in the industrial world [2].

Health care can be transformed in a similar manner. In fact, some parts of the health care system have already been disrupted, and a transformation of sorts is underway. Outpatient surgical centers have been established that can safely and efficiently offer operative procedures that heretofore have only been performed in high-cost hospitals. Nurse practitioners and other nonphysician clinicians can function as autonomous providers of patient care and perform many of the basic tasks of a primary care physician [8]. Specialists and specialized centers (hospitals) should not be asked, or rewarded, to carry out more simple tasks that can be performed elsewhere. Yet, perversely in the real world, many health care plans have done just that.

Several US states and some insurance plans have regulations that preclude nurse practitioners from performing simple diagnostic tests and therapeutic in terventions. More highly trained physicians, in order to maintain their income stream, are forced to see patients with common, simple problems. A production line is instituted in the physician's office and office visits must, by necessity, be brief and perfunctory. Instead of an upmarket migration of services where nurse practitioners or physician assistants (with appropriate enabling technology) are permitted to manage simple problems, there is a downmarket migration of services by the physician. It is no wonder that less actual care is given, and patient dissatisfaction is increased. Less expensive personnel are not utilized to perform tasks that are within their realm to accomplish when armed with appropriate (disruptive) technology. The lessons from industry have been neglected and a fundamental engine of potential medical progress has been stifled.

To frame the health care problem more clearly, it is necessary to look at the delivery of health care in terms of systems. Human disease and its management can be categorized into several tiers of complexity, ranging from the most simple to the very intricate. In the simplest tier of disease, accurate data collection reveals an unambiguous diagnosis that can be managed with a straightforward treatment protocol of medical therapy. This disease recognition and treatment process can be described as a rule-based process. In the middle levels of disease complexity, no single piece of information yields a diagnosis. Rather, multiple data points suggest a diagnosis and treatment program through a process of discernment by the physician called pattern recognition. In the most complex disease states, the diagnosis is obscure and requires the collective experience and judgment of a team of clinicians. Multiple tests are required and the diagnosis and treatment is arrived at in a problem-solving mode [2].

Considering the above, it is clear that at the most simple levels of disease, a rule-based process would establish the diagnosis and dictate therapy. Medical treatment could then be initiated by well-trained non-physician clinicians and less highly skilled physicians. Application of the rule-based process would specify a proven therapeutic strategy. Technologies are available to facilitate this process. For example, a sore throat can be evaluated by a trained nonphysician clinician; appropriate, convenient, outpatient cultures (technology) obtained; and antibiotic therapy initiated on receipt of a streptococcal infection report.

Similarly, enabling technologies such as unsophisticated, inexpensive, office-based ultrasound would allow primary care physicians to evaluate breast lumps and, if cystic, manage them conservatively. Appropriate management would be initiated without referral for costly hospital or specialist evaluation. An upward migration of service will have occurred. In a similar way, endovascular stenting in an outpatient setting has the potential to cause an upward migration of service and reduce the need for a more costly surgical team, operating rooms, and hospital stay. In all of these situations, technology can be disruptive of the status quo and result in an upmarket migration of services where less skilled persons perform procedures that are more sophisticated in a less expensive way.

The introduction of new technology is as critical in the field of medicine as it has been in industry. A good guide to the introduction of technology is found in the "Statement on Emerging Surgical Technologies and the Evaluation of Credentials" promulgated by the American College of Surgeons [9]. The position taken by the American College of Surgeons recognizes that the introduction and application of any new technology should proceed through a series of steps intended to ensure its safety, appropriateness, and cost-effectiveness. These steps or recommendations suggest that the development of new technology must be accompanied by a scientific assessment of safety, efficacy, and need. Diffusion into clinical practice requires appropriate education of surgeons and evaluation of their use of the new technology. Finally, widespread application of new technologies must be continuously assessed and compared with alternative therapies to ensure appropriateness and cost-effectiveness through outcome studies.

The guidelines of the American College of Surgeons regarding technology are reasonable and patient centered. Disruptive medical technologies exist that enable persons who are less skilled to perform tasks traditionally completed by more highly trained specialists. By allowing less highly trained and less expensive practitioners to perform more highly skilled tasks with dis ruptive technologic innovations, more patients can be served with safety, efficiency, and cost-effectiveness.

References

1. Beruhe MS (1999) Webster's II new college dictionary. Houghton Mifflin, Boston

2. Christensen C, Thomas C, Hart S (2001) The great disruption. Foreign Aff 80:2

3. US Department of Health and Human Services, Centers for Medicare & Medicaid Services (2002) National health care trends in public versus private funding, selected calendar years 1965-2000. http://www.cms.hhs.gov/research-ers/pubs/datacompendium/2002/02pg14.pdf. Accessed 10 March 2003

4. US Department of Health and Human Services, Centers for Medicare & Medicaid Services (2003) Report details national health care spending increases in 2001. http://cms. hhs.gov/media/press/release.asp?Counter=693

5. Roger CM, Seward WF (1996) Socio-economic factbook for surgery, 1996-1997. American College of Surgeons, Chicago

6. US Census Bureau. Health insurance coverage: 2001. http:// www.census.gov/hhes/www/hlthin01.html. Accessed 10 March 2003

7. Ritchie WP, Rhodes RS, Biester TW (1999) Work loads and practice patterns of general surgeons in the United States, 1995-1997. Ann Surg 230:533-543

8. Cooper RA, Henderson T, Dietrich CL (1998) Roles of nonphysician clinicians as autonomous providers of patient care. JAMA 280:795-802

9. American College of Surgeons (2000) Statement on emerging surgical technologies and the evaluation of credentials. http://www.facs.org/fellows_info/statements/st-18.html

The Scientific, Social, and Ethical Implications of Disruptive Technologies

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