polymerase chain reaction (PCR), and monoclonal antibodies, providing physicians with new, accurate, and rapid information.

On the therapeutic side, devices save lives and improve quality of life. Dialysis therapy extends lives for end-stage renal disease patients, orthopedic implants enable patients to walk again, and minimally invasive technologies allow surgeries that are safer, with less pain and trauma, requiring significantly shorter hospital stays.

The United States is clearly the leader in medical device innovation. In 1998, the United States medical device and diagnostics industry was responsible for nearly $70 billion in production, which is almost 50% of the total world consumption of medical technology. The United States exports significantly more devices than it imports, netting a trade surplus of almost $10 billion. Further, United States medical device patents outnumber foreign patents by more than three to one.

What makes the United States system so special? Kraemer believes that a fundamental part of the success of the United States is that it is a society that promotes and rewards innovation. The United States has a strong science base and an entrepreneurial culture of sophisticated and efficient financial markets, intellectual property protection, and a health care system that for the most part has been willing to pay for technological advances.

CHALLENGES TO INNOVATION

Despite being the best system in the world, however, the United States faces major challenges that can undermine the viability of innovation and access to better health care. One striking characteristic is that medical device innovation often requires the contributions of a diverse array of scientific and engineering expertise. Something as seemingly basic as the materials used in medical products, for example, have made lasting contributions to health care in ways people often take for granted. For example, the first plastic blood collection container enhanced the safety and quality of stored blood and made possible the separation of individual blood components. Thus, modern blood component transfusion therapy was made possible by plastics. Miniaturized circuitry for pacemakers, mathematical algorithms used in MRI, and greater understanding of fluid mechanics for heart valves were all developed outside the conventional areas of medical research.

Obviously researchers cannot script innovation. At times it occurs in a great stroke of luck or insight. At other times it is a gradual process with new devices piggy-backing off earlier ones. Innovation extends well beyond laboratories, including the many instances of clinicians finding new indications for already-launched technology, as well as breakthroughs that have occurred at the intersection of multiple scientific and technical streams of progress.

An example of an early innovation that continues to find new applications in medicine is the laser. Invented in 1958, the laser was first applied in health care as a non-contact scalpel. New applications of lasers include reshaping cor-



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