Innovation and Invention in Medical Devices Workshop Summary (2001) / Chapter Skim
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1 Introductory Overview
1 Introductory Overview
Pages 1-8
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Beyond the considerable attention that such big-ticket technologies as computer-assisted tomography and magnetic resonance imaging have received, there is no doubt that these technologies have changed the mainstream practice of medicine. However, diagnostic technology is not limited to capital equipment imagers.
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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.
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First, the United States has a strong commitment to basic science, which forms the basis for future innovations. The United States funds more basic research than the next six countries combined.
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PAYMENT ISSUES Payment issues are of increasing concern to the health care industry. Everybody talks about the rising costs of health care and the need to find ways of managing costs more effectively.
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This affects the policy debate and the likelihood of success of policy initiatives regarding health care technology. It is a complicated issue that must be addressed.
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This posed a significant disincentive for innovation by raising costs for manufacturers and making providers reluctant to participate in clinical trials. In 1995, the Health Care Financing Administration (HCFA)
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If a person is a government agency charged with protecting against potential health hazards of something new, or charged with minding the public purse, it may make sense to err on the side of delay, but from the perspective of some patients and their doctors, that same delay can be a life and death proposition. Even when researchers have enough evidence to understand the safety, efficacy, and cost of a device, the interpretation of value can vary depending on perspective, including those of patients, hospitals, managed care organizations, technology assessment agencies, the government, and society at large.
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The bar is set high. Researchers need ongoing dialogue from all perspectives to define and redefine as necessary what they must achieve in clinical benefits and how they are willing to pay for these benefits.
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