The Artificial Heart Prototypes, Policies, and Patients (1991) / Chapter Skim
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9. Roles of Government and Industry in Medical Technology Research, Development and Use
9. Roles of Government and Industry in Medical Technology Research, Development and Use
Pages 151-172
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From page 151... ...
It also reviews the most appropriate organizational approaches to interdisciplinary R&D and to industry-university relations, the optimal manner in which to accomplish the type of interdisciplinary collaborative research that the artificial heart program represents, and the possible adverse effect of industry support of academic R&D on open communication among mechanical circulatory support system (MCSS) researchers.
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From page 152... ...
Consequently, national security R&D, the development of nuclear energy for power generation, exploration of outer space, and the support of medical and basic scientific research dominated federal spending in the first two postwar decades. As the scale of federal R&D grew and as its purposes embraced domestic policy concerns, a relatively clear conceptual rationale emerged for the respective roles of the public and private sectors in the support of R&D, which has implications for MCSS development.
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From page 153... ...
The conceptual rationale discussed above provides little clear guidance to policymakers and other interested parties, who usually include the government, academic institutions and researchers, and private firms. Parti
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From page 154... ...
Status of the Artificial Heart Program The foregoing discussion is relevant to NHLBI's role in MCSS research in academe and private industry because, despite almost 30 years of NHLBI support, questions persist about the appropriateness of that support. The mission statements of NHLBI and NIH provide little guidance on the types of research to support (e.g., basic or applied research)
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From page 155... ...
In summary, historical analysis of the application of economic theory leads to no conclusive answer about the propriety of continuing federal support, through the artificial heart program, for MCSS development. This committee, along with NHLBI decision makers each time they face funding issues, must balance the benefits and risks.
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From page 156... ...
Nevertheless, the SBIR program has responded to the medical device industry's interest and to specific needs related to the artificial heart. As of August 1990, eight of NHLBI's SBIR awards, with a total annual value of $888,000, were under the artificial heart program (NHLBI, 1990~.
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From page 157... ...
The committee noted two concerns in relation to these foreign efforts: Will the United States be able to exploit the commercial opportunities provided by its research investment in the artificial heart program? Is the current U.S.
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From page 158... ...
, health benefits, management and accountability issues, and industrial policy issues. Actions of Congress, NHLBI, and the National Heart, Lung, and Blood Advisory Council indicate that, historically, these bodies have implicitly considered the artificial heart program to be in the public interest, although with reservations.
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From page 159... ...
While the potential exists for this R&D to yield substantial international-trade benefits, the committee believes that potential benefits to patients should be the primary justification for NHLBI to continue to support MCSS development. ROLE OF GOVERNMENT IN THE USE OF MEDICAL TECHNOLOGY One analyst of the impact of public policies on medical device innovation has coined the term polyintervention to describe the policy environment created by numerous government actions (Foote, 1991~.
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From page 160... ...
Medicare and Other Third-Party Payers The success of marketing endeavors depends greatly on third-party payment policies, including decisions about coverage policies and payment rates. Long-term MCSSs present new challenges to the payment policies of Medicare, state Medicaid programs, and private insurers.
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From page 161... ...
Supporters of this view maintain that the United States is a prohealth technology society exerting influence on the delivery of health care worldwide (Foote, 1991~. Particularly since the implementation of the Medicare prospective payment system, others consider that the payment policies of the U.S.
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From page 162... ...
Such developments as these will be very useful to the Medicare program and other third-party payers, possibly making the regulatory hurdles to be overcome by newly approved VADs and TAHs somewhat less daunting than they would otherwise be. Because of the truly interdisciplinary nature of MCSSs, FDA, the Medicare program and the Office of Health Technology Assessment that advises it, and other third-party payers could put the same opportunity to even better use by developing new approaches to their upcoming reviews of MCSS-related applications.
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From page 163... ...
ENCOURAGING INTERDISCIPLINARY AND INDUSTRY-ACADEME COLLABORATION Several factors deter industry support for development of mechanical circulatory support devices, in the context of analyzing the current technological potential and costs of MCSS R&D. This section explores possible structures and mechanisms to overcome factors that deter collaborative, interdisciplinary MCSS research, whether by way of government support of industry, industry support of academic research, or collaboration among academic scientists, engineers, and physicians.
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From page 164... ...
A study panel housed in these organizations' Committee on Science, Engineering, and Public Policy is currently examining public-private R&D ventures, collaborative R&D efforts overseas, foreign government policies to promote technology development, and the role of federal agencies in technology transfer; a report is due in late 1991. Role of Biomedical Engineering Research Another aspect of the artificial heart program that is unusual, in its context at NHLBI, is one of its goals: The program was one of the first within NIH to adopt the goal of developing an industrial capacity in biomedical engineering (Maxwell et al., 1986~.
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From page 165... ...
Even among the larger companies, support for biomedical engineering research may be limited to short-term, product-directed efforts rather than to more basic research and development that could lead to advances over the longer term in such technologies as implantable devices and components, biosensors, biocompatible synthetic materials, and vascular grafts. Foundation support for biomedical engineering research is quite limited.
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From page 166... ...
Another example is NSF's Engineering Research Centers program, which is designed to foster interdisciplinary collaboration of academic and industry researchers in specific areas (see Office of Technology Assessment, 1990~. One engineering research center, at Duke University, is in the biomedical engineering field.
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From page 167... ...
If similar efforts are to be mounted in biomedical research, further study of the program in these particular respects is warranted. The committee suggests that the artificial heart program, as well as similar efforts that may be undertaken in the future, may be more successful in stimulating interdisciplinary collaborative research, cost-sharing with industry, and other innovative R&D-sponsorshin mechanisms if NHLBI r 1 1 ~ ~ spec~ca~y addresses ways in which such flexibility of approaches can be best achieved.
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From page 168... ...
NHLBI might also consider sponsoring a formal collaborative arrangement that encompasses both public- and private-sector interests in biomedical engineering, in order to achieve maximum advantage from the artificial heart program's available funds. Organizations such as SEMATECH may be useful models (Congressional Budget Office, 19901.
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From page 169... ...
Concern remains about the possible deleterious effect of these relationships on the traditional collegial communication among researchers that has been so valuable in the MCSS arena. The committee suggests that the MCSS research community discuss this specific issue at a forthcoming professional conference and urges that industry representatives and academic MCSS developers, alike, avoid arrangements that impede collegial communications.
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From page 170... ...
As discussed further in Chapter 10, NHLBI's continuing support of applied research, development work, and clinical trials in this field is warranted by the potential benefits to patients that this R&D appears likely to yield, given the committee's conclusion that privatesector support for these activities will not be forthcoming at least until the first long-term VAD has been approved for general use. Moreover, policy changes by NHLBI could provide greater flexibility in the funding approaches and mechanisms used in this continuing R&D support, which in turn may prove to be useful to government support of other types of collaborative biomedical research involving academe, industry, or both.
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From page 171... ...
Background paper prepared for the IOM Committee to Evaluate the Artificial Heart Program of the NHLBI. Maxwell, J
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From page 172... ...
1988. Federal support of medical device innovation.
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