The Impact of Academic Research on Industrial Performance (2003) / Chapter Skim
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3. Report of the Panel on the Medical Devices and Equipment Industry
3. Report of the Panel on the Medical Devices and Equipment Industry
Pages 77-114
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From page 77... ...
This assessment is especially timely in view of the fundamental changes occurring in the American health-care system, including academic medicine, and American higher education, which are putting unprecedented pressures on both academic medical centers and medical device firms. In the course of this study, the panel reviewed the literature, developed several case studies, and sent a questionnaire to individuals in academia, the medical device industry, and government.
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Are the current mechanisms for university-industry collaboration, both formal and informal, adequate? How might academic research contribute more effectively to the medical device industry in the future?
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From page 79... ...
This report attempts to weigh the effects of these changes on university-industry relations and consider how university contributions to the medical device industry in this rapidly changing environment could be enhanced. DEFINITION OF THE INDUSTRY Main Components Medical devices encompass a heterogeneous group of products, ranging from low-tech, inexpensive devices, such as tongue depressors and disposable needles, to sophisticated devices, such as implanted therapeutic devices, lithotripters, and magnetic resonance imaging (MRI)
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sales subsidiaries, and many also have extensive research and manufacturing activities in the United States. As of 1999, both domestic and foreign medical device firms operating in the United States employed almost 300,000 workers, and the medical device industry was one of the fastest growing manufacturing sectors in the U.S.
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From page 81... ...
Innovative Small Firms The existence of numerous small, innovative start-up companies in the medical device industry has been well documented. A study of publicly traded medical
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INNOVATION SYSTEM The medical device industry depends heavily on an infrastructure of institutions and activities outside the industry. Traditionally, both large and small firms have depended heavily on nonmedical industry sectors (e.g., those that deliver customized components or highly specialized materials)
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Research Universities and Academic Medical Centers Research universities are key players in the medical device innovation system. Basic advances in physics, materials sciences, optics, analytical methods, and computer science have resulted in many new device capabilities.
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Universities also provided institutional funding to support the direct costs of research (Commonwealth Fund Task Force on Academic Health Centers, 1999~. Federal Agencies Federal support for R&D in medical devices flows through multiple institutional and disciplinary channels.
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From page 85... ...
NHLBI has also invested in clinical trials of cardiac devices, for example, to determine the effectiveness of defibrillatory in high-risk patients with coronary artery disease and in the left ventricular-assist device for end-stage patients with heart failure. Determining the portion of the NIH budget directly related to R&D on medical devices, however, is problematic.
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From page 86... ...
For Class 3 devices, the sponsor must demonstrate safety and efficacy before the FDA grants marketing approval. Approximately 10 percent of medical devices fall into Class 3; examples include left-ventricular assist devices and laser angioplasty devices.
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From page 87... ...
market expanded in the l990s, which allowed venture capitalists to exit projects and thereby reap rewards for the risk they had borne; small companies subsequently had access to large pools of liquid capital for future expansion. IPO investment in the medical device industry rose from $410 million in 1995 to $1.268 billion in 1996; much of this growth was in the cardiovascular device sector.
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From page 88... ...
Finally, the payment for treatment of patients in clinical trials is becoming increasingly contentious, which could inhibit the refinement of devices and the collection of data on medical devices. Traditionally, industry has supported the evaluation of medical devices, government has supported the evaluation of major clinical procedures and off-label uses, and payers have supported (often unknowingly)
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From page 89... ...
Business schools, which train people in the management sciences, have expanded programs that offer MD/MBA programs. Research in the Physical Sciences and Engineering Because markets for medical devices are often fragmented and relatively small, the medical device industry historically has not invested heavily in basic research but has depended heavily on scientific and technological capabilities developed in other sectors.
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From page 90... ...
In a 1998 study of trends in medical device technology conducted by the FDA, a survey revealed six somewhat overlapping "trend categories": computerrelated technology; molecular medicine; home care and self-care; minimally invasive procedures; combination drug/device products; and organ replacements and assist devices (Herman et al., 1998~. Most of these categories reflect contributions either from universities or other industry sectors.
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From page 91... ...
By the 1980s, many of these uncertainties had been overcome, and lasers were soon used in a wide range of clinical specialties, including gynecology, gastroenterology, and cardiology. Flexible gastrointestinal endoscopy was first developed in the early 1960s with significant academic contributions by physicists van Heel in Holland and Hopkins and Kapany in the United Kingdom (Gelijns and Rosenberg, 1999~.
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From page 92... ...
The increase in interdisciplinary research collaborations has also been stimulated by several federal funding initiatives. For instance, several engineering research centers funded by NSF perform research relevant to medical devices.
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CIMIT enables the Army to leverage research dollars and provides a conduit for transitioning research and technology into clinical practice or the device industry. Academic Medical Centers AMCs conduct research that contributes to the development and diffusion of medical devices.
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Compared to other service industries, especially financial services, the diffusion of information technology in health care has been slow. The role of university faculty in developing and commercializing health information systems is reviewed in the following case study.
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An example of a major academic contribution began with research at the Laboratory of Computer Science at the Massachusetts General Hospital (MGH) , one of the principal teaching hospitals of Harvard Medical School.
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Dr. Billings started a company that grew into Quintiles, a major corporation that supports clinical trials, pharmacoeconomics, and the health service research needs of the pharmaceutical, biotechnology, and medical device industries.
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To overcome this hurdle, researchers often form partnerships with industrial firms with the applicable technological expertise and interest in the proposed application. The contributions of academic faculty in the development of device prototypes can be documented for the whole clinical spectrum of medical device categories, ranging from diagnostic devices to therapeutic devices.
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From page 98... ...
Case Study: Development of Focused Ultrasound Therapies Clinical ultrasound works much the same way as radar energy is produced by a transducer, and the reflected energy is received and processed by a receiver. The time between signal transmission and reception correlates directly with distance, and the amplitude of the return indicates the material properties of the reflecting surface.
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From page 99... ...
By the early l990s, the potential for focused ultrasound was beginning to be realized. Numerous studies on the use of focused ultrasound for prostate hyperplasia were conducted at various AMCs; focused ultrasound therapy on brain tissue without prior removal of a section of the skull was initially demonstrated at Brigham (Hynynen and Jolesz, 1998)
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From page 100... ...
CROs are private, for-profit organizations engaged in the management of clinical trials, including protocol design, patient recruitment, data collection, data management, monitoring, and analysis. In the medical device industry, CRO use is not common; only 13 percent of medical device firms use CROs (whereas 90 percent of drug firms use CROs)
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From page 101... ...
University research could make significant contributions to evaluative research for medical devices by addressing some of the methodological challenges of device randomized control trials (RCTs)
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The identification of new applications, sometimes totally unexpected, is an important contribution of academic researchers to the medical device industry (Rosenberg, 1996; Gelijns et al., 1998~. Mechanisms of Transfer from Academia to Industry Advances have been transferred to industry by various routes.
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Trends, Opportunities, Challenges, and Gaps Although university research has made substantial contributions to the medical devices and equipment industry in the past, the rapidly changing healthcare environment is creating both new opportunities and new challenges for university-industry interactions. In recent years, the NIH budget has grown, allowing for an increase in research on the biological bases of health and disease.
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From page 104... ...
Traditionally, the research results of AMCs that have been most important in the development of medical devices were not patented but were placed in the public domain through open publication. In recent years, as a result of a number of changes in federal policy, there has been a major upsurge in university patenting and licensing.
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From page 105... ...
Federal agencies that fund academic research relevant to the medical device industry should support research on the effectiveness of current incentives for transferring research findings to the industry and ways of improving the transfer process. Given the short product life cycles of many medical devices, the timing of decisions and processes pertaining to transfer affects the short windows of commercial opportunity.
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From page 106... ...
Given that all parties physicians, patients, manufacturers, and payers benefit from the rigorous information on the value of new and improved medical devices, the panel recommends that payers, National Institutes of Health, and medical device firms define the circumstances under which public-private support for device trials is appropriate. REFERENCES AdvaMed (Advanced Medical Technology Association)
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1994. Medical Device Innovation: Opportunities and Barriers for Small Firms.
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Medical Device Industry. Washington, D.C.: Health Industry Manufacturers Association.
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2. Overall, would you describe the impact of academic research on industrial performance in the medical devices and equipment industry as (Please put an X in one box)
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From page 110... ...
5. What are significant emerging trends or problems that the medical devices and equipment industry will face in the future that could benefit from academic research?
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Session I Basic Academic Scientific and Engineering Research: Contributions to the Medical Device Industry Moderator: Clifford Goodman, The Lewin Group Speaker: Donald Engelman, Yale University Speaker: Robert Ne rem, Georgia Institute of Technology Respondent: John Linehan, The Whitaker Foundation 12 p.m.
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What have we learned today about the impact of academic research on performance in the medical device industry? How can the university research contribution and impact be enhanced?
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Elizabeth Jacobson Deputy Director for Science Center for Devices and Radiological Health Kenneth H Keller HHH Institute for Public Affairs John Linehan The Whitaker Foundation Stephen Merrill National Research Council Dane Miller Airport Industrial Park Warsaw, Indiana Alan Moskowitz Columbia Medical Center Richard Nelson Columbia University Robert M
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From page 114... ...
Taylor Director of Research National Venture Capital Association Frederick Telling * Vice President Pfizer Samuel O
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