Innovation and Invention in Medical Devices Workshop Summary (2001) / Chapter Skim
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5 The Challenges Ahead
5 The Challenges Ahead
Pages 61-68
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From page 61... ...
It is responsible for over 1.5 million myocardial infarctions annually and over 200,000 sudden cardiac deaths. In addition, the problem of congestive heart failure is one of the leading causes of expenditures for hospitalization.
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From page 62... ...
It is also possible to utilize near infrared spectroscopy, both diffuse reflectance and Raman forms, to identify the chemical composition of tissue. Other techniques proposed to identify vulnerable plaque include increased temperature detection, and, in non-invasive tests, ultra fast CT, and magnetic resonance imaging.
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From page 63... ...
Five issues face clinical trials of medical devices: informed consent versus tinkering, incentive versus protection from conflict of interest, global markets and standards versus global regulatory standstills, access to medical products versus avoidance of risk, and evolutionary innovation versus regulation. If researchers had ways of collecting the data so they did not spend all the venture capital raised trying to do the clinical trials, one could spend more of it on working on the inventions.
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From page 64... ...
A crucial problem is that no one has a clear sense of data requirements for proving whether a device is cost-effective or how to adequately demonstrate outcomes or clinical effectiveness for the purposes of payment. Recent legislation considerably reforms the inherent reasonableness authority and the way new technologies, and particularly more expensive innovative technologies, are reimbursed in the outpatient setting.
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From page 65... ...
(premarket notifications of intent to market a product that is substantially equivalent to one already legally marketed) without any clinical data, are judged substantially equivalent, and are approved based on performance standards.
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From page 66... ...
Nevertheless, she concluded, more and more industry is coming to recognize that when they talk about innovation, it is not just FDA, but the payment folks have to be brought in as well. Robert Califf of Duke University brought up the perception of care providers that anything can be listed and added at a price, but when they add up the cost of providing care relative to what researchers get paid, and Medicare is actually pretty generous compared to most managed care now, available or not, they just cannot afford to do it.
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From page 67... ...
The other is the professional writing company, where the authors listed actually do not even know what is in the paper. Robert Anderson of Duke suggested that the manufacturers and HIMA have to take a look at these practices as well as academia, and that perhaps they ought to have an institutional review board.
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From page 68... ...
68 INNOVATION AND INVENTIONIN MEDICAL DEVICES Bouxsein closed the session with an anecdote about Uwe Reinhardt that illustrates this difference in the roles of FDA and HCFA. Reinhardt once told an audience like this one that they may not realize it but there are two ways of doing a tonsillectomy, both equally effective.
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