New Medical Devices Invention, Development, and Use (1988) / Chapter Skim
Currently Skimming:
Summarizing Reflections
Summarizing Reflections
Pages 164-174
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 164... ...
So although this volume was conceived and assembled in the interest of encouraging and guiding innovation, we should not feel too bad about the accomplishments so far. The second impression is a sense that the rubric "medical devices" covers an almost unencompassable range of technologies—from rather simple classical aids, such as crutches and eyeglasses, to novel hightechnology instruments and implantable organs, and from inexpensive devices used intimately by individuals, to capital hardware used in large institutions for the benefit of many thousands.
|
From page 165... ...
The overarching concerns of everyone in the enterprise are to ensure quality and to preserve the ethical complexion of care, even as costs are being subjected to vigorous campaigns of containment. Seymour Perry and others make it clear that health care is being monitored and evaluated more systematically than ever before.
|
From page 166... ...
If the invention looks promising, it moves on into premarket evaluation, being put through carefully staged testing, perhaps on animals first, then on people, to gain realistic assessment of its medical potential. In part because of the enormous diversity of these products, in part because of the intensity of their medical effects, and in part because of the pace and complexity of their design evolution, the choice of criteria by which medical devices should be evaluated is not always clear or fully anticipatable.
|
From page 167... ...
For all of us who are the ultimate consumers of devices, surely, despite a variety of problems and costs, we have never been better served. The test questions to this broad issue are: Are any major, promisingly beneficial medical devices being denied to the world because of lack of support for, or impediments to, R&D?
|
From page 168... ...
Peter Carpenter describes how his firm has gone about marketing its IUD, taking elaborate precautions to inform potential users of benefits and risks and secure informed consent. If any proposed devices are being orphaned because the potential market for them is small, despite serious medical neediness, their orphan status may be recognized and special support sought for them.
|
From page 169... ...
At the symposium John T Watson of the National Heart, Lung, and Blood Institute proposed forming a committee to advise a consortium of federal agencies in identifying opportunities and reducing barriers to innovation.
|
From page 170... ...
First, market elasticity is not simple, and the Econ-1 version of supply-and-demand may well not hold; that is, raising medical costs may not necessarily result in people buying less. Second, because in general in recent years hospitals have experienced rising income from public funds, the income stream has swamped the substitution stream; overall demand simply has increased.
|
From page 171... ...
Of course, the distributive economic-ethical problem is that whereas medical costs mostly are borne by society's various collective health care financing pools, health benefits from those expenditures accrue to individuals and, in a more diffuse sense, to their families, associates, and society in general. DIFFUSION The spread of medical devices throughout the market depends on perceived need, economic considerations, ethical constraints, and a host of other factors covered in the various papers in this volume.
|
From page 172... ...
No doubt there are openings for further IOM/NAE surveys of research needs, perhaps in quite specialized areas. Also deserving of Academy attention might be aspects of medical device reliability criteria, reliability testing regimens, and quality assurance.
|
From page 173... ...
IDENTIFYING NEEDS AND OPPORTUNITIES In some ways it appears that the most neglected step in the innovation scheme is that last long feedback loop: The one from the ultimate user community back to the start of the whole process. How, for instance, do practicing physicians, or nursing home operators, or, for that matter, hockey trainers or just folks, who perceive a health problem send the request back to the device enterprise: Please develop such-and-such a gizmo to relieve our problem?
|
From page 174... ...
At the outset of the symposium, no doubt anticipating the frustrations we would experience as we wrestled with this amorphous issue, Sam Thier affirmed straightforwardly: "The end, of course, is prevention of disease, correction of disease, and rehabilitation from disease."
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.