New Medical Devices Invention, Development, and Use (1988) / Chapter Skim
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Technological Innovation and Medical Devices
Technological Innovation and Medical Devices
Pages 35-48
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From page 35... ...
I will illuminate the process of technological innovation in the field of medical devices by posing five questions. I would prefer to provide empirical answers to these questions and to use evidence drawn entirely from experiences with medical devices to identify what matters, what works and what does not work, and what the obstacles are to achieving more effective innovation.
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From page 36... ...
An overriding issue with these topologies is that our thinking about innovations in the medical field is dominated by images that come largely from the pharmaceutical industry. If most of us were asked to describe technological innovation in medical devices, we would speak about basic research that is carried out in large organizations and that generates fundamental knowledge used to create radical innovations in medical devices.
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From page 37... ...
If it is, then one should expect that a high degree of technological change will be required- possibly true invention and perhaps providing a real opportunity for basic scientific and engineering research to play an important role. If, however, a medical device is based on a technology that is well founded and widely diffused, the device innovation will likely merely involve upgrading, enhancing, and expanding current applications.
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From page 38... ...
. If Shaw's findings can be applied generally, then only a minority of medical device innovations bring a new functionality to health care providers.
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From page 39... ...
Perhaps only coincidentally, that device was 1 of only 6 cases of market failure among the 34 medical innovations studied by Shawl Additional information about user and manufacturer initiatives for the 34 British medical equipment innovations was gathered by Shaw but not published with his dissertation. Four users started their own companies to manufacture their innovative devices.
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From page 40... ...
medical device innovations, these data clearly identify the locus of innovation for medical devices. The process of medical device innovation is dominated primarily by individuals, usually in academic and clinical settings, who are involved in the development and use of new technology in their respective fields.
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From page 41... ...
This was true both for MIT faculty members and for clinical and academic physicians. Results of these studies permit us to conclude that inventive users are the principal driving force behind most medical device innovations, either as developers and initial implementers or in close association with commercial developers.
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From page 42... ...
WHICH COMPANIES CONTRIBUTE TO MEDICAL DEVICE INNOVATIONS? An earlier study of innovation in nonmedical fields may provide some insight into the characteristics of firms that innovate in the field of medical devices.
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From page 43... ...
real time Electronically switched real time Stored gray scale Electronic focus Microprocess controls Digital scan converter Computed sonography U
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From page 44... ...
showed that increased FDA regulations led to decreased innovation of x-ray devices, especially by small firms. A 1986 study of innovation in contact lenses by the Office of Technology Assessment also expressed concern that small firms would be disproportionately affected by FDA regulations, particularly in the emerging technologies of soft and gaspermeable contact lenses (U.S.
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From page 45... ...
If the larger company's role in medical device innovation is to acquire other firms (and, thereby, technological innovations) , perhaps we should focus our attention exclusively on the activities of smaller firms.
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From page 46... ...
The patterns described here suggest that we need to support potentially synergistic relationships between large and small companies in the medical device industry. Potential ties that need to be examined and, perhaps, fostered range from sponsored research to venture capital to acquisition and alliances, and have been increasing rapidly in biotechnology and medical device fields in recent years.
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From page 47... ...
federal funding of innovation stages beyond research, such as product development and research on market applications. Programs such as these exist in several countries that are trying to foster competitive industrial innovation.
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