Technological Innovation Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper (1989) / Chapter Skim
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3. The Development of Medical Devices
3. The Development of Medical Devices
Pages 23-33
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From page 23... ...
Bioengineering research will be defined as the application of engineering knowledge and concepts to the understanding of the human body, its interactions with machines, and to the development of new and improved medical devices. This definition is very similar to a definition provided in a recent National Research Council report (106)
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From page 24... ...
While patent protection is extremely important to the pharmaceutical research and development process -- partially because of the long duration of the R&D process and the relative ease with which drugs can be copied -- the value of patent protection in medical device development is much less evident. In the device area, it probably is easier to invent around a patent, and the research and development time is generally much shorter.
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From page 25... ...
and Finkelstein underlined the importance of users with regard to the automated clinical chemical analyzer (69~. For example, the initial prototype of an auto analyzer was developed by Skeggs in the pathology department of Case Western Reserve University; Technicon then made a licensing agreement with Skeggs to patent the auto analyzer and further developed and marketed the machine (147~.
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From page 26... ...
Little consultants to provide insight into the safety and efficacy testing practices of medical device firms (5~. This analysis revealed that most devices were tested during their development, but that the extent and nature of clinical evaluation varied considerably among products.
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From page 27... ...
Class ~ devices include such instruments as tongue depressors, which do not support or sustain human life and do not present a potentially unreasonable risk of illness or injury. They are subject to the general controls used before passage of the Medical Device Amendments, such as regulations regarding registration, premarketing notification, record keeping, labelling, and GMP regulations.
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From page 28... ...
Therefore, according to Spilker, clinical testing usually first involves an initial pilot stage during which the prototype's design and materials are further 37 A significant risk device is legally defined as an implant and presents a potential for serious risk to the health and safety or welfare of a subject; is purported or represented to be for use in supporting or sustaining human life and presents a potential for serious risk to the health and safety or welfare of a subject; is for use of substantial importance in diagnosing, curing, mitigating or treating disease and presents a potential for serious risk to the health and safety or welfare of a subject; or otherwise presents a potential for serious risk. 38 Including also those cases where an IDE application is not necessary, but clinical trials~are conducted.
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From page 29... ...
number of true positives/ true positives plus false positives) and the predictive value of a negative test result (i.e.
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From page 30... ...
Ophthalmic IDEs, for example, called for an average of 280 patients, while all other IDEs involved about 150 patients (17~. 40 The ROC analysis allows one to compare the technical performance of diagnostic tests over a range of different cutoff points or reference values that denote a positive test result.
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From page 31... ...
However, the next model of a medical device often differs in materials and/or design, and these differences may affect clinical risks and benefits. Recently proposed Amendments to the 1976 medical device legislation would allow the FDA to waive data requirements for PMAs following that of the innovator.
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From page 32... ...
it has been observed that medical device manufacturers react to the demand for products that are cost-effective over the short term and neglect R&D projects dealing with products that are cost-effective over the longer run43. With these changes in reimbursement, the coverage decision, e.g.
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From page 33... ...
An advantage of using modern observational data bases is that they represent continuous monitoring of the use of devices in practice and their outcomes. Uncertainty, however, remains as to the strengths and weaknesses of these methods in providing reliable evidence (62~.
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