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The Physician, the Manufacturer, and Medical Devices

The Physician, the Manufacturer, and Medical Devices Abstract • Better communication between physicians and manufacturers of medical devices is becoming increasingly important due to wider usage of these devices, as well as more intense scrutiny by consumer interest groups. Physicians should therefore have more complete knowledge of techniques of new product development. A new product typically passes through at least six stages, as follows: (1) idea conception; (2) merit and feasibility study; (3) design and testing; (4) production preparation; (5) market preparation; and (6) marketing. These steps are completed over a period of several years at an ever increasing cost. We propose that interaction procedures be undertaken so as to enhance direct physician-manufacturer communications in the medical device arena. Some possible techniques of improving these communications include the direct training of physicians and manufacturers in each other's problems, the establishment of hospital engineering groups, the placement of medical consultants in industry, and the active participation in device standards-generating groups and other groups of mutual interest. (Arch Surg 110:1511-1515, 1975) References 1. Anderson NG: Engineering versus disease . Ann Biomed Eng 2:1-18, 1974.Crossref 2. Bradford RT: Medical specialists in legal medicine . J Legal Med 1:32-37, 1974. 3. Radzius JR: Medical devices and judicial legislation . Med Instrum 7:145-147, 1973. 4. A national conference on medical devices . Med Instrum 3 ( (pt 1) ):177-213, 1969. 5. Federal Food, Drug, and Cosmetic Act of 1938 , US Dept of Health, Education, and Welfare, Public Health Service, Food and Drug Administration, 1938. 6. Miller MJ: Medical device legislation . Hospitals 47:81-88, 1973. 7. Radzius JR: The current status of medical device legislation . J Legal Med 1:48-51, 1973. 8. Association for the advancement of medical instrumentation: Federal drug administration conference on medical device standards . Med Instrum 6:288-315, 1972. 9. Lenfant C: Medical devices control: A panacea? N Engl J Med 289:1310, 1973.Crossref 10. Proposed International Standards Organization Standard Specifications for Breathing Machines for Medical Use . Providence, RI, International Standards Organization, Sectional Committee 1 ISO/TC121/W53, 1972. 11. Standards for Anesthesia and Breathing Equipment: Proposed American National Standards Institute Standard Specifications for Breathing Machines for Medical Use . Providence, RI, American National Standards Institute, Committee Z-79.4, 1974. 12. Cheney FW: The need for standards of performance . Anaesthesia 35:307-308, 1971.Crossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Surgery American Medical Association

The Physician, the Manufacturer, and Medical Devices

Archives of Surgery , Volume 110 (12) – Dec 1, 1975

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Publisher
American Medical Association
Copyright
Copyright © 1975 American Medical Association. All Rights Reserved.
ISSN
0004-0010
eISSN
1538-3644
DOI
10.1001/archsurg.1975.01360180081018
Publisher site
See Article on Publisher Site

Abstract

Abstract • Better communication between physicians and manufacturers of medical devices is becoming increasingly important due to wider usage of these devices, as well as more intense scrutiny by consumer interest groups. Physicians should therefore have more complete knowledge of techniques of new product development. A new product typically passes through at least six stages, as follows: (1) idea conception; (2) merit and feasibility study; (3) design and testing; (4) production preparation; (5) market preparation; and (6) marketing. These steps are completed over a period of several years at an ever increasing cost. We propose that interaction procedures be undertaken so as to enhance direct physician-manufacturer communications in the medical device arena. Some possible techniques of improving these communications include the direct training of physicians and manufacturers in each other's problems, the establishment of hospital engineering groups, the placement of medical consultants in industry, and the active participation in device standards-generating groups and other groups of mutual interest. (Arch Surg 110:1511-1515, 1975) References 1. Anderson NG: Engineering versus disease . Ann Biomed Eng 2:1-18, 1974.Crossref 2. Bradford RT: Medical specialists in legal medicine . J Legal Med 1:32-37, 1974. 3. Radzius JR: Medical devices and judicial legislation . Med Instrum 7:145-147, 1973. 4. A national conference on medical devices . Med Instrum 3 ( (pt 1) ):177-213, 1969. 5. Federal Food, Drug, and Cosmetic Act of 1938 , US Dept of Health, Education, and Welfare, Public Health Service, Food and Drug Administration, 1938. 6. Miller MJ: Medical device legislation . Hospitals 47:81-88, 1973. 7. Radzius JR: The current status of medical device legislation . J Legal Med 1:48-51, 1973. 8. Association for the advancement of medical instrumentation: Federal drug administration conference on medical device standards . Med Instrum 6:288-315, 1972. 9. Lenfant C: Medical devices control: A panacea? N Engl J Med 289:1310, 1973.Crossref 10. Proposed International Standards Organization Standard Specifications for Breathing Machines for Medical Use . Providence, RI, International Standards Organization, Sectional Committee 1 ISO/TC121/W53, 1972. 11. Standards for Anesthesia and Breathing Equipment: Proposed American National Standards Institute Standard Specifications for Breathing Machines for Medical Use . Providence, RI, American National Standards Institute, Committee Z-79.4, 1974. 12. Cheney FW: The need for standards of performance . Anaesthesia 35:307-308, 1971.Crossref

Journal

Archives of SurgeryAmerican Medical Association

Published: Dec 1, 1975

References