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Federal Policies and the Medical Devices Industry (Part 20

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References

1.

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3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

Abelson, D. S., Director, Technical Trade Bar-riers, Office of the U.S. Trade Representative,Washington, DC, personal communication,NOV. 29, 1983.Adams, W., Surgilite International, Inc., com-ments made at OTA workshop, December 1982.Agress, P., “Problems Encountered in Market-ing U.S. Medical Devices in Japan: DiscussionsBetween the Two Governments Aimed at Eas-ing Difficulties, ” Food Drug Cosmetic Law J.38:43, 1983.American Association for Respiratory Ther-apists, “Guidelines for the Use of IntermittentPositive Pressure Breathing,” Dallas, TX, April1979.American Health Planning Association, Reportof the Commission on Capital Policy, Washing-ton, DC, March 1984.American Hospital Association, Division ofHealth Financing Policy, Office of Public Pol-icy Analysis, Hospital-Blue Cross Contract Pro-visions, July 1, 1981, AHA catalog No. 073200,Chicago, IL, February 1982.American Hospital Association, Hospital Regu-lation, Report of the Special Committee on theRegulatory Process, Chicago, IL, 1977.American Hospital Association, Office of Pub-lic Policy Analysis, “Incorporating Capital Costsinto Medicare Prospective Prices, ” unpublisheddraft, Chicago, IL, July 1983.American National Standards Institute, Direc-tory of International and Regional StandardsOrganizations (New York: ANSI, 1982).American Society for Parenteral and Enteral Nu-trition, “Parenteral and Enteral Nutrition, ” un-published briefing paper, Washington, DC,Nov. 18, 1982.American Society for Parenteral and Enteral Nu-trition, Public and Private Insurance Coverageof Parenteral and Enteral Nutrition Services,background paper prepared by Memel, Jacobs,Pierne & Gersh, Washington, DC, March 1983.AMP, Inc. v. Gardner, 389 F. 2d 825 (1968);cert. denied 393 U.S. 825 (1968).Anbar, M., “University-Based R&D: A New De-velopment in National Economy, ” Medical De-vice & Diagnostic Industry 5(12):26-29, Decem-ber 1983.Anderson, G., and Ginsburg, P. B., “Prospec-tive Capital Payments to Hospitals,” Health Af-fairs 2(3):52-63, fall 1983.

15<

16.

17.

?.8.

19.

20.

21.

22.

23.

24.

25.

26.

Arakaki, E., U.S. Department of Commerce,Washington, DC, personal communications,February and August 1984.Arizona Board of Regents, “Patent Policy of theArizona Board of Regents,” adopted Apr. 16,1977,Arthur D. Little, Inc., Cost of Compliance WithGood Manufacturing Practices Regulations bythe Medical Device Industry, prepared for theFood and Drug Administration, Department ofHealth and Human Services, contract No. 223-79-8052 (Springfield, VA: National Technical In-formation Service, Department of Commerce,March 1982).Arthur Young & Co. and The Emergency CareResearch Institute, A Profile of the MedicalTechnolog y Industry and Governmental Pol-icies, final report, vol. 1, contract No. 233-79-3011, report to the National Center for HealthServices Research, U.S. Department of Healthand Human Services, Hyattsville, MD, June 30,1981.Axelson, P., U.S. Veterans Administration Re-habilitation Research and Development Center,Palo Alto, CA, personal communication, July1983.Ayres, S. M., “Magnitude of Use and Costs ofIn-Hospital Respiratory Therapy,” Am. Rev.Resp. Dis. 122(5):11-13 (pt. 2), November 1980.Baker, D. F., speech presented at the Ninth An-nual AAMI/FDA Conference on Medical De-vice Regulation, Arlington, VA, Nov. 10, 1982.Bandy, W. C., U.S. Department of Commerce,Bureau of Industrial Economics, Washington,DC, personal communication, January 1983.Banta, H. D., “Computed Tomography: CostContainment Misdirected” (editorial), Am. J.Public Health 70:215, 1980.Banta, H. D., Ruby, G., and Burns, A. K.,“Using Coverage Policy to Contain MedicareCosts,” in U.S. Congress, House Committee onWays and Means, Subcommittee on Health,Proceedings of the Conference on the Future ofMedicare, Committee Print No. 23 (Washing-ton, DC: U.S. Government Printing Office,1984).Barach, A. L., and Segal, M. S., “The Indiscrim-inate Use of IPPB, ” JAMA 231(11):1141-1142,Mar. 17, 197s.Barth, J. R,, and Cordes, J. J., “Capital Mar-kets, Government Regulation, Tax Policy and

237

238 ● Federal Policies and the Medical Devices Industry

27.

28.

29.

30.

31.

32.

33.

34.

35.

36.

37.

38.

39.

40.

41.

the Financing of Medical Device Innovations, ”contract report prepared for the Office of Tech-nology Assessment, U.S. Congress, Washing-ton, DC, February 1984.Barth, J. R., Cordes, J. J., and Tassey, G., “TheImpact of Recent Changes in Tax Policy on In-novation and R& D,” in Strategic Managementof Industrial R&D: Interdisciplinary Perspec-tives, B. Bozeman, M. Crow, and A. Link (eds.)(Lexington, MA: Lexington Books/D.C. Heath& Co., 1984).Batres, Valdes, Wygard y Associadoes, S. C.,“Market Survey of Medical Equipment (Mexi-co), ” prepared for U.S. Trade Center, April1982.Beck, R. H., “The Effects of Copayment on thePoor,” ]. Hum. Resour. (1):129, 1974.Becton, Dickinson& Co. v. Food and Drug Ad-ministration; United States v. Becton, Dickin -son & Co.; and In the IWatter of the Establish-ment Inspection of Bard-Parker, Division ofBecton-Dickinson Co.; 589 F. 2d 1175 (2d Cir.1978).Berenson, R., Washington, DC, persor.al com-munication, January 1984.Bialys, S., U.S. Veterans Administration, Hines,IL, personal communication, May 1983.Biles, B., Schramm, C. J., and Atkinson, J. G.,“Hospital Cost Inflation Under State Rate-Setting Programs,” Al. Engl. J. Med. 303(12):664, Sept. 18, 1980.Biomedical Business International, “Medical Nu-tritional: Markets, Trends, Outpatient Servicesand Synergies, ” VII(3) :18-19, Feb. 8, 1984.Biomedical Business International, “Trends inClinical Testing,” VI(14):124-126, Aug. 1 0 ,1983.Blue Cross and Blue Shield Association, “Med-ical Necessity Guidelines on Respiratory Care(Inpatient),” Chicago, IL, Oct. 20, 1982.The Blue Sheet, “Health Planning Will GetFunding If Legislation Clears,” 27(5):14-15, Feb.1, 1984.The Blue Sheet, “New York Certificate-of-NeedReview to Focus on New Projects’ OperatingCosts,” 26(25):12-13, June 22, 1983.Booker, H., U.S. Veterans Administration,Washington, DC, personal communications,November 1982 and April 1984.Bovbjerg, R. R., Diamond, L. H., Held, P. J.,et al., “Continuous Ambulatory Peritoneal Dial-ysis: Preliminary Evidence in the Debate OverEfficacy and Cost,” Health Affairs 2(2):96-102,summer 1983.Bozeman, B., Crow, M., and Link, A. (eds.),

42.

43.

44.

45.

46.

47.

48.

49.

50.

51.

52.

53.

Strategic Management of Industrial R&D: Inter-disciplinary Perspectives (Lexington, MA: Lex-ington Books/D.C. Heath & Co., 1984).Bradburd, R. M., “Veterans AdministrationProcurement and the Market for Medical Equip-merit, ” contract report prepared for the Officecf Technology Assessment, U.S. Congress,Washington, DC, Oct. 19, 1983 (draft).Braun, S. R., Smith, F. R., McCarthy, T. M.,et al., “Evaluating the Changing Role of Respi-ratory Therapy Services at Two Hospitals, ”)AMA 245(20):2033-2037, May 22-27, 1981.Brennan, M. F., “Total Parenteral Nutrition inthe Cancer Patient,” IVew Engl. J. Med. 30s(7):375-382, Aug. 13, 1981.Breslar, J., U.S. Veterans Administration, Wash-ington, DC, personal communications, May andJune 1983.Bridgman, E., “The Impact of the GATT Stand-ards Code and United States Trade AgreementAct on Private Sector Standards Development,”presented at the Ninth Annual AAMI/FDAConference on Medical Device Regulation, Arl-ington, VA, Nov. 10, 1982.Britain, R., U.S. Department of Health andHuman Services, Food and Drug Administra-tion, comments made at OTA Workshop on theMedical Device Amendments of 1976, Washing-ton, DC, May 19, 1983.Britain, R., U.S. Department of Health andHuman Services, Food and Drug Administra-tion, Silver Spring, MD, personal communica-tion, August 1983.Britt, M. R., Child, S. R., and Grantham, M.L., Reduction of Intermittent Positive PressureBreathing (IPPB) Usage in Surgical Patients bya PSRO, Utah PSRO, Salt Lake City, UT, n.d.Brook, R. H., Williams, K. N., and Rolph, J.E., “Controlling the Use and Cost of MedicalServices: The New Mexico Experimental Medi-cal Care Review Organization—A Four-YearCase Study,” Medical Care 16(9) (Suppl.), Sep-tember 1978.Bunker, J. P., Fowles, J., and Schaffarzick, R.,“Evaluation of Medical Technology Strategies:Evaluation of Coverage and Reimbursement,”IV. Engl. J. Med. 306(10):620, Mar. 11, 1982.Business Management Consultants, Ltd., “Surveyof the United Kingdom Market for MedicalEquipment, ” report prepared for the U.S. De-partment of Commerce, International TradeAdministration, Office of Trade InformationServices, Aldershot, Hampshire, U. K., June 1s,1983.Campbell, J,, “The 1976 Medical Device Amend-

References • 239

54,

55.

56.

57.

58.

59.

60.

61.

62.

63.

64.

65.

66.

67.

ments and the 510(k) Process, ” presented to theFood and Drug Law Institute, Washington, DC,May 1, 1983.Carney, T. P., President, Metatech Corp., pa-per prepared for the Office of Technology As-sessment, U.S. Congress, Washington, DC,1983.Carroll, M. S., and Arnett, R. H., III, “PrivateHealth Insurance Plans in 1977: Coverage,Enrollment, and Financial Experience,” HealthCare Finazz. Rev. 1(2):3, fall 1979.Carter, C., “Conditions for the Successful Useof Science,” Science 219(4590):1295-1298, Mar.18, 1983.Chassin, M., “Chapter IV, Certificate of Need,”Medica] Care 16(10) (%ppl.):21-26, October1978.Cherniak, et al., “Home Care of Chronic Res-piratory Disease,” JAMA 208:821, 1969.Chrysomilides, S. A., and Kaminski, M. V.,“Home Enteral and Parenteral Nutritional Sup-port: A Comparison,” Am. J. Clin. IVutr. 34(10):2271-2275, October 1981.Coelen, C., and Sullivan D., “An Analysis ofthe Effects of Prospective Reimbursement Pro-grams on Hospital Expenditures,” Health CareFinazz. Rev. 2(3):1, winter 1981.Cohen, A. B., and Cohodes, D. R., “Certificateof Need and Low Capital-Cost Medical Tech-nology,” Milbank Mere. Fund Q. 60(2):307-28,spring 1982.Cohen, J. S., Research Chemist, National Insti-tute of Child Health and Human Development,National Institutes of Health, Bethesda, MD,personal communication, Aug. 1, 1983.Cohodes, D. R., “The State Experience WithCapital Management and Capital ExpenditureReview Programs,” article cited in “Health Cap-ital Issues, ” papers presented at the Health Cap-ital Conference sponsored by the Bureau ofHealth Facilities, Feb. 19-20, 1980.Cohodes, D. R., “Which Will Survive? The $150Billion Capital Question, ” Inquiry 20:5-11,spring 1983.Collins, E., “Tax Incentives for Industrial R&D:Effects of the New Provisions and Proposals forFurther Action,” mimeo, National Science Foun-dation, Washington, DC, 1983.Comanor, W. S., “Market Structure, ProductDifferentiation, and Industrial Research,” Q. J.Econ. 85:639-657, November 1967.Committee for Economic Development, Re-search and Policy Committee, Stimulating 7’ech-

68.

69.

70.

71.

72.

73.

74.

75.

76.

77.

78.

79.

nological Progress (New York: The HeffernanPress, Inc., 1980).Cook, C., U.S. Veterans Administration, Wash-ington, DC, personal communication, Decem-ber 1982.Coombs, F., U.S. Veterans Administration,Washington, DC, personal communication, Jan-uary 1983.Cordes, J. J., “The Impact of Tax and FinancialRegulatory Policies on Industrial Innovation,”report of a workshop sponsored by the NationalResearch Council and the National Academy ofEngineering, July 20, 1978 (Washington, DC:National Academy of Sciences, 1980).Cromwell, J., Ginsburg, P., Hamilton, D., etal., Incentives and Decisions Underlying Hos-pitals’Adoption and Utilization of Major Cap-ital Equipment (Cambridge, MA: Abt Associ-ates, 1975), as cited in (351).Cromwell, J., and Kanak, J., “The Effects ofProspective Reimbursement Programs on Hos-pital Adoption and Service Sharing,” HealthCare Finan. Rev. 4(2):67, December 1982.Cutler, I. R., “The European Scene With Respectto Standards and National Regulatory Require-ments for Medical Devices and Equipment, ” pa-per presented at the Ninth Annual AAMI/FDAConference on Medical Device Regulation, Ar-lington, VA, Nov. 9-10, 1982.Cutler, S., Health Care Financing Administra-tion, Baltimore, MD, personal communication,Aug. 17, 1983.Damadian, R., Minkoff, L., Goldsmith, M., etal., “Tumor Imaging in a Live Animal by FieldFocusing NMR (Fonar),” Physiol. Chem. &Phys. 8:61-65, 1976.Damadian, R., Zaner, K., and Her, D., “HumanTumors by NMR,” Physiol. Chem. & Phys.5:381-402, 1973.Damadian, R., Zaner, K., Her, D., et al., “Hu-man Tumors Detected by Nuclear Magnetic Res-onance,” Proc. IVat. Acad. Sci. USA 71(4):1471-1473, 1974.Davis, C., Health Care Financing Administra-tion, testimony at hearing on Proposed Prospec-tive Reimbursement Rates for the End-Stage Re-nal Disease Program, before the Subcommitteeon Health, Committee on Finance, U.S. Senate,Mar. 15, 1982 (Washington, DC: U.S. Govern-ment Printing Office, 1982).Demlo, L. K., Hammons, G. T., Kuder, J. M.,et al., “Report of a Study on Decisionmakingby Medicare Contractors for Coverage of Med-

240 . Federal Policies and the Medical Devices Industry

80.

81.

82.

83.

84.

85.

86.

87.

88.

89.

90.

91.

92.

93.

94.

ical Technologies, ” College of Medicine andGraduate College of University of Iowa Hospi-tals and Clinics, contract report prepared for theOffice of Technology Assessment, U.S. Con-gress, October 1983 (draft).Devices and Diagnostics Letter, “FDA DeniesPetition To Simplify 510(k) Procedures,” 10(33),Aug. 1911983.Devices and Diagnostics Letter, “FDA LimitsNumber of YAG Laser Investigations, ” 10(50),Dec. 16, 1983.Devices am3Diagnostics Letter, “Firms Line UpBehind Petition To Revamp 510(k) Rule,” 10(1),Jan. 7, 1983.Devices and Diagnostics Letter, “HRG TakesNeuro Device Submission Argument to Dingell,”9(50), Dec. 10, 1982.Devices and Diagnostics Letter, “InvestigationalDevices Need Not Be Loss-Leaders,” 9(51):2,Dec. 17, 1982.Devices and Diagnostics Letter, “NaderitesSpurned On Effort To Force Device Standards,”9(49), Dec. 3, 1982.Devices and Diagnostics Letter, “PMA Require-ments May Stifle Cerebella Stimulator, ” 11(2),Jan. 13, 1984.Devices and Diagnostics Letter, “Progress To-ward Revising Class II Standards Starts, ” 10(48),Dec. 2, 1983.Devices and Diagnostics Letter, “YAG LaserStudies Limited to 500 Patients, 6 Months, ”10(41):1, Oct. 14, 1983.diMonda, R., “How Hospitals Perceive Stand-ards,” Medical Instrumentation 13(4):200-3,July-August 1979.Dolan, A. M., “The Development of Consen-sus Standards for Medical Devices in Canada, ”Medical Progress Through Technology 6(3):137-40, June 1979.Donaldson, J. L., Deputy Director, Office ofProducts Standards Policy, Office of the Direc-tor, National Bureau of Standards, Washington,DC, personal communication, Nov. 29, 1983.Dowdal, T. G., U.S. General Accounting Of-fice, letter to Carolyn K. Davis, Administrator,Health Care Financing Administration, re: Anal-ysis of Medicare Durable Medical EquipmentClaims in Georgia, Idaho, and Southern Califor-nia (GAO/HRD-84-40), Feb. 13, 1984.Downs, F., U.S. Veterans Administration,Washington, DC, personal communications,November 1982 and June 1983.Drug Reform Law (Law on the Reform of DrugLegislation), Federal Republic of Germany, Aug.24, 1976, Bundesgesetzblatt IBGB1].

95.

96.

97.

98.

98a.

99.

100.

101.

102.

103.

104.

105.106.

107.

108.

109.

110.

Dun & Bradstreet, Dun’s Financial Profiles, 1981Jndustry Norms, Three Years, vols. I and II,New York, November 1981.Dunkelberg, J, S., Furst, R. W,, and Roenfeldt,R. L., “State Rate Review and the RelationshipBetween Capital Expenditures and OperatingCosts,” Inquiry 20:240-247, fall 1983.Eads, G. C., “Regulation and Technical Change:Some Largely Unexplored Influences, ” Am.Econ. Rev. 70(2):50, May 1980.Eggers, P. W., Office of Research, Health CareFinancing Administration, Baltimore, MD, per-sonal communication, February 1984, as citedin (260).Eisner, R., Albert, S. H., and Sullivan, M. A.,“Tax Incentives and R&D Expenditures, ” pre-sented at the 16th CIRET Conference, Washing-ton, DC, September 1983.Eli Lilly & Co., “Lilly Hospital Pharmacy Sur-vey, ‘82,” Indianapolis, IN, 1982,Emergency Care Research Institute, “NMR: StillToo Early for Answers to Many Questions,” is-sues in Health Care Technology, November1983.Engelberg, A. B., “Patent Term Extension: AnOverreaching Solution to a Nonexistent Prob-lem,” Health Affairs 2:34-45, spring 1982.EUROTASC (European Regulatory-TechnicalAffairs Study Committee), Six-Volume Report,September 1981.Evans, C. C., U.S. Veterans Administration,Washington, DC, personal communication,Mar. 5, 1984.Evans, C. C., Holden, F., and Speight, J., “ADRG Based Resource Allocation System for theVeterans Administration,” Allocation Develop-ment Service, U.S. Veterans Administration,unpublished paper, 1983.Exporters’ Encyclopedia, 2:481-482, 1405-1428.Farrow, S. C., Kaluzny, A. D., and Ricketts,-r., “Proceedings of a Conference on HealthServices Research Issues in the Veterans Admin-istration, ” J. Med. Systems 5(1/2):1-16, 1981.Feder, J., Medicare: The Politics of Federal Hos-pital Insurance (Lexington, MA: LexingtonBooks, 1977).Feder, J., Hadley, J., and Mullner, R., “PoorPeople and Poor Hospitals: Implications forPublic Policy,” J. Health Polit. Policy Law,forthcoming.Feil, C., Associate Manager of Public Informa-tion, Underwriters Laboratory, Northbrook, IL,personal communication, September 1983.Feldstein, M. S., and Taylor, A. K., The Rapidl?ise of Hospital Costs, a report to the President’s

References • 241

111.

112,

113.

114.

115.

116.

117.

118.

119.

120.

121.

122.

123.

Council on Wage and Price Stability (Washing-ton, DC: U.S. Government Printing Office,1977).Feldstein, P. J., “Relying on Regulation To Im-prove Hospital Performance, ” FIeakh Care Eco-rtornics (New York: John Wiley & Sons, 1979).Fellner, W., “The Influence of Market Structureon Technological Progress, ” Quality J. Econ.65:560, November 1951, as cited in (274).Ferry, T. P., Gornick, M., Newton, M., et al.,“Physicians’ Charges Under Medicare: Assign-ment Rates and Beneficiary Liability, ” ~ealthcare I?inan. I?ev. 2:49-73, winter 1980,Fineberg, H. V., “Gastric Freezing—A Study ofDiffusion of a Medical Innovation,” in Instituteof Medicine and National Research Council,Medical Technology and the Health Care Sys-tem: A Study of Equipment-Embodied Technol-ogy (Washington, DC: National Academy ofSciences, 1979).Finkel, M. J., “The Development of OrphanProducts,” Al. Engl. J. Med. 307(15):963-964,Oct. 7, 1982.Finkel, M. J., Director, Office of Orphan Prod-ucts Development, Food and Drug Administra-tion, Rockville, MD, personal communications,Jan. 25 and Apr. 15, 1984.Flaherty, R,, Director, Diagnostic Standards andScientific Affairs, Health Industry Manufac-turers Association, Washington, DC, personalcommunication, July 29, 1983.Flink, R. C., “Standards: A Benefit or Burdento Industry?” Medical Instrumentation 13(4):197-8, July-August 1979.Foster, H. S., Attorney at Law, O’Conner andHannan, Washington, DC, personal communi-cation, April 1984.Foster, H. S., “The Impact of Federal and StateRegulatory Programs on the Ambulatory Lab-oratory Testing Industry and the Demand forInstrumentation,” contract report prepared forthe Office of Technology Assessment, U.S. Con-gress, Washingtonr DC, January 1984 (reviseddraft).Foster, M. E., “Sweeping Amendments to Stand-ards and Certification System Adopted, ” EastAsian Exec. Rep. 5(7):9,13-14, July 15, 1983.Fuji National City Consulting Ltd., “Survey ofJapanese Markets for Medical and Dental Equip-merit, ” vol. 2, prepared for the U.S. Embassy,May 1983.The Futures Group, “Characterization of In-novations Introduced on the U.S. Market in1982,” contract report prepared for the U.S.Small Business Administration, contract #SBA-6050-OA-82, Glastonbury, CT, March 1984.

124.

125.

126.

127.

128.

129.

130.

131.

132.

132a.

133.

134.

135.

136.

137.

Gellman Research Associates, Inc., The Rela-tionship Between Industn”al Concentration, FirmSize, and Technological Innovation, report pre-pared for the Office of Economic Research, Of-fice of Advocacy, U.S. Small Business Admin-istration, Washington, DC, May 11, 1982.Giannini, M., U.S. Veterans Administration,Washington, DC, personal communication, No-vember 1982.Gibson, R. M., “National Health Expenditures,1978, ” Health Care Finan. Rev. 1:1-36, summer1979.Gibson, R. M., and Waldo, D. R., “NationalHealth Expenditures, 1981,” Health Care Finan.Rev. 4(1):1-35, September 1982.Gibson, R. M., Waldo, D. R., and Levit, K. R.,“National Health Expenditures, 1982,” HealthCare Finan. Rev. 5(1):1-31, fall 1983.Gold, J., Office of Health Planning, U.S. De-partment of Health and Human Services, Pub-lic Health Service, Health Resources and Serv-ices Administration, Washington, DC, personalcommunication, Apr. 12, 1984.Goldschmidt, P. G., U.S. Veterans Administra-tion, Washington, DC, personal communica-tion, January 1983.Grace Commission, President’s Private SectorSurvey on Cost Control: Task Force Report onthe Veterans Administration, draft, Washing-ton, DC, May 1983.Graham, et al. v. John Deere Co. of KansasC’ity, et al., 383 U.S. 1 (1966).Grayson, R. T., “Effects of Regulatory Controlson the Accuracy of Clinical Laboratory Tests, ”J. Medical Technology (forthcoming).Greenfield, W. M., “New Approaches To Usingthe Determination-of-Need Process To ContainHospital Costs,” IV. Engl. J. Med. 309(6):372-375, Aug. 11, 1983.Greer, D. F., and Rhoades, S. A., “Concentra-tion and Productivity Changes in the Long andShort Run, ” South. Econ. J. 43:1031, October1976, as cited in (274).Griessbach, L., German American Chamber ofCommerce, personal communication, Nov. 29,1983.Hadley, D., Health Care Financing Administr-ation, Baltimore, MD, personal communication,Aug. 11, 1983.Hadley, J., “Critique of Peter Fox’s ‘PhysicianReimbursement Under Medicare: An Overviewand a Proposal for Area-Wide Physician Incen-tives, ‘ “ in U.S. Congress, House Committee onWays and Means, Subcommittee on Health,Proceedings of the Conference on the Future ofMedicare, Committee Print No. 23 (Washing-

242 . Federal Policies and the Medical Devices Industry

138.

139.

140.

141.

142.

143.

144.

145.

146.

147.

148.

149.

150.

ton, DC: U.S. Government Printing Office,1984).Hadley, J., and Feder, J., “Hospital Cost Shift-ing,” Urban Institute working paper #3179-07(Washington, DC: The Urban Institute, 1984).Hadley, J., Holahan, J., and Scanlon, W., “CanFee-for-Service Reimbursement Coexist WithDemand Creation?” Inquiry 16(3):247, fall 1979.Hadley, J., Juba, D., Swartz, K., et al., Alter-native Methods of Developing a Relative ValueScale of Physicians’ Services (Washington, DC:The Urban Institute, February 1983).Hamilton, R., “Certificate of Need: Scope ofCoverage,” paper presented at the AmericanHealth Planning Association and the NationalHealth Lawyers Association, Washington, DC,Dec. 7, 1983.Harrnan, A. J., “Industrial Innovation and Gov-ernmental Policy: A Review and Proposal Basedon Observation of the U.S. Electronics Sector, ”Tech. Forecast. Soc. Change 18:15, 1980.Hayes, A. H., Jr., Statement of the Commission-er, Food and Drug Administration at Hearingson FDA Oversight: Medical Devices, U.S.Congress, House Committee on Energy andCommerce, Subcommittee on Oversight and In-vestigations, July 16, 1982, serial No. 97-144(Washington, DC: U.S. Government PrintingOffice, 1982).Hazelwood, C. F., Cleveland, G., Medina, D.,“Relationship Between Hydration and ProtonNuclear Magnetic Resonance Relaxation Timesin Tissue of Tumor-Bearing and Non-tumorBearing Mice: Implications for Cancer Detec-tion,”J. Natl. Cancer Inst. 52:1849-1853, 1974.Health Industry Manufacturers Association,Guidelines for the Development of VoluntazyDevice Law Standards, HIMA Report No. 79-6, Washington, DC, October 1979.Health Industry Manufacturers Association, I.n-ternational Activities Survey, HIMA Document10, vol. 2, Washington, DC, July 1980.Heimburger, H. C., “Home Parenteral Nutri-tion,” Ala. J. Med. Sci. 19(4):377-380, October1982.Hellinger, F. J., “The Effect of Certificate-of-Need Legislation on Hospital Investment, ” In-quiry 13:187-193, June 1976.Higson, G. R., “The UK Department of Healthand Social Security’s Scientific and TechnicalServices Branch,” J. Medical Engineering andTechnology 7(3):130-35, May/June 1983.Holder, J., U.S. Veterans Administration, Wash-ington, DC, personal communication, June1983.

151.

152.

153.

154.

155.

156.

157.

158.

159.

160.

161.

162.

163.

164.

165.

166.

Holland, D., “The Effect of Taxation on Effort:Some Results for Business Executives,” NationaZTax Association—Proceedings of the 62nd An-nual Conference, September 1969.Hollis, D. P., Saryan, L. A., Eggleston, J. C.,et al., “Nuclear Magnetic Resonance Studies ofCancer,” J. Natl. Cancer Inst. 54:1469-1472,1975.Home Health Line, “A Big Chill Settles OverPart A Home Hyperalimentation,” 1X:22-24,Jan. 30, 1984.Home Health Line, “Atlanta Home Care Semi-nar—National Medical Enterprises V. P. Living-ston Says Home Care Low Priority for Hospi-tals; Manufacturers Expand Into Home CareCenters,” VIII:212-214, Nov. 21, 1983.Home Health Line, “Changing Face of MedicareHome Health” (table), VIII:28, Feb. 4, 1983.Home Health Line, “DME Under $120 ShouldBe Purchased, GAO Report Says, ” VIII:126,July 18, 1983.Home Health Line, “GAO Again Finds DME Ex-cess Rental—This Time in ‘High-Cost’ OxygenConcentrators, ” 1X:53, Feb. 27, 1984.Home Health Line, “GAO Finds Only $18 Mil-lion in HHA DME Expenditures, ” 1X:85, Apr.9, 1984.Home Health Line, “Medicare Home HealthOutlays Up 1,000% From 1974 (table),” VIII:136, July 25 and Aug. 1, 1983 (combined issue).Home Health Line, “Medicare Home HealthYearly Outlays to Break $3 Billion by End ofDecade, Total Hospice Outlays Equal $815 Mil-lion Before Sunset, ” 1X:43, Feb. 13, 1984.Home Health Line, “NAMES Presses ‘Freedomof Choice’ in Hospital DME Referrals, ” 1X:49,Feb. 20, 1984.Home Health Line, “Region V Flattens DailyCare After Consulting HCFA; Says PatientShould Be in Skilled Nursing Facility If Cheaper, ”VIII:167-168, Sept. 12, 1983.Howard, A. J., “European Medical Device Reg-ulations: An Update,” Medical Device and Diag-nostic Industry 5(9):46-50, September 1983.Hulse, J. W., “The Impact of Foreign Regula-tion on International Trade: Potential Barriersto U.S. Products, ” paper presented at the NinthAnnual ~1/FDA Conference on MedicalDevice Regulation, Arlington, VA, Nov. 10,1982.Iglehart, J., “Health Report/Federal Regulationof Medical Devices Gets Serious Attention inCongress,” NationaZJournal Reports, pp. 1184-1188, Aug. 11, 1973.IMS America, Ltd., Rockville, MD, unpublished

References . 243

167.

168.

169.

170.

171.

172.

173.

174.

175.

176.

177.

178.

179.

180.

data provided to the Office of TechnologyAssessment, U.S. Congress, under contract, De-cember 1983.IMS America, Ltd., Veterans AdministrationPrice Analysis of Hospital Supply and Pharma-ceutical Products, Order No. TE-QI-83, Rock-ville, MD, May 1983.Institute of Medicine and National ResearchCouncil, Medical Technology and the HealthCare System: A Study of Equipment-EmbodiedTechnology (Washington, DC: National Acad-emy of Sciences, 1979).International Organization for Standardization,MEMENTO 1978 and 1983 (Geneva, Switzer-land: 1S0, 1978 and 1983).InterStudy, “The December 1983 HMO Enroll-ment in the U. S.: A Mid-Year Census” (Ex-celsior, MN: InterStudy, 1984).In the Matter of the Establishment Inspection ofPortex, Inc., Food and Drug Administration,Appellant, 595 F. 2d 84 (lst Cir. 1979).Janssen, T. J., and Saffran, G. T., “Reimburse-ment for Durable Medical Equipment, ” HeaZthCare Finan. Rev. 2(3): 94, winter 1981.Japan Ministry of Health and Welfare, “Meas-ures Taken by the Japanese Ministry of Healthand Welfare (MHW) for Further Opening theJapanese Market Regarding Pharmaceuticals,Food, Etc.,” April 1983.Jarvis, A. E., “A Detailed Review of the Medi-cal Device Regulations of Major Importers ofU.S. Products,” paper presented at the NinthAnnual AAMI/FDA Conference on MedicalDevice Regulation, Arlington, VA, Nov. 10,1982.Jewkes, J., Sawers, D., and Stillerman, R., TheSources of Invention, 2d ed. (New York: Nor-ton, 1969).Joint Commission on Accreditation of Hospitals,Accreditation Manual for Hospitals 1983, Chi-cago, IL, 1982.Joskow, P. L., Controlling Hospital Costs: TheRole of Government Regulation (Cambridge,MA: The Massachusetts Institute of TechnologyPress, 1981).Kamien, M. I., and Schwartz, N. L., “On theDegree of Rivalry for Maximum InnovativeActivity,” Q. J. Econ. 90(2):245-260, May 1976.Kamien, M. I., and Schwartz, N. L., MarketStructure and Innovation (Cambridge, MA:Cambridge University Press, 1982).Kasper, J. A., Prescribed Medicines: Use, Ex-penditures, and Sources of Payment, Data Pre-view 9, DHHS publication No. (PHS) 82-3320,National Health Care Expenditures Study, Na-

181,

182.

183.

184.

185.

186.

187.

188.

189.

190.

191.

192.

193.

194.

tional Center for Health Services Research, U.S.Department of Health and Human Services,Hyattsville, MD, April 1982.Kaye, Scholer, Fierrnan, Hays, & Handler,“Governmental Barriers to International Tradein Medical Devices in the United States, UnitedKingdom, France, The Federal Republic of Ger-many, Canada, Japan, and Mexico, ” contractreport prepared for the Office of TechnologyAssessment, U.S. Congress, Washington, DC,February 1984.Kelly, P., and Kranzberg, M. (eds. ), Techno-logical Innovation: A Critical Review of Cur-rent Knowledge (San Francisco: San FranciscoPress, 1978).Kenney, M., independent consultant, Berkeley,CA, personal communication, Apr. 19, 1984.Kessler, P., “You: Putting Teeth Into Bonding,”The Washington Post, C5 (co1. 2), July 5,1983.Kettering, V., U.S. Department of Commerce,Bureau of Industrial Economics, Washington,DC, personal communication, February 1984.Kidder, Peabody & Co., Baxter Travenol Lab-oratorz”es, Inc.: 1983 Review and Outlook, Com-pany Follow-up, May 13, 1983.Kimberly, J. R., “Hospital Adoption of Innova-tions in Medical and Managerial Technology:Individual, Organizational and Contextual/Environmental Effects,” Executive Summary,National Science Foundation Grant No. PRA76-23080, March 1978.Kindel, K., “Survey of the Market for MedicalEquipment in Germany,” prepared for the U.S.Department of Commerce, Berlin, March 1981.Kleinfield, N. R., “The Home Health CareBoom,” The New York Times, sec. Dl, June 30,1983.L. W. Bergman& Co., “Financial Issues in Bio-technology, ” contract report prepared for theOffice of Technology Assessment, U.S. Con-gress, Washington, DC, March 1983.Lauterbur, P. C., “Image Formation by InducedLocal Interactions: Examples Employing NuclearMagnetic Resonance,” Nature 242:190-191,1973.Law on Technical Equipment and Devices, Fed-eral Republic of Germany, June 24, 1968, asamended Aug. 13, 1979, BundesgesetzblattIBGB1], p. 1432.Lepon, J., and Gawron, E., Kornmeier, McCar-thy, Lepon, and Harris, “Medical Device Stand-ards and International Trade, ” contract reportprepared for the Office of Technology Assess-ment, U.S. Congress, Washington, DC, 1983.Lewis, P., “U.S. and Third World At Odds Over

244 • Federal Policies and the Medical Devices Industry

195.

196.

197.

198.

199.

200.

201.

202.

203.

204.

205.

206.

207.

208.

Patents,” The New York Tines, D1 (co]. 1),Oct. 5, 1982.Liaison and Coordination Headquarters onStandards and Certification Systems, “Improve-ment of Japan’s Standards and Certification Sys-tems, Etc.,” Mar. 26, 1983.Liefer, L., U.S. Veterans Administration Reha-bilitation Research and Development Center,Palo Alto, CA, personal communication, July1983.Louis Harris & Associates, Inc., A Survey ofMedical Device Manufacturers, study No. 802005,report submitted to the Bureau of Medical De-vices, Food and Drug Administration, U.S. De-partment of Health and Human Services, July1982.Luft, H. S., Health Maintenance organizations:Dimensions of Performance (New York: JohnWiley & Sons, Inc., 1981).Lupovich, P., “Changes in the Clinical Labora-tory,” paper prepared for the Office of Technol-ogy Assessment, U.S. Congress, Washington,DC, February 1984.Mansfield, E., Industrial Research and Techno-logical Innovation (New York: W. W. Norton& Co., 1968).Mansfield, E., and Wagner, S., “Organizationaland Strategic Factors Associated With Probabil-ities of Success in Industrial R and D,” J. Busi-ness 48:179-98, April 1975, as cited in (274).Marcus, P., U.S. Department of Commerce,Washington, DC, personal communication, Jan-uary 1984.Markham, J. W., “Market Structure, BusinessConduct, and Innovation, ” Am. Econ. Rev.60:323, 1965, as cited in (182).Martin, D. R., Director, International Investiga-tions Staff, Executive Directorate for RegionalOperations, Food and Drug Administration,Rockville, MD, personal communication, Dec.16, 1983.Medical Devices, Diagnostics and Instrumenta-tion Reports (The Gray Sheet), “Abbott’s Alpha-Fetoprotein Diagnostic Kit for Testicular Can-cer,” 10(8):9-10, Feb. 20, 1984.Medical Devices, Diagnostics and Instrumenta-tion Reports (The Gray Sheet), “Annual Reg-istration of Medical Device Firms TemporarilyDelayed,” 10(3), Jan. 16, 1984.Medical Devices, Diagnostics and Instrumenta-tion Reports (The Gray Sheet), “Contact LensGuidelines: FDA Is Establishing Working Group,”9(48), Nov. 28, 1983.Medical Devices, Diagnostics and Instrumenta-tion Reports (The Gray Sheet), “NMR Purchases

209.

210.

211.

212.

213.

214.

215.

216.

217.

218.

219.

220.

221.

222.

223.

in New York Limited to 13 Sites Under HealthPlanning Commission Proposal; Wisconsin,Oregon, North Carolina Also Move To RestrictPurchases,” pp. 9-10, Feb. 27, 1984.Medical Devices, Diagnostics and Instrumenta-tion Reports (The Gray Sheet), reporting on tes-timony of NIH Director James Wyngaarden totwo subcommittees of the House Science andTechnology Committee, 8(40), Oct. 4, 1982.Medical Devices, Diagnostics and Instrumenta-tion Reports (The Gray Sheet), “Sealants Are‘Highly Effective’ and ‘Safe’,” 9(50):12-13, Dec.12, 1983.Medical Device and Diagnostic Industry, “TheEffect of DRGs on Devices and Diagnostics, ”6(2):31-36, February 1984.Medical World News, “Physician-Office Lab Re-sults Less Accurate Than Those of LicensedLabs, Study Shows,” 25(3):46-47, Apr. 9, 1984.Medsger, B., “The Most Captive Consumers: Atthe Mercy of the Wheelchair Barons, ” The Pro-gressive, pp. 34-39, March 1979.Mixon, A. M., III, President, Invacare Corp.,personal communication, Aug. 16, 1983.Miyamo, H., Japan Ministry of InternationalTrade and Industry, personal communication,NOV. 16, 1983.Moliter, R. M., General Electric Co., Washing-ton, DC, personal communication, Nov. 18,1983.“More Patents Bear the Label ‘Made in Japan’, “National journal 14:1069, June 12, 1982.Morrone, F., U.S. Veterans Administration,Washington, DC, personal communication,June 1983.Mosley, M., “Talking Points on U.S. Exportsof Medical Instruments, ” paper presented at themeeting of the Association for the Advancementof Medical Instrumentation, Arlington, VA,Oct. 10, 1982.Mossinghoff, G. J., Patent and TrademarkCommissioner, commenting on the 1983 leg-islative proposals, Chemical & EngineeringNews 60(33): Aug. 16, 1982.Motley, H, L., Werko, L., Cournard, A., et al.,“Observations on the Clinical Use of Intermit-tent Positive Pressuref”J. Aviation Med. 18:417-435, October 1947.Mullin, P., Joint Commission on Accreditationof Hospitals, Chicago, IL, personal communi-cation, Apr. 17, 1984.Myers, S., and Marquis, R. G., SuccessfulIndustrial Innovations, NSF-No. 69-17 (Wash-ington, DC: U.S. Government Printing Office,1969).

References • 245

224.

225.

226.

227.

228.

229.

230.

231.

232.

233.

234.

235.

236.

National Academy of Sciences, Elealth Care forAmerican Veterans, prepared for the Commit-tee on Veterans Affairs, U.S. House of Repre-sentatives, Committee Print No. 36 (Washing-ton, DC: U.S. Government Printing Office,1977).National Academy of Sciences, Assembly of LifeSciences, Final l?eport of tZze Cozrzznittee onProsthetics Research in the Veterans Adminis-tration, 1976.“National Survey of Hospital and Non-HospitalClinical Laboratories,” Laboratory Mgt. 17(3):33-48, March 1979.Needleman, J., and Lewin, L. S., “The Impactof State Regulation on the Adoption and Diffu-sion of New Medical Technology, ” Appendix Fin Institute of Medicine and National ResearchCouncil, Medical Technology and the HealthCare System: A Study of Equipment-EmbodiedTechnology (Washington, DC: National Acad-emy of Sciences, 1979).Nelson, R. R. (cd.), Government and 7’echni-cal Progress: A Cross-Industry Analysis (NewYork: Pergamon Press, 1982).Nelson, R. R., “Government Stimulus of Tech-nological Progress: Lessons From American His-tory,” in Government and Technical Progress:A Cross-Indust~Analysis, R. R. Nelson (cd.).Nelson, R. R., “The Simple Economics of BasicScientific Research,” J. Political Economy 67:297-306, June 1959.Nelson, R. R., and Langlois, R. N., “IndustrialInnovation Policy: Lessons From American His-tory,” Science 219:814-818, Feb. 18, 1983.Nelson, R. R., and Winter, S. G., “In Searchof a Useful Theory of Innovation, ” ResearchPolicy 6:36-76, 1977.Newhouse, J. P., Manning, W. G., Morris, C.N., et al., “Some Interim Results From a Con-trolled Trial of Cost Sharing in Health Insur-ance,” Al. Engl. ]. Med. 305:1501, 1981.Obermayer, J., The Role of Patents in the Com-mercialization of New Technology for Small In-novative Companies (Cambridge, MA: Research& Planning Inc., 1981).Olsson, J., Manager, Safety and RegulatoryEngineering, General Electric Co., Medical Sys-tems Operation, Milwaukee, WI, personal com-munication, Aug. 15, 1983.Organization for Economic Cooperation andDevelopment, Innovation in Small and A4ediumFirms (Paris: Organization for Economic Coop-eration and Development, 1982).

237.

238.

239.

240.

241.

242.

243.244.

245.

246.

247,

248.

249.

250.

251.

Over, A. M., Jr., Bradburd, R. M., Williams,R. C., Jr., et al., Determinants of Current andFuture Expenditures on Durable Medical Equip-ment by Medicare and Its Program Beneficiaries,contract report submitted to the Health CareFinancing Administration, U.S. Department ofHealth and Human Services, Baltimore, MD,April 1983.Palmer, F,, U.S. Veterans Administration Mar-keting Center, Hines, IL, personal communica-tion, May 1983.Pauly, M., Doctors and Their Workshops: Eco-nomic Models of Physician Behavior (Chicago:University of Chicago Press, 1980).Pavliscak, M., U.S. Department of Commerce,Washington, DC, personal communication,June 1984.Peter Barnard Associates, “International Mar-ket Research Survey of the Canadian Market forMedical Equipment,” prepared for the U.S. De-partment of Commerce, July 1983.Pharmaceutical Affairs Law, Aug. 10, 1950, asamended.Pharmaceutical Affairs Law, No. 145, 1960.Pharmaceutical Manufacturers Association,Medical Dew”ces and Diagnostic Products Indus-try: A Profile, Washington, DC: March 1982.Phillips, L., National Research Director, Para-lyzed Veterans of America, Washington, DC,personal communication, June 1983.Pierce, A. K., “Scientific Basis of In-HospitalRespiratory Therapy,” Am. Rev. Resp. Dis.122(5 ):1-2 (pt. 2), November 1980.Policy Analysis, Inc., “Evaluation of the Effectsof Certificate of Need Programs, ” Volume III:Analytic Reports, contract report prepared forthe Bureau of Health Planning and ResourcesDevelopment, Health Resources Administra-tion, Department of Health and Human Serv-ices, contract No. 231-77-0114 (Brookline, MA:Policy Analysis, Inc., August 1980. )Pontoppidian, H., “Mechanical Aids to LungExpansion in Non-intubated Surgical Patients, ”Am. Rev. Resp. Dis. 122(5): 11-13 (pt. 2), No-vember 1980.Porges, A., Assistant General Counsel, Officeof the U.S. Trade Representative, personalcommunication, Dec. 14, 1983.Powell, R. S., Program Director, Diagnostic Im-aging Research Branch, National Cancer Insti-tute, National Institutes of Health, Bethesda,MD, personal communication, July 29, 1983.Predicasts Forecasts, No. 91, Apr. 22, 1983.

25-406 0 - 84 - 17

246 ● Federal Policies and the Medical Devices Industry

252,

253.

254.

255.

256.

257.

258.

259.

260.

261.

262.

263.

264.

265.

Public Citizen Health Research Group, “Com-ments of Public Citizen Health Research Groupon FDA’s Proposed Classification of Generaland Plastic Surgery Medical Devices, ” Washing-ton, DC, June 21, 1982.Public Citizen Health Research Group, petitionto the National Center For Devices and Radio-logical Health, Food and Drug Administration,to call for safety and effectiveness data on 16devices used in obstetrics and gynecology,Washington, DC, Mar. 2, 1983.Radiation Emitting Devices Act and Regula-tions, as amended, Nov. 8, 1977.“Regulations Respecting Medical Devices,” P.C.1975-2031, Aug. 27, 1975, as amended.Rettig, R. A., “End-Stage Renal Disease and the‘Cost’ of Medical Technology,” in Medical Tech-nology: The Culprit Behind Health Care Costs?S. Altman and R. Blendon (eds. ) (Washington,DC: U.S. Department of Health, Education, andWelfare, 1979).Reynolds, C., U.S. Department of Health andHuman Services, Food and Drug Administra-tion, Silver Spring, MD, personal communica-tion, February 1984.Robb, W. L., Vice-President and General Man-ager, General Electric Co., Medical SystemsOperations, Milwaukee, WI, personal comm-unication, October 1982.Roberts, E. B., et al. (eds. ), Biomedical Innova-tion (Cambridge, MA: The Massachusetts Insti-tute of Technology Press, 1981).Romeo, A. A., “The Hemodialysis Equipmentand Disposable Industry, ” contract report pre-pared for the Office of Technology Assessment,U.S. Congress, February 1984 (revised draft).Romeo, A. A., “Interindustry and Interfirrn Dif-ferences in the Rate of Diffusion of an Innova-tion, ” Rev. Econ. Stat. 57:311, August 1975, ascited in (274).Rosenbloom, R. S., “Technological Innovationin Firms and Industries: An Assessment of theState of the Art,” in Technological Innovation:A Critical Review of Current Knowledger P.Kelly and M. Kranzberg (eds. ) (San Francisco:San Francisco Press, 1978).Rothwell, R., “Marketing a Success Factor in In-dustrial Innovation,” Mgt. Decision 14(1):43,1976.Rothwell, R., “Some Indirect Impacts of Gov-ernment Regulation on Industrial Innovation inthe United States, ” Technological Forecastingand Social Change, Elsevier North Holland,Inc., 19:57-80, 1981.Russell, L. B., “The Diffusion of Hospital Tech-

266.

267.

268.

269.

270,

271.

272.

273.

274.

275.

276.

277.

278.

nologies: Some Econometric Evidence,” J. Hu-man Resources 12:482-502, fall 1977.Russell, L. B., Technology in Hospitals: Medi-cal Advances and Their Diffusion (Washington,DC: The Brookings Institution, 1979).Safir, A., “How Ophthalmology Changed Dur-ing My Career, ” paper prepared for the Officeof Technology Assessment, U.S. Congress,Washington, DC, 1983.Sahal, D., Patterns of Technological .lknovation(Reading, MA: Addison-Wesley, 1981).Salans, L. B., Acting Director, National Insti-tute of Arthritis, Diabetes, and Digestive andKidney Diseases, National Institutes of Health,testimony at hearing, The End Stage Renal Dis-ease Program (Part 2-Treatment Standards andMethods), before the Subcommittee on Govern-ment Operations, House of Representatives,Apr. 28, 1982 (Washington, DC: U.S. Govern-ment Printing Office, 1982).Salkever, D. S., and Bice, T. W., “The Impactof Certificate-of-Need Controls on Hospital In-vestment,” MiZbank Mere. Fund Q. 54(2):185-214, spring 1976.Sanford C. Bernstein & Co., Inc., The KidneyDialysis Industry, New York, February 1981.Scheffler, R. M., and Delaney, M., “AssessingSelected Respiratory Therapy Modalities: Trendsand Relative Costs in the Washington, DCArea,” in The Implications of Cost-EffectivenessAnalysis of Medical Technology/BackgroundPaper #12:Case Studies of Medical Technol-ogies, prepared for the Office of TechnologyAssessment, U.S. Congress (Washington, DC:U.S. Government Printing Office, April 1981).Scherer, F. M., “Demand-Pull and Technologi-cal Invention—Schmookler Revisited, ”J. I.ndus-tria] Econ. 30(3):225-237, March 1982.Scherer, F. M., Industrial Market Structure andEconomic Performance, 2d ed. (Chicago: RandMcNally College Publishing Co., 1980).Schifrin, L. G., and Rich, W. J., “The ContactLens Industry: Structure, Competition, andPublic Policy,” contract report prepared for theOffice of Technology Assessment, U.S. Con-gress, Washington, DC, 1983 (draft).Schmookler, J., Invention and Economic Growth(Cambridge, MA: Harvard University Press,1966).Schroeder, S., and Showstack, J. A., “FinancialIncentives to Perform Medical Procedures andLaboratory Tests: Illustrative Models of OfficePractice,” Medical Care 16(4):289-298, April1978.Schwartz, S., American College of Physicians,

References ● 247

279.

280.

281.

282.

283.

284.

285.

286.

287.

288.

289.

290.

291.

292.

Philadelphia, PA, personal communication, July18, 1983.Scitovsky, A. A., and McCall, N., “Coinsur-ance and the Demand for Physician ServicesFour Years Later,” Soc. Sec. Bull. 40:19, May1977.Shapley, W. H., Teich, A. H., and Weinberg,J. P., AAAS Report VIII: Research and Devel-opment, FY 1984, a report prepared for the Ex-ecutive Officer and the AAAS Committee onScience, Engineering, and Public Policy (Wash-ington, DC: American Association for the Ad-vancement of Science, 1983).Shepard, D. S., Associate Professor, HarvardSchool of Public Health, Center for the Analy-sis of Health Practices, Boston, MA, personalcommunication, Apr. 30, 1984.Shepard, D. S., and Karen, S. L., The Marketfor Wheelchairs: Innovations and Federal Pol-icy, contract report prepared for the Office ofTechnology Assessment, U.S. Congress, Wash-ington, DC, 1984 (forthcoming).Shils, M. E., “Registry of Patients on HPN,” inHome Parenteral Nutrition (symposium pro-ceedings, American Society for Parenteral andEnteral Nutrition), pp. 42-44, Washington, DC,1980.Sholer, J., Abbott Laboratories, Chicago, IL,personal communication, Oct. 6, 1983.Showstack, J. A., Blumberg, B. D., Schwartz,J., et al., “Fee-for-Service Physician Payment:Analysis of Current Methods and Their Devel-opment,” Inquiry 16(3):230, fall 1979.Sira Institute Ltd., “Report on Medical Equip-ment Study —France, ” vol. 2, prepared for theU.S. Embassy, Kent, England, Mar. 31, 1981.Skalnik, B., “IPPB: A Question of Quality, ”Resp. Ther. 6:81-83, November-December 1976.Sommer, J., Deputy Director, The American Le-gion, Washington, DC, personal communica-tion, July 1983.Stanford University, “Policy on Tangible Re-search Property, ” memo from the Vice Provostand Dean of Graduate Studies and Research tomembers of the Academic Council and membersof the Academic Staff-Research, Mar. 16, 1982.Steiger, E., The Cleveland Clinic, Cleveland,OH, personal communication, April 1984.Steinberg, E. P., and Cohen, A. B., “NuclearMagnetic Resonance Imaging Technology: AClinical, Industrial and Policy Analysis,” con-tract report prepared for the Office of Tech-nology Assessment, U.S. Congress, Washing-ton, DC, 1984.Stevenson, G. L., “FEC Acceptancef Growth,

293.

294.

295.

295a

296.

297.

298.

299.

300.

301.

302.

303.304.305.306.307.308.309.

310.

311.312.

313.

Cost Benefits Confirmed,” Emergence, June 1983(special issue).Stewardson, J. D., Regulatory Standards Ad-ministrator, Cobe Laboratories, Inc., Lakewood,CO, personal communications, Dec. 6 and 13,1983.Sugar-man v. Forbragd, 405 F. 2d 1189 (9th Cir.1968).Swartz, K., Senior Analyst, The Urban Institute,Washington, DC, personal communication,April 1984.Swartz, K., The Urban Institute, “The Chang-ing Face of the Uninsured, ” paper prepared forpresentation at the First Annual Meeting of theAssociation for Health Services Researchers,Panel on “Health Care for the Poor in an Eraof Retrenchment, ” Washington, DC, June 11,1984.Swartz, K., “Who Has Been Without Health In-surance? Changes Between 1963 and 1979, ” Ur-ban Institute working paper (Washington, DC:The Urban Institute, April 1984).Swift, C., National Cancer Institute, Bethesda,MD, personal communication, Apr. 12, 1984.Thompson, F., Health Policy and the Bureau-cracy: Politics and Implementation (Cambridge,MA: The Massachusetts Institute of TechnologyPress, 1983).Traub, J., National Institute for HandicappedResearch, Washington, DC, personal commu-nication, February 1984.Travers, P., U.S. Congress, General Account-ing Office, Washington, DC, personal commu-nication, April 1984.Turner, R., Mexico Desk Officer, Office ofTrade Administration, U.S. Department ofCommerce, Washington, DC, personal commu-nication, Aug. 30, 1983.United States v. An Article of Drug . . . Bacto-unidisk, 394 U.S. 784 (1969).U. S., Federal Register 41:22620, June 4, 1976.U. S., Federal Register 44:53577, Sept. 14, 1979.U. S., Federal Register 45:65619, Oct. 3, 1980.U. S., Federal Register 45:69678, oct. 21, 1980.U. S., Federal Register 45:76183, Nov. 18, 1980.U. S., Federal Register 45:81769, Dec. 12, 1980.U. S., Federal Register 46:57568-69, Nov. 24,1981.U. S., Federal Register 47(189):42906, Sept. 29,1982.U. S., Federal Register 47:2810, Jan. 19, 1982.U. S., Federal Register 47:24332, June 3, 1982(Initiation of Investigation pursuant to 19 U.S.C.$337).LJ. S., Federal Register 47:53402, Nov. 26, 1982.

248 ● Federal Policies and the Medical Devices Industry

314.315.

316.

317.318.319.320.321.322.

323.324.325.

326.

327.

328.

329.

330.

331.

332.

U. S., Federal Register 47:54990, Dec. 7, 1982.U. S., Federal Register 48(2):299-315, Jan. 4,1983.U.Sv Federal Register 48(92~ Mar. 11, 1983,Final Rule, Department of Health and HumanServices, Health Care Financing Administration,42CFR, Part 405.U.SWFederalRegister48:13020, Mar. 29,1983.U.SVFederalRegister48:24014, May27,1983.U.S_ Federal Register 48:25126, June3, 1983.U.SVFederalRegister48:27723, June 17,1983.U.SVFederalRegister48:40272, Sept. 6,1983.U.Sv FederalRegister48:40960r Sept. 12,1983(Institution of Investigation pursuant to 19U.s.c. $337).U.Sv FederalRegister48:56778, Dec. 23,1983.U.SV Federal Register 49:1177, Jan. 10, 1984.U.S. Congress, Congressional Budget Office,The Effect ofPSROsonHealth CareCosts: Cur-rent FindingsandFuture Evaluations (Washing-ton, DC: U.S. Government Printing Office, June1979).U.S. Congress, Congressional Budget Office,The Impact of PSROS on Health Care Costs:Update of CBO’S 1979 Evaluation (Washington,DC: U.S. Government Printing Office, January1981).U.S. Congress, Congressional Budget Office,Veterans Administration Health Care: Planningfor 1990, Washington, DC, February 1983.U.S. Congress, Congressional Research Service,Medical Devices: A Brief Review of Legislationand Issues Related to Regulation (Washington,DC: U.S. Government Printing Office, 1974).U.S. Congress, General Accounting Office,“Centers for Disease Control Should Discon-tinue Certain Diagnostic Tests and Charge forOthers,” report No. 83-37, Washington, DC,Apr. 16, 1983.U.S. Congress, General Accounting Office,Computed Tomographic Scanners: Opportunityfor Coordinated Federal Planning Before Sub-stantial Acquisitions, Report No. HRD-78-41,Washington, DC, January 1978.U.S. Congress, General Accounting Office, Fed-eral Regulation of Medical Devices—ProblemsStill To Be Overcome, GAO/1-iRD-83-53 (Gai-thersburg, MD: General Accounting Office,September 1983).U.S. Congress, General Accounting Office, Hu-man Resources Division, “VA Needs To Im-prove Its Quality Assurance Program for Med-ical Supply and Equipment Items” (PLRD-82-44)

333.

334.

335.

336.

338.

338.

339.

340.

341.

342.

unpublished memorandum report, Washington,DC, February 1982.U.S. Congress, General Accounting Office,Medicare Payments for Durable Medical Equip-ment Are Higher Than Necessary, ComptrollerGeneral’s Report to the Congress, GAO/HRD-82-61, Washington, DC, July 1982.U.S. Congress, General Accounting Office,Problems With Evaluating the Cost Effectivenessof Professional Standards Review Organization(Washington, DC: U.S. Government PrintingOffice, July 19, 1979).U.S. Congress, General Accounting Office, VANeeds Better Visibility Over Medical CenterPurchases, report No. PSAD 81-16, Washing-ton, DC, December 1980.U.S. Congress, House Committee on Energyand Commerce, FDA Oversight: Medical De-vices, hearings before the Subcommittee onOversight and Investigations, July 16, 1982,serial No. 97-144 (Washington, DC: U.S. Gov-ernment Printing Office, 1982).U.S. Congress, House Committee on Energyand Commerce, Subcommittee on Health andthe Environment, “Oversight Hearing on theMedical Device Amendments of 1976, ” Wash-ington, DC, Feb. 24, 1984.U.S. Congress, House Committee on Energyand Commerce, Subcommittee on Oversightand Investigations, Medical Device Regulation;The FDA’s Neglected Child, An Oversight Re-port on FDA Implementation of the Medical De-vice Amendments of 1976, Committee Print 98-F(Washington, DC: U.S. U.S. Government Print-ing Office, May 1983).U.S. Congress, House Committee on Interstateand Foreign Commerce, Medical Devices, hear-ings before the Subcommittee on Public Healthand the Environment, Oct. 23-24, 1973, serialNo. 93-61 (Washington, DC: U.S. GovernmentPrinting Office, 1973).U.S. Congress, House of Representatives, TheMedical Device Amendments of 1976, 94thCong., 2d sess., 1976, House Report No. 94-853(Washington, DC: U.S. Government PrintingOffice, 1976).[J. S. Congress, Office of Technology Assess-ment, Diagnosis Related Groups (DRGs) andMedicare Program: Implications for MedicalTechnology—A Technical Memorandum, GPOstock No. 052-003-00919-6 (Washington, DC:U.S. Government Printing Office, July 1983).U.S. Congressr Office of Technology Assess-

References ● 249

343.

344.

345.

346.

347.

348.

349.

350.

351.

352.

353.

ment, The Impact of Randomized Clinical Trialson Health Policy and Medical Practice—Back-ground Paper, GPO stock No. 052-003-00924-2 (Washington, DC: U.S. Government PrintingOffice, 1983).U.S. Congress, Office of Technology Assess-ment, The Implications of Cost-EffectivenessAnalysis of Medical Technology, GPO stockNo. 052-003-00765-7 (Washington, DC: U.S.Government Printing Office, August 1980).U.S. Congress, Office of Technology Assess-ment, Medical Devices and the Veterans Adminis-tration—A Technical Memorandum, Washing-ton, DC, in press, n.d.U.S. Congress, Office of Technology Assess-ment, Medical Technology and Costs of theMedicare Program, GPO stock No. 052-003-00957-9 (Washington, DC: U.S. GovernmentPrinting Office, July 1984).U.S. Congress, Office of Technology Assess-ment, Medical Technology Under Proposals Toincrease Competition in Health Care, GPOstock No. 052-003-00892-1 (Washington, DC:U.S. Government Printing Office, 1982).U.S. Congress, Office of Technology Assess-ment, Patents and the Commercialization ofNew Technology (Washington, DC: U.S. Gov-ernment Printing office, 1984 (in press)).U.S. Congress, Office of Technology Assess-ment, Policy Implications of the Computed To-mography (CT) Scanner, GPO stock No. 052-003-00565-4, (Washington, DC: U.S. Govern-ment Printing Office, August 1978).U.S. Congress, Office of Technology Assess-ment, PoZicy Implications of the Computed To-mography (CT) Scanner: An Update, GPOstock No. 052-003-00793-2 (Washington, DC:U.S. Government Printing Office, January1981).U.S. Congress, Office of Technology Assess-ment, The Safety, Efficacy, and Cost Effective-ness of Therapeutic Apheresis, GPO stock No.003-052-00918-8 (Washington, DC: U.S. Gov-ernment Printing Office, 1983).U.S. Congress, Office of Technology Assess-ment, Strategies for Medical Technology Assess-ment, GPO stock No. 052-003-00887-4 (Wash-ington, DC: U.S. Government Printing Office,1982).U.S. Congress, Office of Technology Assess-ment, Technology and Handicapped People,GPO stock No. 052-003-00874-2 (Washington,DC: U.S. Government Printing Office, 1982).U.S. Congress, Office of Technology Assess-ment, Technology, Innovation, and Regional

354,

355.

356.

357.

358.

359.

360.

361.

362.

363.

Economic Development: Census of State Gov-ernment Initiatives for High-Technology Indus-trial Development— Background Paper, GPOstock No. 052-003-00912-9 (Washington, DC:U.S. Government Printing Office, May 1983).U.S. Congress, Office of Technology Assess-ment, Technology, Innovation, and RegionalEconomic Development: Encouraging High-Technology Development—Background Paper#2, GPO stock No. 052-003-00942-1 (Washing-ton, DC: U.S. Government Printing Office,February 1984).U.S. Congress, Senate, CZinical Laboratory Irn-provement Act of 1977, S. Report No. 95-360,95th Cong., Ist sess. (Washington, DC: U.S.Government Printing Office, 1977).U.S. Congress, Senate Committee on Finance,End-Stage Renal Disease (ESRD) Program UnderMedicare, Committee Print 97-9, September1981 (Washington, DC: U.S. Government Print-ing Office, 1982).U.S. Constitution, Article 1, Section 8, Clause8 (the patent clause of the Constitution).U.S. Council of Economic Advisers, EconomicReport of the President and the Annual Reportof the Council of Economic Advisers (Washing-ton, DC: U.S. Government Printing Office, Feb-ruary 1983).U.S. Department of Agriculture, Department ofCommerce, Department of State, and Office ofthe U.S. Trade Representative, Report to theUnited States Congress on the Agreement onTechnical Barriers to Trade—’’Standards Code”(Washington, DC: U.S. Government PrintingOffice, 1983).U.S. Department of Commerce, Bureau of theCensus, 1963 Census of Manufactures, Indus-try Series, MC63-I-36E and MC63-I-38A (Wash-ington, DC: U.S. Government Printing Office,1966).U.S. Department of Commerce, Bureau of theCensus, 1972 Census of Manufactures, Indus-try Series, NIC72-I-36E and MC72-I-38B (Wash-ington, DC: U.S. Government Printing Office,1976).U.S. Department of Commerce, Bureau of theCensus, 1977 Census of Manufactures, Indus-try Series, MC77-I-38B and MC77-I-36F (Wash-ington, DC: U.S. Government Printing Office,June 1980).U.S. Department of Commerce, Bureau of theCensus, 1977 Census of Manufactures, GeneralSummary, Subject Series, MC77-SR-1 (Wash-ington, DC: U.S. Government Printing Office,April 1981).

250 • Federal Policies and the Medical Devices Industry

364.

365.

366.

367.

368.

369.

370.

371.

372.

373.

374.

U.S. Department of Commerce, Bureau of theCensus, 1982 Census of Manufactures, Prelimi-nary Report Industry Series, MC82-I-36F-3(P),MC82-I-38B-l(P), MC82-I-38B-2(P), MC82-I-38B-3(P), MC82-I-38B-4(P) (Washington, DC:U.S. Government Printing Office, 1984).U.S. Department of Commerce, Bureau of theCensus, 1979 Annual Survey of Manufactures,Value of Product Shipments, M79(AS)-2 (Wash-ington, DC: U.S. Government Printing Office,October 1981).U.S. Department of Commerce, Bureau of theCensus, Annual Survey of Manufactures, Sta-tistics for Industry Groups and Industries, foryears 1958, 1963, 1972, 1977 and 1981.U.S. Department of Commerce, Bureau of theCensus, Statistical Abstract of the United States:1982-83 (103d cd.) Washington, DC, 1982.U.S. Department of Commerce, Bureau of In-dustrial Economics, 1983 U.S. Industrial Out-look (Washington, DC: U.S. Government Print-ing Office, January 1983).U.S. Department of Commerce, Bureau of In-dustrial Economics, 1984 U.S. Industrial Out-look (Washington, DC: U.S. Government Print-ing Office, January 1984).U.S. Department of Commerce, Bureau ofIndustrial Economics, Capital, Energy, andProductivity Studies Division, Washington, DC,unpublished data, January 1984.U.S. Department of Commerce, Bureau ofIndustrial Economics, Office of Producer Goods,Science and Electronics Division, “United StatesExports of Selected Commodities by Country,January-December 1981,” unpublished, Wash-ington, DC, Mar. 5, 1982.U.S. Department of Commerce, Bureau of In-dustrial Economics, Office of Producer Goods,Science and Electronics Division, “United StatesExports of Selected Commodities by Country,January-September 1982,” unpublished, Wash-ington, DC, Nov. 23, 1982.U.S. Department of Commerce, Bureau of In-dustrial Economics, Office of Producer Goods,Science and Electronics Division, “United StatesImports of Selected Commodities by Country,January-December 1981,” unpublished, Wash-ington, DC, Mar. 5, 1982.U.S. Department of Commerce, Bureau of In-dustrial Economics, Office of Producer Goods,Science and Electronics Division, “United StatesImports of Selected Commodities by Country,January-September 1982,” unpublished, Wash-ington, DC, Nov. 26, 1982.

375.

376.

377.

378.

379.

380.

381.

382.

383.

384.

385.

386.

387.

388.

U.S. Department of Commerce, Bureau of In-dustrial Economics, Office of Research, Analy-sis, and Statistics, Washington, DC, unpub-lished data, 1984.U.S. Department of Commerce, InternationalTrade Administration, Countryman..et Survey:Medical Equipment France, CMS 78-010, Wash-ington, DC, June 1978.U.S. Department of Commerce, InternationalTrade Administration, Country Market Survey:Medical Equipment Germany, CMS 82-516,Washington, DC, February 1982.U.S. Department of Commerce, InternationalTrade Administration, Country Market Survey:Medical Equipment Mexico, CMS 79-004, Wash-ington, DC, February 1979.U.S. Department of Commerce, InternationalTrade Administration, Technical Barriers toTrade, vol. 4 (Washington, DC: U.S. Govern-ment Printing Office, 1981).U.S. Department of Commerce, InternationalTrade Administration, The Tokyo Round TradeAgreements Technical Barriers to Trade, vol. 4(Washington, DC: U.S. Government PrintingOffice, September 1981).U.S. Department of Commerce, Patent andTrademark Office, Office of Patent Programand Documentation Control, unpublished data,Washington, DC, February 1984.U.S. Department of Commerce, Patent andTrademark Office, Office of Technology Assess-ment and Forecast, “OTAF Custom Report, AllTechnologies Report, January 1963-June 1983”(mimeo), Washington, DC, 1983.U.S. Department of Commerce, Patent andTrademark Office, Washington, DC, unpub-lished data, 1984.U.S. Department of Health and Human Serv-ices, Food and Drug Administration, FDA Com-pliance Policy Guide No. 715Sg.03, Silver Spring,MD, Oct. 1, 1980.U.S. Department of Health and Human Serv-ices, Food and Drug Administration, unpub-lished data, Silver Spring, MD, 1983.U.S. Department of Health and Human Serv-ices, Bureau of Medical Devices Standards Sur-vey 1982, International Edition (Washington,DC: U.S. Government Printing Office, 1982).U.S. Department of Health and Human Serv-ices, Food and Drug Administration, Bureau ofMedical Devices, “Policy for Class II MedicalDevices,” unpublished internal draft, SilverSpring, MD, August 1982.U.S. Department of Health and Human Serv-

References ● 251

389.

390.

391.

392,

393.

394.

395.

396.

397.

ices, Food and Drug Administration, Bureau ofMedical Devices, Product Development Pro-tocol Guideline, Silver Spring, MD, 1980.U.S. Department of Health and Human Serv-ices, Food and Drug Administration, Bureau ofMedical Devices, Regulatory Requirements forMarketing a Device (Washington, DC: U.S.Government Printing Office, 1982).U.S. Department of Health and Human Serv-ices, Food and Drug Administration, Office ofEconomic Analysis, compilation of unpublisheddata from the U.S. Patent and Trademark Of-fice, Washington, DC, December 1983.U.S. Department of Health and Human Serv-ices, Food and Drug Administration, Office ofPlanning and Evaluation, Baseline Zlata on theAvailability of Medical Devices and In-VitroDiagnostic Products, OPE Study 54 (Rockville,MD: Food and Drug Administration, Office ofPlanning and Evaluation, July 1980).U.S. Department of Health and Human Serv-ices, Food and Drug Administration, Office ofPlanning and Evaluation, Baseline Data OnMedical Device Establishments, OPE Study 59(Rockville, MD: Food and Drug Administra-tion, Office of Planning and Evaluation, Sep-tember 1981).U.S. Department of Health and Human Serv-ices, Food and Drug Administration, Office ofPlanning and Evaluation, Baseline Data on Med-ical Device Industries in the Census of Manu-factures, OPE Study 53 (Rockville, MD: Foodand Drug Administration, Office of Planningand Evaluation, July 1980).U.S. Department of Health and Human Serv-ices, Food and Drug Administration, Office ofPlanning and Evaluation, Rockville, MD, un-published data, 1983.U.S. Department of Health and Human Serv-ices, Health Care Financing Administration,1979 PSRO Program Evaluation (Washington,DC: U.S. Government Printing Office, 1980).U.S. Department of Health and Human Serv-ices, Health Care Financing Administration,1981 End-Stage Renal Disease Annual Report toCongress (Washington, DC: U.S. GovernmentPrinting Office, 1981.)U.S. Department of Health and Human Serv-ices, Health Care Financing Administration,“Annual Report to the Congress from the Sec-retary of Health and Human Services on theProfessional Standards Review OrganizationsProgram Fiscal Year 1980,” mimeo, February1981.

398.

399.

400.

401.

402.

403.

404.

405.

406.

407.

408.

409.

U.S. Department of Health and Human Serv-ices, Health Care Financing Administration,“Draft Report of HCFA Task Force on Inde-pendent Laboratories,” Aug. 17, 1983, as citedin Foster, 1984.U.S. Department of Health and Human Serv-ices, Health Care Financing Administration, Of-fice of Research and Demonstrations, Medicare:Use of Home Health Services, 1980, preparedby Kathryn D. Barrett, Baltimore, MD, July1983 (draft).U.S. Department of Health and Human Serv-ices, Health Care Financing Administration,“PSRO Evaluation,” Health Care Financing: Re-search and Demonstrations in Health Care Fi-nancing 1980-1981, HCFA publication No. 03144,Rockville, MD, 1982.U.S. Department of Health and Human Serv-ices, National Institutes of Health, NationalCancer Institute, unpublished data supplied byG. Wilson, Bethesda, MD, December 1983.U.S. Department of Health and Human Serv-ices, National Institutes of Health, NationalHeart, Lung, and Blood Institute, Task Force Re-port on Pulmonary Technology, NIH publica-tion No. 81-2110, Bethesda, MD, July 1981.U.S. Department of Health and Human Serv-ices, National Institutes of Health, National In-stitute for Neurological and Communicable Dis-ease and Stroke, Request for Proposals, “OrphanProducts Development Studies” (RFP #NIH-NINCDS-8407), Bethesda, MD, Jan. 23, 1984.U.S. Department of Health and Human Serv-ices, National Institutes of Health, Office of Pro-gram Planning and Evaluation and the Divisionof Research Grants, N..H Data Book 1983,Washington, DC, June 1983.U.S. Department of Health and Human Serv-ices, Public Health Service, Annual Report:Activities of the Orphan Products Board, March1982-May 1983, Washington, DC, 1983.U.S. Department of Health and Human Serv-ices, Public Health Service, Bureau of HealthMaintenance Organizations and Resources De-velopment, Office of Health Planning, StatusReport on State Certificate of Need Programs,Rockville, MD, March 1983.U.S. Department of Health and Human Serv-ices, Request for Proposal No. HCFA-84-015,Operation of Utilization and Quality ControlPeer Review Organizations, Feb. 28, 1984.U.S. Department of Health and Human Serv-ices, unpublished statistical data, 1983.U.S. Department of Health, Education, and

252 • Federal Policies and the Medical Devices Industry

410.

411.

412.

413.

414.

415.

416.

417.

418.

419.

420,

421.

Welfare, Health Care Financing Administration,Professional Standards Review Organization1978 Program Evaluation, HEW publication No.HCFA-03000, Washington, DC, January 1979.U.S. Department of Health, Education, andWelfare, National Institutes of Health, AntenataZDiagnosis, NIH publication No. 79-1973, Be-thesda, MD, April 1979.U.S. Department of Health, Education, andWelfare, Public Health Service, PSRO: An Ini-tial Evaluation of the Professional Standards Re-view Organization, “Vol. 1: Executive Sum-mary,” Washington, DC, February 1978.U.S. Department of Health, Education and Wel-fare, et al., Rehabilitation Engineering: A Planfor Continued Progress (Charlottesville, VA:Rehabilitation Engineering Center, University ofVirginia, 1978),U.S. Department of Health, Education, andWelfare, Public Health Service, Report of thePresident’s Biomedical Research Panel, “Appen-dix A: The Place of Biomedical Science in Medi-cine and the State of Science, ” DHEW publica-tion No. (OS) 76-501, Washington, DC, Apr. 30,1976.U.S. Department of the Treasury, Internal Rev-enue Service, A General Descn”ption of the Cor-poration Sourcebook, publication 647 (Wash-ington, DC, U.S. Government Printing Office,revised June 1983).U.S. Department of the Treasury, Internal Rev-enue Service, Corporation Income Tax Returns,Statistics of Income, for years 1963,1967,1972,1977 and 1980, Washington, DC, U.S. Govern-ment Printing Office.U.S. Department of the Treasury, Internal Rev-enue Service, Sourcebook of Statistics of In-come, for years 1963, 1967, 1977, and 1980,Washington, DC, U.S. Government PrintingOffice.U.S. Department of the Treasury, Internal Rev-enue Service, Sourcebook of Statistics of In-come, for years 1976-80, as cited in (26).U.S. Department of the Treasury, Office of TaxAnalysis, unpublished data, Washington, DC,1983.U.S. Executive Office of the President, Officeof the U.S. Trade Representative, A Preface toTrade (Washington, DC: U.S. GovernmentPrinting Office, 1982).U.S. Executive Office of the President, Officeof the U.S. Trade Representative, “Status ofTokyo Round MTN Agreement Signatures andAcceptances, ” Nov. 1, 1983.U.S. National Science Foundation, Federal

422.

423.

424.

425.

426.

427.

428.

429.

430.

431.

432.

433.

434.

435.

Funds for Research and Development: FiscalYears 1980,1981, and 1982, NSF 81-325 (Wash-ington, DC: NSF, 1981).U.S. National Science Foundation, NationalPatterns of Science and Technology Resources,1982, NSF 82-319, Washington, DC, 1982.U.S. National Science Foundation, Research andDevelopment in Industry, 1979, detailed statis-tical tables, NSF 81-324, Washington, DC, 1981.U.S. NTational Science Foundation, “Survey ofIndustrial Research and Development, ” con-ducted by the U.S. Bureau of the Census, Wash-ington, DC, 1982.U.S. Small Business Administration, The Stateof Small Business: A Report to the President(Washington, DC: U.S. Government PrintingOffice, 1984).U.S. Veterans Administration, 1982 Annual Re-port, Washington, DC, 1983.U.S. Veterans Administration, Assistant Inspec-tor General for Auditing, “Report of Audit: Pro-curement and Monitoring of Pacemakers, ” Proj-ect No. 101A-79-42, Washington, DC, Feb. 13,1980.U.S. Veterans Administration, Brief of Officeof Procurement and Supply, unpublished, Wash-ington, DC, December 1982.U.S. Veterans Administration, Department ofMedicine and Surgery, “Chief Medical Director’sPreface to Strategic Outlook,” draft 5, version2, Washington, DC, May 1983.U.S. Veterans Administration, Department ofMedicine and Surgery, letter to Honorable AlanK. Simpson, Chairman, Senate Committee onVeterans Affairs, concerning the VA Rehabilita-tion Engineering Center (VAREC), Washington,DC, May 12, 1983.U.S. Veterans Administration, Department ofMedicine and Surgery, Veterans AdministrationProsthetic and Sensory Aids Program SinceWorld War 11 (Washington, DC: U.S. Govern-ment Printing Office, 1977).U.S. Veterans Administration, Medical DistrictInitiated Program Planning: Guidance for thePreparation of Medical District Plans, vol. 1,Washington, DC, June 1983.U.S. Veterans Administration, Office of Plan-ning and Program Evaluation, RehabilitativeEngineering Research and Development Pro-gram Evaluation, Washington, DC, August1981.U.S. Veterans Administration, Office Of Pro-curement and Supply, “Evaluation of New Prod-ucts,” Washington, DC, January 1983.U.S. Veterans Administration, Rehabilitation

References • 253

436.

437.

438.

439.

440.

441.

442.

443.

444.

445.

446.

447.

448.

Research and Development Service, “Develop-ment and Evaluation Program, ” Washington,DC, 1983.Urban Systems Research and Engineering, andPolicy Analysis, Inc., Certificate of Need Pro-grams: A Rev.z”ew, Analysis, and Annotated Bib-liography of the Research Literature, preparedunder contract No. HRA-231-77-0114 for theDepartment of Health, Education, and Welfare,publication No. (HRA) 79-14006 (Washington,DC: U.S. Government Printing Office, Novem-ber 1978).Utterback, J. M., “Innovation in Industry andthe Diffusion of Technology,” Science 183:620-626, Feb. 15, 1974.Utterback, J. M., and Abernathy, W. J., “A Dy-namic Model of Process and Product Innova-tion,” Omega 3:639-656, 1975, as cited in (259).“VA Prosthetics . . . Some Recommendations,”DAV Magazine 24(8):8-9, August 1982.Venture Capital Journal, “Capital Transfusion1982,” 23(1):6, January 1983.Venture Capital Journal, “Evolution of an In-dustry: Venture Capital Redefined for the 1980’s,”January 1980.Venture Capital Journal, “Venture Capital Dis-bursements 1981: A Statistical Overview, ” 22(6):7, June 1982.Venture Economics, Wellesley Hills, MA, “Ven-ture Capital Investment in the Medical HealthCare Field,” contract report prepared for the Of-fice of Technology Assessment, U.S. Congress,Washington, DC, August 1983.Vlassembrouck, J. M., Surgical Products Divi-sion, 3M, Minneapolis, MN, personal commu-nication, Dec. 21, 1983.Von Hippel, E., “Appropriability of InnovationBenefit as a Predictor of Functional Locus of In-notation, ” unpublished, MIT Sloan School ofManagement, Cambridge, MA, 1979, as citedin (259).Von Hippel, E., “A Review of Data Bearing onthe User’s Role in Industrial Innovation,” unpub-lished, MIT Sloan School of Management, Cam-bridge, MA, 1978, as cited in (259).Wagner, J., “The Economic Evaluation of Medi-cine: A Review of the Literature, ” prepared forthe Pharmaceutical Manufacturers of America,mimeo, Oct. 1, 1982.Wagner, J. L., et al., Final Report: A Study ofthe Impact of Reimbursement Strategies on theDiffusion of Medical Technologies, Vol. II: Ap-pendices, report submitted to the Health CareFinancing Administration, HCFA/HHS grant #

449.

450.

451.

452.

453.

454.

455.

456.

457.

458.

459.

460.

461.

462,

18-p-97113/3-01 (Washington, DC: The UrbanInstitute, 1982).Wagner, L., Program Analyst, Office of the Di-rector, National Institutes of Health, Bethesda,MD, personal communication, Dec. 30, 1983.Warner, K. E., “Effects of Hospital Cost Con-tainment on the Development and Use of Med-ical Technology, ” Milbank Mere. Fund Q.56(2):187-211, 1978.Washington Report on Medicine and Health37(39):4, Oct. 3, 1983.Washington Report on Medicine and Health38(9):1, Feb. 27, 1984.Washington Report on Medicine and Health,“Perspectives: Health Planning Looks to the Fu-ture,” 37(48), Dec. 5, 1983,Weinstein, M. C., and Stason, W. B., “Cost-Ef-fectiveness of Coronary Artery Bypass Sur-gery,” Circulation 66(5) Part II, AHA Mono-graph No. 92, Technology Assessment Forumon Coronary Artery Bypass Surgery: Economic,Ethical and Social Issues, November 1982.Westphal, M., Frazier, E., and Miller, M. C.,“Changes in Average Length of Stay and Aver-age Charges Generated Following Institution ofPSRO Review,” Health Services Research 14(4):253-265, winter 1979.Williams, K., Health Insurance Association ofAmerica, Washington, DC, personal communi-cation, December 1982,Willingmyre, G. T., Reuse of Single-Use Hemo-dialyzers (Washington, DC: Health IndustryManufacturers Association, 1979).Willingmyre, G. T., Vice President for Techni-cal Affairs, Health Industry ManufacturersAssociation, comments made at meeting, Nov.28, 1983.Wilson, et al., “Intermittent Positive PressureBreathing,” Calif. Med. 87:161, 1957.Wilson, G. H., Special Assistant for Diagnos-tic Imaging Research, National Cancer Institute,National Institutes of Health, Bethesda, MD,personal communications, June 24, 1983 andSeptember 1983.Wineman, R., memorandum to file, re summaryof meeting concerning end-stage renal diseaseissue, Jan. 21, 1980, reprinted in The End StageRenal Disease Program (Part 2-Treatment Stand-ards and Methods, Hearing before Subcommit-tee of the Committee on Government Opera-tions, House of Representatives, Apr. 28, 1980(Washington, DC: U.S. Government PrintingOffice, 1982).Wisconsin Hospital Association, Report on

254 ● Federal Policies and the Medical Devices Industry

463.

464.

465.

WHA’S Evaluation of the Wisconsin Certificateof N4Program, July 23, 1982 (working draft).Wishinsky, H., Vice President, Scientific andRegulatory Affairs, Professional Products Group,Miles Laboratories, Inc., Elkhart, IN, personalcommunication, Dec. 14, 1983.Witt, A., U.S. Department of Health and Hu-man Services, Food and Drug Administration,Office of General Counsel, Food and Drug Divi-sion, personal communication, April 1984.Wright, D., U.S. Veterans Administration,Rehabilitation Engineering Center, New York,NY, personal communication, June 1983.

466. Zakupowsky, A., and Sunley, E., “An EarlyAssessment of the Capital Cost Recovery Sys-tem for R&D Equipment Provided by the Eco-nomic Recovery Tax Act of 1981, ” working pa-per prepared for the National Science Foundation,Washington, DC, September 1982.

467. Ziment, I., “Intermittent Positive PressureBreathing,” Respiratory Care, G. Burton, G.Gee, and J. Hodgkin (eds.) (Philadelphia: J. B.Lippincott, 1977).