Hostname: page-component-cd9895bd7-lnqnp Total loading time: 0 Render date: 2024-12-25T04:36:59.887Z Has data issue: false hasContentIssue false

Developing and Assessing an Implantable Insulin Infusion Pump: Interactions of University, Industry, and Government

Published online by Cambridge University Press:  10 March 2009

Christopher D. Saudek
Affiliation:
The Johns Hopkins University

Extract

The validity of technology assessment may depend largely upon who performs the job, and when they get involved. The options are many. Industry may hire a small private laboratory to perform animal trials on a completed device or drug; manufacturers may support their own in-house laboratories or even study beds; industry may contract with hospitals or private medical groups to evaluate a potential product. It is the thesis of this discussion that there is a different option which brings together the strengths of three often stubbornly independent institutions: industry, university-based investigators, and federal science granting agencies.

Type
Special Section: Transplantation and Artificial Organs
Copyright
Copyright © Cambridge University Press 1986

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1.Alejandro, R., Cutfield, R., Shienvold, F. L., Latif, Z., & Mintz, D. H.Successful long-term survival of pancreatic islet allografts in spontaneous or pancreatectomy-induced diabetes in dogs. Diabetes, 1985, 34, 825–28.CrossRefGoogle ScholarPubMed
2.Araki, Y., Solomon, B. A., Basile, R. M., & Chick, W. L.Biohybrid artificial pancreas: Long-term insulin secretion by devices seeded with canine islets. Diabetes, 1985, 34, 850–54.CrossRefGoogle ScholarPubMed
3.Blackshear, P. J., Shulman, G. I., Roussell, A. M., Nathan, D. M., Minaker, K. L., Rowe, J. W., Robbins, D. C., & Cohen, A. M.Metabolic response to three years of continuous, basal rate intravenous insulin infusion in Type II diabetic patients. Journal Clin Endocrinology and Metabolism, 1985, 61, 753760.CrossRefGoogle ScholarPubMed
4.Blackshear, P. J., Rohde, T. D., Prosl, F., & Buchwald, H.The implantable infusion pump: A new concept in drug delivery. Medical Progress through Technology, 1979, 6, 149–61.Google ScholarPubMed
5.Brownlee, M. & Cerami, A.Glycosylated insulin complexed to concanavalin A: Biochemical basis for a closed-loop insulin delivery system. Diabetes, 1983, 32, 499504.CrossRefGoogle ScholarPubMed
6.Buchwald, H. & Rohde, T. D.Implantable infusion pumps. Chicago, IL: Year Book Medical Publishers, Inc., 1984.Google ScholarPubMed
7.Conant, J. B.Science and common sense. New Haven, CT: Yale University Press, 1951.Google Scholar
8.Diabetes in America: Diabetes data compiled 1984, NIH Publication No. 85–1468, Washington, DC: U.S. Department of Health and Human Services, 1985.Google Scholar
9.Koenig, R., Peterson, C., Jones, R., Saudek, C., Lehrman, M., & Cerami, A.Correlation of glucose regulation and hemoglobin A1c in diabetes mellitus. New England Journal of Medicine, 1976, 295, 417–20.CrossRefGoogle Scholar
10.Mecklenburg, R. S., Benson, E. A., Benson, J. W. Jr, Blumenstein, B. A., Fredlund, P. N., Guinn, T. S., Metz, R. J., & Nelson, R. L., Long-term metabolic control with insulin pump therapy. New England Journal of Medicine, 1985, 313, 465–88.CrossRefGoogle ScholarPubMed
11.Mecklenburg, R. S., Benson, E. A., Benson, J. W., Fredlund, P. N., Guinn, T., Metz, R. J., Nielsen, R. L., & Sannar, C. A.Acute complications associated with insulin infusion pump therapy: report of experience with 161 patients. Journal of the American Association of Medicine, 1984, 252, 3265–69.CrossRefGoogle ScholarPubMed
12.National Diabetes Data Group, Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes, 1979, 28, 1039–57.CrossRefGoogle Scholar
13.Pfeiffer, E. F.Report of the Third Workshop of the EASD Study Group on Artificial Insulin Delivery Systems, Pancreas and Islet Transplantation (AIDSPIT). Diabetologia, 1984, 27, 607–08.CrossRefGoogle Scholar
14.Rupp, W. M., Barbosa, J. J., Blackshear, P. J., McCarthy, H. B., Rohde, T. D., Goldenberg, F. J., Rublein, T. G., Dorman, F. D. & Buchwald, H.The use of an implantable insulin pump in the treatment of Type II diabetes. New England Journal of Medicine, 1982, 307, 265–70.CrossRefGoogle ScholarPubMed
15.Schade, D. S., Santiago, J. V., Skyler, J. S., & Rizzer, R. A., Intensive insulin therapy. Princeton, NJ: Excerpta Medica, 1983.Google Scholar
16.Scharp, D. W.Transplantation for the diabetic. Diabetes Dateline, 1985, 6, 13.Google Scholar
17.Scharp, D. W. (ed.). World Journal of Surgery, 1984, 8, 135275.CrossRefGoogle Scholar
18.Sun, A. M., Parisius, W., Healy, G. M., Vacek, I., & Macmorine, H. G.The use in diabetic rats and monkeys, of artificial capillary units containing cultured islets of langerhans (artificial endocrine pancreas). Diabetes, 1977, 26, 1136–39.CrossRefGoogle ScholarPubMed
19.Tze, W. J., Wong, F. C., Chen, L. M., & O'Young, S.Implantable artificial endocrine pancreas unit used to restore normoglycemia in the diabetic rat. Nature, 1976, 264, 466–67.CrossRefGoogle Scholar