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Assessment of medical devices: How to conduct comparative technology evaluations of product performance

Published online by Cambridge University Press:  01 October 2007

Lawton R. Burns ,
Eric T. Bradlow ,
J. Andrew Lee  and
Anthony C. Antonacci
Lawton R. Burns
Affiliation:
Wharton School—University of Pennsylvania
Eric T. Bradlow
Affiliation:
Wharton School—University of Pennsylvania
J. Andrew Lee
Affiliation:
Wharton School—University of Pennsylvania
Anthony C. Antonacci
Affiliation:
Cornell University and Christ Hospital
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Abstract

Objectives: U.S. expenditures on medical devices ($70 billion in 2003) are one of the fastest growing components of hospital costs. Physicians’ selection of medical devices lacks an evidence base on the comparative clinical effectiveness of these products. Comparative studies (e.g., vendor 1 versus vendor 2, technology A versus technology B) are increasingly promoted in the public sector as a means of cost containment, value-based purchasing, and quality improvement. This study illustrates how hospitals and physicians can conduct comparative technology assessments of product performance.

Methods: Surgeons evaluated comparable medical devices manufactured by eight different vendors in standardized surgical procedures. Devices included sutures and endomechanical products, which account for $2.5 billion of total device spending. Evaluations covered multiple performance dimensions, including ergonomics, functionality, clinical acceptability, and vendor preference.

Results: One vendor's products garnered consistently high ratings from surgeons, while two other vendors garnered consistently low ratings. Differences in ratings were statistically significant and persist when controlling for physician background characteristics and prior experience. Study results were used by a large hospital group purchasing organization to select which vendors to contract with for these products.

Conclusions: Comparative technology evaluations assist physicians and hospitals in making cost-effective purchases of devices. These evaluations provide robust information on the performance of products routinely used by clinicians. Such evaluations can be carefully designed to have scientific rigor and clinical credibility.

Keywords

Medical devicesComparative evaluationTechnology assessment
Type
GENERAL ESSAYS
Information
International Journal of Technology Assessment in Health Care , Volume 23 , Issue 4 , October 2007 , pp. 455 - 463
Copyright
Copyright © Cambridge University Press 2007

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References

REFERENCES

1.ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic. JAMA. 2002;288:2981–2997.CrossRefGoogle Scholar
2.Battles, JB, Smith, SR, Bosco, L. Expectations and current activities in drug safety. Presentation to AHRQ, January 6, 2005. Available at: http://www.iom.edu/Object.File/Master/24/538/Drug%20Safety%20Meeting%201%20Battles.ppt.Google Scholar
3.Black, N. Why we need observational studies to evaluate the effectiveness of health care. BMJ. 1996;312:1215–1218.CrossRefGoogle ScholarPubMed
4.Bland, JM, Altman, D. Cronbach's alpha. BMJ. 1997;314:572.CrossRefGoogle ScholarPubMed
5.Burns, LR.The health care value chain. San Francisco: Jossey-Bass; 2002.Google Scholar
6.Burns, LR.The business of healthcare innovation. New York: Cambridge University Press; 2005.CrossRefGoogle Scholar
7.Burns, LR. Growth and innovation in medical devices: A conversation with Stryker chairman John Brown. Health Aff (Millwood). 2007;26:w436-w444.CrossRefGoogle Scholar
8.Burns, LR, Lee, JA, Bradlow, ET, Antonacci, A. Surgeon evaluation of suture and endo-mechanical products. J Surg Res. In press.Google Scholar
9.Campbell, DT, Stanley, JC. Experimental and quasi-experimental designs for research. Chicago, IL: Rand McNally College Publishing Company; 1963.Google Scholar
10.Clancy, CM. Getting to ‘smart’ health care. Health Aff (Millwood). 2006;25:w589-w592.CrossRefGoogle ScholarPubMed
11.Cronbach, LJ. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16:297–333.Google Scholar
12.ECRI. Assessment of suture products, mechanical devices, and endoscopic surgical devices. ECRI Project 450201 Prepared for Novation, Inc. Herts, UK: ECRI; March 2004.Google Scholar
13.Trocars, ECRI.: Safety and selection. Health Devices. 1998;27:374–406.Google Scholar
14.Faulkner, BC, Gear, AG, Hellewell, TB, et al. Biomechanical performance of a braided absorbable suture. Surg Gynecol Obstet. 1981;153:835–841.Google Scholar
15.Faulkner, BC, Tribble, CG, Thacker, JG, Rodeheaver, GT, Edlich, RF. Knot performance of polypropylene suture. J Biomed Mater Res. 1996;33:187–192.3.0.CO;2-M>CrossRefGoogle Scholar
16.Henry, D, Hill, S. Comparing treatments. BMJ. 1995;310:1279.CrossRefGoogle ScholarPubMed
17.Kassirer, JP.On the take. New York: Oxford University Press; 2005.CrossRefGoogle ScholarPubMed
18.Lin, KY, Farinholt, H-MA, Reddy, BR, Edlich, RF, Rodeheaver, GT. The scientific basis for selecting surgical sutures. J Long Term Eff Med Implants. 2001;11:29–40.CrossRefGoogle ScholarPubMed
19.Mahar, M.Money-driven medicine. New York: Harper Collins; 2006.Google Scholar
20.McCarty, M. Baucus geared up to shape U.S. healthcare ‘season of reform’. Medical Device Daily. 2007; February 14. Available at: http://www.medicaldevicedaily.com. Accessed: February 26, 2007.Google Scholar
21.McEvoy, JP, Lieberman, JA, Stroup, TS, et al. Effectiveness of clozapine, olanzapine, quetiapine and risperidone in patients with chronic schizophrenia who failed prior atypical antipsychotic treatment. Am J Psychiatry. 2006;163:600-610.CrossRefGoogle ScholarPubMed
22.Medicare Payment Advisory Commission. Report to the Congress: Issues in a modernized medicare program. Washington, DC: MedPAC; June 2005.Google Scholar
23.Neumann, PJ, Rosen, AB, Weinstein, MC. Medicare and cost-effectiveness analysis. N Engl J Med. 2005;353:1516-1521.Google Scholar
24.The OrthoPeople. Direct-to-consumer education and marketing in orthopaedics: Perspectives from surgeon and customer. 2000. Available at: http://www.orthoworld.com/knowledge/pubs/surveydtc0005h.htm.Google Scholar
25.Pisano, GP, Bohmer, RM, Edmondson, AC. Organizational differences in rates of learning: Evidence from the adoption of minimally invasive cardiac surgery. Manage Sci. 2001;47:752–768.CrossRefGoogle Scholar
26.Rosser, JC, Lynch, PJ, Haskamp, LA, et al. Are video game players better at laparoscopic surgical tasks? Paper presented at the Medicine Meets Virtual Reality Conference, Newport Beach, CA; January 2004.Google Scholar
27.Schneller, ES, Smeltzer, LR. Strategic management of the health care supply chain. San Francisco: Jossey-Bass; 2006.Google Scholar
28.Stevens, AJ, Raftery, J, Roderick, P. Can health technologies be assessed using routine data? Int J Technol Assess Health Care. 2005;21:96–103.CrossRefGoogle ScholarPubMed
29.Szarmach, R, Livingston, J, Rodeheaver, G, Thacker, J, Edlich, R. An innovative surgical suture and needle evaluation and selection program. J Long Term Eff Med Implants. 2002;12:211–229.Google Scholar
30.Szarmach, R, Livingston, J, Edlich, R. An expanded surgical suture and needle evaluation and selection program by a healthcare resource management group purchasing organization. J Long Term Eff Med Implants. 2003;13:155–170.CrossRefGoogle ScholarPubMed
31.Szarmach, R, Livingston, J, Rodeheaver, G, Thacker, J, Edlich, R. An endomechanical product evaluation and selection program by a healthcare resource management group purchasing organization. J Long Term Eff Med Implants. 2004;14:261–284.CrossRefGoogle ScholarPubMed
32.Tunis, SR, Stryer, DB, Clancy, CM. Practice clinical trials: Increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003;290:1624–1632.CrossRefGoogle ScholarPubMed
33.Wilensky, GR. Developing a center for comparative clinical effectiveness. Health Aff (Millwood). 2006;25:w572–w585.CrossRefGoogle Scholar