Physician-industry cooperation in the medical device industry

Health Affairs

Volumn 27, Issue 6, 2008, Pages 1532-1543

  Chatterji, Aaron K ^a   Fabrizio, Kira R ^a   Mitchell, Will ^a   Schulman, Kevin A ^a,b  

^a DUKE UNIVERSITY   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONFLICT OF INTEREST; DEVICE; INDUSTRY; PATENT; PHYSICIAN; PRODUCT DEVELOPMENT; UNITED STATES;

COOPERATIVE BEHAVIOR; EQUIPMENT AND SUPPLIES; HUMANS; INDUSTRY; ORGANIZATIONAL POLICY; PATENTS AS TOPIC; PHYSICIANS;

EID: 56649095741     PISSN: 02782715     EISSN: 02782715     Source Type: Journal    
DOI: 10.1377/hlthaff.27.6.1532     Document Type: Article

References (41)

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4. AdvaMed, The Medical Technology Industry at a Glance, 2004, http://www.advamed.org/NR/rdonlyres/0A261055-827C-4CC6-80B6-CC2D8FA04A33/0/ ChartbookSept2004.pdf (accessed 1 August 2008);
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11. Studies have long documented the role of physicians in medical product use and diffusion. See, for instance, J.S. Coleman, E. Katz, and H. Menzel, Medical Innovation: A Diffusion Study (Indianapolis: Bobbs-Merrill Co., 1966);
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17. We focus on the nineteen U.S. Patent and Trademark Office (USPTO) classes that contain medical device innovations, as determined by the USPTO.
18. For further details on the matching process, see A.K. Chatterji and K. Fabrizio, "Professional Users as a Source of Innovation: Physician Innovation in the Medical Device Industry" (Working Paper, Duke University, Durham, North Carolina, 2008).
19. Inventor status on a patent confers an individual with a legal right to exclude others from use. See B.H. Hall and R.H. Ziedonis, "The Patent Paradox Revisited: An Empirical Study of Patenting in the U.S. Semiconductor Industry, 1979-95," RAND Journal of Economics 32, no. 1 (2001): 101-128;
20. and A. Mossoff, "Rethinking the Development of Patents: An Intellectual History, 1550-1880," Hastings Law Journal 52 (2001): 1255-1322. Therefore, patent inventors are not added superfluously.
21. The number of inventors on inventions including at least one physician range from one to twelve. The number of inventors on other patents in the sample range from one to twenty. Of the physician patents, 43 percent include only the physician as a solo inventor, 27 percent include the physician and one other inventor, and 16 percent include three inventors. The greatmajority (88 percent) of inventionswith a physician-inventor include only one physician-inventor, while an additional 9 percent include two physicians, and less than 3 percent include more than two physicians. We examined the possibility that physicians' solo-invented patents might look quite different from those inventions with a physician as part of an inventing team. Controlling for the effect of having at least one physician-inventor on a patent, results suggest no additional difference in the number of citations received (importance) or number of industry citations received for patents on which the physician is a solo inventor or for patents that contain multiple inventors who are all physicians.
22. D.S. Chisum, Chisum on Patents: A Treatise on the Law of Patentability, Validity, and Infringement (New York: Bender, 2002), sec. 22.03.
23. This measure of importance has been used numerous times in the economics of innovation literature and has been shown to be positively related to market value. See B.H. Hall, A. Jaffe, and M. Trajtenberg, "Market Value and Patent Citations," RAND Journal of Economics 36, no. 1 (2005): 16-38.
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26. For further details on how the generality score is calculated, see Chatterji and Fabrizio, "Professional Users as a Source of Innovation."
27. E. von Hippel, The Sources of Innovation (Oxford: Oxford University Press, 1988). The measure of innovation differs across studies, including patents, products, and major contributions.
28. Additional analysis found that the differences between physician patents and nonphysician patents are most dramatic among the most highly cited patents. We confirmed these results using regression analysis controlling for year and other patent characteristics, which the authors can provide on request. Send email to ronnie@duke.edu. Chatterji and Fabrizio, "Professional Users as a Source of Innovation," provides further detail concerning these data.
29. In any such comparison, the noted differences might be partly driven by selection. In our context, differing costs (real or opportunity costs) may generate differing hurdles of expected value of the invention that must be overcome to pursue a patent. If, as a result, physicians have a different propensity to patent their inventions relative to corporations or other individual inventors, then the sets of patented inventions might not be truly comparable. We examined this possible bias in two ways. First, we compared inventions with physician-inventors that were assigned to corporations with other corporate-assigned patents, and similarly compared noncorporate physician and nonphysician patents. That comparison yielded results very similar to those reported here. Second, we made use of the "primary employment" data for the physician-inventors to examine whether or not physicians who we would expect to incur greater (opportunity and real) costs when pursuing a patent application demonstrate the expected bias in the outcome variables. We did not find such a pattern. These robustness tests give us confidence that the basic differences that we found between physician-generated inventions and other inventions are not driven by selection bias generated by a difference in opportunity costs.
30. It might also be useful to link medical device patents to Food and Drug Administration (FDA)-approved products to provide another view of the importance of physicians in the product development process, but there is no systemic documentation of which patents apply to which medical device products.
31. Hall et al., "Market Value and Patent Citations."
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37. J.S. Klein, "Stark Laws: Conquering Physician Conflicts of Interest?" Georgetown Law Journal 87, no. 2 (1998):499-529.
38. K.P. Weinfurt et al., "Consistency of Financial Interest Disclosures in the Biomedical Literature: The Case of Coronary Stents," PLoS ONE 3, no. 5 (2008): e2128.
39. Regarding continuing medical education, see Accreditation Council for Continuing Medical Education, "ACCME Standards for Commercial Support: Standards to Ensure the Independence of CME Activities," http://www.accme.org/dir_docs/doc_upload/68b2902a-fb73-44d1-8725- 80a1504e520c_uploaddocument.pdf (accessed 1 August 2008).
40. Regarding peer-reviewed literature, see International Committee of Medical Journal Editors, "Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication," October 2007, http://www.icmje.org (accessed 1 August 2008).
41. Regarding clinical investigation, see U.S. Food and Drug Administration, "Guidance: Financial Disclosure by Clinical Investigators," 20 March 2001, http://www.fda.gov/oc/guidance/financialdis.html (accessed 1 August 2008).