Abstract
Each year, the United States invests about $45 billion in research conducted by federal researchers within federal laboratories. These efforts generate extensive social benefits when results are transferred to the private sector. It is important that we effectively quantify the economic and societal impact of federal technology transfer activities to inform taxpayers and policymakers about the value of public investments in this form of research. The Argus II device, an artificial retina commercialized in the United States by Second Sight in 2013, provides a rich example of how private sector innovation can be enhanced by research collaborations with federal labs and academia. Over the 25-year journey from idea to product, Second Sight carried out research and development collaborations with six Department of Energy national laboratories and seven universities. The case of Argus II also offers valuable insight into (1) how private industry, academia, and government can work together to bring socially beneficial innovations to fruition and (2) the tradeoffs inherent in these public–private collaborations. In this paper, we use a Markov model to estimate the realized and potential future social benefits associated with Argus II. We provide an interactive tool that can be used to replicate our findings and modify assumptions using updated patient information as it becomes available. We also provide insight into the aspects of federal involvement surrounding the development of Argus II that contributed to its successful commercialization and discuss other spillover benefits from these public–private collaborations.
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Notes
See Scott (2009) for an example of an assessment of the benefits and costs of public–private partnerships for innovation.
See http://www.rdmag.com/award-winners/2009/07/artificial-retina-generates-sight for more detail.
The FDA designates rare diseases as those affecting fewer than 200,000 people in the United States.
These figures are not capitalized or adjusted for the rate of failures.
The predecessor first generation artificial device retina device was known as the Argus I or A-16 for the 16-electrode array. This device was developed with private funds. The third-generation device with a 256-electrode array was largely developed through the DOE artificial retina project, but it has not been commercialized.
Other innovations attributed to Mann include infusion and insulin pumps, spinal cord stimulators, inhalable insulin, and the application of battery technology developed for satellites to pacemakers (Second Sight 2016b).
NIH describes bioengineering research grants as encouraging “bioengineering applications that will accelerate the development and adoption of promising tools and technologies that can address important biomedical problems… The goal of the program is to support projects that can realize meaningful solutions within 5–10 years.” (https://grants.nih.gov/grants/guide/pa-files/PAR-16-116.html).
QALYs account for the disutility of living with an illness or other physical impairment. The QALY of a person at full physical and mental capacity is 1, while the QALY associated with death is 0. The QALY of a person who is physically, mentally, or emotionally impaired due to illness or disability will lie somewhere between 0 and 1 depending on the severity of their condition. For states of health deemed worse than death, negative QALY values are possible (Sassi 2006).
One patient in the clinical trials had choroideremia rather than RP.
Two devices in the clinical trial failed at approximately four years after implantation but were not explanted and remained safely implanted at the five-year follow-up.
This is the approach employed in the Health Quality Ontario (2016) cost-efficacy study.
For the past several decades, a single QALY has typically been valued at $50,000. However, Neumann et al. (2014) summarize the many opinions over time that this value is too low. Based on their review of the literature, they suggest treating $50,000 per QALY as a lower bound and considering the additional thresholds of $100,000 per QALY and $200,000 per QALY (Neumann et al. 2014).
The tool was developed in the R software version 3.3.3 using the Rstudio GUI and the shiny dashboard package. Other packages used in the analysis and tool design are: data.table, markovchain, and shinyBS.
The Monte Carlo simulation component of the tool is currently under construction.
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Acknowledgements
The authors would like to thank Alan C. O’Connor, Troy J. Scott, Jeffery M. Alexander, Matthew McMahon, Robert Greenberg, and James D. Weiland for their valuable input.
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This study was funded by RTI International.
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Walsh, A.C., Salem, M.E., Oliver, Z.T. et al. Social and economic impact of the commercialization of the Argus II artificial retina in the United States. J Technol Transf 43, 1607–1630 (2018). https://doi.org/10.1007/s10961-017-9610-z
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DOI: https://doi.org/10.1007/s10961-017-9610-z