1. Impact of Monetary and Non-Monetary Support
Preliminary Analysis of the Impact of Funding from the National Consortium for Pediatric Device Innovation
Shelby Wailes, Emily Blum MD, Peter C.W. Kim MD, CM, PhD
Background
The pediatric medical device industry is extremely challenging due to a small market and complicated regulatory requirements. Additionally, innovation itself is challenging, and even if a device is created, most will not be a lucrative endeavor in the long run. Despite these obstacles, creating pediatric medical devices is a vital societal need and must be incentivized.
The government is taking their role to incentivize this space through the Pediatric Device Consortia Grant Program. In 2009, the FDA started the Pediatric Device Consortia Grant Program in order to support “the development of nonprofit consortia designed to stimulate projects which will promote pediatric device development” (U.S. Food and Drug Administration). In 2012, the mechanism of support shifted from direct grants for projects to regional centers of Pediatric Device Consortia (PDC) that hold competitions for funding and support.
Conclusion
The origins of the pediatric medical device projects are similar to those of the adult medical device industry where innovation largely comes from serial entrepreneurs, people with previous experience at a large medical device company, and physician-entrepreneurs (Chatterji). Since both groups of founders have similar backgrounds, we should target adult medical device developers to enter the pediatric space.
The monetary and non-monetary support did not make a statistically significant difference in the outcomes of the devices going through the consortium. This is probably due to the small survey rate of 10% used in this preliminary analysis. However, the support does seem to be correlated with higher awareness of the processes and structure of commercializing medical devices.
Preliminary Results
Origins of Innovation
Impact of Monetary and Non-Monetary Support
By the time of the contest, 50% of the devices that started off at academic institutions became part of a private company. The group that received funding was made up entirely of private companies.
The majority of devices had a group of founders exclusively from the US. The most common origin outside of the US was Asia, with 4 of the 13 projects having at least 1 founder from Asia. All of the devices that received funding had founders exclusively from the US; however, none of the devices that received only non-monetary support had founders exclusively from the US.
Founders are motivated mainly by business opportunity, profession a medical professional, and personal experience.
Many founders have a medical professional on their team as well as someone with previous experience as a medical device developer. However, a minority of founding teams contain someone with formal business training.
Purpose
This study examines the origins of pediatric medical devices and evaluates the effectiveness of PDC support for pediatric medical device innovation and development.
Next Steps
Going forward, data should be analyzed again once the survey response rate reaches 30%. Furthermore, this study should be replicated across other PDC. However, incentivizing innovation should not stop with PDC. There needs to be a consensus among all key stake holders, including policy makers, big device companies, payers, and regulators, in order to create more pediatric device innovation.
Methods
This study uses data from contests hosted by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) in Washington, DC. The consortium hosts biannual contests at which pediatric medical device projects compete for monetary and nonmonetary support such as regulatory, legal, and business advice. We compared the groups that received monetary support, only non-monetary support, and no support.
A survey was sent out to all 147 applicants that went through at least one of the 3 contests hosted by the NCC-PDI in the years 2014 and The survey consisted of an average of 45 questions that asked about the origin, current status, and financials of the projects. The study uses a strict 10-month cutoff since the contest as the minimum follow up time before analyzing the impact of the support. 10 months was chosen given the short duration of the life cycle of a medical device. Of all the devices, 10 received monetary support, 35 received non-monetary support, and 102 received no support at all. 13 founders responded to the survey. 7 of their projects were in the control group, 2 in the non-monetary support group, and 4 in the monetary support group. Data was collected and managed through Redcap electronic data capture tools. Chi square analysis and analysis of variance were performed. A p value of .05 was used to determine statistical significance.
References
"Pediatric Device Consortia Grant Program." Pediatric Device Consortia Grant Program. U.S. Food and Drug Administration, n.d. Web. 26 July 2016
Stiglitz, Joseph E., and Scott J. Wallsten. "Public-Private Technology Partnerships: Promises and Pitfalls." The American Behavioral Scientist 43.1 (1999): ProQuest. Web. 26 July 2016.
U.S. Government Accountability Office. “Pediatric Medical Devices.” GAO. Washington: Office, Dec Web. 26 July 2016.
Chatterji, Aaron K. “Spawned with a Silver Spoon? Entrepreneurial Performance and Innovation in the Medical Device Industry.” Wiley InterScience, Web. 26 July 2016.