The pediatric medical device development (PMDD) process is highly complex, beset by a variety of financial, technical, medical, and regulatory barriers. Startup company innovators and academic investigators often struggle with accessing specialized knowledge relating to regulatory requirements, product development, research, and marketing strategies.

The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) conducted an educational needs assessment to understand knowledge gaps and inform our educational strategy.

We surveyed a total of 49 medical device startups and 52 academic investigators. Electronic surveys were developed for each group on Qualtrics and focused on manufacturing, regulatory, research, commercialization, and funding. Descriptive statistics were used.

A larger proportion of academic investigator respondents had a clinical background compared to the startup respondents (45% vs. 22%). The biggest barriers for academic investigators were understanding regulatory and safety requirements testing (52%) and finding and obtaining non-dilutive funding was the most difficult (54%). Among startups, understanding clinical research methods and requirements was the biggest barrier (79%).

Startup companies and academic investigators have similar, but not identical, educational needs to better understand the PMD development process. Investigators need more support in identifying funding sources, while startup companies identified an increased need for education on research regulatory topics. These findings can help guide curriculum development as well as opportunities for partnerships between academia and startups.

The National Center for Advancing Translation Science (NCATS) is implementing a new strategic management plan called the results-based accountability framework. This framework is part of the common metrics initiative. For successful implementation and adoption of new management strategies, it is important to assess current stakeholders’ experiences and needs.

Interviews were conducted with principal investigators who are conducting research and supported by the Center for Clinical Translational Science at the University of Utah. Between July and August 2016, 15 interviews were completed and audio recorded. A qualitative content analysis was conducted on the transcripts.

Results indicated the need to provide education about the continuum of clinical translational research; time constraints during pre-award; barriers to IRB submissions; difficulty balancing other responsibilities in academic health centers; and the need for shared study coordinator resources.

Implementing a new management philosophy requires an understanding key stakeholders attitudes and needs. The research identified ways to help engage investigators with centralized resources supported by NCATS and implementation of common metrics at this university.