Table 3. Key selection criteria used to filter early signals data sources for innovations with high transformative potential.

Early signals data source	Key selection criteria
Trends in Online News/Announcement Activity	• Include only web surveillance on innovation from set of biomedical-focused science and technology blogs and social media accounts with track record of recognizing innovative discoveries as selected by Sanford and other medical experts
High Impact Research Publications	• Include articles from key journal set that has record of publishing research related to medical innovation, as identified by journal index measures • Identify articles in key journals over past 5 years which have within-journal, within-year forward citation levels three standard deviations or higher above-average levels
NIH Transformative Research Awards	• Only include research project awards (R01 equivalents, cooperative agreements, and other project grants) over the past 5 years • Only consider grants funded through Office of the Director/Office of Strategic Coordination, which is key source for NIH transformative research awards, NIH Common Fund research areas (cross-center collaborative research in high priority areas), and other high priority/expedited research funding sources
High Impact Patents	• Identify provisional patent applications over the past 5 years in patent classes that are focused around biomedical technologies using detailed patent class definitions related to diagnostic, therapeutic, and medical device applications • Identify patents which have within-detailed patent class, within-year forward citation levels three standard deviations or higher above-average levels
SBIR Awards	• Include only Phase 2 awards that demonstrate progress on validating concepts which received initial Phase 1 awards • Only consider awards from NIH in major disease areas to limit the scope of company applications to potentially transformative biomedical areas
Early Stage Venture Capital Investment	• Only consider companies in biomedical and biotech industry classifications • Identify companies receiving greater than $10M in funding in early rounds (seed/early stage) over the past 5 years as an indicator of high transformative potential
FDA Expedited Review Programs	• Approvals data from key fast track and innovation programs at CDRH and CDER over the past 5 years:  • CDER New Molecular Entity/New Therapeutic Biologic Designation  • CDER Breakthrough Therapy Designation  • CDER Accelerated Approval Designation  • CDRH Device Pre-Market Approval Expedited Review