Founder of Device Events
Presentation: Breast Implant Illness: The Criticality of Adverse Event Data
Ms. Tomes is the pioneer and creative force behind Device Events, an innovative medical device surveillance and metric reporting system. Since the company’s founding in 2015, Ms. Tomes has been transforming the way patterns of adverse events in medical device usage are identified and tracked - a process that significantly helps healthcare professionals mitigate risk and make safer, more informed healthcare decisions for their patients.
Ms. Tomes helped lead the charge to mine breast implant data from the FDA, and assisted the FDA in identifying 446,000 additional adverse events that had been submitted to the FDA over a 20 year period. This data had not previously been available to the public. Her expertise stems from an extensive background in public health. Prior to founding Device Events, she served as the FDA’s Adverse Events Subject Matter Expert for Devices and Unique Device Identification (UDI).
Ms. Tomes has made her mark as an industry expert and collaborates with several prominent teaching hospitals in adverse event reporting, device recall, and data quality troubleshooting. She co-authored the American Heart Journal’s UDI Demonstration Abstract on Cardiac Stents with colleagues in public health from Mercy Health, the Mayo Clinic, Boston Scientific, Duke University, Medtronic, Abbott Laboratories, and the FDA. Her latest coup for Device Events was clinching a $100,000 award for her efforts at the Rise of the Rest bus tour, a campaign by AOL founder Steve Case’s venture fund “Revolution,” which supports entrepreneurs in emerging startup ecosystems across the country.
She appeared in The Bleeding Edge, a Netflix documentary produced by Amy Ziering, Amy Herdy and Kirby Dick (director of The Hunting Ground). Over 50 award-winning journalists worldwide use Device Events to identify risky devices on which to report.
Her work has been featured on CNBC’s Power Lunch and CNN, and in the New York Times, JAMA Internal Medicine, Washington Post Magazine, the Implant Files, and the British Medical Journal. She also maintains an active speaking schedule presenting to numerous FDA public workshops and industry conferences, educating healthcare audiences nationwide about the importance of medical device surveillance.