Device Events, LLC

Speaker Bio

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’ 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), where her leadership yielded two major initiatives. She spearheaded a team of architects in the development of a UDI system (the Global UDI Database), and oversaw the internal replacement of Manufacturer and User Facility Device Experience (MAUDE) (the Center for Devices and Radiological Health’s adverse event reporting system). She also expanded UDI stakeholder engagement, which attracted high-level representation from CMS, Kaiser Permanente, the National Committee of Vital Health Statistics (NCVHS), and the Joint Commission.

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. She currently heads a workgroup for the FDA’s Medical Device Epidemiology Network (MDEpiNet), which develops case studies on real-world device usage to improve the accurate identification of and communication about medical devices. Her latest coup for Device Events was clinching a $100,000 award for her efforts at the Rise of the Rest bus tour this fall, a campaign by AOL founder Steve Case’s venture fund “Revolution,” which supports entrepreneurs in emerging startup ecosystems across the country.

Her work has been featured on CNBC’s Power Lunch and CNN, and in the New York Times, Washington Post Magazine, 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 on topics ranging from UDI compliance to UDI in Meaningful Use and Claims.