Gynesonics, a women’s healthcare company developing and commercializting symptomatic uterine fibroid treatment technology, has named James Sparks as vice president of manufacturing, effective immediately. Sparks reports directly to Chief Operating Officer Jordan Bajor.
 
Sparks has more than 26 years of experience in the medical device industry focused on manufacturing and engineering management. Most recently, from September 2013 to March 2016, he served as vice president of manufacturing and engineering at Tridien Medical, a manufacturer of patient positioning devices and support surfaces to assist caregivers in preventing and treating pressure ulcers. Sparks’ responsibilities at Tridien included managing three domestic manufacturing facilities with more than 300 employees. Prior to that he performed senior manufacturing/operations leadership roles with Class III implantable heart valves/transcatheter delivery systems (Medtronic plc), Class II therapeutic laser systems (BIOLASE), Class II/III cardiology and electrophysiology products (J&J/Biosense Webster). He began his career with Baxter/Edwards Life Sciences as a manufacturing/packaging engineer.
 
“James’ track record in leading the growth and development of medical device manufacturing organizations includes both domestic and off shore operations,” Bajor explained. “He has demonstrated expertise in cellular manufacturing, demand flow and lean operations techniques. Most importantly, he has applied his skills and experience in successfully supporting rapid commercial growth with the most rigorously regulated medical devices.”
 
Chris Owens, Gynesonics president and CEO, added: “James has tremendous experience in scaling high growth medical devices, reducing costs, simplifying process while maintaining the highest level of quality. These skills have been developed and utilized at companies which are benchmarked for manufacturing excellence in medical technology. His expertise at ramping manufacturing organizations is an essential addition to our management team. James will continue to develop our manufacturing systems and processes while implementing our global manufacturing plan to support the global launch and rapid uptake of our Sonata System. We are pleased to have James join the team.”
 
Sparks has a bachelor of science degree in engineering technology from West Coast University and an M.B.A. in technology management from the University of Phoenix. He completed six sigma training and implementation with Johnson & Johnson and served for four years in the U.S. Air Force as a metrologist.
 
The Sonata System, the next generation of Gynesonics’ technology platform (the previous generation referred to as VizAblate), uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance. The Sonata System, including the SMART Targeting Guide, enables the operator to target fibroids and optimize ablations within them. Sonata System’s design provides a straightforward, transcervical access for a uterus, preserving incision-free fibroid treatment. This intrauterine approach is designed to avoid the peritoneal cavity. In October 2014, Gynesonics announced U.S. Food and Drug Administration approval of the SONATA IDE pivotal trial for their latest generation Sonata System.
 
Gynesonics is a women’s healthcare company focused on minimally invasive solutions for symptomatic uterine fibroids. Gynesonics has developed the Sonata System for the transcervical treatment of symptomatic uterine fibroids under intrauterine sonography guidance. The Sonata System is CE Marked and approved for sale in the European Union. Sonata System is not available for sale in the United States. Gynesonics is a privately held company with headquarters in Redwood City, Calif.