SynCardia, manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, has announced that Brian Brogie has joined the company as vice president of Manufacturing and Facilities. A press release reports that Brogie will oversee manufacturing of SynCardia’s product line, which includes the commercially approved 70cc SynCardia temporary Total Artificial Heart and the new, investigational 50cc Total Artificial Heart for smaller patients.
He will also be looking after the Companion 2 hospital driver for powering the Total Artificial Heart from implant until the patient stabilises and the Freedom portable driver (a wearable power supply that allows clinically stable patients to be discharged from the hospital).
Michael Garippa, president and chief executive officer of SynCardia, comments: “Brian has more than 30 years of experience, skills and knowledge in manufacturing, project management, process improvement and supplier management. His track record of success in highly regulated industries, including medical devices, pharmaceuticals and aerospace, will help ensure that we continue to provide hospitals around the world with the products they need, when they need them, to save the lives of patients with end-stage heart failure.”
Prior to joining SynCardia, Brogie served as director of Manufacturing for Gilead Sciences, where he led a team responsible for manufacturing two injectable drug products and packaging 12 solid oral dose products. Among his most critical duties were ensuring Current Good Manufacturing Practice (cGMP) compliance, executing spending within a US$24 million manufacturing budget and facilitating the introduction of new products to the company’s production line. Brogie previously held similar positions with Oso BioPharmaceuticals and BF Goodrich Aerospace.
“Working for SynCardia is an once-in-a-lifetime opportunity. No one else is doing what they do for heart failure patients, and it is an honour to join the team,” Brogie comments.