Cirtec Takes Over Active Implantable Device Facility
Los Gatos, Calif.-based Cirtec Medical Systems LLC has invested in Valencia, Calif.-based Core Manufacturing LLC, taking a significant equity and controlling board position. The investment will create a new entity called Core Manufacturing—A Cirtec Company, formed in cooperation with the Alfred Mann Foundation for Scientific Research. Core was the active implantable device manufacturing facility for Alfred Mann, and will now be controlled by Cirtec.
Active implantable devices are typically high-tech devices that work constantly, such as pacemakers, and are usually designated as Class III by the U.S. Food and Drug Administration, requiring the most stringent assessment procedures.
“As Cirtec continues to expand its business supporting the active implantable market the addition of Core’s volume manufacturing will enable our customers to grow seamlessly with Cirtec from concept to market success,” said Peter Howard, CEO of Cirtec Medical Systems.
Core Manufacturing provides manufacturing capabilities for active implantable devices. Its outsourcing capabilities include rapid-turn prototyping, full turn-key assembly and test, along with sterilization, inspection and metrology for active implantable devices. Cirtec hopes to provide OEMs and start-ups with a single stop outsource solution for bringing their active implantable devices to market safely and cost effectively via Core’s assembly and test capability and Cirtec’s active implant design, development and pilot manufacturing.
“Core Manufacturing is thrilled to partner with Cirtec and the Alfred Mann Foundation,” said Joel Hirsch, president of Core Manufacturing. “Core will offer unique suite of outsourced service capabilities that currently does not exist in the marketplace. By combining Cirtec’s leading implantable device design and development capability with Core’s rapid-turn prototyping and volume assembly and test capability, we will now offer our clients and new customers a complete outsource solution for their active implantable device programs.”
“While the Alfred Mann Foundation’s investment in Core is passive, we are pleased to finally identify a reliable, consistent solution to high rate manufacturing of our implantable devices,” added Mark Chamberlain, chief operating officer of the Alfred Mann Foundation. “We believe that Core will be of great benefit to members of the medical device community that avail themselves of Core’s expertise in implantable device manufacturing.”