Major advances in cardiac surgical procedures continue to make headlines as new products are developed that are less invasive, easier to use, and produce more effective patient outcomes. One such device—the FasTac Flex steerable lead implant tool—addresses the challenges of surgically placing a sutureless, screw-in lead on the heart’s epicardial surface designed by Enpath Medical Inc.
Molded by Minnesota Rubber and Plastics, the product is a good example of a growing trend in the medical device industry—the partnering of a product’s complete manufacturing with a qualified and experienced supplier. Not only has the outsourcing arrangement proved effective for Enpath Medical, it has facilitated a timely introduction of the FasTac to the medical community.
“The innovative, steerable design was very challenging,” reported Peter Horwich, marketing manager for Enpath Medical Systems. “Working from our original design concept, Minnesota Rubber and Plastics responded well to our needs and gave us production quantities in less than 9 months. With 32 components in the final assembly, that time frame was a real achievement for them.”
“Using SolidWorks® 3D CAD software, we took Enpath Medical’s concept and transformed it into a manufacturable product in less than two months,” reports Larry Klimek, Minnesota Rubber and Plastics design engineer. “We did all of the detail work to achieve functionality of the product. We designed the internal components, the snap-fit design and material formulation specification. We took their CAD designed style and shape and refined it so that all of the internal components fit and operated properly. This was challenging in keeping with a compact, ergonomic design that was comfortable to handle and easy to operate. The design had to instill confidence in the user.”