By Edited by Kathryn Tomiello
Edited by Kathryn Tomiello, Staff Editor
Companies in the medical electronics industry have traditionally resisted outsourcing their products. Many insiders claim that outsourcing production is too risky if their suppliers cannot meet their level of quality control. This industry absolutely cannot afford defects. What’s more, attaining approval for a medical device for implantation in a patient’s body – a device that the patient’s life may depend upon – requires extensive certification. The FDA regularly inspects device manufacturers as well as their suppliers.
Despite this resistance, many companies are recognizing the benefits of partnering with qualified and experienced suppliers for the manufacture of their devices. Through these joint efforts, medical device manufacturers can market new devices sooner by focusing more of their resources on development and marketing.
The FasTac® Flex from Enpath Medical, Inc., gives surgeons extra mobility and range of motion in
placing and affixing pacemaker leads on the heart’s surface.
This process has worked well for Enpath Medical, that partnered with Minnesota Rubber and Plastics for the production of the FasTac@ Flex, a steerable screw-in lead implant tool for placing and affixing pacemaker leads on the heart’s surface. This device is a less invasive mini-thoracotomy and thoracoscopic method for surgeons performing remote distal deflection operations, remote lead rotation for insertion of the helix into the heart’s myocardium, and remote lead release and regrasping techniques.
Enpath looked for a reputable manufacturer that could best suit its special requirements. “Enpath has a long list of steerable catheter projects in development,” said Peter Horwich, marketing manager for Enpath Medical Systems. “The innovative, steerable design was challenging,” reported Horwich. “Working from our original design concept, Minnesota Rubber responded well to our needs and gave us production quantities in less than nine months.”
When S & W merged with Minnesota Rubber and Plastics, Enpath recognized a good opportunity. The combined organization had both plastic and rubber molding capabilities and the required medical device manufacturing certifications.
The FasTac® Flex.
Minnesota Rubber had extensive rubber and plastics molding experience, particularly with medical silicone overmolding, as well as a successful history developing innovative sealing devices. Integrating these into successful product assemblies is important in medical device manufacturing.
The FasTac Flex consists of a handle assembly, including a release lever, rotation collar, and a rotatable wheel that deflects the collet (ferrule) at the distal tip of the shaft from 0 to 75°. The rotation collar rotates the lead for fixation, and the release lever opens the collet for release or regrasping of the lead. The tool’s shaft incorporates lead management grooves that hold the lead body. The device comprises 32 components, none of the molded plastic parts include fasteners, screws, nuts, or welding. Its adjustable deflection angle, with a half turn of the articulating wheel and the rotating collar, operates in either direction. It gives surgeons extra mobility and range of motion during procedures.
“Response time was important to us on this project,” reported Horwich. “Minnesota Rubber had a good reputation in this area and put together a team including component designers, material specialists, mold designers, and process engineers.
“Using SolidWorks® 3D CAD software, we took Enpath’s concept and transformed it into a product ready-to-manufacture in less than two months,” reported Larry Klimek, Minnesota Rubber design engineer. “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 project’s engineers specified three major components into mating halves that snapped together: the handle assembly, the rotation collar, and the rotatable wheel. For example, the team used the eDrawings® design communication tool in SolidWorks. This let them share sketches and models of these components as they were developed so that functional and aesthetic aspects could be discussed between designers at Enpath and Minnesota Rubber. Recipients could zoom in, rotate, and manipulate a solid model on screen as if they were holding it in their hands.
Component molding for the FasTac Flex is done in Minnesota Rubber and Plastics’ class 100,000 molding facilities on Toyo PLCS9 presses equipped with Yushin robots.
Clean room, quality inspection, and validation technicians at Enpath Medical assemble, inspect, and package the FasTac Flex product prior to shipment.
“We reduced our design cycles,” stated Klimek, “and created an open communications pipeline between Enpath, our toolmakers, moldmakers, and design team.” This cut weeks off the development time.
Without using fasteners, screws, nuts or welding, the molded plastic parts integrate into a completed assembly, which is done manually in just minutes.
Making the FastTac Flex medical grade
Strict medical regulations limited material choices for the FastTac Flex device. Because the device fits into the chest cavity, all plastic materials in the FastTac Flex had to
withstand ETO sterilization and be part of Enpath’s biocompatibility database.
The molded components are made from a polycarbonate resin formulation. For a “touch/feel” control sensation of the rotation collar, rotatable wheel, and the release switch, a sanoprene
elastomer formulation was overmolded on those components. Custom colorization of all components completed the desired aesthetics.
Enpath Medical, Inc.
Minnesota Rubber and Plastics
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