News | PMC Smart Solutions

Cincinnati, Ohio January 21, 2009

PMC Medical announces its recent registration to ISO 13485:2003, as one in the series of strategic steps to continue its growth in the Medical Device market and to support its proprietary PMC SMART SolutionsTM approach. Registration comes on the heels of over $2 million of investment in its Medical business over the past two years, including expansion with a state of the art clean room and all-electric Milacron Roboshot presses.

PMC Medical is targeted at complex medical device contract manufacturing for surgical devices, implantable biomaterials for Orthopedic, Spine, Cardiology and other applications, and PEEK and other high-temperature thermoplastic-based instrumentation.

“As a supplier into Implantable Biomaterials and Surgical Device markets, ISO 13485 certification is a requirement to meet our customers’ demanding expectations,” stated Lisa Jennings, President of PMC Medical, and the fourth generation owner. “PMC has always put our quality system at the core of our entire company. For PMC, our quality system is not a book of procedures, but how we truly run our business and essential to managing risk for our medical customers and ourselves.”

ISO 13485 certification is the fifth quality system that PMC has successfully implemented and maintained with a perfect record. “When customers visit our facility, they feel the difference in an organization where quality is truly the essence of our culture,” Jennings said.

After 80 years in business, PMC Medical enters into an elite group of ISO 13485 certified medical device contract manufacturers based in Ohio. “As a member of BioOhio and affiliated with several Indiana organizations, PMC is a part of an amazing opportunity and transition that is taking place in the Midwest. BioOhio has been essential to our growth and the state’s support of BioOhio’s programs is propelling Ohio to be one of the premier Lifesciences states in the U.S.,” said Jennings.

PMC Medical continues rapid expansion into medical device contract manufacturing, offering customers services including design for manufacturability, hyper-precision injection molding, complete in-house assembly and packaging, as well as sterilization management. PMC’s services are wrapped into a proprietary system called PMC SMART SolutionsTM.

With its headquarters in Cincinnati, Ohio and manufacturing facilities in Shelbyville, Indiana, San Jose Iturbide, Mexico and Wiesau, Germany, PMC offers a global presence to customers. In the U.S., PMC is becoming a critical part of the rise of Ohio as one of the fastest growing centers for medical devices.

For further information, please contact Ms. Lisa Jennings at 513-557-5222 / [email protected]

For more information, send email to [email protected].

Medical Design Article, December 1, 2007

Like any other medical manufacturing process, plastic injection molding must hold to rigorous standards of cleanliness and accuracy. Our company uses what we call the special “Scientific Manufacturing Assures Reliable Throughput” or Smart method. A conventional use of scientific molding rarely goes beyond cavity-pressure monitoring. Smart, on the other hand, considers this and all other aspects of injection-molding as well as secondary operations to develop a well defined, controlled manufacturing process.

Besides customer requirements, the method considers product development from design through manufacturing and from the point of view of the plastic pellet. The method includes three essential areas: environment, equipment, and employee education.

For example, Smart works to control every stage of the environment surrounding the resin. This might entail, for example, controlling flow, humidity, and temperature. And the facility has a predictive-maintenance program in place to anticipate repairs and reduce the risk of equipment failure. These safeguards reduce variation in manufacturing for maximum throughput.

The method also considers each piece of equipment the plastic pellet encounters, before, during, and after processing. It specifies comprehensive standards for handling, data input, visual management, and inspection for reliable plastic processing.

Component tooling plays an especially critical role for equipment. Each mold is carefully designed, using software for prototyping, solid modeling, and mold-flow analysis. Molds are built with collaboration among tool builders, project managers, and the production floor.

Last, and perhaps most importantly — employee education. Employees are trained and certified by internal and external verifiers on the widely recognized Global Standards of Plastics Certification program. Following the Smart method requires a complete cultural investment. But the effort is well worth results. These include 0 PPM quality levels, and consistent just-in-time delivery.

The three articles in this section provide a varied perspective on the rapidly developing landscape of injection molding. The first tells how to find a molder capable of manufacturing parts smaller than a 0.5 in3. The second discusses how monitoring more than cavity pressure improves dimensions and tolerances, and the last assists with transitioning a critical part from one mold shop to another.

For more information, send email to [email protected].

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