Plastics News Article, December 15, 2009

Injection molder PMC LLC continues to expand its medical business with the addition of a new 75-ton all-electric Nissei press.

"We are fortunate that in an otherwise flat economy, our medical device business is experiencing an accelerating growth trend,” said Lisa Jennings, president of the company's medical unit, in a news release.

Cincinnati-based PMC jumped into medical molding about three years ago, and it built a Class 100,000 clean room at its plant in Shelbyville, Ind. With the new Nissei press, the company has now spent in excess of $3 million in the plant, equipment and resources.

Jennings said the company has added nine new customers in the past six months.

PMC, which was founded in 1929, molds and assembles devices for orthopedic, spine, cardiovascular, electrosurgical and other applications. The new Nissei vertical press will give the company the ability to insert mold delicate components for implantable and non-implantable medical devices, said Mike Scarpa, PMC’s vice president of operations and engineering.

PMC touts its SMART (Scientific Manufacturing Assures Reliable Throughput) method, which it says goes beyond conventional cavity-pressure monitoring to include all other aspects of injection molding and secondary operations. Jennings said the methodology helps meet growing demand for lower-cost disposable devices.

PMC also does manufacturing in San Jose Iturbide, Mexico, and Wiesau, Germany.

PMC Medical is leading the industry in process development innovation, applying unique injection mold temperature control technology using pressurized water for high-temperature medical and implantable biomaterial applications. 
 
PMC recently completed a study comparing the performance of electric heat versus the PMC OTMS for injection molding of high-temperature biomaterials, such as implantable grades of PEEK. The PMC OTMS study was conducted by PMC Medical in our medical device molding operation located in Shelbyville, IN.
PMC's scientific study confirmed expectations that the PMC OTMS provided significant benefits over typical mold temperature control techniques used by the industry.

Technology Improvements with PMC OTMS Processing:
• Reduced shot-to-shot mold temperature variation by 75%
• Maintained more uniform temperature gradient across the surface of the mold
• Simplified mold setup and debugging
• Improved mold temperature control in a clean room environment

Medical Device Benefits with PMC OTMS Processing:
• Delivered a 30% improvement in crystallinity in the molded part
• Decreased dimensional variation along the length of the part by 50%, allowing for tighter as-molded tolerances
• Reduced stress in the molded part
• Improved yields due to reduction in scrap
• Reduced tool cost
• Improved machining characteristics
• Reduced cycle times for larger parts

For more details and the complete technical report on PMC OTMS, contact Phil Cashen at 630.650.0343 or by email at pcashen@pmcsmartsolutions.com.

Source: Soapbox, 6/30/2009

PMC Smart Solutions, a family-owned fourth-generation plastics company, has taken its specialized auto parts and electronics molding and assembly process into the medical devices field.

The Price Hill-headquartered company, founded in 1929, is three years into developing its medical division.

“We made the decision to broaden our scope and get into medical devices, and we decided to do it in a very structured, proactive way. There were already people identifying this as an attractive market part in plastics manufacturing,” said PMC President Lisa Jennings.

PMC is known globally for its expertise in manufacturing highly specialized auto safety components, including parts for fuel, brake, steering, transmission and other engine systems. In an effort to diversify its product base, the company invested $2 million in a federally certified “clean room,” a sterile environment required for manufacturing medical devises. The company modified and adopted some new manufacturing processes to take on the new endeavor.

“We’re focused on really difficult safety parts, brake and fuel systems. The types of requirements are really similar to manufacturing medical devises,” Jennings said.

PMC designs and manufactures a host of implantable and non implantable parts for orthopedic, spine, cardiovascular, drug delivery and other devices.

The company has a 200-person assembly plant in Shelbyville, Ind., but could expand into the Greater Cincinnati area and is working with BIO Ohio to explore expansion, Jennings said.

Writer: Feoshia Henderson
Source: Lisa Jennings, President of PMC Smart Solutions

PMC Medical is pleased to announce the development of unique technologies and services for Orthopedic, Spine, Cardio and other implantable and high-temperature polymer-based medical devices.

PMC Optimized Thermal Management System (OTMS)
PMC Medical’s latest technology innovation is the PMC Optimized Thermal Management System. PMC OTMS offers more uniform heat control, providing shorter processing times and a more consistent processing window, while delivering better control of the crystalline structure. PMC is conducting injection molding process improvement studies with the PMC OTMS system, for implantable and technical grades of PEEK (Polyetheretherketone, Polyaryletherketone), PPSU (Polyphenylsulfone, Radel®), PSU (Polysulfone, Udel®), PEI (Polyetherimide, Ultem®), and other high temperature materials.

The objective of PMC OTMS is to optimize thermal control in the molding process, to improve the physical properties and cost drivers of the molded components. PMC OTMS is being developed with input from our customers and our material suppliers. The primary benefits for biomaterial and high-temperature polymer-based medical devices can include:

• Cost reduction – reduction in material usage and cycle time
  
• Tighter as-molded tolerances
  
• More consistent structural properties
  
• Part-to-part consistency and reliability
  
• Greater design flexibility
  
• Improved machining characteristics
  

Upcoming studies will include process optimization for bioresorbable materials, implantable elastomeric polycarbonate materials, and other new biomaterials.

PMC Biomaterial Sampling Tools
PMC Medical is offering medical device customers a sampling tool incorporating PMC OTMS technology. Sampling services offer medical device customers the opportunity for:

• Biomaterial and high-temperature material studies and testing
  
• Basic injection-molded shapes for machining into devices and trial parts
  

Sampling tool sizes available include:

• 1” x 5” x 0.100”
  
• 1” x 5” x 0.200”
  

PMC can provide additional geometries upon request, catering to unique device needs.

For more information, please contact Phil Cashen at 630-650-0343 or pcashen@pmcsmartsolutions.com.

PMC Medical is an innovator of biomaterial and high-temperature thermoplastic material processing and tooling technologies for the medical device industry. PMC’s unique offering provides customers with a trusted source for specialty materials expertise, while providing a complete range of services through packaging and sterilization management. An ISO 13485:2003 certified contract manufacturer with 80-years of experience, PMC’s services include design for manufacturability, prototyping and sampling, hyper-precision injection molding, assembly, packaging, and sterilization management. PMC Medical is based in Cincinnati, Ohio, with facilities in Indiana, Mexico and Germany.
www.pmcsmartsolutions.com

Plastics News Article, February 2, 2009

With an investment of $2 million over the past two years, PMC LLC is building its PMC Medical division to add more medical device work. “Our medical business is growing significantly. The rest of the business is holding steady with the economy,” said Lisa Jennings, president of PMC LLC, in a recent telephone interview.

PMC Medical recently gained ISO 13485:2003 certification and is targeting the surgical device and implantable biomaterial markets. Its products are used in orthopedic, spine, cardiology and other applications.

The company, which is headquartered in Cincinnati, put up a Class 100,000 clean room along white room space at its manufacturing plant in Shelbyville, Ind. It has also installed two all-electric Milacron Roboshot presses — with clamping forces of 33 and 110 tons — and the company plans to add another in 2009.

“We are in process of exploring Class 10,000 for some implantable devices,” she said.

Shelbyville has 70,000 square feet of space and includes a tool room. Overall, it has 40 presses, ranging up to 400 tons.

Lowell Green, the company’s director of manufacturing, served as the general contactor in the construction of the clean room. He designed a clean room that is modular and expandable.

The company has focused in the past on commercial electronics and automotive work. It specializes in high-temperature specialty materials, such as polyetheretherketone. It also has done many metal-to-plastic conversions.

Jennings said PMC’s work with high-temperature materials, insert molding and assembly has led to enquiries about medical work. She said the company’s systems and processes have been valuable assets in adding the new work.

PMC stresses its quality systems and has a proprietary PMC Smart Solutions system.

She said that moving into medical work meant hiring experienced staff and also adding extensive training.

“Our approach at PMC was to develop all these things and build a resume before approaching the medical community,” said Jennings, who is the fourth generation family member to lead the company.

Jennings’ great-grandfather Ed Gerdes founded the company in 1929 with Joe Merke. Her father, Thom Gerdes, is currently chairman.

PMC also does manufacturing in San Jose Iturbide, Mexico, and Wiesau, Germany.

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.