Plastics News Report
WESTLAKE, OHIO (May 19, 5:10 p.m. ET)

At the recent Plastics in Medical Devices conference in Westlake, several speakers touched on an emerging trend: implantable devices. Lisa Jennings, president of PMC LLC in Cincinnati, shares lessons learned in her 15 years' experience with injection molding such products.

In this brief video clip, Jennings describes strategies for serving the implantable sector including partnering with supplier companies, as well as information about some of the most promising markets for implantable products.

Jennings is a fourth-generation owner of PMC, an 80-year-old injection molder and contract manufacturer serving the medical, commercial electronics and transportation markets.

Under her guidance, the Cincinnati firm has become a leader in supplying implantable and non-implantable medical devices and surgical instrumentation. In addition to its Ohio headquarters, PMC also operates a production facility in Shelbyville, Ind., as well as joint venture plants in Mexico and Germany.

By Frank Esposito | PLASTICS NEWS STAFF

WESTLAKE, OHIO (April 20, 1:40 p.m. ET) -- The medical device market can be a rewarding one for plastics processors, but it’s not a market you can wander into and hope to succeed.

The volume of requests for medical projects is growing at Parker Hannifin Corp., a Cleveland-based manufacturing giant that uses engineering resins, fluoropolymers and urethanes in its seal products. But Dale Ashby — vice president of technology and innovation for the firm’s sealing and shielding group — said that those increased requests bring with them a lot of work in material selection, as well as part production.

“The main question that every customer has is : ‘How long can I expect this product to last in my application?’ “ Ashby said at the Plastics in Medical Devices conference, held April 12-14 in Westlake.

“We need well-defined expectations of performance from our customers to make predictions on seal life,” he added. “Modeling is very important. It’s step No. 1 in proving useful life. Tools and modeling continue to improve, and OEMs have more knowledge than ever before.”

Parker, a supplier to many major OEMs, rang up sales of more than $10 billion in 2009. The firm employs 62,000 at almost 300 plants worldwide.

Parker made a big move in the medical field in 2008, when it created a new medical systems division in its seals group. The new division was based on six businesses — five in California and one in Indiana — that Parker had acquired from HTR Holding Corp. Those businesses make plastic and elastomeric components for medical devices such as intravenous equipment, drug-infusion pumps, respirator hoses and catheters sold directly to OEMs. The group performs injection molding, rapid prototyping and similar services.

Ashby said that in material selection, it’s important for processors to consider physical properties such as elasticity and lubricity, and mechanical properties such as flex resistance and toughness. In thermal properties, processors need to be aware of melt flow index and thermal conductivity; while in electrical properties, surface resistivity and arc resistance can impact material choice. Chemical resistance to solvents and cleaning solutions also plays a role.

Injection molder PMC LLC of Cincinnati is among the ranks of firms that successfully have entered the medical field in recent years. But even for PMC, doing so took a pretty big leap of faith, according to President Lisa Jennings.

“We bought the equipment for medical molding, had a clean room ready and did sample molding before we even had a customer,” she said at the event. “But based on our evaluation of what PMC is capable of — making millions of parts at 0 PPM quality levels — we determined that medical was a good niche for us.

“We had best-in-practice standards that weren’t available to most of the medical device group.”

PMC also “had to develop a medical culture” that was different from automotive and other markets it had participated in over the course of its 81-year history.

“We needed to consider all areas of our business and manufacturing systems,” said Jennings, who is also a fourth-generation owner of the firm. “For clean-room classification, we had to create an environment to insure that implant molding is controlled and consistent.”

“We learned that having the right processing equipment is the foundation for repeatable processing of implantable polymers. We also learned that customer validations are custom and are up to interpretation.”

PMC — which operates plants in Indiana, Mexico and Germany — now produces medical items used in orthopedics, sports medicine, spinal care, cardiovascular care and drug delivery. PMC’s medical products are based on polyetheretherketone (PEEK), thermoplastic polyurethances and ultra-high-end bioabsorbable and bioresorbable resins, which are used in implants and other devices.

“Some of these materials can cost from $125 a pound to thousands of dollars per pound, so there can’t be any material wasted,” Jennings said. “That’s a huge consideration.”

By Frank Esposito | PLASTICS NEWS STAFF
Posted April 15, 2010

WESTLAKE, OHIO (April 15, 4:10 p.m. ET) -- U.S. health-care reform might prove popular among the uninsured, but it’s shaping up to be less popular among the medical device community.

The potential impacts of reform had been on the medical market’s radar screen well before President Barack Obama signed the Patient Protection and Affordable Care Act into law on March 23. And although the exact costs of the bill — which will be phased in over several years — are unknown, medical device executives already see some potential downsides.

“I’m not a fan of it,” industry veteran Len Czuba said of the new law. “There’s going to be added cost to device makers in the form of taxes. And if their profits are affected, who’s going to want to invest?”

Czuba was interviewed at the Plastics in Medical Devices conference, held April 12-14 in Westlake.

“There also are going to be added costs for employers to have insurance. And when that happens, the first things companies usually do are freeze hiring and cut heads,” he said.

Health-care reform “may have good intentions, but you have to realize it’s going to be expensive,” added Czuba, who is president of Czuba Enterprises Inc., a consulting firm in Lombard, Ill.

At injection molding firm PMC LLC of Cincinnati, President Lisa Jennings said she is concerned about increases in both business costs and competitive pressure that could result from the new law.

“Everybody’s concerned about risk. And, unfortunately, any cuts in spending could come straight from research and development,” added Jennings, whose firm entered the medical molding field about four years ago, and now supplies medical devices and surgical instruments.

But since the reforms don’t go into effect immediately, Jennings said there is a chance for change “before it goes into play.”

“We really don’t know all the details right now, but between the new taxes and other areas, we’re going to be impacted one way or another,” she said.

Atek Medical President Chris Oleksy, who spoke at the event, estimated the initial tax on makers of medical parts to be about $2 billion. But he added that “something had to be done” to change a system that saw the ranks of U.S. citizens without health insurance grow from 31 million in 1987 to 47 million in 2006 — an increase of 51 percent in just 20 years.

“People in Washington and others affected by this were concerned that we can’t go another 20 years and have a 50 percent increase happen again,” said Oleksy, whose firm is a unit of injection molder Atek Cos. of Minneapolis. “If the uninsured are treated in an emergency room, where do those costs go? It’s not a model that’s sustainable.”

Oleksy added that the need to take costs out of the system because of the reforms will lead many medical manufacturers to redesign their products in order to reduce material costs.

Short-term effects of the new law could be increased demand as more people enter the health system, but also downward pressure on pricing, according to Larry Johnson, healthcare marketing director for PolyOne Corp., a leading compounder and concentrate maker based in Avon Lake, Ohio.

Those lower prices — as well as increasing demand in developing parts of the world — eventually could lead some medical manufacturing to exit the U.S., Johnson said. R&D spending also could be reduced as companies’ healthcare costs increase.

“R&D is an investment, and investments have to pay off,” he said.

Cleveland-based manufacturing giant Parker Hannifin Corp. also might be affected by the new legislation. But Dale Ashby, vice president of innovation and technology for the firm’s sealing and shielding group, said he’s “more optimistic than pessimistic” about potential outcomes.

“I’m concerned about the possibility of higher costs,” Ashby explained. “But I also see opportunities for home health care and other products and technologies.”

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.

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.