Today's Medical Developments
August 2011

PMC, a fourth-generation, familyowned plastic injection molder based in Cincinnati, OH, does not shy away from the toughest jobs in medical devices.

In applications such as orthopedics, spinal, arthroscopic/sports medicine, cardiovascular, tissue biopsy, and more, the company produces components for implantables, handheld surgical instruments, and finished medical electronic devices – both sterile and non-sterile, Class 2 and Class 3. PMC also provides complex assembly and sterile packaging (thermoform and pouch) and manages sterilization for finished devices.

To meet some of these tough manufacturing requirements, PMC must continuously adapt and improve. This is why company leaders have developed a rigorous system they call SMART (Scientific Manufacturing Assures Reliable Throughput). SMART is a scientific approach that PMC applies to every aspect of product/project development and manufacturing. It focuses on following the value stream from material receipt through delivery to customers, enabling the company to deliver, with consistency, complex, hyper-precision components, and assemblies.

DESIGN, ENGINEERING

The depth of experience PMC has in its technical staff is essential to its SMART approach. The company provides frontend
design and engineering support to customers, often working with them in the early concept stage. Services include design for manufacturability to help optimize products for lean, cost-effective manufacturing. It also provides manufacturing engineering services as customers consider scalability and multiple manufacturing options.

PMC engineers use ProEngineer in house, but also work with models from all of the major software programs.

The company has a dedicated Director of Process Innovation to work on both proprietary processing technologies for new applications, and to help solve the most challenging molding applications for customers. PMC’s engineering staff also brings together product design, mechanical, manufacturing, and tooling engineering team members.

FACILITIES, MATERIALS

PMC invests extensively in state-of-the-art facilities to meet the precise demands of medical devices, including a Class 100,000 cleanroom, ISO 13485:2003 certification, and FDA Good Manufacturing Practices compliance at its plant in Shelbyville, IN.

The company also works with a variety of advanced materials, including:

• PEEK - Unfilled and filled polyetheretherketone;
  
• Bioabsorbables - Lactide, Polylactide, Polyglycolide, and Lactide/Glycolide copolymers;
  
• TPU - Thermoplastic Polycarbonate Urethane;
  
• PPSU - Polyphenylsulfone; and
  
• ABS and PC - Acrylonitrile Butadiene Styrene and Polycarbonate.
  

ADVANCED EQUIPMENT
PMC uses present processing challenges as well as high material costs, making efficient, exacting processing equipment a must.

“When materials cost thousands of dollars per pound, every fraction of material savings we can achieve is important,” says PMC President Lisa Jennings.

Working closely with the PMC team to address the unique needs of their sophisticated operation, Milacron Plastics Machinery has supplied Roboshot all-electric injection molding machines.

PMC deploys a total of six Roboshot's - two 33-ton, one 110-ton, two 165-ton, and one 380-ton. Lowell Green, director of manufacturing, PMC mentions several ways the machines from Milacron support the ultra-precise molding:

• Customizing input/output signals and controls for new applications;
  
• Quick troubleshooting with robust controls;
  
• Shot-to-shot consistency;
  
• Fast startup - for example, a new eight-cavity, hot runner stripper plate tool running consistently after just five shots; and
  
• Shot size flexibility.
  

The greater control of shot size, allows PMC to use injection rather than extrusion for very small implantable parts, and also use much less material, according to Jennings.

Perhaps mot importantly, the machines are capable of achieving tolerance levels as low as 15u to 25u - one of the many reasons Milacron has become PMC's provider of choice for new horizontal injection-molding purchases.

"We partner with Milacron because they help us optimize repeatability and precision control of all molding functions," Green says.

Today, Milacron continues to apply its all-electric expertise technology to configure the machines for PMC's challenging applications, while ensuring maximum uptime and productivity.

"We are running 24 hours a day, so when we need something serviced, it is critical that it be done immediately." Jennings says. "The reliability of both our machines and our manufacturing partners is important, and we get that with Milacron.

PMC
Cincinnati, OH

By: Bob Michaels
Published in MPMN, June/July 2011, Volume 27, No. 5

From the ligament-replacement procedure known as Tommy John surgery to reconstructive knee surgery, sports medicine is a way of life for many professional athletes. But it’s not just athletes that suffer from sports-related injuries. As a result of such everyday forms of exercise as jogging and recreational activities ranging from snowboarding to basketball, growing numbers of people are turning up at hospitals with sports-related sprains, breaks, or torn tendons.

Addressing the escalating need to repair sports-induced soft-tissue injuries and reattach soft tissue to bone, Biomet Sports Medicine (Warsaw, IN) has introduced the JuggerKnot. This anchor technology, according to the company, may eliminate many soft-tissue repair concerns associated with bone loss and hardware issues. “It’s an all-suture anchor,” comments Kevin Stone, Biomet Sports Medicine’s vice president of research and development. “It does not have the typical plastic or metal anchoring element seen in other anchors, and its small size allows for flexibility in the placement of the anchors to achieve the desired surgical repair.” Additionally, the anchors’ small size preserves more of the patient’s bone.

Made of high-strength polyethylene MaxBraid suture material with a polyester-sleeve anchoring element, the 1.4-mm anchor is placed in a prepared hole. Then, when tension is applied to the sutures, the anchor sets by bunching up to a size larger than the prepared hole. “This anchor technology is the first of its kind made entirely of suture material,” according to Stone. “And it has the added benefits of being very small while maintaining high fixation strength.”

To introduce the JuggerKnot system, special insertion tools and guides are required so that the surgeon can properly locate the insertion point for the implant. Addressing the need to manufacture these components, Biomet turned to supplier PMC Smart Solutions (Cincinnati). PMC was well positioned to collaborate with Biomet because it had prior experience with a challenging application that relied on similar techniques and production methods as those used in the JuggerKnot project. “This earlier orthopedic application was also related to sports medicine, and it provided us with the knowledge, skill, and experience to contribute to the JuggerKnot,” says Phil Cashen, PMC’s director of new business development.

Providing injection- and insert-molded components made from biocompatible materials, PMC uses special manufacturing equipment to optimize the insert molding of complex parts, such as those used in the JuggerKnot. “We manufactured the insertion tools and the guides for the system using biocompatible ABS materials,” Cashen remarks. “The insertion tools are insert molded using proprietary mold designs.”

Insert molding flexible nitinol inserts into the insertion tools proved to be a technical challenge, according to Cashen. “To do this, the mold tooling was designed in such a way as to prevent the insert from moving during the molding process.” Because the nitinol inserts are flexible, they tend to push to one side of the tool if they aren’t secured properly in the mold, Cashen adds. “Thus, we developed a mold design that would allow us to achieve the specifications for the insert-molded flexible insert.”

The scope of the project was developed with the understanding that PMC would have to transition through the prototyping phase quickly to get to the production tooling, Cashen states. “We were able to accomplish this because we designed our production tooling to be able to utilize it in the development phase of the project. Our designs used tooling configurations that allowed us to bypass the prototype tooling phase and go directly into production tooling.” And with an eye toward the future expansion of the product line, PMC also developed tooling configurations that will allow Biomet to add new sizes of the product at minimal cost.

Noting that there are a lot of molders out there, Stone states that one of the things that attracted Biomet to PMC was the supplier’s process control systems and its experience with a range of materials. “Although PMC was historically heavily involved in the automotive space, it had excellent systems in place that are absolutely necessary in the medical device arena, and it invested heavily in its medical business unit.” Those qualities, combined with Biomet’s design and development efforts, resulted in a compact, high-strength orthopedic device that represents a giant step forward in suture anchor technology, Stone concludes.

Society of Plastics Engineers
Plastics Engineering
April 2011

Strong and Flexible Implants

In the late 1990s, polyetheretherketone (PEEK) was first used for implants. PEEK-based spinal spacers were used to hold vertebrae upright after disk removal. Unlike titanium, PEEK parts didn't eventually subside into bone, and they allowed visualization of the bone surrounding the implant in X-ray or CT images.

These advantages and others have led to many more PEEK-based implants. Marcus Jarman-Smith is a technology leader at Invibio Ltd., which has been making PEEK-Optima^R polymer for over a decade. He says that in addition to spinal implants, the material holds clear benefits for knee-replacement and hip-replacement parts. PEEK parts don't produce the health concerns associated with the metal against metal wearing of traditional hip replacements. The strength of Invibio's bearing grade, Motis^R, means it can be used alone to make hip-replacement cups instead of combining a metal cup with a polymer liner. The resulting thinner cup requires the removal of less bone. In addition, polymer parts flex and pass on stress to the bone rather than focusing the stress on the implant. This transfer of stress helps bone maintain strength and means that damage is less likely to occur.

"Because of the polymer's high strength and bearing properties, it is starting to be looked at more for trauma applications," says Jarman-Smith. He says that PEEK has a high strength-to-weight ratio and allows more flexing than metal plates and nails used to repair a broken arm or leg. If the patient is a child, or if the patient develops an infection, plates or nails may have to be need removed, which is difficult with metal because it tends to bind to the bone, whereas PEEK doesn't. The Quantum^TM Humeral Composite Nailing System from N.M.B. Medical Applications Ltd. was the first PEEK intramedullary nail to gain FDA approval (March 2010). The nail is made of Invibio's Endolign^R, a composite of continuous carbon fibers in a PEEK-Optima polymer matrix.

For future developments and applications, the company is considering options such as combining PEEK with additives that help it bind better with bone or encourage bone growth. "We also want to see if we can use it to make scaffolds or porous PEEK parts that can support tissue and allow tissue to grow inside and regenerate," says Jarman-Smith.

Although PEEK has many advantages for medical implants, it can be difficult to mold in a clean-room environment because of its high melt temperature. PMC SmartSolutions^TM has been implementing new ways to handle this challenge. The company, founded in 1929, entered the medical molding market four years ago. It specifically focused on long-term surgical implants made of materials such as PEEK because of the potential growth in this market.

"Consistency is very important for implants," says Lisa G. Jennings, president of PMC SmartSolutions^TM. Using heat-transfer oils for mold-temperature control can potentially cause product contamination. Electric cartridge heaters are subject to temperature problems that can affect product consistency because they cannot control the mold's surface temperature in a tight window across a part and often have hot and cold spots along their length. Cartridge heaters are also unable to remove heat from the mold if it becomes too hot.

Thus, PMC examined using pressurized water for precise mold-temperature control. Pressurized water can be heated to temperatures as high as 400°F. The company partnered with Single Temperature Controls of Charlotte, North Carolina, USA, which sells temperature-equilibrium systems that pump water through the mold at a set temperature. Heat is transferred to the mold if the water is hotter than the mold and removed from the mold if the opposite is true.

In PMC's experiments, it found a 44.2°F variance in mold temperature with electric heating and only 5.0°F variance with the water-heated system. The effects from this variance could be seen through a 0.003-inch increase in part shrinkage and average 18.5% reduction in relative crystallinity in the same parts produced using the electric-heated molds.

The pressurized water system has allowed the company to make complex parts of PEEK and other high-melt temperature plastics. For example, it has made insert-molded porous metal parts for orthopedic implants. "We were among the first to use high-pressure water to control mold temperature for making medical-device implants in a clean room," Jennings says. Since PMC shared its data showing the benefits of using water to control mold temperatures, other companies have followed its lead in using this technology. The complete white paper is available on www.pmcsmartsolutions.com.

PlasticsTechnology - October 2010
Processor Strategies - PMC Medical
By Matthew H. Naitove, Executive Editor

Molding medical devices is a high-end business that has proven more resistant to economic swings and to foreign competition than some other plastics markets. On the other hand, there are significant barriers to entry: challenging technical and regulatory standards, highly demanding customers, and a host of well-established competitors. But that’s not enough to discourage all newcomers. Coming from a base in automotive and electronics, PMC, LLC decided to break into medical molding four years ago. It aimed straight for the most exclusive sector—long-term surgical implants. Taking a fresh look at how things are done in this field, PMC pursued innovative technology overlooked by competitors. This technology promises both cost and quality advantages, living up to PMC’s motto: “Smart Solutions.”

PMC (www.pmcsmartsolutions.com) has been family owned and operated since it was founded in 1929. The headquarters office in Cincinnati was formerly a molding plant dedicated to thermoset brake boosters. Today the company focuses on engineering thermoplastics and has around 200 employees and a 70,000-ft2 plant in Shelbyville, Ind., with 40 injection presses of up to 400 tons. It also has a joint-venture plant in Mexico.

In 2007, PMC decided to go after surgical devices and implants for orthopedic, spine, cardiology, and other uses. PMC invested over $2 million in two years to build a Class 100,000 clean room at Shelbyville and install three all-electric presses—two Fanuc Roboshot machines of 33 and 110 tons and a 75-ton Nissei with a vertical clamp. The new PMC Medical division achieved registration to the ISO 13485:2003 medical quality system in late 2008.

A BETTER WAY TO HEAT MOLDS
For making auto parts of PPS, PPA, PEI and other high-temperature resins, PMC uses hot-oil to control its mold temperature. But oil is not desirable for a clean room, so PMC, like all other U.S. medical molders, uses electric cartridge heaters in molds for its PEEK surgical implants, which require temperatures around 400 F. Zoned heating with electrical heaters requires expensive controls on each mold, says Robert Langlois, PMC’s executive director of technology. What’s more, cartridge heaters tend to burn out and thermocouples fail on a regular basis. More important, says Langlois, cartridge heaters tend to have hot and cold spots along their length. And they have no means of removing heat, so cycle times for larger PEEK medical components tend to be fairly long—up to 15 min.

Last year, Langlois contacted a Single Temperature Controls, Charlotte, N.C. (www.single-temp.com), to find out more about its high-temperature, pressurized-water mold-temperature-control units (TCUs). Langlois found Single to be the only source of hot-water TCUs capable of PEEK’s 400 F mold temperature.

Like hot oil, pressurized hot water requires no mold thermocouples and it adds or removes heat as needed. However, the idea of high-pressure hot water scares some people. But Langlois notes that steam escaping from a pinhole leak dissipates so quickly that it’s harmless just 6 in. away.

Langlois ran a head-to-head comparison of hot-water and electrical heating with a test mold for PEEK plaques. He found that hot water reduced shot-to-shot mold-temperature variation by 75%. More important, Langlois said hot-water heating reduced temperature variances along the length of the 5-in. plaque by almost 90%, from 44.2° F with electric heat to 5° F with hot water. That decreased dimensional variation along the part by 50%. Lab analysis confirmed that the larger mold-temperature differentials produced variations in crystallinity along the part, resulting in shrinkage differences and molded-in stresses.

Langlois hopes hot-water heating can cut cycle times for large PEEK parts from 15 min down to 3 min. He also expects lower tool maintenance costs and simpler setup than with electric heaters.

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.

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

January 30, 2009, Medical Design

PMC Medical’s recent registration to ISO 13485:2003 is one in a series of strategic steps to continue its growth in the medical device market, according to the Cincinnati-based company. “As a supplier into the implantable biomaterials and surgical device markets, ISO 13485 certification is a requirement to meet customer expectations,” says PMC President and fourth-generation Owner Lisa Jennings.

ISO 13485 certification is the fifth quality system that PMC (pmcsmartsolutions.com) has implemented and maintained with a perfect record. Registration comes on the heels of a $2 million-plus 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’s contract manufacturing services include design for manufacturability, injection molding, assembly and packaging, and sterilization management.

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.

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 / ljennings@pmcsmartolutions.com.

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.